BIOMERIX SURGICAL MESH, MODEL: RCR-01

K070961 · Biomerix Corporation · FTL · Feb 25, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K070961
• Device Name: BIOMERIX SURGICAL MESH, MODEL: RCR-01
• Applicant: Biomerix Corporation
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Feb 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery. The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.

Device Story

Biomerix Surgical Mesh is a non-absorbable, sterile, single-use implant; composed of polycarbonate polyurethane-urea matrix and polyester suture. Used by surgeons during rotator cuff repair procedures to reinforce soft tissue. Device does not replace body structure or provide primary mechanical strength; primary strength provided by sutures and bone anchors. Mesh supports tissue ingrowth and provides mechanical reinforcement to the repair site. Benefits include enhanced structural support for tendon repair.

Clinical Evidence

No human clinical data provided. Evidence includes material property testing, bench testing to verify performance specifications, biocompatibility testing per ISO 10993-1, and animal studies demonstrating tissue ingrowth and mechanical reinforcement of repairs without adverse clinical effects.

Technological Characteristics

Non-absorbable surgical mesh; materials: polycarbonate polyurethane-urea matrix and polyester suture. Biocompatibility tested per ISO 10993-1. Sterile, single-use device.

Indications for Use

Indicated for reinforcement of soft tissues repaired by suture or suture anchors during rotator cuff repair surgery.

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

• DePuy Restore® Orthobiologic Soft Tissue Implant (K031969)
• Artimplant AB Sportmesh™ (K052830)
• Ethicon Mersilene Polyester Fiber Mesh (pre-amendment)
• Zimmer Collagen Repair Patch (K053562)
• Biomerix Vascular Occlusion Device (K043371)

Submission Summary (Full Text)

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Sponsor:
Biomerix

page 1 of 2

Biomerix Surgical Mesh
K070961

## APPENDIX B 510(K) SUMMARY

| Applicant Name: | Biomerix Corporation<br>1700 Rockville Pike, Suite 400<br>Rockville, MD 20852<br>Phone: [phone]<br>Fax: [phone] | FEB 25 2003 |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Christina L Kichula<br>Director, RA/QA | |
| Date Prepared: | February 13, 2008 | |
| Device Trade Name: | Biomerix Surgical Mesh | |
| Device Common Name: | Polymeric surgical mesh | |
| Classification Name: | Mesh, surgical, polymeric | |
| Predicate Devices: | DePuy Restore® Orthobiologic Soft Tissue Implant,<br>K031969<br>Artimplant AB Sportmesh™ (K052830)<br>Ethicon Mersilene Polyester Fiber Mesh (pre-<br>amendment)<br>Zimmer Collagen Repair Patch (K053562)<br>Biomerix Vascular Occlusion Device (K043371) | |
| Device Description: | The Biomerix Surgical Mesh is a non-absorbable mesh<br>manufactured from a polycarbonate polyurethane-urea<br>matrix and standard polyester suture. The Biomerix<br>Surgical Mesh is provided sterile for single use. | |
| Intended Use: | The Biomerix Surgical Mesh is intended for the<br>reinforcement of the soft tissues which are repaired by<br>suture or suture anchors during rotator cuff repair<br>surgery.<br><br>The mesh is not intended to replace normal body<br>structure or provide full mechanical strength to support<br>the rotator cuff. Sutures used to repair the tear, and<br>sutures or bone anchor systems used to attach the<br>tissue to the bone, provide mechanical strength for<br>tendon repair | |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Device(s): | The Biomerix Surgical Mesh is similar in materials,<br>design, performance and intended use to other surgical<br>mesh devices.<br><br>Any differences in the above characteristics have been<br>adequately tested to support substantial equivalence. | |
| Performance Data: | Material testing was performed to demonstrate that the<br>material properties are suitable for the intended use. | |
| | Bench testing was performed to demonstrate that the<br>devices as manufactured meet the performance<br>specifications. Test results demonstrate that the device<br>meets the specifications and is acceptable for clinical<br>use. | |
| | Extensive biocompatibility testing per ISO 10993-1 was<br>performed to demonstrate that the material is safe and<br>biostable. | |
| | Animal testing demonstrates the ability of the mesh to<br>support tissue ingrowth and mechanically reinforce the<br>repair as compared to surgical controls, without any<br>adverse clinical effects. | |
| Conclusion: | Based on the material, biocompatibility, bench, and<br>animal testing, and the proposed device labeling, the<br>Biomerix Surgical Mesh is substantially equivalent to the<br>identified predicate devices in terms of intended use,<br>safety, and effectiveness. | |

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Sponsor:
Biomerix

070961 page 242

Biomerix Surgical Mesh
K070961

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

FEB 25 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomerix Corporation % Ms. Christina L. Kichula, RAC Director, RA/QA 1700 Rockville Pike, Suite 400 Rockville, Maryland 20852

Re: K070961

Trade/Device Name: Biomerix Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 13, 2008 Received: February 14, 2008

Dear Ms. Kichula:

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 – Ms. Christina L. Kichula, RAC

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 Postmarket 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 N. Mulhearn

- 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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## APPENDIX A

| Indications for Use | |
|---------------------|--|
|---------------------|--|

510(k) Number (if known):

Device Name: Biomerix Surgical Mesh

## Indications for Use:

The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery.

The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Selem

Division of General, Restorative, and Neurological Levices

**510(k) Number** L070921 Page 1 of 1