XENFORM SOFT TISSUE REPAIR MATRIX

K060984 · Tei Biosciences, Inc. · FTM · May 17, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060984
• Device Name: XENFORM SOFT TISSUE REPAIR MATRIX
• Applicant: Tei Biosciences, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: May 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Xenform Soft Tissue Repair Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of colon, rectal, urethral, and vaginal prolapse; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.

Device Story

Xenform Soft Tissue Repair Matrix is an acellular, resorbable collagen patch derived from bovine skin. Supplied as a sterile sheet, it is trimmed and sutured by surgeons during pelvic floor procedures to reinforce weakened or damaged soft tissue. The device acts as a scaffold for tissue repair and is fully resorbable over several months. It is intended for use in clinical settings by surgeons for procedures including prolapse repair and urethral slings.

Clinical Evidence

Bench testing only. Biocompatibility assessment performed by an independent laboratory confirmed safety via cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity testing. Manufacturing processes were validated for viral inactivation.

Technological Characteristics

Acellular bovine collagen matrix; thin, flexible, resorbable sheet; supplied sterile. No electronic components or software.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair of damaged/ruptured membranes, specifically for colon, rectal, urethral, and vaginal prolapse, pelvic floor reconstruction, sacrocolposuspension, and urethral sling procedures.

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

• Xenform (K051190)

Submission Summary (Full Text)

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## TEI BIOSCIENCES INC.

3/30/2006

K060984

Xenform Soft Tissue Repair Matrix
Special 510(k) Premarket Notification

## 510(k) Summary

This 510(k) summary for Xenform 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 30, 2006

#### Device Information

Proprietary name: Classification name: Device classification:

Xenform Surgical Mesh Class II

## Device Description

Xenform Soft Tissue Repair Matrix is an acellular collagen material intended to be utilized for surgical procedures pertaining to the pelvic floor. Xenform Soft Tissue Repair Matrix is supplied sterile and provided in sheet form in a variety of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs. Xenform Soft Tissue Repair Matrix is manufactured from bovine skin, one of the purest sources of collagen available. The source material is solely derived from cattle obtained in compliance with US and European regulatory requirements.

#### Intended Use

Xenform Soft Tissue Repair Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of colon, rectal, urethral, and vaginal prolapse; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.

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Xenform Soft Tissue Repair Matrix Special 510(k) Premarket Notification

## Legally Marketed Devices to which Equivalence is Being Claimed

Xenform is substantially equivalent in function and intended use to:

| Predicate<br>Devices | Manufacturer | 510(k) Number |
|----------------------|-----------------|---------------|
| Xenform | TEI Biosciences | K051190 |

#### Summary of Technological Characteristics and Biocompatibility

Xenform Soft Tissue Repair Matrix 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 resorbable over a period of months.

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

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: K060984

Trade/Device Name: Xenform Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: March 30, 2006 Received: May 1, 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 (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. 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,

Z

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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# Indications for Use

510(k) Number (if known): K060984

Device Name: Xenform

Indications For Use:

Xenform Soft Tissue Repair Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of colon, rectal, urethral, and vaginal prolapse; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.

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)

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(Division Sign-Off) (Division Sign of General, Restorative, Division of or of ogical Devices

**510(k) Number** K060984