KTA Adipose Treatment Kit

K190386 · Stemics S.A.S · MUU · Oct 10, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K190386
• Device Name: KTA Adipose Treatment Kit
• Applicant: Stemics S.A.S
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Oct 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KTA Adipose Treatment Kit is intended for medical and surgical procedures involving autologous fat grafting that consists in: -harvesting, -centrifuging, and -reinjecting autologous adipose tissue, Within the same procedure. The KTA Adipose Treatment Kit range consists in a family of products which are designed to harvest, process with minimal manipulation and reinject small - KTAMICRO, KTAEASY, KTAMY - to large -KTAMACRO, KTAMACROMED, KTASPIN - volumes of autologous fat in the following specialties: Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Arthroscopic Surgery,

Device Story

KTA Adipose Treatment Kit is a sterile, single-use disposable system for harvesting, processing (centrifuging), and reinjecting autologous adipose tissue during a single surgical procedure. Kit components include syringes, cannulas, needles, containers, Luer Lock connectors, and a centrifuge nut. Operated by clinicians in surgical settings; device facilitates fat transfer by allowing minimal manipulation of tissue. Output is processed autologous fat ready for reinjection. Benefits include standardized, sterile handling of adipose tissue for reconstructive or surgical grafting needs.

Clinical Evidence

Bench testing only. Testing included shipping validation, real-time and accelerated aging, usability, connection compatibility (forces and seal strength), pressure/vacuum limits, corrosion resistance, assembly, biocompatibility (ISO 10993-1), and cell viability. All tests met predetermined acceptance criteria.

Technological Characteristics

Single-use sterile (EtO) kit. Components: medical-grade plastic syringes, cannulas, needles, centrifuge tubes with filters, Luer Lock connectors. Processing involves manual aspiration and centrifugation. Biocompatible per ISO 10993-1. Shelf life: 3 years. Packaging: Tyvek sealing.

Indications for Use

Indicated for patients undergoing autologous fat grafting procedures 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

• Lipose Fat Transfer System (K081848)
• Harvest AdiPrep™ Adipose Transfer System (K121005)

Submission Summary (Full Text)

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October 10, 2019

Stemics S.A.S % Catherine Gloster President Gloster Biomedical International, LLC 577 North Hope Avenue Santa Barbara, California 93110

Re: K190386

Trade/Device Name: KTA Adipose Treatment Kit Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: February 15, 2019 Received: February 19, 2019

Dear Ms. Gloster:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K190386

Device Name KTA Adipose Treatment Kit

Indications for Use (Describe) The KTA Adipose Treatment Kit is intended for medical and surgical procedures involving autologous fat grafting that consists in: -harvesting, -centrifuging, and -reinjecting autologous adipose tissue, Within the same procedure.

The KTA Adipose Treatment Kit range consists in a family of products which are designed to harvest, process with minimal manipulation and reinject small - KTAMICRO, KTAEASY, KTAMY - to large -KTAMACRO, KTAMACROMED, KTASPIN - volumes of autologous fat in the following specialties:

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) | |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## (7 STEMCIS

# 510(k) Summary

| Submission Date: | 10/6/2019 |
|-----------------------|--------------------------------------------------------------------------|
| K190386 | |
| SUBMITTER INFORMATION | |
| Company Name: | STEMCIS SAS |
| Company Address: | 2 rue du Professeur Paul Milleret<br>25000 Besançon<br>FRANCE |
| Contact Person: | Stéphane Giraud<br>[phone]<br>Email: [e-mail] |

### DEVICE INFORMATION

| Trade Name: | KTA Adipose Treatment Kit |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Adipose Treatment Kit |
| Classification Name: | 21CFR 878.5040 |
| Device Class: | Class II |
| Product code: | MUU |
| Predicate Devices: | K081848 Lipose Fat Transfer System<br>K121005 Harvest AdiPrep™ Adipose Transfer System |
| Device Description: | The KTA Adipose Treatment Kit consists of a sterile (EtO) single use<br>disposable pack used for the aspiration, harvesting, centrifuging and<br>reinjection of autologous adipose tissue during the same procedure.<br>Each kit contains the necessary equipment such as syringes,<br>cannulas, needles, containers, Luer Lock caps / connectors and a<br>standard M8 single use nut for the centrifuge |
| Indications for Use: | The KTA Adipose Treatment Kit is intended for medical and surgical<br>procedures involving autologous fat grafting that consists in:<br>• Harvesting,<br>• Centrifuging, and<br>• Reinjecting autologous adipose tissue,<br>Within the same procedure.<br><br>The KTA Adipose Treatment Kit range consists in a family of products<br>which are designed to harvest, process with minimal manipulation<br>and reinject small – KTAMICRO. KTAEASY, KTAMY – to large – |

