SURGIMEND

K083898 · Tei Biosciences, Inc. · FTM · Feb 4, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083898
• Device Name: SURGIMEND
• Applicant: Tei Biosciences, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Feb 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: - Plastic and reconstructive surgery - Muscle flap reinforcement - Hernia repair including abdominal, inquinal, femoral, diaphraqmatic, scrotal, umbilical, and incisional hernias

Device Story

SurgiMend is an acellular dermal tissue matrix derived from bovine dermis; supplied sterile in various sizes for surgeon trimming. Used in surgical settings for soft tissue reinforcement and repair of damaged membranes. Surgeon implants the matrix to provide structural support where tissue weakness exists. Benefits include facilitating reconstruction and hernia repair. No electronic or algorithmic components.

Clinical Evidence

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

Technological Characteristics

Acellular dermal tissue matrix derived from bovine dermis. Supplied sterile; trimmable by surgeon. No energy source, connectivity, or software. Biocompatibility verified per standard laboratory testing protocols.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair of damaged/ruptured membranes, including plastic/reconstructive surgery, muscle flap reinforcement, and hernia repair (abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional).

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

• SurgiMend (K071807)
• TissueMend (K020488)

Submission Summary (Full Text)

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# TEI BIOSCIENCES INC.

1/23/2008

#### SurgiMend Special 510(k) Premarket Notification

K08 3898

# 510(k) Summary

K08 3878
1/2

FEB - 4 2009

This 510(k) summary for SurqiMend 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 Requlatory Affairs

## Date Prepared

July 31, 2007

### Device Information

Proprietary name: SurgiMend Collagen Matrix for Soft Tissue Reconstruction Classification name: Surgical Mesh Device classification: Class II

# Device Description

SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

#### Intended Use

SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.

SurgiMend is specifically indicated for:

- Plastic and reconstructive surgery
- Muscle flap reinforcement
- Hernia repair including abdominal, inquinal, femoral, diaphraqmatic, scrotal, umbilical, and incisional hernias

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# Legally Marketed Devices to which Equivalence is Being Claimed

SurgiMend is substantially equivalent in function and intended use to:

| Predicate Device | Manufacturer | 510(k) Number |
|------------------|-----------------|---------------|
| SurgiMend | TEI Biosciences | K071807 |
| TissueMend | TEI Biosciences | K020488 |

#### Summary of Technological Characteristics and Biocompatibility

SurgiMend is substantially equivalent to other surgical meshes with respect to its design and intended use.

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

റ

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three stripes forming its wing and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

FEB - 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K083898

Trade/Device Name: SurgiMend Collagen Matrix for Soft Tissue Reconstruction Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: January 23, 2009 Received: January 26, 2009

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pestmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely vours.

Mark M. Millman

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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SurqiMend Special 510(k) Premarket Notification

Ka 83898

### Indications for Use

# 510(k) Number (if known): K083898

Device Name: SurgiMend Collagen Matrix for Soft Tissue Reconstruction

Indications for Use:

SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptwred soft tissue membranes.

SurgiMend is specifically indicated for:

- Plastic and reconstructive surgery .
- Muscle flap reinforcement
- Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias

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 of General, Restorative, and Neurological Devices