ADIPREP ADIPOSE TRANSFER SYSTEM

K121005 · Harvest Technologies, Corp. · MUU · Sep 21, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121005
• Device Name: ADIPREP ADIPOSE TRANSFER SYSTEM
• Applicant: Harvest Technologies, Corp.
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Sep 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2

Intended Use

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

Device Story

AdiPrep Adipose Transfer System is a sterile, single-use disposable process pack used with the SmartPReP2 centrifuge; designed for aspiration, harvesting, and concentration of autologous adipose tissue. System components include syringes with removable plungers, centrifuge tubes with filters, aspiration/injection cannulas, and skin puncture needles. Operated by clinicians in surgical settings; adipose tissue is harvested using a separate lipoplasty system, then processed in the AdiPrep pack via centrifugation (approx. 4 minutes at 1250 g-force) to concentrate the tissue. The resulting concentrated autologous adipose product is then transferred by the clinician for the intended surgical application. The device facilitates tissue concentration, potentially improving graft quality for reconstructive or surgical procedures.

Clinical Evidence

Bench testing only. Comparative study verified that the output of the AdiPrep system (nucleated cell count and viability) is substantially equivalent to the Viafill and Vortech predicate devices. Results indicated functional equivalence within the intended use.

Technological Characteristics

Components include medical-grade plastic syringes, centrifuge tubes with filters, and stainless steel cannulas. Sterilized via Ethylene-Oxide (EtO) gas. Operates via centrifugation (1250 g-force for 4 minutes) using the SmartPReP2 laboratory centrifuge. Designed for 5 mL to 25 mL fill volumes. Biocompatibility confirmed per ISO 10993.

Indications for Use

Indicated for patients undergoing medical procedures requiring harvesting and transfer of autologous adipose tissue; used for concentrating adipose tissue harvested via legally marketed lipoplasty systems across various surgical specialties including neurosurgery, gastrointestinal, urological, plastic/reconstructive, general, orthopedic, gynecological, thoracic, laparoscopic, and arthroscopic 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

• Viafill System (K081848)
• Vortech Adipose Transfer System (K100114)

Submission Summary (Full Text)

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K121005 page 1/4

# 510(k) SUMMARY

| 510(k) Summary of Safety and Effectiveness | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared: | September 18, 2012 |
| Applicant/Sponsor: | Harvest Technologies Corporation<br>40 Grissom Road, Suite 100<br>Plymouth, MA 02360 |
| Phone Number: | 508-732-7541 |
| Fax Number: | 508-732-0400 |
| Contact Person: | Susan Finneran - Director Regulatory Affairs |
| Device Trade Name: | Harvest AdiPrep™ Adipose Transfer System |
| Common name: | Fat Concentration System |
| Classification Name: | Lipoplasty System, Class II<br>(21 CFR 878.5040, Suction Lipoplasty System,<br>Product Code MUU) |
| Legally Marketed Devices<br>to Which Substantial<br>Equivalence Is Claimed: | K081848, Viafill System, Lipose Corporation and,<br>K100114, Vortech Adipose Transfer System, Biomet Biologics,<br>Inc. |
| Device Description: | The Harvest AdiPrep Adipose Transfer System consists of a<br>disposable process pack to be utilized with the SmartPReP2<br>centrifuge. The process pack is a sterile (EtO) single<br>use disposable pack used for the aspiration, harvesting, and<br>transferring of autologous adipose tissue. It is intended for the<br>concentration of aspirated adipose tissue for subsequent transfer<br>during the same procedure. |
| Indications for Use: | The AdiPrep™ Adipose Transfer System is used in medical<br>procedures involving the harvesting and transferring of autologous<br>adipose tissue. The AdiPrep system is used for concentrating<br>adipose tissue harvested with a legally marketed lipoplasty system.<br>The AdiPrep™ Adipose Transfer System is intended for use in the<br>following surgical specialties when the concentration of harvested<br>adipose tissue is desired.<br>• Neurosurgery<br>• Gastrointestinal Surgery<br>• Urological Surgery<br>• Plastic and Reconstructive Surgery<br>• General surgery |

- Orthopedic Surgery .

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- . Gynecological Surgery
- Thoracic Surgery .
- Laparoscopic Surgery .
- Arthroscopic Surgery ●

#### Substantial Equivalence:

The device system has been cleared by the FDA by the 510(k) Premarket Notification process. This submission describes this new adipose concentration system as compared to the predicate devices.

### Technological Characteristics:

Based on the intended use, design, materials, and technological characteristics presented in this premarket notification as summarized in Table 1 below, the Harvest AdiPrep Adipose Transfer System has been shown to be substantially equivalent to the currently marketed predicate devices. Biocompatibility testing was conducted as per ISO 10993 to demonstrate that the materials used in the manufacture of the the AdiPrep Adipose Transfer System are suitable for the intended use.

Clinical Testing:

Clinical testing was performed to determine substantial equivalence to the predicate device. The testing included verification that the output of the AdiPrep Adipose Transfer System is substantially equivalent to the predicate Viafill System (Lipose Corp.) and the Vortech Adipose Transfer System (Biomet Biologics). The results indicated the devices were functional within their intended use. A summary of the results appears in Table 1 below.

