SMARTGRAFT 30 SYSTEM

K141591 · Ingeneron, Inc. · MUU · Sep 24, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141591
• Device Name: SMARTGRAFT 30 SYSTEM
• Applicant: Ingeneron, Inc.
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Sep 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SmartGraft™ 30 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraff™ 30 system is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system. The SmartGraft™ 30 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

SmartGraft™ 30 System is a disposable process pack used with an InGeneron Tissue Processing Unit (centrifuge); facilitates harvesting, centrifugation, and transfer of autologous adipose tissue. Input: lipoaspirate harvested via legally marketed lipoplasty system. Operation: low g-force centrifugation to concentrate adipose tissue. Output: concentrated autologous adipose tissue for transfer during the same procedure. Used in clinical settings by surgeons across multiple specialties (neurosurgery, plastic, orthopedic, etc.). Benefits: provides concentrated adipose tissue for body contouring or surgical reconstruction; maintains cell viability comparable to unprocessed tissue.

Clinical Evidence

Bench testing only. Studies evaluated system usability and performance in producing concentrated adipose tissue from lipoaspirate. Nucleated cell viability of concentrated tissue was compared to unprocessed adipose tissue, demonstrating no adverse impact on viability. Specification comparisons confirmed equivalence in operating principles and performance metrics.

Technological Characteristics

Single-use disposable process pack; medical-grade polymers; low g-force centrifugation principle; gamma irradiation sterilization; biocompatibility per ISO 10993. System is used with a separate centrifuge unit.

Indications for Use

Indicated for patients requiring autologous adipose tissue concentration for aesthetic body contouring or other surgical procedures across neurosurgery, GI, urological, plastic/reconstructive, general, orthopedic, gynecological, thoracic, laparoscopic, and arthroscopic specialties.

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

• Vortech™ Adipose Transfer System (K100114)
• AdiPrep™ Adipose Transfer System (K121005)

Submission Summary (Full Text)

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

September 24, 2014

InGeneron Incorporated Ms. Anita Kadala Chief Executive Officer/General Counsel 8205 El Rio Houston, Texas 77054

Re: K141591

Trade/Device Name: SmartGraft™ 30 System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: August 28, 2014 Received: September 3, 2014

Dear Ms. Kadala:

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 (reporting of medical

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K141591

Device Name SmartGraft™ 30 System

#### Indications for Use (Describe)

The SmartGraft™ 30 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraff™ 30 system is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system.

The SmartGraft™ 30 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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| <span style="text-decoration: underline;"><b></b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"><b>X</b></span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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### Section 5: 510(k) Summary

## 510(k) Summary of Safety and Effectiveness

| Date Summary Prepared: | 10 June 2014<br>Revised: 19 September 2014 |
|------------------------|--------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | InGeneron, Inc.<br>8205 El Rio<br>Houston, TX 77054 |
| Contact Person: | Anita Kadala – CEO/General Counsel<br>Tel: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Device Trade Name: | SmartGraft™ 30 System |
| Common Name: | Suction Lipoplasty System |
| Classification Name: | Suction Lipoplasty System, Class II |
| Regulation: | 21 CFR 878.5040, Suction Lipoplasty System |
| Product Code: | MUU |

| Legally Marketed Devices<br>To Which Substantial<br>Equivalence is Claimed: | K100114 Vortech™ Adipose Transfer System, Biomet<br>Biologics, Inc. and,<br>K121005 AdiPrep™ Adipose Transfer System from<br>Harvest Technologies Corp. |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The SmartGraft™ 30 System is a disposable process pack<br>to be used with the InGeneron Tissue Processing Unit<br>(centrifuge). The process pack is a collection of sterile<br>single-use off-the-shelf and proprietary components used<br>during the process of harvesting, centrifugation and<br>transferring of autologous adipose tissue. It is intended for<br>the concentration of aspirated adipose tissue for subsequent<br>transfer during the same procedure. |
| Indications For Use: | The SmartGraft™ 30 System is intended to be used in<br>medical procedures involving the harvesting, centrifugation<br>and transferring of autologous adipose tissue. The<br>SmartGraft™ 30 System is used for concentrating adipose<br>tissue for aesthetic body contouring, and for tissue that has<br>been harvested with a legally marketed lipoplasty system. |
| | The SmartGraft™ 30 System is intended for use in the<br>following surgical specialties when the concentration of<br>harvested adipose tissue is desired. |
| | * Neurosurgery,<br>* Gastrointestinal Surgery,<br>* Urological Surgery,<br>* Plastic and Reconstructive Surgery,<br>* General Surgery,<br>* Orthopedic Surgery,<br>* Gynecological Surgery,<br>* Thoracic Surgery,<br>* Laparoscopic Surgery,<br>* Arthroscopic Surgery |
| Substantial Equivalence: | The SmartGraft™ 30 System is believed to be substantially<br>equivalent to the two referenced legally marketed predicate<br>devices in that it has the same intended use, same operating<br>principles and same function within the medical procedure,<br>uses equivalent polymeric materials of construction, are all<br>provided as sterile single-use disposables. The<br>SmartGraft™ 30 device is sterilized using the same<br>sterilization method as one referenced legally marketed<br>predicate device. Substantial equivalence to a legally<br>marketed predicate device in reference to biocompatibility<br>for the intended use using was determined using a<br>recognized standard. The SmartGraft™ 30 System and<br>both referenced legally marketed predicate devices are<br>intended to be used for the same application across the<br>same range of surgical specialties. |

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## Technological Characteristics:

The SmartGraft™ 30 System is substantially equivalent to the two legally marketed predicate devices cited based on technological characteristics. The SmartGraft™ 30 and the two legally marketed predicates cited all are used in the concentration of adipose tissue harvested with legally

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marketed lipoplasty systems. All three are single-use devices made of medical-grade polymer materials. The SmartGraft™ 30 device and at least one other predicate are tested for biocompatibility to ISO 10993. All three are sterilized using standard sterilization methods for sterile single-use devices. The SmartGraft™ 30 device and one predicate device use gamma irradiation for sterilization, whereas the other predicate device utilizes EO gas sterilization. All three devices utilize a centrifuge-like device using relatively low g-force for short periods of time for concentration of adipose tissue for transfer. The volume of adipose tissue processed by the SmartGraft™ 30 System is essentially identical to one of the predicate devices. Both of these volumes are smaller than the volume processed by the other predicate device.

Bench Testing: Determination of substantial equivalence was substantiated by a tabular specification comparison between the SmartGraft™ 30 and the two legally marketed predicate devices, and through two non-clinical studies involving only the SmartGraft™ 30 system. Both usability of the system according to Instructions for Use, and operation of the system to produce concentrated adipose tissue from lipoaspirate were tested. Concentrated adipose tissue produced using the SmartGraft™ 30 system was investigated further evaluating the nucleated cell viability of the concentrated adipose tissue compared to unprocessed adipose tissue. The results of the viability evaluation indicate that the SmartGraft™ 30 system does not adversely impact viability of the adipose tissue. Impact of the SmartGraft™ 30 system on cell viability is then substantially equivalent to that of predicate devices. A specification comparison between the SmartGraft™ 30 System and predicate devices was also used to make a determination of substantial equivalence. The specification comparison shows that all three use low g-force centrifugation for a short period of time as an operating principle to obtain concentrated lipoaspirate. The Usability and Clinical Evaluation protocols and corresponding reports indicate that that the SmartGraft™ 30 System performs to specification, and can be operated successfully with the Instructions for Use provided (Appendix 1 -Appendix 4).