COSMATRIX

K060829 · Tei Biosciences, Inc. · FTM · May 17, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060829
• Device Name: COSMATRIX
• Applicant: Tei Biosciences, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: May 17, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CosMatrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

Device Story

CosMatrix is a sterile, remodelable collagen matrix derived from bovine skin. It is supplied as a thin, flexible sheet that surgeons trim to size and suture to surrounding tissues to reinforce areas of soft tissue weakness. The device is intended for use in plastic and reconstructive surgery. It functions by providing a scaffold that is fully remodeled by the patient's body over a period of months. It is a mechanical implant; no electronic or software components are involved.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including a comprehensive biocompatibility assessment (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity) and validation of viral inactivation manufacturing processes.

Technological Characteristics

Remodelable collagen matrix derived from bovine skin. Form factor: thin, flexible sheet, trimmable. Sterilization: sterile. Mechanism: mechanical reinforcement of soft tissue via suturing, followed by biological remodeling. No energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery where soft tissue weakness exists.

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

• TissueMend (K020455)
• Permacol (K013625)
• SIS Plastic Surgery Matrix (K034039)

Submission Summary (Full Text)

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# viated 510(k) Premarket Notification

# 510(k) Summary

MAN 17 2006

This 510(k) summary for CosMatrix is being submitted in accordance with the requirements of 21 CFR 807.92.

# Submitted by

TEI Biosciences Inc. 7 Elkins Street Boston, MA 02127 [phone] [phone] (fax)

#### Contact Person

Kenneth James, Ph.D. Vice President, Product Sciences and Regulatory Affairs

#### Date Prepared

March 22, 2006

# Device Information

Proprietary name Classification name Device classification CosMatrix mesh, surgical, polymeric Class II (21CFR878.3300)

#### Device Description

CosMatrix is a remodelable collagen matrix derived from bovine skin to be used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

### Intended Use

CosMatrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

# Legally Marketed Devices to which Equivalence is Being Claimed

CosMatrix is substantially equivalent in function and intended use to:

| Predicate Device | Product Code | Manufacturer | 510(k) Number |
|----------------------------|--------------|-----------------------------|---------------|
| TissueMend | FTM | TEI Biosciences | K020455 |
| Permacol | FTM | Tissue Science Laboratories | K013625 |
| SIS Plastic Surgery Matrix | FTM | Cook Biotech | K034039 |

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K060829

Abbreviated 510(k) Premarket Notification

# Summary of Technological Characteristics and Biocompatibility

CosMatrix is substantially equivalent to other surgical meshes with respect to its design as a thin, flexible, polymeric sheet which can be sutured to surrounding tissues to secure it in place. In addition, the device is fully remodelable over a period of months.

A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of CosMatrix. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity. The manufacturing methods for CosMatrix were also tested by an independent laboratory to assure safe levels of viral inactivation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2006

TEI Biosciences, Inc. % Kenneth James, Ph.D. VP, Product Sciences and Regulatory Affairs 7 Elkins Street Boston, Massachusetts 02127

Re: K060829

Trade/Device Name: CosMatrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: March 22, 2006 Received: April 3, 2006

Dear Dr. James:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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# Page 2 - Kenneth James, Ph.D.

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Hubert Lenard us

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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TEI BIOSCIENCES INC.

Abbreviated 510(k) Premarket Notification

CosMatrix

2. INDICATIONS FOR USE OF THE DEVICE

510(k) Number (if known):

K060829

Device Name: CosMatrix

Indications for Use: CosMatrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

Prescription Use
(Part 21 CFR 801 Subpart D) \

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hebert Remmers

Division of General, Restorativ and Neurological Devices age 1 of

**510(k) Number** K060829