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# (ĮSTEMCIS

| | KTAMACRO, KTAMACROMED, KTASPIN – volumes of autologous fat<br>in the following specialties:<br><br>Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic<br>and Reconstructive Surgery, General Surgery, Orthopedic Surgery,<br>Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery,<br>Arthroscopic Surgery. | |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Performance Data: | Bench testing has been performed to demonstrate the substantial<br>equivalence of the devices to the predicates. Bench testing included:<br>shipping validation, real time and accelerated aging, usability testing,<br>connections compatibility (connective forces and connection seal<br>strength), maximum pressure and vacuum, dimensional analysis,<br>resistance to corrosion, assembly testing, biocompatibility testing,<br>and cell viability testing. | |
| Technological Characteristics<br>and Comparison to Predicate<br>Device(s): | This submission describes the KTA Adipose Treatment Kit as<br>compared to the predicate devices. Based on the intended use,<br>design, materials, and technological characteristics presented in this<br>premarket notification as summarized in the Table below, the<br>STEMCIS KTA Adipose Treatment Kit has been shown to be<br>substantially equivalent to the currently marketed predicate devices. | |

### SUBSTANTIAL EQUIVALENCE COMPARISON CHART

| Features | Subject device<br>KTA range | K081848 Predicate | K121005 Predicate |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification and<br>regulation number | System, Suction, Lipoplasty<br>21CFR 878.5040 | System, Suction, Lipoplasty<br>21CFR 878.5040 | System, Suction, Lipoplasty<br>21CFR 878.5040 |
| Product code | MUU | MUU | MUU |
| Features | Subject device<br>KTA range | K081848 Predicate | K121005 Predicate |
| Indications for use<br>& intended use | The KTA Adipose Treatment<br>Kit is intended for medical and<br>surgical procedures involving<br>autologous fat grafting that<br>consists in:<br>• Harvesting,<br>• Centrifuging, and<br>• Reinjecting<br>autologous adipose<br>tissue,<br> | The Lipose Fat Transfer<br>System is intended to be<br>used in the aspiration,<br>harvesting, and reinjecting of<br>autologous fat | The AdiPrep™ Adipose<br>Transfer System is used in<br>medical procedures involving<br>the harvesting and<br>transferring of autologous<br>adipose tissue. The AdiPrep™<br>system is used for<br>concentrating adipose tissue<br>harvested with a legally<br>marketed system.<br><br>The AdiPrep™ adipose<br>transfer system is intended<br>for use in the following<br>surgical specialties when the<br>concentration of harvested<br>adipose tissue is desired.<br>Neurosurgery,<br>Gastrointestinal Surgery,<br>Urological Surgery, Plastic<br>and reconstructive Surgery,<br>General Surgery, Orthopedic<br>Surgery, Gynecological<br>Surgery, Thoracic Surgery,<br>Laparoscopic Surgery,<br>Arthroscopic Surgery |
| Technological<br>characteristics<br>Processing pack<br>components | 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,<br>centrifuge tubes with filter,<br>aspiration & fat injection<br>cannula, fat injection<br>syringes, skin puncture<br>needles, and oil extraction<br>syringe & needle | Components-syringes with<br>removable plunger,<br>centrifuge tubes with filter,<br>aspiration & fat injection<br>cannula, fat injection<br>syringes, skin puncture<br>needles, and oil extraction<br>syringe & needle. Cannula &<br>syringes composed of<br>medical grade plastics |
| Sterilization<br>method | Ethylene-Oxide Gas (EtO) | Gamma radiation | Ethylene-Oxide Gas (EtO) |
| Sterility Assurance<br>Level | SAL 10-6<br>Shelf life: 3 years | SAL 10-6 | SAL 10-6 |
| Features | Subject device<br>KTA range | K081848 Predicate | K121005 Predicate |
| Packaging | Tyvek® sealing | Tyvek® sealing | Tyvek® sealing |
| Disposable or<br>reusable | Single use, disposable | Single use, disposable | Single use, disposable |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |

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# (7 STEMCIS

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## OSTEN

### NON-CLINICAL PERFORMANCE DATA

### SAFETY BENCH TESTING

In accordance with ISO 10993-1, KTA Adipose Treatment Kit is categorized as an external communicating device with limited contact duration (<24 hours) with tissues. The biocompatibility tests recommended by ISO 10993-1 were performed. Results showed that the KTA Adipose Treatment Kit showed no cytotoxic potential, no delayed sensitization was observed and irritation response met the requirements and is considered non-irritant.

### PERFORMANCE TESTING

In vitro testing was performed on the KTA Adipose Treatment Kit in accordance with ISO/IEC standards and/or internal procedures / European standards to assure reliable design and performance. In vitro testing included:

- . Side testing applying to catheters / introducers (Cannulas 3.2 bars air pressure resistance),
- Connective forces,
- . Connection seal strength,
- . Maximum pressure and vacuum,
- . Resistance to corrosion,
- . Biocompatibility,
- . Cell viability,
- Usability testing,

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## (ĮSTEMCIS

- Assembly testing,
- . Shipping test,
- Shelf-life (accelerated aging and real time).

All testing met their predetermined acceptance criteria.

### CONCLUSION

KTA Adipose Treatment Kit is substantially equivalent to the predicate devices in Indications for Use, composition and design. It is as safe and as effective as the predicate. STEMCIS considers KTA Adipose Treatment Kit to be substantially equivalent to the predicate devices.