TEPHAFLEX SURGICAL FILM

K072520 · Tepha, Inc. · FTL · Nov 29, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072520
• Device Name: TEPHAFLEX SURGICAL FILM
• Applicant: Tepha, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Nov 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TephaFLEX® Surgical Film is intended for temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.

Device Story

TephaFLEX Surgical Film is an absorbable, protective film used for temporary wound support and reinforcement of soft tissues or fascial defects (e.g., hernia repair). The device is applied by surgeons in an operating room setting. It functions as a physical barrier to reinforce tissue and minimize potential tissue attachment to the device when in contact with viscera. The film is designed to be absorbed by the body over time, providing temporary support during the healing process. Clinical benefit is derived from the mechanical reinforcement of weakened tissue and the reduction of adhesions in cases of visceral contact.

Clinical Evidence

No clinical data. Substantial equivalence was established through physical and in vivo animal testing, which confirmed the mechanical strength of the film is equivalent to predicate devices.

Technological Characteristics

Absorbable surgical film; intended for soft tissue reinforcement and hernia repair. Mechanical properties verified via physical and in vivo animal testing to ensure equivalence to predicate surgical films.

Indications for Use

Indicated for patients requiring temporary wound support, soft tissue reinforcement, or repair of hernia or fascial defects. May be used where the device contacts viscera to minimize potential tissue attachment.

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

• MAST Biosurgery, Inc. - Surgi-Wrap Film
• OsteoBiologics, Inc. - PlastiFIIm
• Tepha, Inc. - TephaFLEX Absorbable Mesh

Submission Summary (Full Text)

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K072520

II

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NOV 2 9 2007

99 Hayden Avenue Suite 360 Lexington, MA 02421 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 Film |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Tepha, Inc.<br>99 Hayden Avenue, Suite 360<br>Lexington, MA 02421<br>Telephone: [phone]<br>Fax: [phone] |
| Device Classification Name: | CFR §878.3300<br>Surgical Mesh |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic<br>Act, the device classification is Class II, Performance Standards. |
| Predicate Devices: | MAST Biosurgery, Inc. - Surgi-Wrap Film<br>OsteoBiologics, Inc. -- PlastiFIIm<br>Tepha, Inc. - TephaFLEX Absorbable Mesh |
| Device Description: | TephaFLEX surgical film is intended for temporary wound<br>support, to reinforce soft tissues where weakness exists, or for<br>the repair of hernia or other fascial defects that require the<br>addition of a reinforcing material to obtain the desired surgical<br>result. The absorbable protective film also may help minimize the<br>potential tissue attachment to the device in case of direct contact<br>with the viscera. |
| Safety and Performance: | Physical and in vivo animal testing was performed on the<br>TephaFLEX surgical film which determined the film to be<br>substantially equivalent to the mechanical strengths of the<br>predicate devices under indication for use conditions. |
| Conclusion: | Based on the indications for use, technological characteristics,<br>and safety and performance testing, the TephaFLEX surgical film<br>has been shown to be substantially equivalent to predicate<br>devices under the Federal Food, Drug and Cosmetic Act. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized symbol. The symbol is a representation of a human figure or figures, possibly suggesting care or support. The overall design is simple and professional, reflecting the department's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2007

Tepha, Inc. % Ms. Mary P. LeGraw Sr. Dirctor, Regulatory Affairs 99 Hayden Avenue Lexington, Massachusetts 02421

Re: K072520

Trade/Device Name: TephaFLEX® Surgical Film Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, NWJ Dated: October 30, 2007 Received: October 31, 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 (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. Andrew Barriskill

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 yours.

Mark N. Millman

- 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): K072520

TephaFLEX® Surgical Film Device Name:

Indications for Use:

TephaFLEX® Surgical Film is intended for temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.

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

Over-The-Counter (21 CFR 801 Subpart C)

(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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Division of Ger and Neurologic

510(k) Number K072520