APR 25 2012510(k) Summary

CareFusion Nicolet EDX with Synergy Software

[A summary of 5 10(k) safety and effectiveness information in accordance with 21 CFR 807.92]

1. Submitter / 5 10(k) Holder

Name CareFusion 209, Inc.Address 1850 fleming Way, Middleton WI 53562Establishment Reg. No. 3008289288Contact person Mr. Curtis TruesdalePhone number 608-829-8684Fax number 608-829-8769Email Curtistmesdae@carefusion.comDate prepared April 18, 2012

2. Device Name

Proprietary name CareFusion Nicolet EDX with Synergy Software

Common name Diagnostic Electromyograph

Device Class Class II

Classification name Evoked Response Electrical Stimulator [primary]Diagnostic ElectromyographNerve Conduction Velocity Measurement DeviceNon-normalizing Quantitative Electroencephalograph SoftwareEvoked Response Auditory StimulatorEvoked Response Photic StimulatorEvoked Response Mechanical Stimulator

Product Code, Regulation GWF 21 CER §882.1870 [primary]IKN 21 CFR §890.1375JXE 21ICFR §882.1550OLT 21 CFR §882. 1400GWJ 21 CRF §882.1900OWE 21 CFR §882.1890GZP 21 CFR §882.1880

5 10(k) Summary, CareFusion Nicolet EDX with Synergy Software [(120979] Page 1lof 14

3. Predicate Devices 510(K) Device NameNumber

KI 12052 CareFusion Nicolet EDX with Viking SoftwareK965065 CareFusion Synergy Mobile SystemK070l09 NeuroMetrix Advance System

4. Device Description

The CareFusion Nicolet EDX system with Synergy Software (Synergy EDX) is designed for theacquisition, display, analysis, reporting, and management of electrophysiological informationfrom the human nervous and muscular systems. The system is designed to perform nerveconduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing,and intra-operative monitoring (10M). Synergy EDX provides a variety of tests spanning thevarious modalities.

The Synergy EDX consists of the following major components:" Nicolet EDX console base unit;* Synergy control panel;* Nicolet amplifier (there are two types available: 2 channel (AT2) with two non-switched

amplifier channels and an 8 channel (AT2 + 6) amplifier with two non-switched and sixswitched amplifier channels;

" Desktop or laptop computer with a keyboard and mouse;* Display monitor; and* Synergy Software

The Synergy EDX optional accessories/components consists of the following:* Nicolet HB6 or HB7 Head Boxa Stimulator probes (RS 10 probe, WR 50 Probe, S403 probe)* SPI/5P2 electrical stimulator switching units* Footswitches (single and triple)

0LED goggles* Patient response button* Photic strobe* Headphones or other auditory transducers* Cart* Isolation transformer* Printer

Description of Major Components

Nicolet EDX Console Base:The console base is an AC mains powered electrical device that houses the core Nicolet EDXhardware, and provides interconnection capability with the rest of the Nicolet EDX hardware andPC. This is exactly the same as in the Nicolet EDX with Viking software system. The PCcontains the software.

510(k) Summary, CareFusion Nicolet EDX with Synergy Software [K(120979] Page 2 of 14

Synergy Control Panel:The control panel along with the mouse is the primary user interface for the Nicolet EDX system.The control panel contains a variety of controls that allow the user to access and use the NicoletEDX system from the touch of a button or knob. This control panel performs similar functions asthe Viking control panel from the Nicolet EDX with Viking software system.

Nicolet Amplifiers (A T2 and A T2 + 6):The Nicolet amplifiers are DC powered electrical devices that record, amplify and transmitresponses from the nerve and/or muscle to the Nicolet EDX console base. The AT2 amplifiercollects up to two channels of neurophysiological information and the AT2 + 6 amplifier collectsup to 8 channels of neurophysiological information. These are exactly the same amplifiers as inthe Nicolet EDX with Viking software system.

Personal Computer (PC) with Keyboard and Mouse:The Nicolet EDX system hardware is used in conjunction with a personal computer (PC), which isoffered in either a desktop or laptop configuration. These are exactly the same PCs as in theNicolet EDX with Viking software system. The Synergy software is supplied preloaded onto thePC.

Display Monitor:The desktop PC version requires a display monitor which is provided with the Nicolet EDXsystem hardware. The laptop version does not require a separate display monitor beyond thebuilt-in laptop display; however, an external display monitor may be used if desired. Theadditional display monitor is facilitated through the connection to an isolation transformer that isincluded with a desktop PC and available as an optional accessory for laptop based systems.These are exactly the same monitors and isolation transformer as in the Nicolet EDX with Vikingsoftware system.

Description of Optional Accessory Components

HB6 and HB7 Head Boxes:The HB6 and HB7 Head Boxes are passive devices. These are exactly the same head boxes as inthe Nicolet EDX with Viking software system. They can be connected to the AT2+6 Amplifiervia a cable to allow the electrodes' receptacles to be in closer proximity to the patient.

