12774 federal register /vol. 64, no. 49/monday, march 15 ... · 12774 federal register/vol. 64, no....

12774 Federal Register / Vol. 64, No. 49 / Monday, March 15, 1999 / Proposed Rules

send it to the Manager, International Branch,ANM–116.

Note 4: Information concerning theexistence of approved alternative methods ofcompliance with this AD, if any, may beobtained from the International Branch,ANM–116.

(e) Special flight permits may be issued inaccordance with sections 21.197 and 21.199of the Federal Aviation Regulations (14 CFR21.197 and 21.199) to operate the airplane toa location where the requirements of this ADcan be accomplished.

Note 5: The subject of this AD is addressedin Dutch airworthiness directive BLA 1998–110, dated August 31, 1998.

Issued in Renton, Washington, on March 9,1999.Darrell M. Pederson,Acting Manager, Transport AirplaneDirectorate, Aircraft Certification Service.[FR Doc. 99–6210 Filed 3–12–99; 8:45 am]BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Parts 864, 866, 868, 870, 872,874, 876, 878, 884, 886, and 888

[Docket No. 99N–0035]

Medical Devices; Reclassification of 38Preamendments Class III Devices intoClass II

AGENCY: Food and Drug Administration,HHS.ACTION: Proposed rule.

SUMMARY: The Food and DrugAdministration (FDA) is proposing toreclassify 38 preamendments class IIIdevices into class II (special controls).FDA is also identifying the proposedspecial controls that the agency believeswill reasonably ensure the safety andeffectiveness of the devices. Thisreclassification is being proposed on theagency’s own initiative based on newinformation. This action is being takenunder the Federal Food, Drug, andCosmetic Act (the act), as amended bythe Safe Medical Devices Act of 1990(the SMDA) and the FDA ModernizationAct of 1997 (FDAMA). The agency isalso proposing that the identification ofsix of the devices subject to thisproposal be modified to more accuratelyreflect the characteristics of devicesactually being marketed.DATES: Written comments by June 14,1999. See section X of this document forthe proposed effective date of a finalrule based on this document.ADDRESSES: Submit written commentsto the Documents Management Branch

(HFA–305), Food and DrugAdministration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852.FOR FURTHER INFORMATION CONTACT:Janet L. Scudiero, Center for Devicesand Radiological Health (HFZ–410),Food and Drug Administration, 9200Corporate Blvd., Rockville, MD 20850301–594–1184.SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

The act, as amended by the 1976Medical Device Amendments (theamendments) (Pub. L. 94–295), theSMDA (Pub. L. 101–629), and FDAMA(Pub. L. 105–115), establishes acomprehensive system for the regulationof medical devices intended for humanuse. Section 513 of the act (21 U.S.C.360c) establishes three categories(classes) of devices, depending on theregulatory controls needed to providereasonable assurance of their safety andeffectiveness. The three categories ofdevices are class I (general controls),class II (special controls), and class III(premarket approval).

Under section 513 of the act, devicesthat were in commercial distributionbefore May 28, 1976 (the date ofenactment of the amendments),generally referred to as preamendmentsdevices, are classified after FDA has: (1)Received a recommendation from adevice classification panel (an FDAadvisory committee); (2) published thepanel’s recommendation for comment,along with a proposed regulationclassifying the device; and (3) publisheda final regulation classifying the device.FDA has classified mostpreamendments devices under theseprocedures.

Devices that were not in commercialdistribution prior to May 28, 1976,generally referred to as postamendmentdevices, are classified automatically bystatute (section 513(f) of the act (21U.S.C. 360c(f)) into class III without anyFDA rulemaking process. Those devicesremain in class III and requirepremarket approval, unless and untilFDA issues an order finding the deviceto be substantially equivalent, undersection 513(i) of the act (21 U.S.C.360c(i)), to a predicate device that doesnot require premarket approval, orreclassifies the device under 513(f). Theagency determines whether new devicesare substantially equivalent topreviously offered devices by means ofpremarket notification procedures insection 510(k) of the act (21 U.S.C.360(k)) and part 807 of the regulations(21 CFR part 807).

A preamendments device that hasbeen classified into class III may be

marketed, by means of premarketnotification (510(k)) procedures,without submission of a premarketapproval application (PMA) until FDAissues a final regulation under section515(b) of the act (21 U.S.C. 360e(b))requiring premarket approval.

The SMDA added section 515(i) (21U.S.C. 360e(i)) to the act. This sectionrequires FDA to issue an order tomanufacturers of preamendment classIII devices and substantially equivalentpostamendments devices for which nofinal regulation requiring thesubmission of PMA’s has been issued.This order requires such manufacturersto submit to the agency a summary of,and a citation to, any informationknown or otherwise available to themrespecting such devices, includingadverse safety and effectivenessinformation that has not been submittedunder section 519 of the act (21 U.S.C.360i), which requires manufacturers,importers, distributors, and device userfacilities to submit adverse event reportsof certain device-related events andreports of certain corrective actionstaken. Section 515(i) of the act (21U.S.C. 360e) also directs FDA to eitherrevise the classification of the deviceinto class I or class II or require thedevice to remain in class III andestablish a schedule for the issuance ofa rule requiring the submission ofPMA’s for those devices remaining inclass III.

In the Federal Register of May 6, 1994(59 FR 23731), FDA announced theavailability of a document setting forthits strategy for implementing section515(i) of the act. Under this plan, theagency divided preamendment class IIIdevices into the following three groups:Group 1 devices are devices that FDAbelieves raise significant questions ofsafety and/or effectiveness, but are nolonger used or are in very limited use;Group 2 devices are devices that FDAbelieves have a high potential for beingreclassified; and Group 3 devices aredevices that FDA believes are currentlyin commercial distribution and are notlikely candidates for reclassification.FDA also announced its intention to callfor submission of PMA’s for the 15highest priority devices in Group 3, andfor all Group 1 devices. The agency alsoannounced its intention to issue anorder under section 515(i) of the act forthe remaining Group 3 devices and forall Group 2 devices.

In the Federal Register of August 14,1995 (60 FR 41984 and 41986), FDApublished two orders for certain class IIIdevices, requiring the submission ofsafety and effectiveness information inaccordance with the preamendmentsclass III strategy for implementing

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section 515(i) of the act. FDA publishedtwo updated orders in the FederalRegister of June 13, 1997 (62 FR 32352and 32355). The orders described indetail the format for submitting the typeof information required by section 515(i)of the act so that the informationsubmitted would clearly supportreclassification or indicate that a deviceshould be retained in class III. Theorders also scheduled the requiredsubmissions in groups, at 6-monthintervals, beginning on August 14, 1996.

Reclassification of classifiedpreamendments devices is governed bysection 513(e) of the act (21 U.S.C.360c(e)). This section provides that FDAmay, by rulemaking, reclassify a devicebased upon ‘‘new information.’’ Thereclassification can be initiated by FDAor by the petition of an interestedperson. The term ‘‘new information,’’ asused in section 513(e) of the act (21U.S.C. 360c(e)), includes informationdeveloped as a result of a reevaluationof the data before the agency when thedevice was originally classified, as wellas information not presented, not

available, or not developed at that time.(See, e.g., Holland Rantos v. UnitedStates Department of Health, Education,and Welfare, 587 F.2d 1173, 1174 n.1(D.C. Cir. 1978); Upjohn v. Finch, 422F.2d 944 (6th Cir. 1970); Bell v.Goddard, 366 F.2d 177 (7th Cir. 1966).)

Reevaluation of the data previouslybefore the agency is an appropriate basisfor subsequent regulatory action wherethe reevaluation is made in light ofchanges in ‘‘medical science.,’’ (seeUpjohn v. Finch, supra, 422 F.2d at951), or in light of newly availableregulatory controls (cf. Ethicon, Inc. v.FDA, 762 F. Supp. 382, 388–389 (D.D.C.1991)), such as special controls ordesign controls. However, regardless ofwhether data before the agency are pastor new data, the ‘‘new information’’ onwhich any reclassification is based isrequired to consist of ‘‘valid scientificevidence,’’ as defined in section513(a)(3) of the act (21 U.S.C. 360c(a)(3))and § 860.7(c)(2) (21 CFR 860.7(c)(2)).FDA relies upon ‘‘valid scientificevidence’’ in the classification process

to determine the level of regulation fordevices.

II. Regulatory History of the Devices

The 38 devices subject to thisproposal were classified by final rulespublished in the Federal Register inparts 864, 866, 868, 870, 872, 874, 876,878, 884, 886, and 888 (21 CFR parts864, 866, 868, 870, 872, 874, 876, 878,884, 886, and 888). In the proposedrules upon which the final rules werebased, FDA considered therecommendations of the deviceclassification advisory panels regardingthe classification of preamendmentsmedical devices. Subsequently, FDAclassified the devices subject to thisproposal into class III, because therewas insufficient information todetermine that class I or class II controlscould provide reasonable assurance ofthe safety and effectiveness of thesedevices. The Federal Register citationsand publication dates for the proposedand final rules classifying the devicessubject to this proposal are provided inTable 1. as follows:

TABLE 1.—PUBLICATION DATES FOR THE PROPOSAL AND FINAL RULES CLASSIFYING THE DEVICES SUBJECT TO THISPROPOSAL

21 CFR Part and Device Proposed Rule Final Rule

Part 864, Hematology/Pathology September 11, 1979, 44 FR 52950 September 12, 1980, 45 FR 60576Part 866, Immunology/Microbiology April 22, 1980, 45 FR 27204 November 9, 1982, 47 FR 50283Part 868, Anesthesiology November 2, 1979, 44 FR 63292 July 16, 1982, 47 FR 31130Part 870, Cardiovascular March 9, 1979, 44 FR 13284 February 5, 1980, 45 FR 7904Part 872, Dental December 30, 1980, 45 FR 85962 August 12, 1987, 52 FR 30082Part 874, Ear, Nose, and Throat January 22, 1982, 47 FR 3280 November 6, 1986, 51 FR 40389Part 876, Gastroenterology/Urology January 23, 1981, 46 FR 7562 November 23, 1983, 48 FR 53012Part 878, General and Plastic Surgery January 19, 1982, 47 FR 2810 June 24, 1988, 53 FR 23856Part 884, Obstetrical and Gynecological April 3, 1979, 44 FR 19894 February 26, 1980, 45 FR 12682Part 886, Ophthalmic January 26, 1982, 47 FR 3694 September 2, 1987, 52 FR 33346Part 888, Orthopedic July 2, 1982, 47 FR 29052 September 4, 1987, 52 FR 33686

In accordance with section 513(e) ofthe act and § 860.130 (21 CFR 860.130),based upon new information received orotherwise available to the agency withrespect to the devices subject to thisproposal, FDA, on its own initiative, isproposing to reclassify 38preamendments class III devices to classII. Consistent with the act and theregulation, FDA did not refer theproposed reclassifications to the panelsfor their recommendations on therequested change in classifications.

III. Proposed Changes to Device Namesand Identifications

Since initial classification of the 38devices subject to this proposal, therehave been many advances in themedical device industry. Theseadvances have led to many changes,including the use of alternative

materials, and/or modifications of theintended uses for some devices. Becausethe changes have been of sufficientlylow impact on safety and effectiveness,FDA determined that the modifieddevices were substantially equivalent tothe respective predicate devices. Insome cases, however, the substantiallyequivalent device differs slightly fromthe device description found in theagency’s regulations. In order to moreaccurately reflect the characteristics ofthe actual marketed devices subject tothis proposal, the agency is proposingcertain technical amendments be madeto six device identifications, as listed insection III of this document. The agencystresses that these amendments are notintended to impose any additionalrestrictions on the marketed devices;rather, they are intended to accuratelyreflect the characteristics of marketed

devices. The following changes indevice identifications are beingproposed.

A. Section 876.5860—High PermeabilityHemodialysis System

A high permeability hemodialysissystem is a device intended for use asan artificial kidney system for thetreatment of patients with renal failure,fluid overload, or toxemic conditions byperforming such therapies ashemodialysis, hemofiltration, andhemoconcentration. Using ahemodialyzer with a semipermeablemembrane that is more permeable towater than the semipermeablemembrane of the conventionalhemodialysis system described in§ 876.5820, the high permeabilityhemodialysis system removes toxins orexcess fluid from the patient’s blood



using the principles of convection (viaa high ultrafiltration rate) and/ordiffusion (via a concentration gradientin dialysate). During treatment, bloodfrom the patient is circulated throughthe hemodialyzer’s blood compartment,while the dialysate solution flowscountercurrent through the dialysatecompartment. In this process, toxinsand/or fluid are transferred across themembrane from the blood to thedialysate compartment. Thehemodialysis delivery machine controlsand monitors the parameters related tothis processing, including the rate atwhich blood and dialysate are pumpedthrough the system, and the rate atwhich fluid is removed from the patient.The high permeability hemodialysissystem consists of the following devices:

(1) The hemodialyzer consists of asemipermeable membrane with an invitro ultrafiltration coefficient (Kuf)greater than 12 milliliters per hour permillimeters of mercury (mL/h/mmHg),and is used with either an automatedultrafiltration controller or anothermethod of ultrafiltration control toprevent fluid imbalance.

