510(k) summary may 16 2014 llc - food and drug …510(k) summary 510(k) -arloqo series k131096...

510(k) Summary510(k) -AR1000 Series K131096 MAY 16 2014Arobella Medical, LLC

510(k) Summary (K131096)

In accordance with the requirements of 21 CFR 807.92, Arobella Medical issubmitting the following 510(k) summary for the AR1000 Ultrasonic Wound TherapySystem and its variants. (Reference previous 51 0(k) K062544)

807 .92(~a)( 1)Submitter Information

Arobella Medical LILC5929 Baker Road, Suite 470Minnetonka, MN 55345Main: (952) 345-6840Fax: (952) 345-6841

Contact Person:Matthew BerscheidDirector of Quality and Regulatory AffairsOffice: (952) 288-2801Fax: (952) 345-6841Cell (612) 998-7416

Date: May 16, 2014

807.92(a)(2)

Trade Names: AR1000/B Ultrasonic Wound Therapy System, AR1000/B QousticWound Therapy System TM (QWTS), or Qoustic Choice Wound Therapy SystemCommon Name: Ultrasonic Wound Therapy SystemClassification Name(s): Ultrasonic Surgical Instrument; Wound Cleaner, UltrasoundProduct Classification: Class 11 or in the alternate UnclassifiedProduct Code: LFIL

807 .92(a)(?3)Predicate Device(s)

Arobella Medical, LLC AR1 000 Ultrasonic Wound Therapy System K062544Misonix, Inc SonicOne Ultrasonic Wound Debridlement System Ki112782Celferation Celleration Mist Therapy System Ki122246Soring Gmbh SONOCA 180 /185 Wound Care System K072904

Section 005_51 0(k) Summary Page 005-1 of 005-13

510(k) Summary510(k) -ARlOQO Series K131096Arobella Medical, LLC

807.92(a)(4)Device Description

The ARi 000 Ultrasonic Wound Therapy System and its variants use ultrasonicenergy from a generator delivered by a conductive cable to a hand held converterthrough the converter's distal end probe and liquid coupling medium: to performwound therapy; to perform ultrasonic surgical, excisional, and or sharp-edge selectivedissection procedures; with the intended end result to promote healing.

The ARi 000 Ultrasonic Wound Therapy System generator utilizes commonlyavailable wall outlet power (85 -26OVAC, 50/60Hz) to produce the ultrasonic signal. Aconductive cable connects the generator to the hand held converter. The hand heldconverter converts the signal into ultrasonic mechanical displacement in the distalend probe or Qurette. The ultrasonic mechanical displacement energy is applied tothe treatment site by the distal end probe or Qurette through direct contact or non-contact techniques. The ultrasonic mechanical displacement energy is alsotransmitted as ultrasonic energy to the treatment site via the liquid coupling medium.

The AR1000 Ultrasonic Wound Therapy System distal end probe or Qurette is usedwith contact or non-contact modes to achieve intended wound therapy modalities topromote wound healing. This is achieved through the use of the low-frequency,control led-i nte nsity, ultrasonic energy to perform ultrasonic dissection andfragmentation of tissues, debridlement of wound tissue (acute and chronic wounds,burns, diseased or necrotic tissue), and surgical, excisional or sharp-edge incisions.

The AR1000 Ultrasonic Wound Therapy System distal end probe or Qurette is usedwith contact or non-contact modes to achieve wound therapy and promotes woundhealing through the ultrasonic dissection and fragmentation of tissues, debridementof wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue)through the use of the low-frequency, control led-intensity, non-thermal ultrasonicenergy.

The AR1000 Ultrasonic Wound Therapy System ultrasonic energy, via the liquidcoupling medium to the treatment site, promotes wound healing through the lavageof wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) andcleansing irrigation of the site for the removal of debris, exudates, fragments,bacteria, and other matter.

The ARi 000 Ultrasonic Wound Therapy System uses continuous ultrasonic energyto propel the liquid medium (e.g. sterile saline, or other appropriate US FDA clearedmedium) into a solution stream and couples the delivery of ultrasonic energy to thetreatment site. This is accomplished by the ultrasonic energy application to the

Section 0055 10(k) Summary Page 005-2 of 005-13

510(k) Summary510(k) - AR1000 Series K131 096Arobella Medical, LLC

treatment site where the ultrasonic energy is transmitted via the converter probe(Qurette) and also coupled via the liquid medium to the treatment site.