Electrical Stimulator Probes:There are three types of electrical stimulator probes available for use with the Nicolet EDXSystem Hardware: (1) the WR 50 comfort Plus Probe, (2) the RS 10 Comfort Probe and (3) theS403 Probe. These are exactly the same Stimulus Probes as in the Nicolet EDX with Vikingsoftware system. The probes connect to the Nicole EDX console base via a cable. Each probecontains a tip that facilitates direct stimulus contact to the patient when activated. The probes candeliver a stimulus ranging from 0 - 400 V / 0 - 100 mA.

SP-IISP-2 Electrical Stimulus Switching Units:The SP- I and SP-2 Stimulus Switching Units allow the user to connect multiple sets of electrodeson the patient for stimulation at different locations. These are exactly the same StimulusSwitching Pods as in the Nicolet EDX with Viking software system.

Foots witch and Triple Footswitch:The footswitches allow the user to activate defined functions such as electrical stimulation and

5 10(k) Summary, Care~usion Nicolet EDX with Synergy Software [K 120979] Page 3 of 14

initiate acquisition of trice data. Pressing the footswitch activates or deactivates the user definedfunction. These are exactly the same footswitches and functions as in the Nicolet EDX withViking software system.

Patient Response Button:The patient response button allows the patient to respond to a rare stimulus during specific EPtesting. This is exactly the same Patient Response Button and function as in the Nicolet EDX withViking software system. The patient presses the button when the rare stimulus is detected. TheNicolet EDX senses the button press and increments a count.

Visual Stimulators:(1) LED goggles are available to provide visual stimulation to the patient when the Visual

Evoked Potential (VEP) software option is in use. These are exactly the same LEDgoggles and function as in the Nicolet EDX with Viking software system.

(2) A photic strobe is also a visual stimulus option. This is exactly the same photic strobe andfunction as in the Nicolet EDX with Viking software system. It can be mounted on anoptional stand. Similar to the other visual stimulus; it is used with the VEP option. Allthree visual stimulators have no controls or indicators and are connected to the NicoletEDX Console Base Unit. This photic strobe was previously cleared under K921927 andK99 1054.

Headphones or other Auditory Transducers:Headphones are available, or other auditory transducers may be used to provide auditorystimulation to the patient through the transducer when the Auditory Evoked Potential (AEP) is inuse. Headphones and transducers have no controls or indicators and are connected to the NicoletEDX Console Base unit auditory stimulator output connectors. These are exactly the sametransducers and function as in the Nicolet EDX with Viking software system.

Cart and Printer:The metal cart provides a convenient way to contain all of the components of the Nicolet EDXSystem Hardware into one mobile location. The cart has lockable wheels and a convenient handleto facilitate movement of the cart. Two articulating arms are provided for mounting the displaymonitor and amplifier. There are multiple shelves present to accommodate the placement andstorage of various Nicolet EDX System Hardware components and supplies. A retractablekeyboard shelf and mouse pad is available. In terms of printing capabilities, a printer equivalent toa DeskJet or Laser printer is available for connection to the system to print reports or screencopies. The cart is exactly the same and functions the same as in the Nicolet EDX with Vikingsoftware system.

5. Indications for Use:

The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting,and management of electrophysiological information from the human nervous and muscularsystems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP),Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials(AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography(EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The

5 10O(k) Summary, CareFusion Nicolet EDX with Synergy Software [K 120979] Page 4 of 14

Nicolet EDX with Synergy Software may be used to determine autonomic responses tophysiologic stimuli by measuring the change in electrical resistance between two electrodes(Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includesassessment of RR Interval variability. The Nicolet EDX with Synergy Software is used to detectthe physiologic function of the nervous system, for the location of neural structures duringsurgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studiesmeasure the electrical responses of the nerve; Electromyography measures the electrical activityof the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The Nicolet EDX with Synergy Software is intended to be used by a qualified healthcare provider.

6 Summary of Technical Characteristics Compared to the Predicate Devices

5 10(k) Summary, CareFusion Nicolet EDX with Synergy Software [K 120979] PageS5 of 14

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7 Summary of Non-Clinical Performance Testing Conducted for the Determination of

Substantial Equivalence

Biocompatibility:

CareFusion has demonstrated the biocompatibility of all direct and indirect patient contactingmaterial associated with the CareFusion Nicolet EUX (Synergy EDX) through compliance withISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process. Test results have indicated that contacting materials complieswith the standard and are safe for its intended use. There are no different materials than in theNicolet EDX with Viking Software.

Software testing:

The Synergy EDX contains MODERATE level of concern software. The software was designedand developed according to a robust software development process, and was rigorously verifiedand validated consistent with the following guidelines:

* FDA guidance: The content of premarket submissions for software contained in medicaldevices, I I May 05;

" FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99; and" FDA guidance: General principles of software validation; Final guidance for industry and

FDA staff, I I Jan 02.The tests results demonstrated that the Synergy EDX complies with its predeterminedspecifications.