(2) The hemodialysis deliverymachine is similar to the extracorporealblood system and dialysate deliverysystem of the hemodialysis system andaccessories (§ 876.5820), with theaddition of an ultrafiltration controllerand mechanisms that monitor and/orcontrol such parameters as fluidbalance, dialysate composition, andpatient treatment parameters (e.g., bloodpressure, hematocrit, urea, etc.).

(3) The high permeabilityhemodialysis system accessoriesinclude, but are not limited to, tubinglines and various treatment relatedmonitors (e.g., dialysate pH, bloodpressure, hematocrit, and bloodrecirculation monitors).

B. Section 878.3610—EsophagealProsthesis

An esophageal prosthesis is a rigid,flexible, or expandable tubular deviceconstructed of a plastic, metal, orpolymeric material that is intended tobe implanted to restore the structureand/or function of the esophagus. Themetal esophageal prosthesis may beuncovered or covered with a polymericmaterial. This device may also includea device delivery system.

C. Section 878.3720—TrachealProsthesis

A tracheal prosthesis is a rigid,flexible, or expandable tubular deviceconstructed of a silicone, metal, orpolymeric material that is intended tobe implanted to restore the structureand/or function of the trachea or

tracheal-bronchial tree. It may beunbranched or contain one or twobranches. The metal tracheal prosthesismay be uncovered or covered with apolymeric material. This device mayalso include a device delivery system.

D. Section 886.3400—KeratoprosthesisA keratoprosthesis is a device

intended to provide a transparentoptical pathway through an opacifiedcornea, either intraoperatively orpermanently, in an eye which is not areasonable candidate for a cornealtransplant.

This identification recognizes thetemporary use of the deviceintraoperatively, and removes thedescription of the device as being madeof only plastic material.

E. Section 886.3920—Aqueous Shunt(previously ‘‘Eye valve implant’’)

An aqueous shunt is a one-way,pressure sensitive device intended to beimplanted to normalize intraocularpressure. The device is intended to treatneurovascular glaucoma or glaucomaswhere medical and conventionalsurgical treatment have failed

The agency is proposing that thename of this device be ‘‘aqueous shunt’’rather than ‘‘eye valve implant,’’because certain marketed devices,which have been determined to besubstantially equivalent to the eye valveimplant, do not contain a valve or avalve-like component.

The agency is also proposing tomodify the identification of this deviceto more accurately reflect the device’sactual use. Because the identified use of‘‘treatment of glaucoma’’ isunnecessarily broad, the agencyproposes that the identification statethat the device may be used for thetreatment of neovascular glaucoma orglaucomas where medical andconventional surgical treatment havefailed.

F. Section 888.3150—Elbow Joint Metal/Polymer Constrained CementedProsthesis

An elbow joint metal/polymerconstrained cemented prosthesis is adevice intended to be implanted madeof alloys such as cobalt-chromium-molybdenum and of an ultra-highmolecular weight polyethylene bushing,and used to replace an elbow joint. Thedevice presents dislocation in more thanone anatomic plane and consists of twocomponents which are linked together.This generic type of device is limited tothose prostheses intended for use withbone cement (§ 888.3027).

The agency is proposing that thename and identification of the elbow

joint metal/metal or metal/polymerconstrained cemented prosthesis bemodified to remove reference to themetal/metal prosthesis, because nometal/metal constrained cementedelbow prosthesis has ever beenmarketed.

IV. Proposed ReclassificationFDA is proposing that the devices

subject to this proposal be reclassifiedfrom class III to class II. FDA believesthat the identified special controlswould provide reasonable assurance ofsafety and effectiveness. Therefore, inaccordance with sections 513(e) and515(i) of the act and § 860.130, based onnew information with respect to thedevices, FDA, on its own initiative, isproposing to reclassify these 38preamendments class III devices intoclass II. The agency has identifiedspecial controls that would providereasonable assurance of their safety andeffectiveness. The agency does notintend to exempt these proposed class IIdevices from premarket notification(510(k)) submissions as provided forunder section 510(m) of the act (21U.S.C. 360(m)).

V. Proposed Special Controls.Because several of the special controls

identified in this proposal apply to 2 ormore of the 38 devices addressed by thisproposal, the agency has determinedthat it would be inefficient andredundant to individually identify, foreach device, shared risks to health andcorresponding special controls toaddress the risks to health. Instead, thisdocument focuses on the specialcontrols, explains the types of risks tohealth addressed by the special controls,and identifies the devices to which thespecial controls apply. For ease ofreview, Table 1 is included in section VIof this document following thediscussion of special controls. Thesummary table identifies each device byname and Code of Federal Regulations(CFR) citation section number, thecitation for the final rule whichclassified the preamendments deviceinto Class III, and the proposed specialcontrols applicable to the device. Thespecial controls identified in thisproposal are of four general types: FDAguidance documents, consensusstandards, device specific labeling, anddesign and performance testing.

A. FDA Guidance DocumentsBased on its premarket and

postmarket experience and thepublished literature, the agency hasdeveloped the guidance documents insection V.A of this document that aredesigned to inform manufacturers of



how the agency evaluates the safety andeffectiveness of devices and reachesdeterminations of substantialequivalence. The guidance documentsare also intended for use by FDAreviewers to ensure consistency ofpremarket reviews. Some FDA guidancedocuments are generic guidancesapplicable to many different devices,while others are applicable to a fewrelated devices, or a specific device. Thegeneric guidance documents may bereferenced, and thereby incorporatedinto, other guidances.

The agency has adopted GoodGuidance Practices (GGP’s), which setforth the agency’s policies andprocedures for the development,issuance, and use of guidancedocuments (62 FR 8961, February 27,1997). When FDA issues a final rulebased on this proposal, all of theguidance documents identified asspecial controls will have been issued inaccordance with GGP’s.

Persons interested in obtaining a copyof a guidance may do so using theWorld Wide Web (WWW). The Centerfor Devices and Radiological Health(CDRH) maintains an entry on theWWW for easy access to informationincluding text, graphics, and files thatmay be downloaded to a personalcomputer with access to the WWW. TheCDRH home page may be accessed athttp://www.fda.gov/cdrh. Guidancedocuments are also available from theDivision of Small Manufacturers’Assistance (HFZ–220), Food and DrugAdministration, Center for Devices andRadiological Health, 1350 Piccard Dr.,Rockville, MD 20850.

FDA guidances are periodicallyupdated as new information becomesavailable. When an FDA guidance thathas been identified as a special controlis revised, a notice of availability of therevised guidance will be published inthe Federal Register, as well as aproposal to amend the special control(s)for the relevant device(s) to include therevised guidance. The following is a listand description of guidance documentsthat FDA proposes to use as specialcontrols:1. Use of International Standard ISO10993, ‘‘Biological Evaluation ofMedical Devices Part I: Evaluation andTesting’’ (biocompatibility guidance)

During the classification of thepreamendments devices, the deviceclassification panels (the panels)identified potential adverse tissuereactions as a risk to health common todevices that contact the body. Theseadverse tissue reactions were identifiedgenerally, or more specifically accordingto the type of tissue reaction (e.g.,sensitization, pyrogen reaction,

hemolysis, etc.). The agency believesthat the information contained in thisbiocompatibility guidance is adequate tocontrol the risks to health related toadverse tissue reaction.

Therefore, the agency is proposingthat the biocompability guidance be aspecial control applied to the following27 devices: Indwelling blood carbondioxide partial pressure (PCO2) analyzer(§ 868.1150), indwelling blood hydrogenion concentration (pH) analyzer(§ 868.1170), indwelling blood oxygenpartial pressure (PO2) analyzer(§ 868.1200), cardiovascularintravascular filter (§ 870.3375),vascular graft prosthesis of less than 6-millimeters diameter (§ 870.3450),pacemaker lead adaptor (§ 870.3620),annuloplasty ring (§ 870.3800),cardiopulmonary bypass defoamer(§ 870.4230), cardiopulmonary bypassarterial line blood filter (§ 870.4260),cardiopulmonary bypass oxygenator(§ 870.4350), OTC (over-the-counter)denture cushion or pad (§ 872.3540),OTC denture reliner (§ 872.3560), OTCdenture repair kit (§ 872.3570), partiallyfabricated denture kit (§ 872.3600), highpermeability hemodialysis system(§ 876.5860), peritoneo-venous shunt(§ 876.5955), endometrial aspirator(§ 884.1060), endometrial brush(§ 884.1100), endometrial washer(§ 884.1185), endoscopic electrocauteryand accessories (§ 884.4100), bipolarendoscopic coagulator-cutter andaccessories (§ 884.4150),keratoprosthesis (§ 886.3400), aqueousshunt (§ 886.3920), elbow joint metal/polymer constrained cementedprosthesis (§ 888.3150), knee jointpatellofemoral polymer/metal semi-constrained cemented prosthesis(§ 888.3540), shoulder joint metal/polymer nonconstrained cementedprosthesis (§ 888.3650), and shoulderjoint metal/polymer semi-constrainedcemented prosthesis (§ 888.3660).2. ‘‘510(k) Sterility Review Guidanceand Revision of 11/18/94 K90–1(Sterility Guidance)’’

During the classification of thepreamendments devices, the panelsidentified potential infection as a risk tohealth common to the use of manydevices. The potential risk of infectionwould be minimized if the device wereproperly sterilized prior to use andappropriately labeled. Sinceclassification of the devices subject tothis proposal, the agency has developedthe sterility guidance. It providesinformation about the use andapplication of national and internationalsterility consensus standards for devicesto be labeled as ‘‘sterile.’’ The agencybelieves that the information containedin this guidance document is adequate

to control for the potential risks tohealth related to infection.

Therefore, the agency is proposingthat the sterility guidance be a specialcontrol for the following 23 devices:Indwelling blood carbon dioxide partialpressure (PCO2) analyzer (§ 868.1150),indwelling blood hydrogen ionconcentration (pH) analyzer(§ 868.1170), indwelling blood oxygenpartial pressure (PO2) analyzer(§ 868.1200), cardiovascularintravascular filter (§ 870.3375),vascular graft prosthesis of less than 6-millimeters diameter (§ 870.3450),pacemaker lead adaptor (§ 870.3620),annuloplasty ring (§ 870.3800),cardiopulmonary bypass defoamer(§ 870.4230), cardiopulmonary bypassarterial line blood filter (§ 870.4260),cardiopulmonary bypass oxygenator(§ 870.4350), electrohydrauliclithotriptor (§ 876.4480), peritoneo-venous shunt (§ 876.5955), endometrialaspirator (§ 884.1060), endometrialbrush (§ 884.1100), endometrial washer(§ 884.1185), endoscopic electrocauteryand accessories (§ 884.4100), bipolarendoscopic coagulator-cutter andaccessories (§ 884.4150),keratoprosthesis (§ 886.3400), eye valveimplant (§ 886.3920), elbow joint metal/polymer constrained cementedprosthesis (§ 888.3150), knee jointpatellofemoral polymer/metal semi-constrained cemented prosthesis(§ 888.3540), shoulder joint metal/polymer nonconstrained cementedprosthesis (§ 888.3650), and shoulderjoint metal/polymer semi-constrainedcemented prosthesis (§ 888.3660).3. ‘‘Guidance Document for theSubmission of Erythropoietin AssayPremarket Notification (510(k))’’

During the classification of thepreamendments devices, theHematology and Pathology DevicesClassification Panel identified as risks tohealth, complications associated withmisdiagnosis of a disease state. Sinceclassification of this device, the agencyhas developed a guidance documentdescribing its present conclusionsregarding the materials, labeling, andtesting controls for erythropoietin assaydevices. Because the agency believesthat the information contained in thisguidance document is adequate tocontrol for the identified risks to health,the agency is proposing that the‘‘Guidance Document for theSubmission of Erythropoietin AssayPremarket Notification (510(k))’’ be aspecial control for the erythropoietinassay (§ 864.7250).4. ‘‘Guidance Document for theSubmission of Fibrin MonomerParacoagulation Test PremarketNotification (510(k))’’



During the classification of thepreamendments devices, theHematology and Pathology DevicesClassification Panel identified as risks tohealth associated with the use of thisdevice, complications associated withmisdiagnosis of a disease state. Sinceclassification of this device, the agencyhas developed a guidance documentdescribing its present conclusionsregarding the materials, labeling, andtesting controls for fibrin monomerparacoagulation test devices. Becausethe agency believes that the informationcontained in this guidance document isadequate to control for the identifiedrisks to health, the agency is proposingthat the ‘‘Guidance Document for theSubmission of Fibrin MonomerParacoagulation Test PremarketNotifications (510(k))’’ be a specialcontrol for the fibrin monomerparacoagulation test (§ 864.7300).5. ‘‘Reviewer Guidance for ClinicalStudies and Labeling for IndwellingBlood Gas Analyzers’’

During the classification of thepreamendments devices, theAnesthesiology and RespiratoryTherapy Device Classification Panelidentified as a risk to health common toindwelling blood gas analyzers, thepotential for inaccurate measurementwhich would lead to inappropriatetherapy. Since their classification, theagency has developed a guidancedocument describing its presentconclusions regarding the appropriateclinical testing to ensure that indwellingblood gas analyzers function properly,and labeling which would ensure thatthe devices would be used properly,thus minimizing the risk of inaccuratemeasurement of blood gasses. Becausethe agency believes that the informationcontained in this guidance document, incombination with the guidancesdescribed below, is adequate to addressthe risks to health, the agency isproposing that the ‘‘Reviewer Guidancefor Clinical Studies and Labeling forIndwelling Blood Gas Analyzers’’ be aspecial control for the following threedevices: Indwelling blood carbondioxide partial pressure (PCO2) analyzer(§ 868.1150), indwelling blood hydrogenion concentration (pH) analyzer(§ 868.1170), and indwelling bloodoxygen partial pressure (PO2) analyzer(§ 868.1200).