The converter has a transducer horn that is made from titanium alloy (TI-6AL-4V).The converter probe Qurette tips are made from titanium alloy (TI-6AL-4V),

No latex is used in this device, including any potential patient-contact areas, andtesting has revealed no negative reactions to the materials used in this device.

Specifications:

Generator Power Source 85 -260V- (VAC), 2.5A, 50/60Hz

Converter Power Output < 140 watts

Amplitude (adjustable) Oumn - 75um (0% to 100% power level)

Frequency 35kHz (±3kHz)

Weight Generator: -12.5 lbsHandheld Converter: -1.0 lbs

Approximate Dimensions System 15 inches Deep x 12 inches Wide x 6inches Height

Handheld Converter: 9 inches x 1.3 inchesdiameter

Storage Temperature -20 to +500 C at a maximum relative humidity of90% (non-condensing)

Operating Temperature 0 to +40' C at a maximum relative humidity of 90%(non-condensing)

Section 005_5 10(k) Summary Page 005-3 ofOO05-13

510(k) Summary510(k) - AR1000 Series K131 096Arobella Medical, LLC

807.92(a)(5)Intended Use(s)

The ARi 000 Series and its variants produce and deliver low frequency ultrasoundused to promote wound healing via:

* Selective and non-selective dissection and fragmentation of soft and or hardtissue;

* Surgical, excisional or sharp-edge wound debridement (acute and chronicwounds, burns) for the removal of nonviable tissue including but not limited todiseased tissue, necrotic tissue, slough and eschar, fibrin, tissue exudates,bacteria and other matter.

Patient population is patients of any age with one or more wounds.Patient population may also exhibit diabetes mellitus (DM).

The ARi 000 Series and its variants is intended for Prescription use.

The ARi 000 Series and its variants produce and deliver low frequency ultrasoundused to promote wound healing via:

* Site cleansing irrigation and lavage of wound tissue (acute and chronicwounds, burns, diseased or necrotic tissue);

" Contact and or non-contact maintenance debridement for the removal ofdebris, exudates, fragments, bacteria, slough, fibrin, excised or fragmentedtissue, and other matter.

IRRIGATION (LAVAGE) FLUID*Irrigation fluid may be sterile de-ionized water, sterile saline solution, other

approved wound therapy or debridement solution.




510O(k) Summary510(k) -AROQO Series K131096Arobella Medical, LLC

The AR1000 Series and its variants produce and deliver low frequency ultrasoundused to promote wound healing by:

Preparing the wound bed for graft or other subsequent procedures usingcontact and or non-contact techniques to achieve wound debridement.




CLU

-IO(N 'a

CD 'E

oo

(D_0c

'- 0

a) I

E 0

U) 03

(DUCL)

00

0 CO

u C

C> w

) C Co

CD 0)

c) 0)

0-

E~ C

C3 iDa0 0uin) _c >

L o < C/i

-cd

>%1 ,-O ( 0, 0C...C mu O c >~

2.2 cm HCoQN 0

0)0

.2 05 *M -(

4-'F mf~f E0E a)) 0 xL

ala ~ M E 0 , aO) C>~c

Cc L)fl %C7cESVLCO' a) 0' 0~~E. - cC

(DC _00 Q) 0

0 ~ Q 0g ED -c .000 00 Moa )( r 0

'E~C r- 'afla)t-0< 05 E5 = --.- C.

zz U) 2 _

CL)-w a

0- 0 00 - a) 0(D .2 C D a) fcE U) )

(UW~~ W~>U~ -Eo 0

<C E

(D a)- a)C9 ~ --O a 0 ~O . M~ . vo n

2n C) a)O C) Wr'n < .c w 0 (

U)c 4o -am-ac-0

0*-

Q- c

(00 >cm (n

OrO) E 0<.0 -0. 2) cu-aow

cow -)wm=LODD HO 0n S-a. fl

(h C) L)0 V

<0~ 0a L(D~) C50 Qc c a =0c

0 C M~ , Ef , o E)

U)-22E)

vcm

(Df c >0 t

T ~ , 2 3

ad) 1 0))nU~ W Uf~ tl

Cc$ 0 C M - UEOUw

-aC)0 aQ M . ?8 w2 o n . S.2 0 )25 00)V 0 a) 2 0 a)l

Za C) 03 -i E) ft >c7c) 0 )Y) WCL

U0 $ 0)m > m0 . Cc U

(U D

F_ 00)rou C) >. r_>

(n =U aW C5w' 'DW9a 0 m aa). EO i=l~ 0 _r ~ C cD > 6 ,coE ma 2 (Ua 0

o ~CCC a)~~ 0o = 2 a) U~c50 0 0 (Uam )D E NO 3)Qw~ 2 CO>%o C 0 -:.r) w: w0 c(Dn gC a) a)

