ORTHOMEND SOFT TISSUE MATRIX

K071807 · Tei Biosciences, Inc. · FTM · Aug 6, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071807
• Device Name: ORTHOMEND SOFT TISSUE MATRIX
• Applicant: Tei Biosciences, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Aug 6, 2007
• 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, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. Reinforcement of soft tissues repaired by sutures or sutures anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

Device Story

SurgiMend is an acellular dermal tissue matrix derived from fetal bovine dermis; supplied sterile in various sizes for surgeon trimming. Used in surgical settings for soft tissue reinforcement and repair of damaged membranes. Surgeon applies matrix to site; sutures or bone anchors provide primary biomechanical strength for tendon repairs. Device acts as scaffold for tissue reinforcement. Benefits include structural support for weakened soft tissues. No electronic or algorithmic components.

Clinical Evidence

Bench testing only. Biocompatibility assessment performed by independent laboratory including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity. Manufacturing methods tested for viral inactivation.

Technological Characteristics

Acellular dermal tissue matrix derived from fetal bovine dermis. Supplied sterile. Dimensions variable, trimmed by surgeon. No electronic components, energy sources, or software.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair, including plastic/reconstructive surgery, muscle flap reinforcement, hernia repair (abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, incisional), and tendon repair reinforcement (rotator cuff, patellar, Achilles, biceps, quadriceps). Not intended to replace body structure or provide full mechanical strength for tendon repairs.

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

• OrthoMend (K051766)
• CosMatrix (K060829)
• TissueMend (K020455)
• OrthADAPT (K071065)

Submission Summary (Full Text)

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**TEI BIOSCIENCES INC.**
8/2/2007

K071807

510(k) Premarket Notification

1/2

AUG -6 2007

## 510(k) Summary

This 510(k) summary for SurgiMend 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

July 31, 2007

## Device Information

| Proprietary name: | SurgiMend Collagen Matrix<br>for Soft Tissue Reconstruction |
|------------------------|-------------------------------------------------------------|
| Classification name: | Surgical Mesh |
| Device classification: | Class II |

#### Device Description

SurgiMend is an acellular dermal tissue matrix derived from fetal 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, inguinal, femoral, . diaphragmatic, scrotal, umbilical, and incisional hernias
- Reinforcement of soft tissues repaired by sutures or sutures . anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles,

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KC718C7

TEI BIOSCIENCES INC. 8/2/2007

SurgiMend 510(k) Premarket Notification

biceps, quadriceps or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

# 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 |
|------------------|-------------------|---------------|
| OrthoMend | TEI Biosciences | K051766 |
| CosMatrix | TEI Biosciences | K060829 |
| TissueMend | TEI Biosciences | K020455 |
| OrthADAPT | Pegasus Biologics | K071065 |

# 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 toxicity, hemolysis, and pyrogenicity. The manufacturing methods for SurgiMend have also been tested by an independent laboratory to assure appropriate levels of viral inactivation.

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Public Health Service

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.

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

AUG - 6 2007

Re: K071807

Trade/Device Name: SurgiMed Collagen Matrix for Soft Tissue Reconstruction Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: June 26, 2007 Received: July 9, 2007

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 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.

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Page 2 - Kenneth James, Ph.D.

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/industry/support/index.html.

Sincerely yours,
Mark A. Milkeren

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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K071807

TEI BIOSCIENCES INC. 8/2/2007

SuraiMend 510(k) Premarket Notification

#### Indications for Use

510(k) Number (if known):

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 ruptured soft tissue membranes.

SurgiMend is specifically indicated for:

- Plastic and reconstructive surgery .
- Muscle flap reinforcement .
- Hernia repair including abdominal, inquinal, femoral, . diaphragmatic, scrotal, umbilical, and incisional hernias
- Reinforcement of soft tissues repaired by sutures or suture . anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

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)

Mark A. Mcllhenny

(Division Sign-Of Division of General, Restorative,

510(k) Number

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