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K12.1005 Page 3/4

| | DEVICES | | |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURES | AdiPrep Adipose Transfer<br>System<br>(This submission) | Lipose Fat Transfer System,<br>K081848, (Predicate device) | Biomet Vortech™ Adipose Transfer<br>System (VATS), K100114, (Predicate<br>device) |
| Indications for<br>Use (IFU) | The AdiPrep™ Adipose<br>Transfer System is used in<br>medical procedures involving<br>the harvesting and transferring<br>of autologous adipose tissue.<br>The AdiPrep system is used for<br>concentrating adipose tissue<br>harvested with a legally<br>marketed lipoplasty system.<br>The AdiPrep™ Adipose<br>Transfer System is intended for<br>use in the following surgical<br>specialties when the<br>concentration of harvested<br>adipose tissue is desired.<br>Neurosurgery, Gastrointestinal<br>Surgery, Urological Surgery,<br>Plastic and Reconstructive<br>Surgery, General Surgery,<br>Orthopedic Surgery,<br>Gynecological Surgery,<br>Thoracic Surgery, Laparoscopic<br>Surgery, Arthroscopic Surgery | The Lipose Fat Transfer<br>System is intended to be used<br>in the aspiration, harvesting,<br>and reinjecting of autologous<br>fat. | The Vortech™ Adipose Transfer System<br>(VATS) is used in medical procedures<br>involving the harvesting and transferring of<br>autologous fat tissue. The VATS System is<br>used for concentrating fat harvested with a<br>legally marketed lipoplasty system. The<br>VATS System is intended for use in the<br>following surgical specialties when the<br>concentration of adipose tissue is desired.<br>Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery |
| FEATURES | DEVICES | | |
| | AdiPrep Adipose Transfer<br>System<br>(This submission) | Lipose Fat Transfer System,<br>K081848, (Predicate device) | Biomet Vortech™ Adipose Transfer<br>System (VATS), K100114, (Predicate<br>device) |
| Processing Pack:<br>-Materials | Components-syringes with<br>removable plunger, centrifuge<br>tubes with filter, aspiration &<br>fat injection cannula, fat<br>injection syringes, skin<br>puncture needles, and oil<br>extraction syringe & needle.<br>Cannula & syringes composed<br>of medical grade plastics. | Components-syringes with<br>removable plunger, centrifuge<br>tubes with filter, aspiration &<br>fat injection cannula, fat<br>injection syringes, skin<br>puncture needles, and oil<br>extraction syringe & needle. | The materials used in the Fat Concentrator,<br>syringes, and accessories consist of medical<br>grade polymers, elastomers, and stainless steel<br>suitable for use in medical devices. All<br>components are packaged, labeled and<br>sterilized as indicated by the manufacturer<br>labeling. |
| -Fill volumes<br>(mL) | Volume = 5 mL to 25 mL | Volume = 5 mL to 20 mL | Volume = 180 mL |
| -Sterilization<br>Method | Ethylene-Oxide Gas (EtO) | Gamma Radiation | Gamma Radiation |
| Autologous<br>Adipose<br>Product*<br>Nucleated Cell<br>Count (x10³/ml of<br>Product) | Mean 1.823<br>Mean 83.5 | Mean 1.848<br>Mean 82.4 | Actual results are not available, however, in<br>K100114, Biomet reported that testing "by<br>direct comparison included verification that<br>the output of the Vortech™ Adipose Transfer<br>System (VATS) is substantially equivalent to<br>the Viafill™ System (Lipose Corp.), the<br>predicate device. Test results for both percent |
| -Nucleated Cell<br>Viability (%) | | | volume reduction and percent cell viability<br>show that the VATS System is substantially<br>equivalent to the Viafill System." |
| Processing<br>Capabilities | | | |
| Volume | Volume = 5 mL to 25 mL | Volume = 5 mL to 20 mL | Volume = 180 mL |
| Low-g-force | Centrifuge to spin for<br>approximately 4 minutes at<br>1250 g-force. | Centrifuge to spin for 2 minutes<br>at 50 g-force. | 4 ½ minute centrifugation process , g-force<br>unknown. |
| Laboratory<br>Centrifuge | SmartPReP2 Centrifuge is a<br>general purpose laboratory<br>centrifuge for clinical use. | Viafill™ System centrifuge is a<br>general purpose laboratory<br>centrifuge. | The VATS reusable portable tabletop base<br>unit is similar to a general purpose laboratory<br>centrifuge. |

# Table 1: SUBSTANTIAL EQUIVALENCE COMPARISON CHART

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

SEP 2 1 2012

Harvest Technologies Corporation % Mr. Gabriel J. Muraca, Jr. Regulatory Affairs Manager 40 Grissom Road, Suite 100 Plymouth, Massachusetts 02360

Re: K121005

Trade/Device Name: AdiPrep™ Adipose Transfer System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: August 29, 2012 Received: August 30, 2012

Dear Mr. Muraca:

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.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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### Page 2 - Mr. Gabriel J. Muraca, Jr.

forth in the quality systems (OS) 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/CDRH0ffices/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/dafault.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melker 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): K121005

## Device Name: AdiPrep™ Adipose Transfer System

Indications for Use:

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

- Neurosurgery .
- Gastrointestinal Surgery t
- Urological Surgery .
- · Plastic and Reconstructive Surgery
- General surgery ●
- . Orthopedic Surgery
- Gynecological Surgery .
- Thoracic Surgery .
- Laparoscopic Surgery
- Arthroscopic Surgery

Prescription Use (Part 21 CFR 801 Subpart D)

#### AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krene for MM
(Division Sign-Off)

Page of

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121005