TISSUEMEND SOFT TISSUE REPAIR MATRIX

K060989 · Tei Biosciences, Inc. · FTM · May 15, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060989
• Device Name: TISSUEMEND SOFT TISSUE REPAIR MATRIX
• Applicant: Tei Biosciences, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: May 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TissueMend Soft Tissue Repair Matrix is intended for 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. TissueMend Soft Tissue Repair Matrix 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. TissueMend Soft Tissue Repair Matrix reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient's own soft tissues.

Device Story

TissueMend is a sterile, remodelable collagen matrix derived from bovine skin; supplied as a flexible sheet. Used by surgeons in clinical settings to reinforce soft tissues during tendon repair procedures. The matrix is trimmed and sutured by the surgeon to the site of repair. It acts as a scaffold that is gradually replaced by the patient's own tissue. It does not provide primary mechanical strength; that is provided by sutures or bone anchors. Benefits include providing a biological scaffold to support natural tissue remodeling during the healing process.

Clinical Evidence

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

Technological Characteristics

Remodelable collagen matrix derived from bovine skin. Flexible sheet form factor. Supplied sterile. No electronic components or software.

Indications for Use

Indicated for reinforcement of soft tissues during tendon repair surgery (rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons) in patients requiring surgical repair with sutures or suture anchors.

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)

Submission Summary (Full Text)

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Kob0989 1/2

TEI BIOSCIENCES INC. 3/30/2006

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

# 510(k) Summary

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

#### Submitted by

61 15 2018

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: TissueMend Soft Tissue Repair Matrix Surgical Mesh Class II

# Device Description

TissueMend 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 sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs.

#### Intended Use

TissueMend Soft Tissue Repair Matrix is intended for 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.

TissueMend Soft Tissue Repair Matrix 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. TissueMend Soft Tissue Repair Matrix reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient's own soft tissues.

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0609812/2

TEI BIOSCIENCES INC. 3/30/2006

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

# Legally Marketed Devices to which Equivalence is Being Claimed

TissueMend is substantially equivalent in function and intended use to:

| Predicate<br>Devices | Manufacturer | 510(k) Number |
|----------------------|-----------------|---------------|
| OrthoMend | TEI Biosciences | K051766 |

# Summary of Technological Characteristics and Biocompatibility

TissueMend is substantially equivalent to other wound dressings with respect to its design as a flexible, collagen sheet which can be used to cover wounds.

A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of TissueMend. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity. The manufacturing methods for TissueMend 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 15 2006

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

Re: K060989

Trade/Device Name: TissueMend 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 (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,

Q. Mark N. Melkerson

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): K060989

Device Name: TissueMend

Indications For Use:

TissueMend Soft Tissue Repair Matrix is intended for 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.

TissueMend Soft Tissue Repair Matrix 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. TissueMend Soft Tissue Repair Matrix reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient's own soft tissues.

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-Division of General, Restorative. and Neurological Devices

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Koco9899 510(k) Number_