TEPHAFLEX SURGICAL MESH

K070894 · Tepha, Inc. · OOD · Apr 13, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070894
• Device Name: TEPHAFLEX SURGICAL MESH
• Applicant: Tepha, Inc.
• Product Code: OOD · General, Plastic Surgery
• Decision Date: Apr 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TephaFLEX® Surgical Mesh is intended wherever temporary wound support is required, to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

Device Story

TephaFLEX® Surgical Mesh is an absorbable surgical mesh composed of poly-4-hydroxybutyrate (P4HB). It provides temporary wound support and reinforcement for soft tissues, hernias, or fascial defects. Used by surgeons in clinical settings for procedures such as pelvic floor reconstruction and prolapse repair. The device acts as a mechanical scaffold to bridge or reinforce tissue during the healing process. It is intended to provide mechanical strength equivalent to predicate absorbable meshes while undergoing absorption in the body.

Clinical Evidence

Bench testing only. Physical testing was performed to determine mechanical strength and demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Absorbable surgical mesh made of poly-4-hydroxybutyrate (P4HB). Class II device (21 CFR 878.3300).

Indications for Use

Indicated for patients requiring temporary wound support, soft tissue reinforcement, or repair of hernia/fascial defects, including vaginal, colon, and rectal prolapse repair, pelvic floor reconstruction, and sacral colposuspension.

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

• Vicryl Mesh (K810428, K851086)
• TephaFLEX Absorbable Suture (K052225)
• Surgi-Wrap Film (K031995, K050332)

Submission Summary (Full Text)

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K070894

Image /page/0/Picture/1 description: The image shows the word "tepha" in a stylized font. The letters are in black, and the word is surrounded by a curved line that starts below the "t" and ends below the "a". The font is bold and sans-serif.

APR 1 3 2007

840 Memorial Drive Cambridge, MA 02139 tel: [phone] fax: [phone]

## Section X Summary of Safety and Effectiveness

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Tepha, Inc. is submitting the following summary of information respecting safety and effectiveness:

| Trade Name: | TephaFLEX® Surgical Mesh |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Tepha, Inc.<br>840 Memorial Drive<br>Cambridge, MA 02139<br>Telephone: [phone]<br>Fax: [phone] |
| Device Classification Name: | CFR §878.3300<br>Absorbable Poly-4-hydroxybutyrate (P4HB) Surgical Mesh |
| Classification: | According to Section 13 of the Federal Food, Drug and<br>Cosmetic Act, the device classification is Class II,<br>Performance Standards. |
| Predicate Devices: | Ethicon, Inc. - Vicryl Mesh - K810428, K851086<br>Tepha, Inc. - TephaFLEX Absorbable Suture - K052225<br>MAST Biosurgery, Inc. - Surgi-Wrap Film - K031995,<br>K050332 |
| Device Description: | TephaFLEX® Surgical Mesh is to be used wherever<br>temporary wound support is required, to reinforce soft<br>tissues where weakness exists or for the repair of hernia<br>or other fascial defects that require the addition of a<br>reinforcing or bridging material to obtain the desired<br>surgical result. This includes, but is not limited to the<br>following procedures: vaginal prolapse repair, colon and<br>rectal prolapse repair, reconstruction of the pelvic floor and<br>sacral colposuspension. |
| Safety and Performance: | Physical testing was performed on the TephaFLEX®<br>surgical mesh which determined the TephaFLEX mesh to<br>be substantially equivalent to the mechanical strengths of<br>the predicate devices under indication for use conditions. |
| Conclusion: | Based on the indications for use, technological<br>characteristics, and safety and performance testing, the<br>TephaFLEX® Surgical Mesh has been shown to be<br>substantially equivalent to predicate devices under the<br>Federal Food, Drug and Cosmetic Act. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tepha Incorporated % Ms. Mary P. LeGraw Director, Regulatory Affairs 840 Memorial Drive Cambridge, Massachusetts 02139

APR 1 3 2007

Re: K070894

Trade/Device Name: TephaFLEX® Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 29, 2007 Received: March 30, 2007

Dear Ms. LeGraw:

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 (OS) 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. Mary P. LeGraw

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.

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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## Indications for Use

510(k) Number (if known):

Not Assigned

TephaFLEX® Surgical Mesh Device Name:

## Indications for Use:

TephaFLEX® Surgical Mesh is intended wherever temporary wound support is required, to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

Nul

Prescription Use: X (21 CFR 801 Subpart D) AND/OR

sion Signon of General, Restorative, d Neurological Devices

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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