To further minimize the risk ofinaccurate measurement by indwellingblood gas analyzers, the agency isproposing that the ‘‘Reviewer Guidancefor Computer Controlled MedicalDevices Undergoing 510(k) Review andthe Reviewer Guidance for Format andContent of Premarket Notifications(510(k) Submissions), Labeling,

Performance and Environmental Testingfor Electronic Devices’’ be specialcontrols for the following three devices:Indwelling blood carbon dioxide partialpressure (PCO2) analyzer (§ 868.1150),indwelling blood hydrogen ionconcentration (pH) analyzer(§ 868.1170), and indwelling bloodoxygen partial pressure (PO2) analyzer(§ 868.1200). These guidance documentsprovide more details about the agency’spresent conclusions regarding testing,labeling, and manufacturing informationwhich would be required for premarketnotifications (510(k)) for these device.The agency believes that these guidancedocuments are adequate to address theidentified risk to health.6. ‘‘Guidance Document for theSubmission of 510(k) PremarketNotifications for CardiovascularIntravascular Filters’’

During the classification of thepreamendments devices, the CirculatorySystem Devices Classification Panelidentified as risks to health thefollowing potential complicationsassociated with the use of thecardiovascular intravascular filter:Pulmonary thromboembolism whenanticoagulants are contraindicated,failure of anticoagulant therapy inthromboembolic diseases, chronicrecurrent pulmonary embolism whereanticoagulant therapy has failed or iscontraindicated. Since classification ofthis device, the agency has developed aguidance document describing itspresent conclusions regarding thelabeling, biocompatibility testing,mechanical testing, sterilizationprocedures and labeling, and clinicaldata controls that would ensure thesafety and effectiveness ofcardiovascular intravascular filtersseeking 510(k) clearance. Because theagency believes that the informationcontained in this guidance document isadequate to control for the identifiedrisks to health, the agency is proposingthat the ‘‘Guidance Document for theSubmission of 510(k) PremarketNotifications for CardiovascularIntravascular Filters’’ be a specialcontrol for the cardiovascularintravascular filter (§ 870.3375).7. ‘‘Document for Special Controls forVascular Prostheses’’

During the classification of thepreamendments devices, the CirculatorySystem Devices Classification Panelidentified as risks to health associatedwith the use of the vascular prosthesis,the potentials for: Thrombosis,embolism, occlusion stenosis, leakage,graft disruption, seroma,pseudoaneurisms, aneurisms, dilation,infection, and device failure. Sinceclassification of this device, the agency

has established certain labeling, testing,and manufacturing controls to minimizethe potential of the identified risks tohealth. These controls are discussed inthis guidance document. Because theagency believes that the informationcontained in this guidance document isadequate to address the identified risksto health, the agency is proposing thatthe ‘‘Document for Special Controls forVascular Prostheses’’ be a specialcontrol for the vascular graft prosthesisof less than 6-millimeters diameter(§ 870.3450).8. ‘‘Document for Special Controls forAnnuloplasty Rings’’

During the classification of thepreamendments devices, the CirculatorySystem Devices Classification Panelidentified as a risk to health associatedwith the use of the annuloplasty ring,the potentials for: Stenosis, thrombosis,thromboembolism, regurgitation, ringfracture, obstruction, low cardiacoutput, ring dehiscence, endocarditis,bleeding, blockage, and suture injury.Since classification of this device, theagency has established certain labeling,testing, and manufacturing controls tominimize the potential of the identifiedrisks to health. These controls arediscussed in this guidance document.Because the agency believes that theinformation contained in this guidancedocument is adequate to address theidentified risks to health, the agency isproposing that the ‘‘Document forSpecial Controls for AnnuloplastyRings’’ be a special control for theannuloplasty ring (§ 870.3800).9. ‘‘Document for Special Controls forthe Cardiopulmonary Bypass Defoamer’’

During the classification of thepreamendments devices, the CirculatorySystem Devices Classification Panelidentified as risks to health associatedwith the use of the cardiopulmonarybypass defoamer, the potentials for:Blood damage, gaseous embolism,thromboembolism, bloodincompatibility, and inadequate bloodflow. Since classification of this device,the agency has established labeling,testing, and manufacturing controls tominimize the potential of the identifiedrisks to health. These controls arediscussed in this guidance document.Because the agency believes that theinformation contained in this guidancedocument is adequate to control for theidentified risks to health, the agency isproposing that the ‘‘Document forSpecial Controls for theCardiopulmonary Bypass Defoamer’’ bea special control for thecardiopulmonary bypass defoamer(§ 870.4230).



10. ‘‘Document for Special Controls forthe Cardiopulmonary Bypass ArterialFilter’’

During the classification of thepreamendments devices, the CirculatorySystem Devices Classification Panelidentified as risks to health associatedwith the use of the cardiopulmonarybypass arterial filter, the potentials for:Gaseous embolism, thromboembolism,blood incompatibility, and inadequateblood flow. Since classification of thisdevice, the agency has establishedcertain labeling, testing, andmanufacturing controls to minimize thepotential of the identified risks tohealth. These controls are discussed inthis guidance document. Because theagency believes that the informationcontained in this guidance document isadequate to control for the identifiedrisks to health, the agency is proposingthat the ‘‘Document for Special Controlsfor the Cardiopulmonary BypassArterial Filter’’ be a special control forthe cardiopulmonary bypass arterial lineblood filter (§ 870.4260).11. ‘‘Information for ManufacturersSeeking Marketing Clearance for Blood–Gas Exchangers (Oxygenators) Used inCardiopulmonary Bypass’’

During the classification of thepreamendments devices, the CirculatorySystem Devices Classification Panelidentified as risks to health associatedwith the use of the cardiopulmonarybypass oxygenator, the potentials for:Failure, improper gas transfer function,hemolysis, destruction of platelets andwhite blood cells, sludging, leaking, andemboli formation. Since classification ofthis device, the agency has developed aguidance document describing itspresent conclusions regarding thetesting, labeling, and manufacturingcontrols that would be necessary toensure the safety and effectiveness ofthe cardiopulmonary bypass oxygenator.The controls are discussed in thisguidance document. Because the agencybelieves that the information containedin this guidance document is adequateto control for the identified risks tohealth, the agency is proposing that the‘‘Information for Manufacturers SeekingMarketing Clearance for Blood–GasExchangers’’ be a special control for thecardiopulmonary bypass oxygenator(§ 870.4350).12. ‘‘Guidance Document for theSubmission of Research and MarketingApplications for Permanent PacemakerLeads’’

During the classification of thepreamendments devices, the CirculatorySystem Devices Classification Panelidentified as risks to health associatedwith the use of the pacemaker leadadaptor, improper pacing, failure to

pace, and tissue damage. Sinceclassification of this device, the agencyhas developed a guidance documentdescribing its present conclusionsregarding the research and marketinginformation which should be submittedto the agency to support 510(k)clearance for pacemaker lead adaptors.Because the agency believes that theinformation contained in this guidancedocument is adequate to control for theidentified risk to health, the agency isproposing that the ‘‘Guidance Documentfor the Submission of Research andMarketing Applications for PermanentPacemaker Leads’’ be a special controlfor the pacemaker lead adaptor(§ 870.3620).13. ‘‘OTC Denture Reliners, Repair Kits,and Partially Fabricated Denture Kits’’

During the classification of thepreamendments devices, the DentalProduct Classification Panel identifiedas risks to health common to the use ofcertain denture accessories,complications resulting from analteration of the vertical dimension of apatient’s jaw and irritation of oraltissues. Since classification of thesedevices, the agency has developed aguidance document describing itspresent conclusions regardingprocedures to minimize the risk of suchcomplications. Because the agencybelieves that the information containedin this guidance document is adequateto control for the identified risks tohealth, the agency is proposing that the‘‘OTC Denture Reliners, Repair Kits, andPartially Fabricated Denture Kits’’ be aspecial control for the following fourdevices: OTC denture cushion or pad(§ 872.3540), OTC denture reliner(§ 872.3560), OTC denture repair kit(§ 872.3570), and partially fabricateddenture kit (§ 872.3600).14. ‘‘Tympanostomy Tubes, SubmissionGuidance for a 510(k) PremarketNotification’’

During the classification of thepreamendments devices, the Ear, Nose,and Throat Devices Classification Panelidentified as risks to health associatedwith the use of the tympanostomy tubewith semipermeable membrane, thepotentials for hearing loss or prematureextrusion. Since classification of thisdevice, the agency has developed aguidance document describing itspresent conclusions regarding thelabeling, testing, and manufacturinginformation which should be submittedto the agency to support 510(k)clearance for tympanostomy tubes.Because the agency believes that theinformation contained in this guidancedocument is adequate to control for theidentified risks to health, the agency isproposing that the document titled

‘‘Tympanostomy Tubes, SubmissionGuidance for a 510(k) PremarketNotification’’ be a special control for thetympanostomy tube withsemipermeable membrane (§ 874.3930).15. ‘‘Guidance for the Content ofPremarket Notifications forIntracorporal Lithotripters’’

During the classification of thepreamendments devices, theGastroenterology–Urology DevicesClassification Panel identified as risks tohealth associated with the use of theelectrohydraulic lithotripter, potential:Infection, tissue damage, failure,breakage, bleeding, pain, renal damage,and the formation of new stones. Sinceclassification of this device, the agencyhas developed a guidance documentdescribing its present conclusionsregarding the labeling, testing, andmanufacturing information whichshould be submitted to the agency tosupport 510(k) clearance forlithotripters. Because the agencybelieves that the information containedin the guidance document, whencoupled with the guidance documentdescribed below, is adequate to controlfor the identified risks to health, theagency is proposing that the ‘‘Guidancefor the Content of PremarketNotifications for IntracorporealLithotripters’’ be a special control forthe electrohydraulic lithotripter(§ 876.4480).

To further minimize the potential riskof infection associated with the reuse ofelectrohydraulic lithotripters, theagency believes that certain labelingregarding the reuse of the device isappropriate. The agency has developeda guidance document describing itspresent conclusions regarding thelabeling for certain reusable devices.FDA is also proposing that the guidancedocument entitled ‘‘Labeling ReusableMedical Devices for Reprocessing inHealth Care Facilities: FDA ReviewerGuidance’’ be a special control for theelectrohydraulic lithotripter(§ 876.4480).16. ‘‘Guidance for the Content of 510(k)sfor Conventional and High PermeabilityHemodialyzers, Guidance for Industryand CDRH Reviewers on the Content ofPremarket Notifications forHemodialysis Delivery Systems,Guidance for the Content of PremarketNotifications for Water PurificationComponents and Systems forHemodialysis, and Guidance forHemodialyzer Reuse Labeling’’

During the classification of thepreamendments devices, theGastroenterology–Urology DevicesClassification Panel identified as risks tohealth associated with the use of thehigh permeability hemodialysis system,



potential infection, electrical injury,adverse tissue reaction, pyrogenreaction, hemolysis, electrolyteimbalance, hypovolemic shock, airembolisms, loss of protein, and bloodloss. Since classification of this device,the agency has developed four guidancedocuments describing its presentconclusions regarding the labeling,testing, and manufacturing informationwhich should be submitted to theagency to support 510(k) clearance forhemodialysis devices and accessories.Because the agency believes that theinformation contained in the guidancedocuments is adequate to control for theidentified risks to health, the agency isproposing that these four guidancedocuments be applied as specialcontrols for the high permeabilityhemodialysis system (§ 876.5860).17. ‘‘Guidance for the Content ofPremarket Notification Submissions forEsophageal and Tracheal Prostheses’’

During the classification of thepreamendments devices, the Generaland Plastic Surgery DevicesClassification Panel and the Ear, Nose,and Throat Devices Classification Panelidentified as potential risks to healthcommon to the use of the esophagealprosthesis and the tracheal prosthesis,certain complications resulting frommigration, obstruction, or placement ofthe devices, and potential gastric refluxassociated with the use of theesophageal prosthesis. Sinceclassification of these devices, theagency has developed a guidancedocument describing its presentconclusions regarding the labeling,biocompatibility testing, mechanicaltesting, sterilization procedures andlabeling, and clinical data controls foresophageal or tracheal prosthesesseeking 510(k) clearance. Because theagency believes that the informationcontained in this guidance document isadequate to control for the identifiedrisks to health, the agency is proposingthat the ‘‘Guidance for the Content ofPremarket Notification Submissions forEsophageal and Tracheal Prostheses’’ bea special control for the following twodevices: Esophageal prosthesis(§ 878.3610) and tracheal prosthesis(§ 878.3720).18. ‘‘Guidance for Evaluation ofLaproscopic Bipolar and ThermalCoagulators (and Accessories)’’

