ST'RIM

K142073 · Thiebaud Sas · MUU · Apr 29, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K142073
• Device Name: ST'RIM
• Applicant: Thiebaud Sas
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Apr 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The st'rim™ fat tissue harvest and injection cannula set is intended for use in aesthetic body contouring.

Device Story

The st'rim™ is a sterile, single-use set for autologous fat tissue harvesting and re-injection during aesthetic body contouring. The set includes one harvesting cannula, three injection cannulas, two incision needles, and a double-ended female Luer Lock connector. The device is used by clinicians in a clinical setting. The clinician uses the harvesting cannula to aspirate fat tissue into a syringe, then uses the Luer Lock connector to transfer the tissue to an injection syringe for re-injection into the patient. The device facilitates the transfer and application of autologous fat for body contouring purposes.

Clinical Evidence

Bench testing only. Laboratory testing evaluated Luer Lock connector performance (gauging, leakage, separation force, torque, assembly, stress cracking). Biocompatibility testing performed per ISO 10993 (Parts 5, 10, 11). Packaging, sterilization, and shelf-life (5 years) validated.

Technological Characteristics

Medical grade stainless steel construction; short-term contact duration. Components include harvesting/injection cannulas, incision needles, and Luer Lock connector. Provided sterile in a preformed plastic tray. Sterilized via Ethylene Oxide (EtO).

Indications for Use

Indicated for aesthetic body contouring in patients undergoing autologous fat tissue harvesting and re-injection.

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

• Tulip Disposable Cannulas (K060089)

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

April 29, 2015

Thiebaud SAS % Ms. Patsy J. Trisler, JD, RAC Trisler Consulting 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815

Re: K142073

Trade/Device Name: st'rim™ Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: March 16, 2015 Received: March 19, 2015

Dear Ms. Trisler:

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) K142073

Device Name st'rim™M

Indications for Use (Describe) The st'rim™ fat tissue harvest and injection cannula set is intended for use in aesthetic body contouring.

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------|--|--|
| | | |

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY— st'rim™ K142073

| Submitter Name: | Thiebaud SAS |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 2 impasse des primbois |
| | 74200 Margencel |
| | France |
| Mailing address: | B.P. 160-F-74204 Thonon-les-Bains CEDEX |
| Contact Person: | Jean-Charles Persat, MD, Ph.D., President |
| Phone Number:<br>Fax Number: | 33 (0)4 50 72 70 80<br>33 (0)4 50 72 54 44 |
| Date Prepared: | March 16, 2015 |
| Device Trade Name: | st'rim™™ |
| Device Class: | II |
| Classification<br>Number: | 21 CFR 878.5040 |
| Classification Name: | Suction Lipoplasty System |
| Product Code: | MUU |
| Predicate Device(s): | K060089, Tulip Disposable Cannulas, Cell Bio-Systems, Inc. |
| Statement of<br>Intended Use: | The st'rim™™ fat tissue harvest and injection cannula set is<br>intended for use in aesthetic body contouring. |
| Device Description: | The st'rim™™ set consists of one tissue harvesting cannula, three<br>injection (application) cannulas, two incision needles, all made<br>of stainless steel, and a capped double-ended female Luer Lock<br>connector for transfer of the fat tissue from the collection<br>syringe to an injection syringe. |
| | The body contacting material is medical grade stainless steel<br>and the contact duration is short-term. |
| | All components are provided in a preformed plastic tray. The<br>set is a sterile, single-use device. |
| Summary of Testing: | Laboratory testing of the st'rimTM Luer Lock connectors was<br>performed to evaluate gauging, liquid and air leaking,<br>separation force, unscrewing torque, ease of assembly,<br>resistance to overriding and stress cracking. |
| | Packaging, sterilization and shelf life information and testing<br>results were provided in the 510(k). The device set has been<br>validated for a shelf life of 5 years. |
| | Biocompatibility testing according to ISO 10993: Parts 5, 10 and<br>11 was performed, and reports were included in the 510(k). |
| Comparison to the<br>Predicate Devices: | The st'rimTM device set has the same intended use and the<br>same principles of operation as the Tulip Disposable Cannulas<br>predicate. Both are intended for harvesting (aspiration) and re-<br>injecting autologous fat tissue. Both devices are made of<br>stainless steel. |
| | The technological differences include length and diameter of the<br>cannulas and a coating on the Tulip predicate while the st'rimTM<br>is uncoated. Sterilization methods also are different: st'rimTM is<br>EtO sterilized, while the Tulip is E-beam sterilized. |
| | None of these differences raise new questions of safety or<br>effectiveness. |
| Conclusion regarding<br>Substantial<br>Equivalence: | The comparisons and data presented in the 510(k) lead to the<br>conclusion that the st'rimTM device set is substantially<br>equivalent to the predicate device. |

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