PREMIUM

K133889 · Cousin Biotech Sas · FTL · Sep 4, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133889
• Device Name: PREMIUM
• Applicant: Cousin Biotech Sas
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Sep 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PREMIUM devices are surgical meshes that are indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Story

PREMIUM is a non-resorbable, light polypropylene surgical mesh used for parietal reinforcement. It is intended for use in surgical procedures to repair hernias or fascial defects by providing structural support. The device is implanted by a surgeon in a clinical setting. It functions as a mechanical reinforcement material to bridge or reinforce tissue defects. The device is provided sterile and is designed to be equivalent to existing polypropylene surgical meshes.

Clinical Evidence

No clinical data has been presented. Bench testing was performed in accordance with the FDA guidance for surgical mesh, including tensile strength, stiffness, suture pullout strength, burst strength, and tear resistance.

Technological Characteristics

Material: Light polypropylene. Type: Non-resorbable parietal reinforcement implant. Mechanical properties: Tensile strength, stiffness, suture pullout strength, burst strength, tear resistance. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring repair of hernia or fascial defects needing reinforcing or bridging material.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• PROLENE SOFT (K001122)

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 4, 2014

Cousin Biotech Mr. Frank Pelletier Regulatory Affairs Director 8 Rue de L'Abbé Bonpain F 59117 Wervicq-Sud, France

Re: K133889

Trade/Device Name: Premium Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: July 31, 2014 Received: August 4, 2014

Dear Mr. Pelletier:

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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Abbreviated 510k PREMIUM

Image /page/2/Picture/1 description: The image shows the word "COUSIN" in large, white, block letters with a black outline. The word is centered over a green diamond shape. Below the word "COUSIN" is a smaller, faded word that appears to be "baseball".

#### INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: PREMIUM Indications for Use:

PREMIUM are surgical meshes that are indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

| Prescription Use<br>✓ | AND/OR | Over-The-Counter Use<br>__________ |
|-----------------------------|--------|------------------------------------|
| (Part 21 CFR 801 Subpart D) | | (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)

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## Abbreviated 510k

# TOUSIN

## PREMIUM

### 510(k) SUMMARY

### As required by section 807.92(c)

| Submitter | COUSIN BIOTECH | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | 8 rue de l'Abbé Bonpain | | | |
| | F59117 WERVICQ SUD FRANCE | | | |
| Contacts | Franck PELLETIER Regulatory Affairs Director<br>[e-mail] | | | |
| Preparation date | 18 December 2013 | | | |
| Trade Name | PREMIUM | | | |
| Common Name | POLYMERIC SURGICAL MESH | | | |
| Classification Name | MESH SURGICAL POLYMERIC | | | |
| Regulation number | 878.3300 | | | |
| Product code | FTL | | | |
| Class | II | | | |
| Legally marketed<br>predicate devices | PREMIUM is compared to PROLENE SOFT (K001122)<br>manufactured by ETHICON, INC. | | | |
| Description | PREMIUM medical devices are surgical meshes with<br>light polypropylene. They are non resorbable parietal<br>reinforcement implants. | | | |
| Intended Use | PREMIUM devices are surgical meshes that are<br>indicated for the repair of hernia or other fascial<br>defects that require the addition of a reinforcing or<br>bridging material to obtain the desired surgical result. | | | |
| Performance data | PREMIUM conforms to the special control "Guidance<br>for the Preparation of a Premarket Notification<br>Application for a Surgical Mesh". Testing include:<br>Tensile strength, Stiffness, Suture pullout strength,<br>Burst strength and Tear resistance.<br>No clinical data has been presented. | | | |

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Abbreviated 510k PREMIUM

Image /page/4/Picture/1 description: The image shows the word "COUSIN" in a stylized font. The word is white with a black outline, and it is set against a green diamond shape. The diamond shape is slightly blurred, and the word "COUSIN" is the main focus of the image.

| Substantial<br>equivalence | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | PREMIUM is substantially equivalent to its predicated<br>devices in terms of intended use, material, design,<br>mechanical properties and function. Non clinical<br>performance testing according to special control<br>demonstrates that PREMIUM is as safe, as effective,<br>and performs as safety and effectively as its predicate<br>devices. |