During the classification of thepreamendments devices, the Obstetricaland Gynecological DevicesClassification Panel identified potentialcomplications from use in pregnantwomen as a risk to health associatedwith the use of endoscopicelectrocautery. Since classification ofthese devices, the agency has developed

a document which provides informationfor the evaluation of laproscopic andbipolar thermal coagulators. Among theinformation contained in this document,is a discussion of the agency’s presentconclusions regarding the labeling,testing, and manufacturing of suchdevices. Because the agency believesthat the information contained in thedocument is adequate to control for theidentified risk to health, the agency isproposing that the ‘‘Guidance forEvaluation of Laproscopic Bipolar andThermal Coagulators (and Accessories)’’be a special control for the endoscopicelectrocautery and accessories(§ 884.4100) and the bipolar endoscopiccoagulator-cutter and accessories(§ 884.4150).19. ‘‘Keratoprosthesis GuidanceDocument’’

During the classification of thepreamendments devices, theOphthalmic Devices Classification Panelidentified as risks to health associatedwith keratoprostheses, potentials forextrusion, infection, adverse tissuereaction, glaucoma, retinal detachment,and development of a retroprostheticmembrane. Since classification of thisdevice, the agency has developed aguidance document describing itspresent conclusions regarding thelabeling, testing, and manufacturinginformation which should be submittedto the agency to support 510(k)clearance for keratoprosthesis devices.Because the agency believes that theinformation contained in the guidancedocument is adequate to control for theidentified risks to health, the agency isproposing that the ‘‘KeratoprosthesisGuidance Document’’ be a specialcontrol for the keratoprosthesis(§ 886.3400).20. ‘‘Aqueous Shunt–510(k)Submission’’

During the classification of thepreamendments devices, theOphthalmic Devices Classification Panelidentified as risks to health associatedwith aqueous shunts, the potentials forhypotony, extrusion, infection, adversetissue reaction, misplacement,migration, and failure to filter. Sinceclassification of these devices, theagency has developed a guidancedocument describing its presentconclusions regarding the labeling,testing, and manufacturing informationto be submitted to the agency to support510(k) clearance for aqueous shunts.Because the agency believes that theinformation contained in the guidancedocument is adequate to control for theidentified risks to health, the agency isproposing that the ‘‘Aqueous Shunt–510(k) Submission’’ be a special controlfor the eye valve implant (§ 886.3920).

21. ‘‘Guidance Document for TestingOrthopedic Implants with ModifiedMetallic Surfaces Apposing Bone orBone Cement, Guidance Document forTesting Non-articulating, MechanicallyLocked’ Modular Implant Componentsand Guidance Document for thePreparation of Premarket Notification(510(k) Applications for OrthopedicDevices’’

During the classification of thepreamendments devices, the Orthopedicand Rehabilitation DevicesClassification Panel identified as risks tohealth common to the use of certainorthopedic implants, the potential for:Pain, loss of joint function, adversetissue reaction, infection, and devicefailure. Since classification of thesedevices, the agency has provided moreinformation about the agency’s presentconclusions regarding the labeling,testing, and manufacturing informationrequired for 510(k) clearance oforthopedic devices, the agency has alsodeveloped the guidance document titled‘‘Guidance Document for thePreparation of Premarket Notification(510(k)) Application for OrthopedicDevices.’’ Because the informationcontained in these guidance documentswill help minimize the risks to health,the agency is proposing that theseguidances be applied as a specialcontrol for the following four devices:Elbow joint metal/polymer constrainedcemented prosthesis (§ 888.3150), kneejoint patellofemoral polymer/metalsemi-constrained cemented prosthesis(§ 888.3540), shoulder joint metal/polymer nonconstrained cementedprosthesis (§ 888.3650), and shoulderjoint metal/polymer semi-constrainedcemented prosthesis (§ 888.3660).

B. Consensus Standards

FDA has a long history ofparticipating in the development ofconsensus standards relating to thesafety and effectiveness of medicaldevices. These consensus standards aredeveloped by independent standardsorganizations based upon discussionsamong experts from industry, theagency, and other interested parties, andafter a series of ballots on draft and finaldocuments. Consensus standards defineterminology, describe test methods, andset performance limits for a givenproduct or products. The agencybelieves that conformity with aconsensus standard helps to ensureacceptable quality and performance ofthe device to which the standard isapplied. The use of standards helps toensure the safety and effectiveness ofthe devices to which the consensusstandards apply, and it helps to



minimize the potential risks to healthassociated with the use of these devices.

Section 204 of FDAMA amendedsection 514 of the act (21 U.S.C. 360d)to allow the agency to recognizeconsensus standards established byinternational and national standardsdevelopment organizations for use incertain regulatory decision makingconcerning devices. On February 25,1998 (63 FR 9561), FDA issued a noticeof availability of a guidance entitled‘‘Guidance on the Recognition and Useof Consensus Standards’’ and alsopublished in that document a list of theconsensus standards that FDA wasrecognizing for use in the premarketreview process. FDA will update thislist at least annually.

Consensus standards are periodicallyupdated as new information becomesavailable. When a consensus standardthat has been identified as a specialcontrol is revised, the agency willpublish in the Federal Register aproposal to amend the special controlsfor the relevant devices to include therevised consensus standard.

Accordingly, the agency is proposingthat the following consensus standardsbe adopted as special controls for thedevices identified:1. American Society for Testing andMaterials (ASTM) Standards

These standards may be obtainedfrom ASTM Customer Services, 100 BarrHarbor Dr., West Conshohocken, PA19428 (Telephone 610–832–9585).ASTM also maintains a site on theWWW at the address ‘‘http://www.astm.org’’.

a. The following standard is proposedas a special control for the cutaneousoxygen monitor (21 CFR 868.2500)ASTM F984–86: ‘‘Specification forCutaneous Gas Monitoring Devices forOxygen and Carbon Dioxide.’’

b. The following seven standards areproposed as special controls for theelbow joint metal/polymer constrainedcemented prosthesis (§ 888.3150), theknee joint patellofemoral polymer/metalsemi-constrained cemented prosthesis(§ 888.3540), the shoulder joint metal/polymer nonconstrained cementedprosthesis (§ 888.3650), and theshoulder joint metal/polymer semi-constrained cemented prosthesis(§ 888.3660):

(1) ASTM F75–92 ‘‘Specification forCast Cobalt–Chromium–MolybdenumAlloy for Surgical Implant Material,’’

(2) STM F799–96 ‘‘Specification forCobalt–28 Chromium–6 MolybdenumAlloy Forgings for Surgical Implants,’’

(3) ASTM F1108–97 ‘‘Specificationfor Ti6Al4V Alloy Castings for SurgicalImplants,’’

(4) ASTM F648–96 ‘‘Specification forUltra–High–Molecular–WeightPolyethylene Powder and FabricatedForm for Surgical Implants,’’

(5) ASTM F1537–94 ‘‘Specificationfor Wrought Cobalt–Chromium–Molybdenum Alloy for SurgicalImplants,’’

(6) ASTM 1044 ‘‘Test Method forShear Testing of Porous MetalCoatings,’’ and

(7) ASTM 1147 ‘‘Test Method forTension Testing of Porous MetalCoatings.’’

c. The following standards areproposed as special controls for theknee joint patellofemoral polymer/metalsemi-constrained cemented prosthesis(§ 888.3540):

(1) ASTM F370–94 ‘‘Specification forProximal Femoral Prosthesis,’’

(2) ASTM F1672–95 ‘‘Specificationfor Resurfacing Patellar Prosthesis,’’ and

(3) ASTM F1223–96 ‘‘Test Method forDetermination of Total KneeReplacement Constraint.’’

d. The following standard is proposedas a special control for the elbow jointmetal/polymer constrained cementedprosthesis (§ 888.3150) ASTM 981:‘‘Practice for Assessment ofCompatibility of Biomaterials forSurgical Implant with Respect to Effectof Material on Muscle and Bone.’’

e. The following standard is proposedas a special control for the shoulderjoint metal/polymer nonconstrainedcemented prosthesis (§ 888.3650), andthe shoulder joint metal/polymer semi-constrained cemented prosthesis(§ 888.3660) ASTM 1378: ‘‘Specificationfor Shoulder Prosthesis.’’2. American National StandardsInstitute/American Association forMedical Instrumentation (ANSI/AAMI)

These standards may be obtainedfrom ANSI/AAMI, 11 West 42d St., NewYork, NY 10036. ANSI also maintains asite on the world wide web at ‘‘http://www.ansi.org’’. FDA proposes thefollowing ANSI/AAMI standards asspecial controls for the identifieddevices:

a. ANSI/AAMI DF2 ‘‘CardiacDefibrillator Devices’’ as applied to theexternal transcutaneous cardiacpacemaker (noninvasive) (21 CFR870.5550);

b. ANSI/AAMI/ISO 11135 ‘‘MedicalDevices–Validation and Routine Controlof Ethylene Oxide Sterilization’’ asapplied to the peritoneo-venous shunt(§ 876.5955); and

c. ANSI/AAMI HF–18‘‘Electrosurgical Devices’’ as applied tothe endoscopic electrocautery andaccessories (§ 884.4100), the bipolarendoscopic coagulator-cutter andaccessories (§ 884.4150), and the

electrohydraulic lithotriptor(§ 876.4480).3. International Standards Organization(ISO).

These standards may be obtainedfrom International Organization forStandardization, Case Postale, Geneva,Switzerland, CH–1121. ISO alsomaintains a site on the world wide webat ‘‘http://www.iso.org’’.

a. FDA proposes the following ISOstandards as special controls for theelbow joint metal/polymer constrainedcemented prosthesis (§ 888.3150), theknee joint patellofemoral polymer/metalsemi-constrained cemented prosthesis(§ 888.3540), the shoulder joint metal/polymer nonconstrained cementedprosthesis (§ 888.3650), and theshoulder joint metal/polymer semi-constrained cemented prosthesis(§ 888.3660):

(1) ISO 5832 ‘‘Implants for Surgery–Metallic Materials;’’

(2) ISO 5833 ‘‘Implants for Surgery–Acrylic Resin Cements;’’ and

(3) ISO 5834 ‘‘Implants for Surgery–Ultra High Molecular WeightPolyethylene;’’

(4) ISO 9001 ‘‘Quality Systems–Modelfor Quality Assurance in Design/Development, Production, Installation,and Servicing;’’ and

(5) ISO 6018 ‘‘General Requirementsfor Marketing, Packaging, andLabeling.’’

b. The following ISO standard isproposed as a special control for theelbow joint metal/polymer constrainedcemented prosthesis (§ 888.3150): ISO14630 ‘‘Non-active Surgical Implants–General Requirements.’’

c. The following ISO standard isproposed as a special control for theknee joint patellofemoral polymer/metalsemi-constrained cemented prosthesis(§ 888.3540): ISO 7207 ‘‘Implants forSurgery–Femoral and TibialComponents for Partial and Total KneeJoint Prostheses.’’4. National Committee for ClinicalLaboratory Standards (NCCLS)

Copies of these standards may beobtained from NCCLS Executive Offices,940 West Valley Rd., suite 1400, Wayne,PA 19087 (Telephone 610–688–0100).NCCLS also maintains a site on theWWW at ‘‘http://www.nccls.org’’.

a. FDA proposes the following NCCLSstandards as special controls for therubella virus serological reagents(§ 866.3510):

(1) NCCLS I/LA6 ‘‘Evaluation andPerformance Criteria for MultipleComponent Test Products Intended forthe Detection and Quantitation ofRubella IgG Antibody,’’



(2) NCCLS D13 ‘‘AgglutinationCharacteristics, Methodology,Limitations, and Clinical Validation,’’

(3) NCCLS I/LA18 ‘‘Specifications forImmunological Testing for InfectiousDiseases,’’

(4) NCCLS EP5 ‘‘Evaluation ofPrecision Performance of ClinicalChemistry Devices,’’ and

(5) NCCLS EP10 ‘‘PreliminaryEvaluation of Quantitative ClinicalLaboratory Methods–Second edition,1993.’’

b. FDA proposes the following NCCLSstandards as special controls for theindwelling blood carbon dioxide partialpressure (PCO2) analyzer (§ 868.1150),the indwelling blood hydrogen ionconcentration (pH) analyzer(§ 868.1170), and the indwelling bloodoxygen partial pressure (PO2) analyzer(§ 868.1200):

(1) NCCLS EP5 ‘‘Evaluation ofPrecision Performance of ClinicalChemistry Devices,’’

(2) NCCLS EP6 ‘‘Evaluation of theLinearity of Quantitive AnalyticalMethods,’’

(3) NCCLS EP7 ‘‘Interference Testingin Clinical Chemistry’’(PO2) analyzer (21CFR 868.1200),

(4) NCCLS EP9 ‘‘User Comparison ofQuantitative Clinical LaboratoryMethods Using Patient Samples,’’ and

(5) NCCLS EP10 ‘‘PreliminaryEvaluation of Quantitative ClinicalLaboratory Methods–Second edition,1993.’’5. International ElectrotechnicalCommission (IEC)

Copies of these standards may beobtained from IEC, AT3, Rue deVarembe, P.O. Box 131, Geneva,Switzerland, ch–1211. IEC alsomaintains a site on the WWW at ‘‘http://www.iec.ch’’.

a. FDA proposes the following IECstandard as special controls for theindwelling blood carbon dioxide partialpressure (PCO2) analyzer (§ 868.1150),the indwelling blood hydrogen ionconcentration (pH) analyzer(§ 868.1170), the indwelling bloodoxygen partial pressure (PO2) analyzer(§ 868.1200), the electrohydrauliclithotripter (§ 876.4480), the endoscopicelectrocautery and accessories(§ 884.4100), and the bipolar endoscopiccoagulator-cutter and accessories(§ 884.4150): IEC 60601 ‘‘ElectricalSafety Standard.’’

b. FDA also proposes the followingIEC standard as a special control for thecutaneous oxygen monitor (§ 868.2500),and the airbrush (§ 872.6080): IEC 601‘‘Medical Device Electrical Standard.’’6. Underwriters Laboratory (UL)

These standards may be obtainedfrom Underwriters Laboratories, Inc.,

333 Pfingsten Rd., Northbrook, IL 60062(Telephone 847–272–8800). UL alsomaintains a site on the WWW at ‘‘http://www.ul.com’’.

