LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200

K092284 · Medical Device Resource Corp. · MUU · Sep 1, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K092284
• Device Name: LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200
• Applicant: Medical Device Resource Corp.
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Sep 1, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in aspirating subcutaneous fatty tissue including autologous fat collection.

Device Story

LipiSystems AquaVage is a sterile canister system used for suction lipoplasty. The device consists of a plastic canister, sterile silicone tubing, and a collection syringe. It interfaces between a suction aspirator and the patient to collect aspirated subcutaneous fat. The system is operated by a clinician in a clinical setting. The device functions by providing a sterile pathway and collection vessel for fat tissue during liposuction procedures. The primary benefit is the collection of autologous fat for aesthetic body contouring. The device is distinguished from the predicate by the inclusion of a sterilized canister system.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Plastic canister, syringe, and silicone tubing. System components include port interfaces for canister-to-tubing and aspirator-to-canister connections, sterile tubing, and a collection syringe. The device is a manual/mechanical suction accessory. Sterilization: The canister system is provided sterile.

Indications for Use

Indicated for patients desiring aesthetic body contouring and autologous fat collection via aspiration of subcutaneous fatty tissue.

Regulatory Classification

Identification

A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.

Special Controls

*Classification.* Class II (special controls). Consensus standards and labeling restrictions.

Predicate Devices

• LS Liposuction Aspirator (K081593)

Submission Summary (Full Text)

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Food and Drug Administration Center for Device and Radiological Health HFZ-401 9200 Corporate Blvd Rockville, MD 20850

SEP - 1,2009

ﺎ

K092284 May 2

July 24th, 2009

Dear Sir/Madam,

Delineated below is the 510(k) Summary:

| Date prepared: | July 24th, 2009 | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner / Preparer / Official Contact: | Melbourne<br>Kimsey II<br>23392 Connecticut Street | |
| Hayward, Ca. 94545 | | |
| 510.909.7882 Mobile | | |
| 510.732.9950 Office | | |
| 510.785.8182 Fax | | |
| Manufacturer: | Medical Device Resource Corporation | |
| Trade Name: | LipiSystems AquaVage | |
| Common Name: | Sterile canister system | |
| Classification Name: | Suction Lipoplasty System, Class II - 21 CFR<br>§ 878.5040, Product Code: MUU<br>21 CFR 880.6960 - Syringe, Class I (Sterile), Product<br>Code: KYZ | |
| Legally marketed device: | K081593 - LS Liposuction Aspirator | |
| Description of Device: | Device function: | 1. Contains port interfaces<br>between: Canister to tubing &<br>aspirator to canister.<br>2. Sterile tubing to connect the<br>interfaces<br>3. Funnel to interface port to<br>tubing.<br>4. Syringe to collect fat. |
| | Device design: | 1. Contents subjected to<br>sterility |
| | Material used: | Plastic Canister, Syringe,<br>silicone tubing |

.

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K092284 page 4/2

| | Physical properties: | Plastic & Silicone |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Intended Use of the Device: | For use in aspirating subcutaneous fatty tissue including<br>autologous fat collection. | |
| Patient population for which the device is<br>intended: | Patients who desire aesthetic body contouring and<br>autologous fat collection | |
| 510(k) Summary continued... | 11 | |
| Technological characteristics: | Same as predicate except canister is sterilized | |
| Determination of substantial equivalence: | SE to the predicate device was based on non-clinical<br>data. Performance and function supported the<br>determination of SE. | |
| Conclusions for safety, effectiveness, and<br>performance of the device: | Predicate device demonstrates safety/effectiveness.<br>Conclusions have been drawn that the device is SE and<br>therefore safe & effective. The device performs better<br>than predicate due to addition of sterilized canister<br>system. | |

Sincerely,

Melbourne Kimsey II President

'

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center ~ WO66-G609 Silver Spring, MD 20993-0002

Medical Device Resource Corporation % Mr. Melbourne Kimsey II President 23392 Connecticut Street Hayward, California 94545

March 21, 2013

Re: K092284

K032264
Trade/Device Name: Lipisystems Aquavage Model AV2000 & 1200 Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU, KYZ Dated: July 24, 2009 Received: August 7, 2009

Dear Mr. Kimsey:

This letter corrects our substantially equivalent letter of September 1, 2009.

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 iv(c) premaint is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivalent in referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to teany management date of the Medical Device Amendments on to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drue commerce prior to May 28, 1976, the enactions of the Frovisions of the Federal Food, Drug, devices that have been reclassified in accordance was are archarded approval (PMA). You may,
and Cosmetic Act (Act) that do not require approval of the Act. The ectoral and Cosmetic Act (Act) that do not require approvisions of the Act. The general
therefore, market the device, subject to the general control provisions of the general therefore, market the device, subject to the generals for annual registration, listing of devices, controls provisions of the Act include requirements for annual regions and adulteration.
good manufacturing practice, labeling, and prohibitions against misbranding and adult

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) minorenas it eppations affecting your device can be
it may be subject to additional controls. Existing major regulation FDA may it may be subject to additional controls. Larsing major regor. of each as an addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 800 federal R found in the Code of Federal Regulations, This any .
publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substance equires with other requirements of the Act
that FDA has made a determination that your device adderacies. You must that FDA has made a determination inal your areas by other Federal agencies. You must
or any Federal statutes and regulations administered by other Federal ion and listing or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: reporting of medic comply with all the Act's requirements, including be novements of medical
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical CFR Part 807); labeling (21 CFR Part 801); incured device reporting (1)
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Melbourne Kimsey II

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s and the superior and the second of the column and CDRUCCRALLSS00 htm for If you desire specific advice for your devices/CDRHCORHOffices/ucm] I S809.htm for and go to mtp://www.loa.gov/Abouth DAVCCMcchions of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) natifiestion" (21CFR Part the Center for Devices and Radionaling by reference to premarket notification" (21 CFR Part note the regulation entitled, "Misoranding of reference to promation
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

CFR Part 803), please go to of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain other general information on your responsional as and its toll-free number [phone] or [phone] or at its Internet address [phone] of [phone] 7100 0100 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

> Sincerely yours, FOR Peter D. Rumm -S

> > Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K092284

Lipisystems Aquavage Model AV2000 & 1200 Device Name:

For use in aspirating subcutaneous fatty tissue including autologous fat collection.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krome
(Division Sign-Off)

(Division Sign-(Division Sign-Sign-Sign-Orthopedic, and Restorative Devices

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510(k) Number: K092284.