TEPHAFLEX MESH

K111946 · Tepha, Inc. · OOD · Sep 26, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111946
• Device Name: TEPHAFLEX MESH
• Applicant: Tepha, Inc.
• Product Code: OOD · General, Plastic Surgery
• Decision Date: Sep 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TephaFLEX mesh is intended to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desire surgical result.

Device Story

TephaFLEX Mesh is a resorbable surgical mesh composed of poly-4-hydroxybutyrate (P4HB). The device is manufactured from undyed, size 5-0 monofilament P4HB fiber knitted into a mesh structure. It is supplied as single sheets of varying dimensions that can be cut by the surgeon to fit the specific anatomical site. The mesh is used by surgeons in clinical settings to provide reinforcement or bridging for soft tissue defects, such as hernias or fascial weaknesses, during plastic and reconstructive procedures. By providing a temporary scaffold, the mesh supports the tissue during the healing process. The device is intended for prescription use only.

Clinical Evidence

No clinical data. Evidence consists of bench testing and in vivo animal studies. Mechanical testing characterized burst strength, suture pull-out strength, tensile strength, and tear resistance. In vivo strength retention was evaluated via a subcutaneous implantation study.

Technological Characteristics

Resorbable surgical mesh made of poly-4-hydroxybutyrate (P4HB). Constructed from knitted size 5-0 monofilament P4HB fiber. Provided as single sheets of varying widths and lengths, cut-to-size by the user. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair in plastic and reconstructive surgery, or for the repair of hernia or other fascial defects where weakness exists.

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

• TephaFLEX® Surgical Mesh
• TephaFLEX® Composite Mesh
• SupraMESH EXTRA™

Submission Summary (Full Text)

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tepha

## ( 04)

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

## Section IX Summary of Safety and Effectiveness (Prepared on July 7, 2011)

SEP 2 6 2011

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® Mesh |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Tepha, Inc.<br>99 Hayden Avenue, Suite 360<br>Lexington, MA 02421 |
| Contact Person: | Mary P. LeGraw, V.P., Regulatory Affairs |
| Device Classification Name: | CFR §878.3300<br>Surgical Mesh |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the<br>device classification is Class II, Performance Standards. |
| Predicate Devices: | TephaFLEX® Surgical Mesh<br>TephaFLEX® Composite Mesh<br>SupraMESH EXTRA™ |
| Device Description: | The TephaFLEX mesh is a resorbable mesh prepared from poly-4-<br>hydroxybutyrate (P4HB). The mesh is prepared from undyed, size 5-0<br>monofilament P4HB fiber that is knitted into a surgical mesh. It is<br>provided in single sheets of varying widths and lengths and may be cut to<br>the shape or size desired for a specific application. |
| Indications for Use | TephaFLEX mesh is intended to reinforce soft tissue where weakness<br>exists in patients requiring soft tissue repair or reinforcement in plastic<br>and reconstructive surgery, or for the repair of hernia or other fascial<br>defects that require the addition of a reinforcing or bridging material to<br>obtain the desire surgical result. |
| Safety and Performance: | Mechanical and <i>in vivo</i> animal testing was performed based on<br>recommendations identified in the FDA surgical mesh guidance<br>document: The Guidance for the Preparation of a Pre-market Notification<br>Application for a Surgical Mesh. Specifically, comparative burst strength,<br>suture pull-out strength, tensile strength and tear resistance strength was<br>characterized. <i>In vivo</i> strength retention was characterized via a<br>subcutaneous implantation study. The mechanical and <i>in vivo</i> data<br>collected determined the mesh to be substantially equivalent to the<br>predicate devices. |
| Conclusion: | Based on the indications for use, technological characteristics, and safety<br>and performance testing, the TephaFLEX mesh has been shown to be<br>substantially equivalent to predicate devices under the Federal Food,<br>Drug and Cosmetic Act. |

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

Tepha, Inc. % Ms. Mary P. LeGraw VP, Regulatory Affairs 99 Hayden Avenue, Suite 360 Lexington, Massachuseus 02421

Re: K111946

Trade/Device Name: TephaFLEX® Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OOD Dated: September 1, 2011 Received: September 2, 2011

SEP 2 6 2Jli

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. 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 not limited to: registration and listing (21

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Page 2 - Ms. Mary P. LeGraw

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Eisie M. Kith.

for

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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## Indications for Use

510(k) Number (if known):

1111946 Unknown

Device Name: TephaFLEX® Mesh

Indications for Use:

The TephaFLEX® mesh is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desire surgical result.

Prescription Use: X (21 CFR 801 Subpart D)

AND/OR

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)

Page 1 of 1
Daniel Krone for MXM

Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111946