FDA proposes the following standardas a special control for the cutaneousoxygen monitor (§ 868.2500): UL 2601–1 ‘‘Standard for Safety, MedicalElectrical Equipment, Part 1: GeneralRequirements for Safety.’’7. The International Federation ofClinical Chemistry (IFCC)

These standards may be obtainedfrom IFCC through their site on theWWW at ‘‘http://www.leeds.ac.uk/ifcc’’.

FDA proposes the following standardas a special control for the cutaneousoxygen monitor (§ 868.2500): ‘‘IFCCGuidelines for Transcutaneous PO2 andPCO2 Measurement.’’8. Centers for Disease Control andPrevention (CDC)

CDC has developed standardsassociated with the detection orprevention of disease. These standardsmay be obtained from the Center forDisease Control and Prevention, MailStop G18, 1600 Clifton Rd., NE.,Atlanta, GA 30333.

FDA proposes the following CDCstandards as special controls for therubella virus serological reagents(§ 866.3510):

(1) ‘‘CDC Low Titer Rubella Standard’’as applied to

(2) ‘‘CDC Reference Panel of WellCharacterized Rubella Sera.’’9. World Health OrganizationInternational (WHO)

WHO has also developed standardsassociated with the detection orprevention of disease. These standardsmay be obtained from the World HealthOrganization International, Laboratoryfor Biological Standards, StatensSeruminstitut, Center for Preventionand Control of Infectious Diseases andCongenital Disorders, 5. Artillerivej,DK–2300 Copenhagen S, Denmark. FDAproposes the following as a specialcontrol for the identified deviceproposed for reclassification: ‘‘WHORubella Standard’’ as applied to rubellavirus serological reagents (§ 866.3510).C. Device-specific Labeling

When considering thepreamendments devices, the panelsidentified certain risks to health whichwould result from the improper use ofa device, or use in impropercircumstances. The agency believes thatgeneral labeling controls such asadequate directions for use, as requiredby section 502(f) of the act (21 U.S.C.352(f)), and the labeling requirementsfor medical devices in 21 CFR part 801,and for in vitro diagnostic products at21 CFR 809.10 minimize the potentialfor most identified risks to health.

However, the agency recognizes that,for certain devices, the general labelingrequirements are not sufficientlyspecific to adequately address andminimize specifically identified risks tohealth. These risks may be addressed bya more specific labeling regulation (e.g.,21 CFR part 801, subpart H), byguidance, or by issuing specific labelingas a special control. Indeed, several ofthe FDA guidance documents, whichhave been identified in this proposal asspecial controls, contain a section ondevice labeling. For other devices, nodevice-specific labeling is addressed inregulations or FDA guidance, althoughthe agency believes that device-specificlabeling would be an appropriatespecial control. Labeling is beingproposed as a special control for thefollowing devices:

1. Tinnitus masker (§ 874.3400)The agency is proposing that the

professional labeling of this devicecontain patient information thatdescribes the risks, benefits, warningsfor safe use, and technical specificationsof the device in terminologyunderstandable to the average layman.Patient information would also includerecommending that the patient seekmedical consultation to determine thecause of tinnitus, fitting of the device,and followup care by a hearing healthcare professional.

2. Tympanostomy tube withsemipermeable membrane (§ 874.3930)

The agency is proposing that thelabeling for this device describe the riskof clogging, and state that the device isintended for use only in ears that havebeen evacuated.

3. Endometrial aspirator (§ 884.1060),endometrial brush (§ 884.1100), andendometrial washer (§ 884.1185)

The agency is proposing that thelabeling for these devices state that thedevice is only intended as an adjunctivetool to evaluate the endometrium, andthat it is contraindicated in cases ofpregnancy, history of uterineperforation, and recent cesarean section.Furthermore, the agency is proposingthat the labeling of the endometrialwasher (§ 884.1185) also contain astatement warning that the deviceshould not be attached to wall or anyexternal suction.

4. Endoscopic electrocautery andaccessories (§ 884.4100) and bipolarendoscopic coagulator-cutter andaccessories (§ 884.4150)

The agency is proposing that thelabeling of these devices: Contain anindication for use statement: ‘‘for femaletubal sterilization,’’ contain instructionsfor use that recommend destruction of atleast 2 cm of the fallopian tube, use ofa ‘‘cut’’ (or undamped sinusoidal)



waveform, and use of minimum powerof 25 watts. For devices that haveammeters, the labeling must state thatactivation of electrode is recommendedfor 4 to 5 seconds after the visualendpoint is reached or current flowceases, to achieve complete destructionof tissue.

D. Design and Performance Testing.The agency has often relied upon

consensus standards for theestablishment of design specificationsfor medical devices. For certain devicesfor which neither consensus standardsnor FDA guidances are available toaddress critical design or performancecriteria, the agency believes it isappropriate to identify designspecifications and performance testingas a special control. Accordingly, designspecifications and performance testing

are proposed as special controls for thefollowing devices:1. External transcutaneous cardiacpacemaker (noninvasive) (§ 870.5550)

The agency is proposing that thisdevice shall not have the capability ofdelivering pulses in excess of 200microamperes with a width less than orequal to 50 milliseconds.2. Tympanostomy tube withsemipermeable membrane (§ 874.3930)

The agency is proposing that themembrane material bepolytetrafluoroethylene (PTFE) sheetingwith no more than a 1-micron pore sizeand 0.003-inch thickness. Furthermore,the agency is proposing to requirefunctional testing of these devices toverify air passage.3. Peritoneo-venous shunt (§ 876.5955)

The agency is proposing that thesedevices provide a specification forbackflow that ensures against excessive

reflux of blood into the shunt.Furthermore, the agency is proposingthat these devices undergo pyrogenicitytesting using either the U.S.Pharmacopeia (USP) Rabbit PyrogenTest or USP Bacterial Endotoxins Test.4. Endometrial aspirator (§ 884.1060),endometrial brush (§ 884.1100), andendometrial washer (§ 884.1185)

The agency is proposing that thesedevices be designed such that thesampling part of the device is coveredwhile entering and leaving the vagina.Furthermore, the agency is proposingthat the endometrial brush (§ 884.1100)be tested to demonstrate adequateadherence of bristles and brush head,and the endometrial washer (§ 884.1185)undergo testing to demonstrate thatmaximum intrauterine pressure doesnot exceed 50 millimeters of mercury.

VI. Summary of Special Controls


12784 Federal Register / Vol. 64, No. 49 / Monday, March 15, 1999 / Proposed RulesT

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1150

Indw

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g bl

ood

car-

bon

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ide

part

ial

pres

sure

(P

CO

2)

anal

yzer

XX

3, 4

, 5

NC

CLS

sta

ndar

ds,

EP

5,E

P6,

EP

7,E

P9,

EP

10,

IEC

560

601

868.

1170

Indw

ellin

g bl

ood

hy-

drog

en io

n co

n-ce

ntra

tion

(pH

) an

-al

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XX

3, 4

, 5

NC

CLS

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EP

5,E

P6,

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P9,

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10,

IEC

606

0186

8.12

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dwel

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PO

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XX

3, 4

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NC

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P6,

EP

7,E

P9,

EP

10,

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606

0186

8.25

00(b

)C

utan

eous

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gen

mon

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AS

TM

6F

984–

86,

IEC

601

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L726

01–1

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CC

8G

uide

lines

for

Tra

nscu

tane

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PO

2an

d P

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2

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men

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0.33

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ardi

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cula

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filte

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870.

3450

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of

less

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7

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ulop

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12785Federal Register / Vol. 64, No. 49 / Monday, March 15, 1999 / Proposed Rules87

0.42

30C

ardi

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mon

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def

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11

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870.

5550

Ext

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Sha

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1387

2.35

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872.

3600

Par

tially

fab

ricat

edde

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e ki

tX

13

872.

6080

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rush

IEC

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874.

3400

Tin

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r sa

feus

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nd t

echn

ical

spec

ifica

tions

874.

3930

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pano

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eabl

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embr

ane

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isk

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ave

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r pa

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6.44

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lect

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606

0187

6.58

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perm

eabi

lity

hem

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lysi

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m

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, 18

, 19

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valid

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21


12786 Federal Register / Vol. 64, No. 49 / Monday, March 15, 1999 / Proposed RulesT

AB

LE2.

—S

UM

MA

RY

OF

SP

EC

IAL

CO

NT

RO

LSLI

ST

ED

BY

DE

VIC

E1—

Con

tinue

d

CF

R S

ectio

nD

evic

e N

ame

FD

A S

teril

ity R

evie

wG

uida

nce

FD

A B

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mpa

tibili

tyG

uida

nce

Oth

er F

DA

Gui

d-an

ce1

Labe

ling

Sta

ndar

dsD

esig

n C

ontr

ols,

Per

form

ance

Tes

ting

884.

1060

End

omet

rial a

spira

-to

rX

XO

nly

for

use

as a

nad

junc

tive

tool

to

eval

uate

the

end

o-m

etriu

m;

Con

trai

ndic

atio

ns:

preg

nanc

y, h

isto

ryof

ute

rine

perf

ora-

tion,

and

rec

ent

cesa

rean

sec

tion

Dev

ice

desi

gn t

o en

-su

re t

hat

the

sam

-pl

ing

part

is c

ov-

ered

whi

le e

nter

-in

g an

d le

avin

gva

gina

884.

1100

End

omet

rial b

rush

XX

Onl

y fo

r us

e as

an

adju

nctiv

e to

ol t

oev

alua

te t

he e

ndo-

met

rium

;C

ontr

aind

icat

ion:

preg

nanc

y, h

isto

ryof

ute

rine

perf

ora-

tion,

and

rec

ent

cesa

rean

sec

tion

Dev

ice

desi

gn s

oth

at t

he s

ampl

ing

part

is c

over

edw

ithin

the

vag

ina,

Tes

ting

to d

em-

onst

rate

ade

quat

ead

here

nce

of b

ris-

tles

and

brus

hhe

ad88

4.11

85E

ndom

etria

l was

her

XX

Onl

y fo

r us

e as

an

adju

nctiv

e to

ol t

oev

alua

te t

he e

ndo-

met

rium

;D

evic

e sh

ould

not

be

atta

ched

to

wal

l or

any

exte

rnal

suc

-tio

n;C

ontr

aind

icat

ions

:P

regn

ancy

, hi

stor

yof

ute

rine

perf

ora-

tion,

and

rec

ent

cesa

rean

sec

tion

Tes

ting

to d

em-

onst

rate

tha

t m

axi-

mum

intr

aute

rine

pres

sure

sho

uld

not

exce

ed 5

0 m

il-lim

eter

s of

mer

-cu

ry;

Dev

ice

desi

gn s

oth

at t

he s

ampl

ing

part

is c

over

edw

ithin

vag

ina

884.

4100

End

osco

pic

elec

troc

aute

ry a

ndac

cess

orie

s

X22

Indi

catio

n: f

emal

etu

bal s

teril

izat

ion;

Tre

atm

ent

inst

ruc-

tions

: ‘‘d

estr

uctio

nof

at

leas

t 2

cm o

ftu

be,’’

; us

e of

acu

t’ (o

r un

dam

ped

sinu

soid

al)

wav

e-fo

rm,

and

min

i-m

um p

ower

of

25w

atts

;F

or d

evic

es w

ith a

m-

met

ers:

act

ivat

ion

of e

lect

rode

for

4to

5 s

econ

ds

IEC

606

01 A

NS

I/A

AM

I H

F–1

8


12787Federal Register / Vol. 64, No. 49 / Monday, March 15, 1999 / Proposed Rules88

4.41

50B

ipol

ar e

ndos

copi

cco

agul

ator

-cut

ter

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emal

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teril

izat

ion;

Tre

atm

ent

inst

ruc-

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: ‘‘d

estr

uctio

nof

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cent

i-m

eter

s of

tub

e,’’;

use

of a

cut

’ (or

unda

mpe

d si

nuso

i-da

l) w

avef

orm

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d m

inim

umpo

wer

of

25 w

atts

;F

or d

evic

es w

ith a

m-

met

ers:

act

ivat

ion

of e

lect

rode

for

4to

5 s

econ

ds

IEC

606

01 o

r A

NS

I/A

AM

I H

F–1

8

886.

