FAT CONCENTRATION SYSTEM

K100114 · Biomet, Inc. · MUU · Sep 29, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100114
• Device Name: FAT CONCENTRATION SYSTEM
• Applicant: Biomet, Inc.
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Sep 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vortech™ Adipose Transfer System (VATS) is used in medical procedures involving the harvesting and transferring of autologous fat tissue. The VATS System is used for concentrating fat harvested with a legally marketed lipoplasty system. The VATS System is intended for use in the following surgical specialties when the concentration of adipose tissue is desired. - Neurosurgery - Gastrointestinal and Affiliated Organ Surgery - Urological Surgery - Plastic and Reconstructive Surgery - General Surgery - Orthopedic Surgery - Gynecological Surgery - Thoracic Surgery - Laparoscopic Surgery

Device Story

VATS system concentrates autologous fat tissue harvested via legally marketed lipoplasty systems. Components include disposable fat concentrator, reusable portable tabletop base unit, and single-use piston syringes. Used in clinical/surgical settings by physicians across multiple specialties. Device processes harvested fat to increase concentration for subsequent transfer. Output is concentrated adipose tissue for surgical use. Benefits include efficient preparation of autologous fat for reconstructive or surgical applications.

Clinical Evidence

No clinical data provided. Substantial equivalence established via non-clinical bench testing comparing VATS output to the Viafill™ System predicate, specifically measuring percent volume reduction and percent cell viability.

Technological Characteristics

System comprises disposable fat concentrator, reusable tabletop base unit, and single-use piston syringes. Materials and manufacturing methods are consistent with previously cleared devices. Mechanical concentration principle. No software or electronic algorithm described.

Indications for Use

Indicated for patients undergoing medical procedures requiring harvesting, concentration, and transfer of autologous fat tissue across various surgical specialties including neurosurgery, GI, urology, plastic/reconstructive, general, orthopedic, gynecological, thoracic, and laparoscopic surgery.

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

• Cytori AFT System (K072587)
• Lipose Fat Transfer System (K081848)

Reference Devices

• Viafill™ System (Lipose Corp.)

Submission Summary (Full Text)

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# 510(k) Summary

Preparation Date:

October 16, 2009

SEP 2 9 2010

Applicant/Sponsor: Biomet Biologics, Inc., P.O. Box 587, Warsaw, IN 46581 Contact Person: Lonnie Witham Vortech™ Adipose Transfer System (VATS) Proprietary Name: Common Name: Fat Concentration System Classification Name: Suction Lipoplasty System MUU (21 CFR 878.5040)

## Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

K072587 Cytori AFT System, Cytori Therapeutics, Inc. K081848 Lipose Fat Transfer System, Lipose Corporation

Device Description:

The VATS System includes a disposable fat concentrator, reusable portable tabletop base unit, and single-use piston syringes.

### Intended Use:

The Vortech™ Adipose Transfer System (VATS) is used in medical procedures involving the harvesting and transferring of autologous fat tissue. The VATS System is used for concentrating fat harvested with a legally marketed lipoplasty system. The VATS System is intended for use in the following surgical specialties when the concentration of adipose tissue is desired.

- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological Surgery
- Plastic and Reconstructive Surgery �
- General Surgery �
- Orthopedic Surgery �
- Gynecological Surgery �
- Thoracic Surgery ø
- Laparoscopic Surgery �
- a

### Summary of Technologies:

The manufacturing methods, components and materials used for the VATS System have been used in devices previous-cleared for commercial distribution.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The testing included verification that the output of the Vortech™ Adipose Transfer System (VATS) is substantially equivalent to the Viafill™ System (Lipose Corp.) predicate device by direct comparison. Test results for both percent volume reduction and percent cell viability show that the VATS System is substantially equivalent to the Viafili™ System, a currently marketed predicate device. The results indicated that both devices were functional within their intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.

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

SEP 2 9 2010

Biomet Biologics, LLC % Mr. Lonnie Witham Regulatory Affairs Consultant 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K100114

Trade/Device Name: Vortech™ Adipose Transfer System (VATS) Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: August 30, 2010 Received: August 31, 2010

Dear Mr. Witham:

We have reviewed your Section 510(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 II (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.

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Page 2 - Mr. Lonnie Witham

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

For Patothm Des D.R

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

SEP 2 9 2010

Device Name:

Indications for Use: VortechTM Adipose Transfer System (VATS)

The Vortech™ Adipose Transfer System (VATS) is used in medical procedures involving the filtering and transferring of autologous fat tissue. The Vorted Adipose Tighster System (VATS) is used for concentrating faction with a legally marketed ipoplasty system. The Vortech™ Adipose Transfer System (VATS) is intended for use in the following surgical specialties when the concentration of adipose tissue is desired.

- Neurosurgery 9
- Gastrointestinal and Affiliated Organ Surgery 0
- ଡ Urological Surgery
- Plastic and Reconstructive Surgery
- General Surgery �
- Orthopedic Surgery 0
- Gynecological Surgery
- Thoracic Surgery
- Laparoscopic Surgery

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number L/60/14