The provided text is a 510(k) summary for the BIOMESH® CA.B.S.'Air® Composite device. It states the purpose of the submission is to demonstrate substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or effectiveness studies (MRMC or standalone).

The relevant section, "Performance data," simply states: "BIOMESH® CA.B.S.'Air® Composite conforms to the special control 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh'." This indicates that the device met the general requirements for surgical mesh, but no specific performance metrics or studies are detailed in the provided text.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample sized used for the test set and the data provenance: This information is not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
Adjudication method for the test set: This information is not present.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not present, and the device described is a surgical mesh, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present, and the device described is a surgical mesh, not an AI diagnostic tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present.
The sample size for the training set: This information is not present.
How the ground truth for the training set was established: This information is not present.

Summary

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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 BIOTECH8 rue Abbe BonpainF59117 WERVICQ SUD FRANCE
Contacts	Franck PELLETIER Regulatory Affairs Managerf.pelletier@cousin-biotech.com
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 toCABS'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 areparietal prosthesis with inflatable expansion balloon andfixation threads.

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And Artist

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Intended Use	BIOMESH® CA.B.S.'Air® Composite is intended for use inall forms of hernia repair requiring reinforcement withnonabsorbable support material.
Performance data	BIOMESH® CA.B.S.'Air® Composite conforms to thespecial control "Guidance for the Preparation of aPremarket Notification Application for a Surgical Mesh".
Substantialequivalence	BIOMESH® CA.B.S.'Air® Composite has the samefundamental scientific technology, operating principleand 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 (800) 638-2041 or (301) 796-7100 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

Page 14 /361

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.