3400

Ker

atop

rost

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3920

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888.

3150

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mer

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-st

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XX

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is

XX

25,

26,

27A

ST

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75–9

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799–

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F12

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26,

27A

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M F

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XX

25,

26,

27A

ST

M F

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8–96

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F13

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ISO

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833,

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18,

9001

1T

he f

ollo

win

g is

a l

ist

of g

uida

nces

FD

A h

as d

evel

oped

to

info

rm m

anuf

actu

res

of h

ow t

he a

genc

y ev

alua

tes

the

safe

ty a

nd e

ffect

iven

ess

of d

evic

es a

nd r

each

es d

eter

min

atio

n of

sub

-st

antia

l equ

ival

ency

:(1

) ‘‘G

uida

nce

Doc

umen

t fo

r th

e S

ubm

issi

on o

f E

ryth

ropo

ietin

Ass

ay P

rem

arke

t N

otifi

catio

n (5

10(k

)),’’

(2)

‘‘Gui

danc

e D

ocum

ent

for

the

Sub

mis

sion

of

Fib

rin M

onom

er P

arac

oagu

latio

n T

est

Pre

mar

ket

Not

ifica

tion

(510

(k))

,’’(3

)‘‘R

evie

wer

Gui

danc

e fo

r C

linic

al S

tudi

es a

nd L

abel

ing

for

Indw

ellin

g B

lood

Gas

Ana

lyze

rs,’’

(4)

‘‘Rev

iew

er G

uida

nce

for

Com

pute

r C

ontr

olle

d M

edic

al D

evic

es U

nder

goin

g 51

0(k)

Rev

iew

,’’(5

) ‘‘R

evie

wer

Gui

danc

e fo

r F

orm

at a

nd C

onte

nt o

f P

rem

arke

t N

otifi

catio

ns (

510(

k) S

ubm

issi

ons)

: La

belin

g, P

erfo

rman

ce a

nd E

nviro

nmen

tal T

estin

g fo

r E

lect

roni

c D

evic

es,’’

(6)

‘‘Gui

danc

e D

ocum

ent

for

the

Sub

mis

sion

of

510(

k) P

rem

arke

t N

otifi

catio

ns f

or C

ardi

ovas

cula

r In

trav

ascu

lar

Filt

ers,

’’(7

) ‘‘D

ocum

ent

for

Spe

cial

Con

trol

s fo

r V

ascu

lar

Pro

sthe

ses,

’’


12788 Federal Register / Vol. 64, No. 49 / Monday, March 15, 1999 / Proposed Rules(8

) ‘‘G

uida

nce

Doc

umen

t fo

r th

e S

ubm

issi

on o

f R

esea

rch

and

Mar

ketin

g A

pplic

atio

ns f

or P

erm

anen

t P

acem

aker

Lea

ds,’’

(9)

‘‘Doc

umen

t fo

r S

peci

al C

ontr

ols

for

the

Car

diop

ulm

onar

y B

ypas

s D

efoa

mer

,’’(1

0) ‘‘

Doc

umen

t fo

r S

peci

al C

ontr

ols

for

the

Car

diop

ulm

onar

y B

ypas

s A

rter

ial F

ilter

,’’(1

1) ‘‘

Info

rmat

ion

for

Man

ufac

ture

rs S

eeki

ng M

arke

ting

Cle

aran

ce f

or B

lood

–Gas

Exc

hang

ers

(Oxy

gena

tors

) U

sed

in C

ardi

opul

mon

ary

Byp

ass,

’’(1

2) ‘‘

Doc

umen

t fo

r S

peci

al C

ontr

ols

for

Ann

ulop

last

y R

ings

,’’(1

3) ‘‘

OT

C D

entu

re R

elin

ers,

Rep

air

Kits

, an

d P

artia

lly F

abric

ated

Den

ture

Kits

,’’(1

4) ‘‘

Tym

pano

stom

y T

ubes

, S

ubm

issi

on G

uida

nce

for

a 51

0(k)

Pre

mar

ket

Not

ifica

tion,

’’(1

5) ‘‘

Gui

danc

e fo

r th

e C

onte

nt o

f P

rem

arke

t N

otifi

catio

ns f

or I

ntra

corp

oral

Lith

otrip

ters

,’’(1

6) ‘‘

Labe

ling

Reu

sabl

e M

edic

al D

evic

es f

or R

epro

cess

ing

in H

ealth

Car

e F

acili

ties:

FD

A R

evie

wer

Gui

danc

e,’’

(17)

‘‘G

uida

nce

for

the

Con

tent

of

510(

k)s

for

Con

vent

iona

l and

Hig

h P

erm

eabi

lity

Hem

odia

lyze

rs,’’

(18)

‘‘G

uida

nce

for

Indu

stry

and

CD

RH

Rev

iew

ers

on t

he C

onte

nt o

f P

rem

arke

t N

otifi

catio

ns f

or H

emod

ialy

sis

Del

iver

y S

yste

ms,

’’(1

9) ‘‘

Gui

danc

e fo

r th

e C

onte

nt o

f P

rem

arke

t N

otifi

catio

ns f

or W

ater

Pur

ifica

tion

Com

pone

nts

and

Sys

tem

s fo

r H

emod

ialy

sis,

’’(2

0) ‘‘

Gui

danc

e fo

r H

emod

ialy

zer

Reu

se L

abel

ing,

’’(2

1) ‘‘

Gui

danc

e fo

r th

e C

onte

nt o

f P

rem

arke

t N

otifi

catio

n S

ubm

issi

ons

for

Eso

phag

eal a

nd T

rach

eal P

rost

hese

s,’’

(22)

‘‘G

uida

nce

for

Eva

luat

ion

of L

apro

scop

ic B

ipol

ar a

nd T

herm

al C

oagu

lato

rs (

and

Acc

esso

ries)

,’’(2

3) ‘‘

Ker

atop

rost

hesi

s G

uida

nce

Doc

umen

t,’’

(24)

‘‘A

queo

us S

hunt

–510

(k)

Sub

mis

sion

,’’(2

5) ‘‘

Gui

danc

e D

ocum

ent

for

Tes

ting

Ort

hope

dic

Impl

ants

with

Mod

ified

Met

allic

Sur

face

s A

ppos

ing

Bon

e or

Bon

e C

emen

t,’’

(26)

‘‘G

uida

nce

Doc

umen

t fo

r T

estin

g N

on-a

rtic

ulat

ing,

Mec

hani

cally

Loc

ked’

Mod

ular

Im

plan

t C

ompo

nent

s,’’

and

(27)

‘‘G

uida

nce

Doc

umen

t fo

r th

e P

repa

ratio

n of

Pre

mar

ket

Not

ifica

tion

(510

(k)

App

licat

ions

for

Ort

hope

dic

Dev

ices

.’’2

Nat

iona

l Com

mitt

ee f

or C

linic

al L

abor

ator

y S

tand

ards

.3

Cen

ters

for

Dis

ease

Con

trol

and

Pre

vent

ion.

4W

orld

Hea

lth O

rgan

izat

ion.

5In

tern

atio

nal E

lect

rote

chni

cal C

omm

issi

on.

6A

mer

ican

Nat

iona

l Sta

ndar

ds I

nstit

ute.

7U

nder

writ

ers

Labo

rato

ries.

8In

tern

atio

nal F

eder

atio

n of

Clin

ical

Che

mis

try.

9A

ssoc

iatio

n fo

r th

e A

dvan

cem

ent

of M

edic

al I

nstr

umen

tatio

n.10

Pol

ytet

raflu

oroe

thyl

ene.

11

Inte

rnat

iona

l Sta

ndar

ds O

rgan

izat

ion.



VII. Environmental Impact

The agency has determined under 21CFR 25.34(b) that this proposedclassification action is of a type thatdoes not individually or cumulativelyhave a significant effect on the humanenvironment. Therefore, neither anenvironmental assessment nor anenvironmental impact statement isrequired.

VIII. Analysis of Impacts

FDA has examined the impacts of theproposed rule under Executive Order12866, and the Regulatory FlexibilityAct (5 U.S.C 601–612) (as amended bysubtitle D of the Small BusinessRegulatory Fairness Act of 1996 (Pub. L104–121), and the Unfunded MandatesReform Act of 1995 (Pub. L. 104–4)).Executive Order 12866 directs agenciesto assess all costs and benefits ofavailable regulatory alternatives and,when regulation is necessary, to selectregulatory approaches that maximizenet benefits (including potentialeconomic, environmental, public healthand safety and other advantagesdistributive impacts and equity). Theagency believes that this proposed ruleis consistent with the regulatoryphilosophy and principles identified inthe Executive Order. In addition, theproposed rule is not a significantregulatory action as defined by theExecutive Order and so is not subject toreview under the Executive Order.

The Regulatory Flexibility Actrequires agencies to analyze regulatoryoptions that would minimize anysignificant impact of a rule on smallentities. Reclassification of thesedevices from class III will relieve allmanufacturers of these devices of thecost of complying with the premarketapproval requirements in section 515 ofthe act. Moreover, compliance withspecial controls proposed for thesedevices will not impose significant newcosts on affected manufacturers as mostof these devices already comply withthe proposed special controls. Becausereclassification will reduce regulatorycosts with respect to these devices, itwill impose no significant economicimpact on any small entities, and it maypermit small potential competitors toenter the marketplace by lowering theircosts. The agency therefore certifies thatthis proposed rule, if issued, will nothave a significant economic impact ona substantial number of small entities.In addition, this proposed rule will notimpose costs of $100 million or more oneither the private sector or state, local,and tribal governments in the aggregate,and therefore a summary statement ofanalysis under section 202(a) of the

Unfunded Mandates Reform Act of 1995is not required.

IX. Paperwork Reduction Act of 1995FDA tentatively concludes that this

proposed rule contains no collections ofinformation. Therefore, clearance by theOffice of Management and Budget underthe Paperwork Reduction Act of 1995 isnot required.

X. Submission of Comments andProposed Effective Dates

Interested persons may, on or beforeJune 14, 1999 submit to the DocketsManagement Branch (address above)written comments regarding thisproposal. Two copies of any commentsare to be submitted except thatindividuals may submit one copy.Comments are to be identified with thedocket number found in brackets in theheading of this document. Receivedcomments may be seen in the officeabove between 9 a.m. and 4 p.m.,Monday through Friday.

FDA proposes that any finalregulation that may issue based on thisproposal becomes effective 30 days afterits date of publication in the FederalRegister.

List of Subjects

21 CFR Part 864Blood, Medical devices, Packaging

and containers.

21 CFR Part 866Biologics, Laboratories, Medical

devices.

21 CFR Parts 868, 870, 872, 874, 876,878, 884, and 888

Medical devices.

21 CFR Part 886Medical devices, Ophthalmic goods

and services.Therefore, under the Federal Food,

Drug, and Cosmetic Act and underauthority delegated to the Commissionerof Food and Drugs, it is proposed that21 CFR parts 864, 866, 868, 870, 872,874, 876, 878, 884, 886, and 888 beamended as follows:

PART 864—HEMATOLOGY ANDPATHOLOGY DEVICES

1. The authority citation for 21 CFRpart 864 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,360j, 371.

2. Section 864.7250 is amended byrevising paragraph (b) and by removingparagraph (c) to read as follows:

§ 864.7250 Erythropoietin assay.

* * * * *

(b) Classification. Class II. The specialcontrol for this device is FDA’s‘‘Guidance Document for Submission ofErythropoietin Assay PremarketNotification (510(k)).’’


§ 864.7300 Fibrin monomerparacoagulation test.

* * * * *(b) Classification. Class II. The special

control for this device is FDA’s‘‘Guidance Document for Submission ofFibrin Monomer Paracoagulation TestPremarket Notification (510(k)).’’

PART 866—IMMUNOLOGY ANDMICROBIOLOGY DEVICES




§ 866.3510 Rubella virus serologicalreagents.


controls for this device are:(1) National Committee for Clinical

Laboratory Standards’:(i) I/LA6 ‘‘Evaluation and

Performance Criteria for MultipleComponent Test Products Intended forthe Detection and Quantitation ofRubella IgG Antibody,’’

(ii) 1/LA18 ‘‘Specifications forImmunological Testing for InfectiousDiseases,’’

(iii) D13 ‘‘AgglutinationCharacteristics, Methodology,Limitations, and Clinical Validation,’’

(iv) EP5 ‘‘Evaluation of PrecisionPerformance of Clinical ChemistryDevices,’’ and

(v) EP10 ‘‘Evaluation of the Linearityof Quantitive Analytical Methods,’’

(2) Centers for Disease Control’s:(i) Low Titer Rubella Standard,(ii) Reference Panel of Well

Characterized Rubella Sera, and(3) World Health Organization’s

International Rubella Standard.

