BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09

K093196 · Cousin Biotech Sas · FTL · Jun 25, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093196
• Device Name: BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
• Applicant: Cousin Biotech Sas
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jun 25, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BIOMESH® CA.B.S.'Air® Composite is intended for use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.

Device Story

BIOMESH® CA.B.S.'Air® Composite is a parietal prosthesis used for hernia repair. The device consists of a surgical mesh, an inflatable expansion balloon, and fixation threads. It is designed to provide reinforcement to the abdominal wall during hernia repair procedures. The device is intended for use by surgeons in a clinical setting. The inflatable balloon facilitates the placement and positioning of the mesh within the surgical site. By providing a nonabsorbable support structure, the device reinforces the weakened tissue, potentially reducing the risk of hernia recurrence and benefiting the patient through improved structural integrity of the repair site.

Clinical Evidence

Bench testing only. The device conforms to the special control 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh'.

Technological Characteristics

Parietal prosthesis comprising a surgical mesh, inflatable expansion balloon, and fixation threads. Nonabsorbable material. Class II device. Product code FTL.

Indications for Use

Indicated for patients requiring hernia repair reinforcement using nonabsorbable support 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

• CABS'AIR (K072962)
• VENTRALEX HERNIA PATCH (K021736)

Submission Summary (Full Text)

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510 (k) BIOMESH CA.B.S. AIR COMPOSITE - K093196 - Additional information - S1 Response to Letter of 01-Dec-09

.

**COUSIN**

S I A T E C H

page 1/2

# JUN 2 5 2010

## 510(k) Summary

#### As required by section 807.92(c)

| Submitter | COUSIN BIOTECH<br>8 rue Abbe Bonpain<br>F59117 WERVICQ SUD FRANCE |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Franck PELLETIER Regulatory Affairs Manager<br>[e-mail] |
| Preparation date | 02nd October, 2009 |
| Trade Name | BIOMESH® CA.B.S.'Air® Composite |
| Common Name | POLYMERIC SURGICAL MESH |
| Classification Name | MESH SURGICAL POLYMERIC |
| Class | II |
| Product Code | FTL |
| CFR section | 878.3300 |
| Device panel | General & Plastic Surgery |
| Legally marketed predicate devices | BIOMESH® CA.B.S.'Air® Composite is compared to<br>CABS'AIR (K072962) manufactured by COUSIN BIOTECH, INC and VENTRALEX HERNIA PATCH (K021736) manufactured by C.R. BARD, INC |
| Description | BIOMESH® CA.B.S.'Air® Composite medical devices are<br>parietal prosthesis with inflatable expansion balloon and<br>fixation threads. |

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| Intended Use | BIOMESH® CA.B.S.'Air® Composite is intended for use in<br>all forms of hernia repair requiring reinforcement with<br>nonabsorbable support material. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data | BIOMESH® CA.B.S.'Air® Composite conforms to the<br>special control "Guidance for the Preparation of a<br>Premarket Notification Application for a Surgical Mesh". |
| Substantial<br>equivalence | BIOMESH® CA.B.S.'Air® Composite has the same<br>fundamental scientific technology, operating principle<br>and intended use as predicate devices. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, positioned to the right. To the left of the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is oriented to follow the curve of the circle.

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

# JUN 2 5 2010

Cousin Biotech S.A.S. % Mr. Franck Pelletier Regulatory Affairs Manager 8 rue de l'Abbé Bonpain Wervicq SUD 59117 France

Re: K093196

Trade/Device Name: BIOMESH® CA.B.S.'AIR® Composite Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, OQL Dated: June 18, 2010 Received: June 21, 2010

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

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Page 2 - Mr. Franck Pelletier

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/CDRH/CDRHOffices/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/default.htm.

Sincerely yours,

Fok Nphm Dih

Nir

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510k Premarket Notification BIOMESH® CA.B.S.'Air® Composite

COUSIN
BIOTECH

### INDICATIONS FOR USE

510(k) Number (if known): K093196 Device Name: BIOMESH® CA.B.S.'Air® Composite Indications for Use:

BIOMESH® CA.B.S.'Air® Composite is intended for use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.

Over-The-Counter Use _ Prescription Use く and/or (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K093196

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