C/ D < <~t 2 )' :_ : 6CM 0 a0

(0U 0

rUG)~a cuL&5 O_r_ ) m ) 0)EM -- N

a)D HO < tC) >0)00 .(6 2 t c 0)C~i a

0) 00 0 CD 00 0

.2 c CO C = >M

V 0 U~ _~ 0- Cc~~~> 0 0) U. c"

0) 20 0w(nCD 0 0) mC- - o o w ~C - W,..

C C> 0 Da)C-0 -

-0 ac )

Ca 0 0cCO c>a) > 0

(D c' af ) W = 02 Cm c w Ec o - rC L 0 0 a)f-DCo E H1w~C=ara- " 0n

-, 'a -0 uCCa ) 0a 0 §.-=0 a

o 0) = ) W = c- )( ) xc

0 CL~

_ o -. 0 x 'E 0 c 0 0

0) EC 0 )(

0)-

U) 0 F

a) o 25 a)~ 05 : O w c = 7 = wQoL 2). FL 3r0) Ona 5m o um-

I - cr0 d)C 'a

0D < OaQS0)o a) 'a20ow. 'gaa) a)

0R =u00)C

IOOL a)a).a < LO >fl 'a' ' Ta2 -)c,0 c -E= ic

W) CD - a n a) c E 2'a

aocm.

0 0(0, a)c -

Q2) ca a

0 (1) flLu 7 a) aa)~n H > U 0 LI) .S>afin

0 -0d) C N

0 Oo 0 C0C c c)

I -. 0- Cfl I EC § 0.t0) 0)

0 N 0 2.2- 00 Eo.2 0?0)

o3 3 0 0 n a -0

-- 0) Q

C: LLO= t D)0

o N ~ j 2 0) QCE (Do N 0t 0 0 (D arfla

cc 04 N5~ N DoEMCW0V)) C C) w0 C

C) 0 0 Ca0 0 (D OL02:3 o0

oI <o 0

N

0W L-3

**t oN " 0N a

C o E~0)t5 u2 a 0 )

Cct cn ) Fu0 .>

0 C (D CDai) 0( C1 CE

N3f V) ~ C a- U) Et

:3 Nn0a L0 L 0 w 0

00 cc -(D0) c00t5 .

CD N~ff Mn- 0 m

-e oo c CL w Cg '~2 *g0 N )= -c00 00 0I ' Cr .

L)~(C0

-0Lo.)a LO(V < l D zC C coW C E2 IQ)oo o E~o yE a) 00 t 2macu0 0 a)0

_So. .-- 8 ) 0 ) 0.? (00)a) .2 a0t mV 0 0 0 0-0 0D t') U) to>0)0uCO o

E5< H I . . C 0 D7 v o t ><aD 0 cV.3 ) I0

20 - iC)C

to C C rCo CD C: E - ,) 0)

mo a)-0 or ca<2~ - C.> m .0-0.

00 0.2 0E 0 ) D

0O rn0) c00) t 0)c0 0 ))Dm -~),-- z? 0 ")HO2 WOO <L <0H HO

510(k) Summary510O(k) - AR 1000 Series K1 31096Arobella Medical, LLC

807.92(b)Safety and Effectiveness

There have been no changes to the AR1 000 Ultrasonic Wound Therapy Systemcleared under 510O(k) K062544 as a result of the proposed labeling changes.

This 510(k) submission supports an expansion of the device's Indications For Use,with respect to K062544, to incorporate expanded patient results and laboratoryfindings.

The expansion of the device's Indications For Use, with respect to K062544, do notraise any new issues of safety or effectiveness.

For safety and effectiveness purposes the AR1000 Ultrasound Wound TherapySystem and its variants is substantially equivalent to the previously cleared ARi 000Ultrasound Wound Therapy System (K062544), the Misonix SonicOne (K1 12782)system, Celleration MIST (K122246) system, the Soring Sonoca (K072904)systems, and the Ethicon (K002906) system.