PART 868—ANESTHESIOLOGYDEVICES






§ 868.1150 Indwelling blood carbondioxide partial pressure (PCO2) analyzer.* * * * *

(b) Classification. Class II. The specialcontrols for this device are:

(1) International StandardsOrganization’s ISO 10993 ‘‘BiologicalEvaluation of Medical Devices Part I:Evaluation and Testing,’’

(2) FDA’s:(i) ‘‘510(k) Sterility Review Guidance

and Revision of 11/18/94 K90–1,’’(ii) ‘‘Reviewer Guidance for Computer

Controlled Medical Devices Undergoing510(k) Review,’’

(iii) ‘‘Reviewer Guidance for ClinicalStudies for Indwelling Blood GasAnalyzers,’’ and

(iv) ‘‘Reviewer Guidance for Formatand Content of Premarket Notifications(510(k) Submissions), Labeling,Performance and Environmental Testingfor Electronic Devices,’’

(3) National Committee for ClinicalLaboratory Standards’:

(i) EP5 ‘‘Evaluation of PrecisionPerformance of Clinical ChemistryDevices,’’

(ii) EP6 ‘‘Evaluation of the Linearity ofQuantitive Analytical Methods,’’

(iii) EP7 ‘‘Interference Testing inClinical Chemistry,’’

(iv) EP9 ‘‘User Comparison ofQuantitative Clinical LaboratoryMethods Using Patient Samples,’’ and

(v) EP10 ‘‘Preliminary Evaluation ofQuantitative Clinical LaboratoryMethods—Second edition, 1993,’’ and

(4) International ElectrotechnicalCommission’s 60601 ‘‘Electrical SafetyStandard.’’


§ 868.1170 Indwelling blood hydrogen ionconcentration (pH) analyzer.* * * * *




and Revision of 11/18/94 K90–1,’’(ii) ‘‘FDA Reviewer Guidance for

Computer Controlled Medical DevicesUndergoing 510(k) Review,’’

(iii) ‘‘Reviewer Guidance for ClinicalStudies for Indwelling Blood GasAnalyzers,’’ and

(iv) ‘‘Reviewer Guidance for Formatand Content of Premarket Notifications(510(k) Submissions), Labeling,Performance and Environmental Testingfor Electronic Devices,’’






(v) EP10 ‘‘Preliminary Evaluation ofQuantitative Clinical LaboratoryMethods—Second edition, 1993,’’ and

(4) International ElectrotechnicalCommission’s 60601 ‘‘Electrical SafetyStandard.’’


§ 868.1200 Indwelling blood oxygen partialpressure (PO2) analyzer.


controls for this device are:(1) FDA’s:(i) ‘‘Reviewer Guidance for Computer

Controlled Medical Devices Undergoing510(k),’’

(ii) ‘‘Reviewer Guidance for ClinicalStudies for Indwelling Blood GasAnalyzers,’’

(iii) ‘‘Reviewer Guidance for Formatand Content of Premarket Notifications(510(k) Submissions), Labeling,Performance and Environmental Testingfor Electronic Devices,’’ and

(iv) ‘‘510(k) Sterility Review Guidanceand Revision of 11/18/94 K90–10,’’






(v) EP10 ‘‘Preliminary Evaluation ofQuantitative Clinical LaboratoryMethods—Second edition, 1993,’’

(3) International ElectrotechnicalCommission’s 60601 ‘‘Electrical SafetyStandard,’’ and

(4) International StandardsOrganization’s ISO 10993 ‘‘BiologicalEvaluation of Medical Devices Part I:Evaluation and Testing.’’

10. Section 868.2500 is amended byrevising paragraph (b)(2) and byremoving paragraph (c) to read asfollows:

§ 868.2500 Cutaneous oxygen monitor.

* * * * *

(b) * * *(2) Classification. Class II. The special

controls for this device are:(i) American Society for Testing and

Materials’ F984–86 ‘‘Specification forCutaneous Gas Monitoring Devices forOxygen and Carbon Dioxide,’’

(ii) International ElectrotechnicalCommission’s IEC 601 ‘‘Medical DeviceElectrical Standard,’’

(iii) Underwriters Laboratory’s‘‘Medical Electrical Equipment (UL2601–1),’’ and

(iv) The International Federation ofClinical Chemistry’s ‘‘Guidelines forTranscutaneous PO2 and PCO2

Measurement.’’

PART 870—CARDIOVASCULARDEVICES




§ 870.3375 Cardiovascular intravascularfilter.


controls for this device are:(1) International Standards

Organization’s ISO 10993 ‘‘BiologicalEvaluation of Medical Devices Part I:Evaluation and Testing,’’ and


and Revision of 11/18/94 K90–10,’’ and(ii) ‘‘Guidance Document for the

Submission of 510(k) PremarketNotifications for CardiovascularIntravascular Filters.’’


§ 870.3450 Vascular graft prosthesis ofless than 6 millimeters diameter.





and Revision of 11/18/94 K90–10,’’ and(ii) ‘‘Document on Special Controls

for Vascular Prostheses.’’14. Section 870.3620 is amended by

revising paragraph (b) and by removingparagraph (c) to read as follows:

§ 870.3620 Pacemaker lead adaptor.

* * * * *




(1) International StandardsOrganization’s ISO 10993 ‘‘BiologicalEvaluation of Medical Devices Part I:Evaluation and Testing,’’ and


and Revision of 11/18/94 K90–1,’’ and(ii) ‘‘Guidance Document for the

Submission of Research and MarketingApplications for Permanent PacemakerLeads.’’


§ 870.3800 Annuloplasty rings.


controls for this device are:(1) FDA’s:(i) ‘‘510(k) Sterility Review Guidance

and Revision of 11/18/94 K90–1,’’ and(ii) ‘‘Document for Special Controls

for Annuloplasty Rings,’’ and(2) International Standards

Organization’s ISO 10993 ‘‘BiologicalEvaluation of Medical Devices Part I:Evaluation and Testing.’’


§ 870.4230 Cardiopulmonary bypassdefoamer.


controls for this device are:(1) FDA’s:(i) ‘‘Bluebook Guidance for Sterility,

K90–1,’’(ii) ‘‘Document for Special Controls

for Cardiopulmonary Bypass Defoamer,’’and



§ 870.4260 Cardiopulmonary bypassarterial line blood filter.


controls for this device are:(1) FDA’s:(i) ‘‘Bluebook Guidance for Sterility,

K90–1,’’ and(ii) ‘‘Document for Special Controls

for Cardiopulmonary Bypass ArterialFilters,’’ and



§ 870.4350 Cardiopulmonary bypassoxygenator.





and Revision of 11/18/94 K90–1,’’ and(ii) ‘‘Information for Manufacturers

Seeking Marketing Clearance for BloodGas Exchangers (Oxygenators) Used inCardiopulmonary Bypass.’’


§ 870.5550 External transcutaneouscardiac pacemaker (noninvasive).


controls for this device are:(1) ‘‘American National Standards

Institute/American Association forMedical Instrumentation’s DF–2,’’ and

(2) The device shall not havecapability of delivering pulses in excessof 200 milliamperes with a width lessthan or equal to 50 milliseconds.

PART 872—DENTAL DEVICES




§ 872.3540 OTC denture cushion or pad.




(2) FDA’s ‘‘OTC Denture Reliners,Repair Kits, and Partially FabricatedDenture Kits.’’


§ 872.3560 OTC denture reliner.



Organization’s ISO 10993 ‘‘Biological

Evaluation of Medical Devices Part I:Evaluation and Testing,’’ and

(2) FDA’s ‘‘OTC Denture Reliners,Repair Kits, and Partially FabricatedDenture Kits.’’


§ 872.3570 OTC denture repair kit.




(2) FDA’s ‘‘OTC Denture Reliners,Repair Kits, Partially Fabricated DentureKits.’’


§ 872.3600 Partially fabricated denture kit.




(2) FDA’s ‘‘OTC Denture Reliners,Repair Kits, Partially Fabricated DentureKits.’’


§ 872.6080 Airbrush.


control for this device is InternationalElectrotechnical Commission’s IEC–601‘‘Medical Device Electrical Standard.’’

PART 874—EAR, NOSE, AND THROATDEVICES




§ 874.3400 Tinnitus masker.


controls for this device are:(1) Patient labeling to include

information about:(i) Risks,(ii) Benefits,(iii) Warnings for safe use, and(iv) Technical specifications, and(2) Medical consultation for:



(i) Determination of the cause oftinnitus,

(ii) Fitting of the device, and(iii) Followup care by a hearing health

care professional.28. Section 874.3930 is amended by

revising paragraph (b) and by removingparagraph (c) to read as follows:

§ 874.3930 Tympanostomy tube withsemipermeable membrane.


controls for this device are:(1) FDA’s ‘‘Tympanostomy Tubes,

Submission Guidance for a 510(k),’’(2) Functional testing to verify air

passage,(3) Use of polytetrafluoroethylene

sheeting with 1.0 micron pore size and0.003 inch thickness as membranematerial, and

(4) Labeling to:(i) Describe risk of clogging, and(ii) State that device is only for use in

ears that have been evacuated.

PART 876—GASTROENTEROLOGY-UROLOGY DEVICES


Authority: 21 U.S.C. 351, 360, 360c, 360e,360j, 360l, 371.


§ 876.4480 Electrohydraulic lithotriptor.


controls for this device are:(1) FDA’s:(i) ‘‘510(k) Sterility Review Guidance

and Revision of 11/18/94 K90–1,’’(ii) ‘‘Guidance for the Content of

Premarket Notifications forIntracorporeal Lithotripters,’’ and

(iii) ‘‘Labeling Reusable MedicalDevices for Reprocessing in Health CareFacilities: FDA Reviewer Guidance,’’

(2) American National StandardsInstitute/American Association forMedical Instrumentation’s HF–18‘‘Electrosurgical Devices,’’ and

(3) International ElectrotechnicalCommission’s IEC 60601 ‘‘ElectricalSafety Standard.’’

31. Section 876.5860 is amended byrevising paragraphs (a) and (b) and byremoving paragraph (c) to read asfollows:

§ 876.5860 High permeability hemodialysissystem.

(a) Identification. A high permeabilityhemodialysis system is a deviceintended for use as an artificial kidney

system for the treatment of patients withrenal failure, fluid overload, or toxemicconditions by performing such therapiesas hemodialysis, hemofiltration, andhemoconcentration. Using ahemodialyzer with a semipermeablemembrane that is more permeable towater than the semipermeablemembrane of the conventionalhemodialysis system described in§ 876.5820, the high permeabilityhemodialysis system removes toxins orexcess fluid from the patient’s bloodusing the principles of convection (viaa high ultrafiltration rate) and/ordiffusion (via a concentration gradientin dialysate). During treatment, blood iscirculated from the patient through thehemodialyzer’s blood compartment,while the dialysate solution flowscountercurrent through the dialysatecompartment. In this process, toxinsand/or fluid are transferred across themembrane from the blood to thedialysate compartment. Thehemodialysis delivery machine controlsand monitors the parameters related tothis processing, including the rate atwhich blood and dialysate are pumpedthrough the system, and the rate atwhich fluid is removed from the patient.The high permeability hemodialysissystem consists of the following devices:

(1) The hemodialyzer consists of asemipermeable membrane with an invitro ultrafiltration coefficient (Kuf)greater than 12 milliliters per hour perconventional millimeter of mercury, andis used with either an automatedultrafiltration controller or anothermethod of ultrafiltration control toprevent fluid imbalance.

(2) The hemodialysis deliverymachine is similar to the extracorporealblood system and dialysate deliverysystem of the hemodialysis system andaccessories (§ 876.5820), with theaddition of an ultrafiltration controllerand mechanisms that monitor and/orcontrol such parameters as fluidbalance, dialysate composition, andpatient treatment parameters (e.g., bloodpressure, hematocrit, urea, etc.).

(3) The high permeabilityhemodialysis system accessoriesinclude, but are not limited to, tubinglines and various treatment relatedmonitors (e.g., dialysate pH, bloodpressure, hematocrit, and bloodrecirculation monitors).



(2) FDA’s:

(i) ‘‘Guidance for the Content of510(k)s for Conventional and HighPermeability Hemodialyzers,’’

(ii) ‘‘Guidance for Industry and CDRHReviewers on the Content of PremarketNotifications for Hemodialysis DeliverySystems,’’

(iii) ‘‘Guidance for the Content ofPremarket Notifications for WaterPurification Components and Systemsfor Hemodialysis,’’ and

(iv) ‘‘Guidance for HemodialyzerReuse Labeling.’’


§ 876.5955 Peritoneo-venous shunt.



Organization’s ISO 10993 ‘‘BiologicalEvaluation of Medical Devices Part I:Evaluation and Testing,’’

(2) FDA’s ‘‘510(k) Sterility ReviewGuidance and Revision of 11/18/94K90–1,’’

(3) ‘‘Pyrogenicity Testing per USPRabbit Pyrogen Test or USP BacterialEndotoxins Test,’’

(4) American National StandardsInstitute/American Association forMedical Instrumentation’s ANSI/AAMI/ISO 11135 ‘‘Medical Devices—Validation and Routine Control ofEthylene Oxide Sterilization,’’ and

(5) Specification for backflow thatensures against excessive reflux of bloodinto the shunt.

PART 878—GENERAL AND PLASTICSURGERY DEVICES


Authority: 21 U.S.C. 351, 360, 360c, 360e,360j, 360l, 371.


§ 878.3610 Esophageal prosthesis.

(a) Identification. An esophagealprosthesis is a rigid, flexible, orexpandable tubular device constructedof a plastic, metal, or polymeric materialthat is intended to be implanted torestore the structure and/or function ofthe esophagus. The metal esophagealprosthesis may be uncovered or coveredwith a polymeric material. This devicemay also include a device deliverysystem.

