FACIAL RECONSTRUCTIVE MESH (FRM)

K063154 · Evera Medical, Inc. · FTL · Jul 10, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063154
• Device Name: FACIAL RECONSTRUCTIVE MESH (FRM)
• Applicant: Evera Medical, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jul 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FRM is intended for use in the reinforcement of soft tissue where weakness exists. It is placed by a surgeon into the tissue by conventional surgical techniques during plastic or reconstructive surgery.

Device Story

Facial Reconstructive Mesh (FRM) is a non-absorbable, sterile, porous surgical mesh; composed of woven polyester fabric, silicone elastomer, and expanded polytetrafluoroethylene (ePTFE). Device is available in various lengths and widths. Used by surgeons during plastic or reconstructive surgery of the face and head to reinforce soft tissue where weakness exists. Implanted via conventional surgical techniques. Provides structural support to soft tissue; benefits patient by facilitating repair or reinforcement in reconstructive procedures.

Clinical Evidence

Bench testing only; no clinical data provided. Safety and effectiveness evaluations based on biocompatibility and biomechanical performance data.

Technological Characteristics

Non-absorbable, sterile, porous surgical mesh. Materials: woven polyester fabric, silicone elastomer, and expanded polytetrafluoroethylene (ePTFE). Form factor: variable lengths and widths. Mechanical fixation via conventional surgical techniques.

Indications for Use

Indicated for soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head. Contraindicated for dermal placement and cosmetic lip filler.

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

• Mersilene Polyester Fiber Mesh (K851086)
• Permacol™ Crosslinked Porcine Dermal Collagen Surgical Mesh (K013625)
• Gore-Tex SAM Facial Implant with Introducer (K952898)
• Bard Composite Prosthesis (K971745)

Submission Summary (Full Text)

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# 510(k) SUMMARY FOR THE FACIAL RECONSTRUCTIVE MESH Submission Date: October 16, 2006 JUL 1 0 2007 Submitter Information: Company Name: Becker and Associates Consulting, Inc. Company Address: 2001 Pennsylvania Ave. NW Suite 575 Washington, DC 20006 Contact Person: Campbell Tuskey 202-822-1844 Campbell.tuskey(@becker-consult.com Device Information: Trade Name: Facial Reconstructive Mesh (FRM) Common Name: Surgical Mesh Classification Name: 21 CFR § 878.3300

Classification Code: FTL

Device Class: Class II

#### Predicate Device(s):

2.0

| Trade Name: | Mersilene Polyester Fiber Mesh |
|---------------|-------------------------------------------------------------|
| Manufacturer: | Ethicon, Inc. |
| K Number: | K851086 |
| Product Code: | FTM |
| Trade Name: | Permacol™ Crosslinked Porcine Dermal Collagen Surgical Mesh |
| Manufacturer: | Tissue Sciences Laboratories PLC |
| K Number: | K013625 |
| Product Code: | FTM |
| Trade Name: | Gore-Tex SAM Facial Implant with Introducer |
| Manufacturer: | W.L. Gore and Associates, Inc. |
| K Number: | K952898 |
| Product Code: | FTL |

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|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Bard Composite Prosthesis |
| Manufacturer: | Davol, Inc. |
| K Number: | K971745 |
| Product Code: | FTL |
| Device Description: | The FRM is a non-absorbable, inert, sterile, porous,<br>surgical mesh composed of reinforcing woven polyester<br>fabric, silicone elastomer and expanded<br>polytetrafluoroethylene (ePTFE). This polymeric mesh is<br>available in a range of lengths and widths to accommodate<br>the surgical application. |
| Intended Use: | The FRM is intended for use in the reinforcement of soft<br>tissue where weakness exists. It is placed by a surgeon into<br>the tissue by conventional surgical techniques during<br>plastic or reconstructive surgery. |
| Indications for Use: | The FRM is intended for use in plastic and reconstructive<br>surgery of the face and head to provide soft tissue repair or<br>reinforcement. |
| Contraindications: | - Dermal placement<br>- Cosmetic lip filler |
| Comparison to<br>Predicate Device: | The FRM has the same intended use and technological<br>characteristics as the predicate devices. Slight differences<br>in design and performance from the cited predicates do not<br>affect either the safety and/or effectiveness of the FRM for<br>its intended use. The safety and effectiveness evaluations<br>based on biocompatibility and biomechanical performance<br>data provided in this 510(k) demonstrate that the FRM is<br>substantially equivalent to the cited predicate devices. |
| Conclusion: | The results of these evaluations of the FRM support the<br>conclusion that it is safe and effective for its intended use<br>and that it is substantially equivalent to the cited predicate<br>device(s) with regards to its safety and effectiveness. |

# CONFIDENTIAL

. .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem featuring four abstract human figures or profiles facing to the right, with flowing lines connecting them. The emblem is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2007

Evera Medical, Inc. % Mr. Randy Kesten Chief Technical Officer 353 Vintage Park Drive, Suite F Foster City, California 94404

Re: K063154

Trade/Device Name: Facial Reconstructive Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 12, 2007 Received: June 14, 2007

Dear Mr. Kesten:

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. Iisting 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 - Mr. Randy Kesten

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/industry/support/index.html.

> Sincerely yours 402

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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### 1. STATEMENT OF INDICATIONS FOR USE

K063154 510(k) Number (if known): ______________________________________________________________________________________________________________________________________________________________________________

Facial Reconstructive Mesh Device Name:

Indications for Use:

The Facial Reconstructive Mesh is intended for use in plastic and reconstructive surgery of the face and head to provide soft tissue repair or reinforcement.

Contraindications:

- Dermal placement
- Cosmetic lip filler

Caution: Federal law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the State in which he / she practices to use or order the use of the device.

| Prescription Use | X<br>(Part 21 CFR 801 Subpart D) |
|------------------|------------------------------------------------|
| | AND/OR |
| | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|-------------------------------------------------------|-------------|
| (Division Sign-Off) | |
| Division of General Restorative, | |
| and Neurological Devices | Page 1 of 1 |
| 510(k) Number | K063154 |