Electrical Safety and Electromagnetic Compatibility (EMC) Testing:

The Synergy EDX was tested for electrical safety. Test results demonstrated that the SynergyEDX complies with the following standards:

* lEG 60601-1: 1988, Amal: 199 1, Am2: 1995, Medical Electrical Equipment, Pant 1:General Requirements for Safety; and

* UL 60601-1: 2006, Medical Electrical Equipment, Part 1: Particular Requirements forSafety.

Electromagnetic Compatibility (EMC) testing was conducted o 'n the Synergy EDX according tothe applicable standard. Test results indicated that the system complies with the following:

* EG 60601-1-2: 2001, AmI1: 2004, Medical Electrical Equipment, Part 1: Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.

Performance Testing - Bench:

The Synergy EDX was tested to assess performance in accordance with requirements of theapplicable performance standard. Test results demonstrated that the Synergy EDX metspecifications and complies with the following standard:

* EG 60601-2-40: 1998, Medical Electrical Equipment, Part 2-40: Particular Requirementsfor the Safety of Electromyographs and Evoked Response Equipment.

Performance Testing - Animal & Clinical:-

510(k) Summary, CareFusion Nicolet EDX with Synergy Software [K(120979] Page 13 of14

Animal testing and clinical testing were not needed to demonstrate safety and effectiveness.

8 Conclusion

The technological characteristics and performance data for the CareFusion Nicolet EDX System

with Synergy Software demonstrates that it is substantially equivalent to the predicate devices.

5 10(k) Summary, CareFusion Nicolet EDX with Synergy Software [K 120979] Page 14 of14

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

10903 New Hampshire AvenueDocument Control Room -W066-G609Silver Spring, MD 20993-0002

CareFusion 209, Inc. APR 2 5202c/o Mr. Curtis D. TruesdaleManager, Regulatory Assurance1850 Deming WayMiddleton, WI 53562

Re: K120979Trade/Device Name: CareFusion Nicolet EDX with Synergy Software

Regulation Number: 21 CER 882.1870Regulation Name: Evoked Response Electrical StimulatorRegulatory Class: Class 11Product Code: GWF, IKN, JXE, OLT, GWJ, GWE, GZPDated: March 28, 2012Received: April 2, 2012

Dear Mr. Truesdale:

We have reviewed your Section 5 10(k) premarket notification of intent to market the device

referenced above and have determined the device is substantially equivalent (for the indications

for use stated in the enclosure) to legally marketed predicate devices marketed in interstate

commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to

devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,

and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).

You may, therefore, market the device, subject to the general controls provisions of the Act: The

general controls provisions of the Act include requirements for annual registration, listing of

devices, good manufacturing practice, labeling, and prohibitions against misbranding and

adulteration. Please note: CDRH does not evaluate information related to contract liability

warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA), it

may be subject to additional controls. Existing major regulations affecting your device can be

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may

publish further announcements concerning your device in the Federal Register.

Page 2 - Mr. Curtis D. Truesdale

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but pot limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related ad-verse events) (21 CFR 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CF1( 1000- 1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasego to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm forthe Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, pleasenote the regulation entitled, "Misbranding by reference to premarket notification" (2 1 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21.CFR Part 803), please go tohttp://w-ww. fda.gov/MedicalDevices/Safetv/Ren~ortaProblem/default.btm for the CDRH 's Officeof Surveillance and BiometricslDivision of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet addresshttp)://www.fda.gov/MedicalDevices/ResourcesforYou/ndustr/default.htm.

Sincerely yours,

Malvina. Eydclman, M.DDirectorDivision of Ophthalmic, Neurological,,

and Ear, Nose and Throat DevicesOffice of Device EvaluationCenter for Devices and

Radiological Health

Enclosure

Indications for Use Form

51 0(k) Number (if known): 1( I Q. a09m-1

Device Name: CareFusion Nicolet EDX with Synergy Software

Indications for Use:

The CareFusion Nicolet EDX is intended for thd acquisition, display, analysis, storage,reporting, and management of electrophysiological information from the human nervous andmuscular systems including Nerve Conduction (NOS), Electromyography (EMG), EvokedPotentials (EP), Autonomic Responses and Intra-Operative Monitoring includingElectroencepha log raphy (EEG).

Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials(AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG),Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent NegativeVariation (CNV). The Nicolet EDX with Synergy Software may be used to determine autonomicresponses to physiologic stimuli by measuring the change in electrical resistance between twoelectrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing alsoincludes assessment of RR Interval variability. The Nicolet EDX with Synergy Software is used

to detect the physiologic function of the nervous system, for the location of neural structuresduring surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studiesmeasure the electrical responses of the nerve; Electromnyography measures the electricalactivity df the muscle and Evoked Potentials measure electrical activity from the CentralNervous System.

The Nicolet EDX with Synergy Software is intended to be used by a qualified healthcareprovide r.

Prescription Use X AND/OR Over-The-Counter Use ___

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(Divisionl Sign-Off)

Divisionl of OphthallmiC, Neurological and Ear.

Nose and Throat Devices

s5IO(k) Nume_ L_

31