(b) Classification. Class II. The specialcontrol for this device is FDA’s‘‘Guidance for the Content of Premarket



Notification Submissions for Esophagealand Tracheal Prostheses.’’


§ 878.3720 Tracheal prosthesis.(a) Identification. The tracheal

prosthesis is a rigid, flexible, orexpandable tubular device constructedof a silicone, metal, or polymericmaterial that is intended to beimplanted to restore the structure and/or function of the trachea ortrachealbronchial tree. It may beunbranched or contain one or twobranches. The metal tracheal prosthesismay be uncovered or covered with apolymeric material. This device mayalso include a device delivery system.

(b) Classification. Class II. The specialcontrol for this device is FDA’s‘‘Guidance for the Content of PremarketNotification Submissions for Esophagealand Tracheal Prostheses.’’

PART 884—OBSTETRICAL ANDGYNECOLOGICAL DEVICES




§ 884.1060 Endometrial aspirator.





(3) Device design so that samplingpart is covered while entering or leavingvagina, and

(4) Labeling to state that the device isonly an adjunctive tool to evaluate theendometrium and to contraindicate useof device in pregnant patients andpatients with a history of uterusperforation or recent cesarean section.


§ 884.1100 Endometrial brush.



Organization’s ISO 10993 ‘‘Biological

Evaluation of Medical Devices Part I:Evaluation and Testing,’’


(3) Device design so that samplingpart is covered while entering or leavingvagina,

(4) Testing to demonstrate adequateadherence of bristles and brush head,and

(5) Labeling to state that the device isonly an adjunctive tool to evaluate theendometrium and to contraindicate useof device in pregnant patients andpatients with a history of uterusperforation or recent cesarean section.


§ 884.1185 Endometrial washer.





(3) Device design so that samplingpart is covered while entering or leavingvagina,

(4) Intrauterine pressure not to exceed50 conventional millimeters of mercury,and

(5) Labeling to:(i) Contraindicate use of the device in

pregnant patients and patients with ahistory of uterus perforation or recentcesarean section,

(ii) Warn that the device should notbe attached to wall or any other externalsource of suction, and

(iii) State that the device is only anadjunctive tool to evaluate theendometrium.


§ 884.4100 Endoscopic electrocautery andaccessories.




(2) FDA’s ‘‘Guidelines for Evaluationof Laproscopic Bipolar and ThermalCoagulators,’’

(3) International ElectrotechnicalCommission’s IEC 60601 ‘‘ElectricalSafety Standard,’’

(4) American National StandardsInstitute/American Association forMedical Instrumentation’s HF–18‘‘Electrosurgical Devices,’’

(5) Labeling: an indication for femaletubal sterilization,

(6) Treatment instructions to:(i) Destroy at least 2 centimeters of a

tube,(ii) Use a cut or undampened

sinusoidal waveform, and(iii) Use a minimum power of 25

watts, and(7) Labeling of devices with ammeters

to activate the electrode for 4 to 5seconds after the visual endpoint isreached or current flow ceases forcomplete destruction of tissue.


§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories.* * * * *



(2) FDA’s ‘‘Guidance for Evaluation ofLaproscopic Bipolar and ThermalCoagulators (and Accessories),’’

(3) International ElectrotechnicalCommission’s IEC 60601 ‘‘ElectricalSafety Standard,’’

(4) American National StandardsInstitute/American Association forMedical Instrumentation’s HF–18‘‘Electrosurgical Devices,’’

(5) Labeling: An indication for femaletubal sterilization,

(6) Treatment instructions to:(i) Destroy at least 2 centimeters of a

tube,(ii) Use a cut or undampened

sinusoidal waveform, and(iii) Use a minimum power of 25

watts, and(7) Labeling of devices with ammeters

to activate the electrode for 4 to 5seconds after the visual endpoint isreached or current flow ceases forcomplete destruction of tissue.

PART 886—OPHTHALMIC DEVICES




§ 886.3400 Keratoprosthesis.(a) Identification. A keratoprosthesis

is a device intended to provide a



transparent optical pathway through anopacified cornea, either intraoperativelyor permanently, in an eye which is nota reasonable candidate for a cornealtransplant.




and Revision of 11/18/94 K90–1,’’ and(ii) ‘‘Keratoprosthesis Guidance

Document.’’44. Section 886.3920 is amended by

revising the section heading andparagraphs (a) and (b) and by removingparagraph (c) to read as follows:

§ 886.3920 Aqueous shunt.(a) Identification. An aqueous shunt is

a one-way, pressure sensitive deviceintended to be implanted to normalizeintraocular pressure. The device isintended to treat neovascular glaucomaor glaucomas where medical andconventional surgical treatment havefailed.




and Revision of 11/18/94 K90–1,’’ and(ii) ‘‘Aqueous Shunts—510(k)

Submissions.’’

PART 888—ORTHOPEDIC DEVICES



46. Section 888.3150 is revised to readas follows:

§ 888.3150 Elbow joint metal/polymerconstrained cemented prosthesis.

(a) Identification. An elbow jointmetal/polymer constrained cementedprosthesis is a device intended to beimplanted to replace an elbow joint. Itis made exclusively of alloys, such ascobalt-chromium-molybdenum, or ofthese alloys and of an ultra-highmolecular weight polyethylene bushing.The device prevents dislocation in morethan one anatomic plane and consists oftwo components which are linkedtogether. This generic type of device islimited to those prostheses intended foruse with bone cement (§ 888.3027).



(i) ISO 5832 ‘‘Implants for Surgery—Metallic Materials,’’

(ii) ISO 5833 ‘‘Implants for Surgery—Acrylic Resin Cements,’’

(iii) ISO 5834 ‘‘Implants for Surgery—Ultra High Molecular WeightPolyethylene,’’

(iv) ISO 14630 ‘‘Non-active SurgicalImplants—General Requirements,’’

(v) ISO 10993 ‘‘Biocompatibility TestMethods,’’

(vi) ISO 9001 ‘‘Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation,and Servicing,’’ and

(vii) ISO 6018 ‘‘General Requirementsfor Marketing, Packaging, andLabeling.’’


and Revision of 11/18/94 K90–1,’’(ii) ‘‘Guidance Document for Testing

Orthopedic Implants with ModifiedMetallic Surfaces Apposing Bone orBone Cement,’’

(iii) ‘‘Guidance Document for thePreparation of Premarket Notification(510(k)) Application for OrthopedicDevices,’’ and

(iv) ‘‘Guidance Document for TestingNon-articulating, ‘Mechanically Locked’Modular Implant Components,’’ and

(3) American Society for Testing andMaterials’:

(i) F75–92 ‘‘Specification for CastCobalt-Chromium-Molybdenum Alloyfor Surgical Implant Material,’’

(ii) F799–96 ‘‘Specification for Cobalt-28 Chromium-6 Molybdenum AlloyForgings for Surgical Implants,’’

(iii) F1108–97 ‘‘Specification forTi6Al4V Alloy Castings for SurgicalImplants,’’

(iv) F648–96 ‘‘Specification for Ultra-High-Molecular-Weight PolyethylenePowder and Fabricated Form forSurgical Implants,’’

(v) F1537–94 ‘‘Specification forWrought Cobalt-Chromium-Molybdenum Alloy for SurgicalImplants,’’

(vi) F981 ‘‘Practice for Assessment ofCompatibility of Biomaterials(Nonporous) for Surgical Implant withRespect to Effect of Material on Muscleand Bone,’’

(vii) F1044 ‘‘Test Method for ShearTesting of Porous Metal Coatings,’’ and

(viii) F1147 ‘‘Test Method for TensionTesting of Porous Metal Coatings.’’


§ 888.3540 Knee joint patellofemoralpolymer/metal semi-constrained cementedprosthesis.




(i) ISO 5832 ‘‘Implants for Surgery—Metallic Materials,’’

(ii) ISO 5833 ‘‘Implants for Surgery—Acrylic Resin Cements,’’

(iii) ISO 5834 ‘‘Implants for Surgery—Ultra High Molecular WeightPolyethylene,’’

(iv) ISO 9001 ‘‘Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation,and Servicing,’’

(v) ISO 7207 ‘‘Implants for Surgery—Femoral and Tibial Components forPartial and Total Knee Joint Prostheses,’’and

(vi) ISO 6018 ‘‘General Requirementsfor Marketing, Packaging, andLabeling.’’




(iii) ‘‘Guidance Document for thePreparation of Premarket Notification(510(k)) Applications for OrthopedicDevices,’’





(iii) F1108–97 ‘‘Ti6Al4V AlloyCastings for Surgical Implants,’’



(vi) F1044 ‘‘Test Method for ShearTesting of Porous Metal Coatings,’’

(vii) F1147 ‘‘Test Method for TensionTesting of Porous Metal Coatings,’’

(viii) F370–94 ‘‘Specification forProximal Femoral Prosthesis,’’ and

(ix) F1672–95 ‘‘Specification forResurfacing Patellar Prosthesis.’’




§ 888.3650 Shoulder joint metal/polymernon-constrained cemented prosthesis.



Organization’s:(i) ISO 10993 ‘‘Biological Evaluation

of Medical Devices Part I: Evaluationand Testing,’’

(ii) ISO 5832 ‘‘Implants for Surgery—Metallic Materials,’’

(iii) ISO 5833 ‘‘Implants for Surgery—Acrylic Resin Cements,’’

(iv) ISO 5834 ‘‘Implants for Surgery—Ultra High Molecular WeightPolyethylene,’’

(v) ISO 9001 ‘‘Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation,and Servicing,’’ and

(vi) ISO 6018 ‘‘General Requirementsfor Marketing, Packaging, andLabeling.’’





(iv) ‘‘Guidance Document for TestingNon-articulating, ‘Mechanically Locked’Modular Implant Components,’’




(iii) F1108–97 ‘‘Ti6Al4V AlloyCastings for Surgical Implants,’’




(vii) F1147 ‘‘Test Method for TensionTesting of Porous Metal Coatings,’’ and

(viii) F1378 ‘‘Specification forShoulder Prosthesis.’’


§ 888.3660 Shoulder joint metal/polymersemi-constrained cemented prosthesis.



Organization’s:(i) ISO 10993 ‘‘Biological Evaluation

of Medical Devices Part I: Evaluationand Testing,’’

(ii) ISO 5832 ‘‘Implants for Surgery—Metallic Materials,’’

(iii) ISO 5833 ‘‘Implants for Surgery—Acrylic Resin Cements,’’

(iv) ISO 5834 ‘‘Implants for Surgery—Ultra High Molecular WeightPolyethylene,’’

(v) ISO 9001 ‘‘Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation,and Servicing,’’ and

(vi) ISO 6018 ‘‘General Requirementsfor Marketing, Packaging, andLabeling,’’









(iii) F1108–97 ‘‘Specification forTi6Al4V Alloy Castings for SurgicalImplants,’’




(vii) F1147 ‘‘Test Method for TensionTesting of Porous Metal Coatings,’’ and

(viii) F1378 ‘‘Standard Specificationfor Shoulder Prosthesis.’’

Dated: March 1, 1999.William K. Hubbard,Acting Deputy Commissioner for Policy.[FR Doc. 99–6266 Filed 3–12–99; 8:45 am]BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD08–99–007]

RIN 2115–AE47

Drawbridge Operation Regulation;Inner Harbor Navigation Canal, LA

AGENCY: Coast Guard, DOT.ACTION: Notice of proposed rulemaking.

SUMMARY: The Coast Guard is proposingto temporarily change the regulation forthe operation of the draw of the L & NRailroad/Old Gentilly Road basculespan drawbridge across the Inner HarborNavigation Canal, mile 2.9 at NewOrleans, Orleans Parish, Louisiana. Thisproposal would allow the draw of theL&N Railroad/Old Gentilly Road basculespan drawbridge to remain closed tonavigation daily from 8 a.m. until noonand from 1 p.m. until 5 p.m. from May17 through May 28, 1999, June 1through July 2, 1999, July 6 throughSeptember 3, 1999 and from September7 through September 22. This proposedtemporary rule will allow forreplacement of the damaged fendersystem, an extensive but necessarymaintenance operation. Presently, thedraw opens on signal at all times.DATES: Comments must be received onor before April 29, 1999.ADDRESSES: Unless otherwise indicated,documents referred to in this notice areavailable for inspection or copying atthe office of the Eighth Coast GuardDistrict, Bridge Administration Branch,Hale Boggs Federal Building, room1313, 501 Magazine Street, NewOrleans, Louisiana 70130–3396 between7 a.m. and 4 p.m., Monday throughFriday, except Federal holidays.Comments should also be submitted tothe same address. The BridgeAdministration Branch of the EighthCoast Guard District maintains thepublic docket for this proposedtemporary rule.FOR FURTHER INFORMATION CONTACT: PhilJohnson, Bridge Administration Branch,at the address given above. Telephone(504) 589–2965.SUPPLEMENTARY INFORMATION:

Requests for Comments

The Coast Guard encouragesinterested parties to participate in thisrulemaking by submitting writtendata,views, or arguments. Personssubmitting comments should includetheir names and addresses, identify thisrulemaking (CGD 08–99–007) and thespecific section of this document to