1.0 Efficacy

This device, like the predicates, is directed for single (1) treatment, and totalrecommended treatments shall be no more than three (3) times per week or asdirected on the order of the physician. A typical treatment regimen is approximatelytwo (2) weeks or more, depending on the size and nature and or condition of thetreated area as well as other subject dependent factors, but may be prescribed formore or less frequent use and or for shorter or longer treatment regimen durations onthe order of a physician.

This device also compares with the predicates, as follows:

1. 1. Controlled ultrasonic delivery with 0.9% sterile saline solution, or other approvedmedium, to lavage the wound tissue (e.g. acute and chronic wounds, burns, diseasedor necrotic tissue), like the Arobella AR1000 (K062544) system and the Celleration(K1 22246) predicate ultrasonic wound system.

1.2. Maintenance debridement of the treatment site for the removal of loosefragments, debris, exudate, bacteria, and other matter, like Arobella AR1000(K062544) system, the Misonix SonicOne (K1 12782) system, the Celleration(K1 22246) system, and the Soring Sonoca (K072904) predicate ultrasonic woundsystem.

Section 005_5 10(k) Summary Page 005-11 of 005-13

510(k) Summary510(k) -AR1000 Series K131096Arobella Medical, LLC

1.3. Ultrasonic selective dissection and debridement of tissue through the use of theprobe (aka Qurette), including parallel to the wound bed surface for shallowseparation of tissue layers, like the predicate Arobella AR1000 (K062544) systemand the Misonix SonicOne (K1 12782) system.

2.0 Safety

The AR1000 Ultrasonic Wound Therapy System and its variants consists of anultrasonic power supply (hereto after referred to as a generator), an ultrasonicconverter hand piece (or just converter), and distal end probe tip (Qurette), a liquidsupply reservoir and delivery tubing. Substantial equivalence has been previouslyestablished between the ARi 000 Ultrasonic Wound Therapy System (K062544) andthe Celleration Mist, and the Misonix SonicOne predicate ultrasonic wound cleanserdevices as outlined under K062544.

2.1 Electrical Safety & Electromagnetic Compatibility

Similar to the relevant predicates, this device complies with the following standards:

* IEC 60601-1 Medical electrical equipment, Part 1: General requirements for basicsafety and essential performance* UL 60601 -1 Medical Electrical Equipment, Part 1: General Requirements for Safety* lEG 60601-1-2 Medical electrical equipment, Part 1-2: Electromagnetic compatibility

-Requirements and tests* EG 60601-1-4 Medical electrical equipment, Part 1-4: Programmable electrical

medical systems* FCC Part 18 - EMC Requirements

2.2 Ultrasonic Safety

Similar to the relevant predicates, this device complies with the following standards:

* 21 CFR 1050.10 -Ultrasonic therapy products* IEC 61847 Ultrasonics - Surgical systems - Measurement and declaration of thebasic output characteristics

Section 005_510(k) Summary Page 005-12 ofOO05-13

510(k) Summary510(k) -AR1000 Series K131096Arobella Medical, LLC

2.3 Biocompatibility

Similar to the relevant predicates, this device was tested for and complies with thestandard ISO 10993-1:2003 - Biological evaluation of medical devices, Part 1:Evaluation and testing and its relevant annexes (based on nature and duration ofpatient contact). All testing was conducted in compliance to 21 CFR, Part 58 GoodLaboratory Practice for Nonclinical Laboratory Studies.

The AR1000 system is routinely used with 0.9% sterile saline solution, which iswidely available for purchase from medical suppliers in bottle or bag form and is to besupplied by the user, as well as the tubing and the valve (for saline flow control). Inthe alternate, the AR1000 can also be used with other appropriate sterile mediumsand US FDA-approved irrigation liquids. This is substantially equivalent to all of thepredicate devices and irrigation solutions.

2.4 Transportati on/Sto rage

Packaging systems for the non-sterile device and for the non-sterile accessories ofthe device (e.g. the converter, tips, shroud, et al) keep the product withoutdeterioration and without a specific level of sterility stipulated, as do the predicatedevices. Those accessories used specifically for treatment (e.g. converter, tip,shroud, etc) are to be sterilized prior to use to minimize the risk of microbialcontamination, as established with the AR1000 K062544 device clearance.

As the device and the accessories are durable goods with little or no notabledeterioration, the shelf life is the product lifecycle, barring storage or transportationdamage, and/or use under extremes of environmental conditions (e.g. temperature,humidity, moisture, etc).

2.5 Reprocessing

The AR1000 system, as well as the AR1000 ultrasonic converter hand piece, is thewound debridement device cleared under K062544 for which reprocessinginstructions have been previously validated and cleared.

