BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215

K082941 · Biomerix Corporation · FTL · Jan 7, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K082941
• Device Name: BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
• Applicant: Biomerix Corporation
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jan 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Biomerix Composite Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other soft tissue defects requiring additional support of a nonabsorbable implant during and after wound healing.

Device Story

Biomerix Composite Surgical Mesh is a non-absorbable, porous polymer scaffold composed of polycarbonate polyurethane urea incorporating knitted polypropylene monofilament fibers. It is used by surgeons in clinical settings to provide structural support for hernia repair and soft tissue defects. The device acts as a permanent implant to reinforce tissue during and after the healing process. It is designed to integrate with surrounding tissue while minimizing foreign body response. The device is provided as a sterile implantable mesh.

Clinical Evidence

No clinical data. Evidence includes bench testing to verify performance specifications and biocompatibility testing per ISO 10993-1. Animal testing demonstrated well-tolerated long-term histomorphologic response, good tissue integration, minimal foreign body response, and no device degradation or necrosis.

Technological Characteristics

Non-absorbable porous polymer scaffold; materials: polycarbonate polyurethane urea and knitted polypropylene monofilament fibers. Biocompatibility testing per ISO 10993-1. Sterile implantable mesh.

Indications for Use

Indicated for patients requiring repair or reinforcement of hernia and soft tissue defects needing nonabsorbable implant support during and after wound healing.

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

• Ethicon Prolene Soft Mesh (K001122)
• Ethicon Mersilene Polyester Fiber Mesh (pre-amendment)
• Biomerix Surgical Mesh (K070961)
• Bard Composix L/P Mesh (K061754)
• W.L. Gore GORETEX® DualMesh® Biomaterial (K992189)
• AMS InteMesh™ (K042592)

Submission Summary (Full Text)

{0}------------------------------------------------

K082941

510(K) SUMMARY

5.0

Page (1) of (2)

| Applicant Name: | Biomerix Corporation<br>47757 Fremont Boulevard<br>Fremont, CA 94538<br>Phone: [phone]<br>Fax: [phone]<br>JAN - 7 2005 |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christina L Kichula<br>Sr. Director, RA/QA/CA |
| Date Prepared: | October 1, 2008 |
| Device Trade Name:<br>Device Common Name:<br>Classification Name: | Biomerix Composite Surgical Mesh<br>Polymeric surgical mesh<br>Mesh, surgical, polymeric |
| Predicate Devices: | Ethicon Prolene Soft Mesh (K001122)<br>Ethicon Mersilene Polyester Fiber Mesh (pre-<br>amendment)<br>Biomerix Surgical Mesh (K070961)<br>Bard Composix L/P Mesh (K061754)<br>W.L. Gore GORETEX® DualMesh® Biomaterial<br>(K992189)<br>AMS InteMesh™ (K042592) |
| Device Description | Biomerix Composite Surgical Mesh is a non-absorbable<br>porous polymer scaffold (polycarbonate polyurethane<br>urea) incorporating knitted polypropylene monofilament<br>fibers. |
| Intended Use | Biomerix Composite Surgical Mesh is intended to assist<br>in the repair and/or reinforcement of hernia and other<br>soft tissue defects requiring additional support of a<br>nonabsorbable implant during and after wound healing. |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Device(s): | The Biomerix Composite Surgical Mesh is similar in<br>materials, design, performance and intended use to<br>other surgical mesh devices.<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.<br>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 |

{1}------------------------------------------------

Biomerix Composite Surgical Mesh Traditional 510(k)

\$\frac{}{\bigodot}\$ \$\bigodot\$2

use.

Extensive biocompatibility testing per ISO 10993-1 was performed to demonstrate that the material is safe and biostable.

Animal testing demonstrates that the mesh exhibits a well-tolerated long-term histomorphologic response with good integration with surrounding tissue, minimal foreign body response, and no evidence of device degradation or adjacent tissue necrosis.

Based on the material, biocompatibility, bench, and Conclusion: animal testing, and the proposed device labeling, the Biomerix Composite Surgical Mesh is substantially equivalent to the identified predicate devices in terms of intended use, safety, and effectiveness.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, clutching a staff with a snake wrapped around it. The eagle and staff are stylized and simplified.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomerix Corporation % Ms. Christina L. Kichula Sr. Director, RA, QA & CA 47757 Fremont Boulevard Fremont, California 94538

JAN - 7 2009

Re: K082941

Trade/Device Name: Biomerix Composite Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: December 16, 2008 Received: December 17, 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.

{3}------------------------------------------------

Page 2 – Ms. Christina L. Kichula

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 CDRI'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 inder 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

{4}------------------------------------------------

Sponsor: Biomerix

#### INDICATIONS FOR USE 4.0

## Indications for Use

510(k) Number (if known):

K082941

Device Name: Biomerix Composite Surgical Mesh

## Indications for Use:

Biomerix Composite Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other soft tissue defects requiring additional support of a nonabsorbable implant during and after wound healing.

Prescription Use × (Part 21 CFR 801 Subpart D)

人类

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 (QDE)

CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number

K082941