ZIMMER COLLAGEN REPAIR PATCH

K053562 · Tissue Science Laboratories, Plc · FTM · Jun 23, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053562
• Device Name: ZIMMER COLLAGEN REPAIR PATCH
• Applicant: Tissue Science Laboratories, Plc
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jun 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Zimmer® Collagen Repair Patch is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff repair surgery. Zimmer® Collagen Repair Patch is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Zimmer® Collagen Repair Patch reinforces soft tissue and provides a scaffold that is eventually incorporated into the patients own soft tissue.

Device Story

Zimmer® Collagen Repair Patch is a surgical mesh scaffold used during rotator cuff repair surgery. It is applied by a surgeon to reinforce soft tissues that have been repaired using sutures or suture anchors. The device acts as a scaffold that is eventually incorporated into the patient's own soft tissue. It does not provide the primary mechanical strength for the repair, which is provided by the sutures and anchors. The device is intended for use in a clinical/surgical setting.

Clinical Evidence

Bench testing only. Biocompatibility studies confirmed non-toxic and non-sensitizing properties. Performance testing demonstrated that materials and design meet specifications for consistent performance during intended use.

Technological Characteristics

Collagen-based surgical mesh scaffold. Designed for soft tissue reinforcement. Biocompatible, non-toxic, non-sensitizing material. Mechanical properties intended to support tissue integration rather than primary structural load-bearing.

Indications for Use

Indicated for reinforcement of soft tissues repaired by sutures or suture anchors during rotator cuff repair surgery. Not intended to replace normal body structure or provide full mechanical strength for repair.

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

• Permacol® Surgical Implant (K021056)
• Restore® Orthobiologic Soft Tissue Implant (K031969)
• CuffPatch™ (K042809)

Submission Summary (Full Text)

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# JUN 2 3 2006

K053562

V2

#### 510(k) SUMMARY

#### Tissue Science Laboratories, plc Zimmer® Collagen Repair Patch

### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Angela L. Bunn, RAC Tissue Science Laboratories, plc 1141 Clark Street Covington, Georgia 30014 USA Tel: (678) 342 - 7808 Fax: (678) 342 - 7844 Email: [e-mail]

Angela L. Bunn, RAC Contact Person:

14th June 2006 Date Prepared:

#### Name of Device and Name/Address of Sponsor

Tissue Science Laboratories, plc 7th Floor, Victoria House Victoria Road Aldreshot Hampshire GU11 1 EJ United Kingdom

#### Trade Name

Zimmer® Collagen Repair Patch

#### Common or Usual Name

Surgical Mesh

#### Classification Name

Surgical Mesh

#### Predicate Devices

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- Tissue Science Laboratories, plc, Permacol® Surgical Implant . (K021056)
- DePuy, Inc., Restore® Orthobiologic Soft Tissue Implant (K031969) .
- Organogenesis, Inc., CuffPatch™ (K042809) .

## Intended Use

Zimmer® Collagen Repair Patch is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff repair surgery.

Zimmer® Collagen Repair Patch is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Zimmer® Collagen Repair Patch reinforces soft tissue and provides a scaffold that is eventually incorporated into the patients own soft tissue.

## Technological Characteristics and Substantial Equivalence

Zimmer® Collagen Repair Patch is substantially equivalent to the predicate devices because it has the same intended use and very similar technological characteristics.

## Performance Data

Biocompatibility and bench studies have been completed and support the safety and effectiveness of Zimmer® Collagen Repair Patch for its intended use.

The biocompatibility test results show that the material used in the design and manufacture of the devices are non-toxic and non-sensitizing to biological tissues consistent with their intended use. Test results demonstrate that the materials chosen and the design utilized in manufacturing the Zimmer® Collagen Repair Patch will meet the established specification necessary for consistent performance during its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB 26 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Covidien % Ms. Angela L. Bunn, RAC Associate Manager 60 Middletown Avenue North Haven, Connecticut 06473

Re: K053562

Trade/Device Name: Collagen Repair Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: April 24, 2006 Received: April 25, 2006

Dear Ms. Bunn:

This letter corrects our substantially equivalent letter of June 23, 2006.

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 (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 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 - Ms. Angela L. Bunn, RAC

This letter will allow you to continue 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 v 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

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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510(k) Number (if known):

K053562

Device Name: Collagen Repair Patch

Indication for Use:

Collagen Repair Patch is intended for the reinforcement of soft tissues which are repaired by sutures or suture anchors, during rotator cuff repair surgery. Collagen Repair Patch is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair. Collagen Repair Patch reinforces soft tissue and provides a scaffold that is eventually incorporated into the patients own soft tissue.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use (Part 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)

Pete Numan
Division Sign-

Division of General, Restorative, and Neurological Devices

Number 14053562