The variant ARlO000 ultrasonic converter hand piece allows for steam sterilization(autoclave) in addition to the previously cleared and validated reprocessingmethodology. This variant may therefore be reprocessed by steam sterilization(autoclave), as well as the previously cleared and validated reprocessingmethodology.

Section 005_5 10(k) Summary Page 005-13 ofO00i-13

DEPATMET O HELTH HUAN ERVCESPublic Health Service

IS DPARTENTOF HALT & HMANSERVCESFood and Doigl Adniinistmtion10903 New Hampshirt AvenueDocument Control Center - W066-G609Silver Spding MD 20993-0002

May 16, 2014

Arobella Medical LLCMatthew BerseheidDirector of Quality and Regulatory Affairs5929 Baker Road, Suite 470Minnetonka, MN 55345

Re: K131096Trade/Device Name: ARIOOO Ultrasonic Wound Therapy SystemRegulation Number: 21 CER 878.4410Regulatory Class: Class 11Product Code: NRBDated: April 03, 2014Received: April 04, 2014

Dear Mr. Bersoheid:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class HI (Special Controls) or class III (PMA), itmay be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

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 not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Matthew Berscheid

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000- 1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80 1), pleasecontact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041or (301) 796-7 100 or at its Internet addresshttr://www.fda.aov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please notethe 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 (21CER Part 803), please go tohttn://www.fdaagov/MedicalDevices/Safetv/ReportaProblem/default.htm for the ClDRH's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)796-7 100 or at its Internet addresshtty://www.fdaspov/MedicalDevices/ResourcesforYou/industr/default.htm.

Sincerely yours,

David Krause -Sfor Binita Ashar, MD, MBA, FACS

Acting DirectorDivision of Surgical DevicesOffice of Device EvaluationCenter for Devices andRadiological Health

cc: DMC510(k) StaffDivision0.0.

Indications for Use

51 0(k) Number (if known): _K1 31096_

Device Name: ARIOO00 Series Ultrasonic Wound Therapy System

Indications For Use:

The AR1000 Series and its variants produce and deliver low frequency ultrasound usedto promote wound healing via:

* Selective and non-selective dissection and fragmentation of soft and or hardtissue;

" Surgical, excisional or sharp-edge wound debridement (acute and chronicwounds, bums) for the removal of nonviable tissue including but not limited todiseased tissue, necrotic tissue, slough and esehar, fibrin, tissue exudates,bacteria and other matter.


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

(Part 21 CFR 80 1 Subpart D) (21 OFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRHK Office of Device Evaluation (ODE)

Jiyoung Dang -SDivision Sign-OffOffice of Device Evaluation

510(k)_Ki 31 096 Page 1 of 3

Indications for Use


Device Name: ARIO000 Series Ultrasonic Wound Therapy System


The AR1000 Series and its variants produce and deliver low frequency ultrasound usedto promote wound healing via:

" Site cleansing irrigation and lavage of wound tissue (acute and chronic wounds,bums, diseased or necrotic tissue);

* Contact and or non-contact maintenance debridement for the removal of debris,exudates, fragments, bacteria, slough, fibrin, excised or fragmented tissue, andother matter.

IRRIGATION (LAVAGE) FLUID*Irrigation fluid may be sterile de-ionized water, sterile saline solution, other

approved wound therapy or debridemnent solution.

Patient population is patients of any age with one or more wounds.Patient population may also exhibit diabetes mellitus (DMV).

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

(Part 21 CFR 801 Su~bpart D) (21 CFR 801 Subpart C)


Concurrence of CDRH, Office of Device Evaluation (ODE)


51 0(k)_K131096 Page 2 of 3

Indications for Use


Device Name: ARI 000 Series Ultrasonic Wound Therapy System


The AR1000 Series and its variants produce and deliver low frequency ultrasound usedto promote wound healing by:

Preparing the wound bed for graft or other subsequent procedures using contactand or non-contact techniques to achieve wound debridement.

Patient population is patients of any age with one or more wounds.Patient population may also exhibit diabetes mellitus (DMV).

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

(Pant 21 CFR 8011 Su~bpart -) (21 CFR 801 Subpart C)


Concurrence of CDRH, Office of Device Evaluation (ODE)


51 0(k)..K1 31 095 Page 3 of 3

510(k) summary may 16 2014 llc - food and drug …510(k) summary 510(k) -arloqo series k131096...

Documents