BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB

K093123 · Biomerix Corporation · FTL · May 13, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093123
• Device Name: BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
• Applicant: Biomerix Corporation
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomerix Ventral Hernia Repair Mesh is intended for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

Device Story

Biomerix Ventral Hernia Repair Mesh is a sterile, composite surgical mesh for hernia repair and soft tissue reconstruction. Device consists of three layers: Biomerix Biomaterial sheet, knitted polypropylene monofilament fibers, and a resorbable lactide-caprolactone film. Resorbable film serves as a barrier to minimize tissue attachment to viscera during wound healing. Provided as sterile, single-use sheets in various sizes. Used by surgeons in clinical settings for ventral hernia repair. Device provides structural support for fascial defects while reducing adhesion risk via the resorbable layer.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing performed per FDA's 1999 Surgical Mesh guidance, biocompatibility testing per ISO 10993-1, and animal testing. Animal studies demonstrated equivalent performance to predicate devices regarding minimization of tissue attachment and histological response.

Technological Characteristics

Composite mesh comprising Biomerix Biomaterial, knitted polypropylene monofilament, and resorbable lactide-caprolactone film. Biocompatibility verified per ISO 10993-1. Sterile, single-use, various dimensions.

Indications for Use

Indicated for patients requiring reconstruction of hernias, soft tissue deficiencies, or temporary bridging of fascial defects.

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

• Biomerix Composite Surgical Mesh (K082941)
• Ethicon PROCEED Surgical Mesh (K060713)
• Apside Surgimesh XB (K072974)
• Biomet Mesofol® Surgical Sheet (K062558)
• MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (K050332)
• Polyganics VivoSorb Sheet (K042811)

Submission Summary (Full Text)

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## 510(K) SUMMARY 1.0

| Applicant Name: | Biomerix Corporation<br>47757 Fremont Boulevard<br>Fremont, CA 94538<br>Phone: [phone]<br>Fax: [phone] | MAY 13 2010 |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Christina L Kichula<br>Sr. Director, RA/QA/CA | |
| Date Prepared: | May 11, 2010 | |
| Device Trade Name:<br>Device Common Name:<br>Classification Name: | Biomerix Ventral Hernia Repair Mesh<br>Polymeric surgical mesh<br>Mesh, surgical, polymeric | |
| Predicate Devices: | • Biomerix Composite Surgical Mesh (K082941) | |
| | • Ethicon PROCEED Surgical Mesh (K060713) | |
| | • Apside Surgimesh XB (K072974) | |
| | • Biomet Mesofol® Surgical Sheet (K062558) | |
| | • MAST Biosurgery Surgi-Wrap MAST Bioresorbable<br>Sheet (K050332) | |
| | • Polyganics VivoSorb Sheet (K042811) | |
| Device Description | The Biomerix Ventral Hernia Repair Mesh is a sterile,<br>composite mesh comprised of three layers: 1) a thin<br>sheet of the Biomerix Biomaterial™, 2) a layer of knitted<br>polypropylene monofilament fibers and 3) a resorbable<br>lactide-caprolactone film. | |
| | The resorbable film separates the permanent mesh from<br>underlying tissues and organ surfaces, and it is designed<br>to minimize the risk of a tissue attachment to the device<br>during the wound healing period. | |
| | The Biomerix Ventral Hernia Repair Mesh is provided<br>sterile for single use and is available as individually<br>packaged thin sheets in various shapes and sizes. | |
| Intended Use | The Biomerix Ventral Hernia Repair Mesh is intended for<br>the reconstruction of hernias and soft tissue deficiencies<br>and for the temporary bridging of fascial defects. The<br>resorbable protective film minimizes tissue attachment to<br>the device in case of direct contact with the viscera. | |
| Device Technological<br>Characteristics and | The Biomerix Ventral Hernia Repair Mesh is similar in<br>materials, design, performance and intended use to | |
| Comparison to<br>Predicate Device(s): | other surgical meshes. Any differences in the above<br>characteristics have been adequately tested to support<br>substantial equivalence. | |
| Performance Data: | Bench testing, conducted in accordance with FDA's<br>Guidance for the Preparation of a Premarket Notification<br>Application for a Surgical Mesh (issued March 2, 1999),<br>was performed to demonstrate that the device as<br>manufactured meets the performance specifications.<br>Test results demonstrate that the device meets the<br>specifications, performs comparably to predicate devices<br>and is acceptable for clinical use. | |
| | Biocompatibility testing in accordance ISO 10993-1<br>standards was conducted, and results demonstrate that<br>the device is biocompatible according to these<br>standards. | |
| | Animal testing demonstrates that the Biomerix Ventral<br>Hernia Repair Mesh performs equivalently to a predicate<br>device in terms of minimization of tissue attachment to<br>the device and histological response. | |
| Conclusion: | Based on the material, biocompatibility, bench, and<br>animal testing, and the proposed device labeling, the<br>Biomerix Ventral Hernia Repair Mesh is substantially<br>equivalent to the identified predicate devices in terms of<br>intended use, safety, and effectiveness. | |

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KOG3123 of 2 2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

MAY 1 3 2010

Re: K093123

Fremont, California 94538

Trade/Device Name: Biomerix Ventral Hernia Repair Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 29, 2010 Received: April 30, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 nov limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Christina L. Kichula

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark M. Milburn

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4.0 INDICATIONS FOR USE

## Indications for Use

KOG3123 510(k) Number (if known):

Device Name: Biomerix Ventral Hernia Repair Mesh

## Indications for Use:

The Biomerix Ventral Hernia Repair Mesh is intended for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

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)

Daniel Keane for MXM
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093123