TEPHAFLEX COMPOSITE MESH

K101287 · Tepha, Inc. · OWT · Aug 30, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101287
• Device Name: TEPHAFLEX COMPOSITE MESH
• Applicant: Tepha, Inc.
• Product Code: OWT · General, Plastic Surgery
• Decision Date: Aug 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

TephaFLEX composite mesh is intended to be used 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: repair of colon and rectal prolapse (excluding rectocele) using an abdominal approach, sacral colposuspension and reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse). The film side of the device may help minimize the potential for tissue attachment to the mesh in case of direct contact with the viscera.

Device Story

TephaFLEX Composite Mesh is a surgical implant consisting of a knitted mesh layer and a solid film layer, both composed of P4HB (poly-4-hydroxybutyrate) monofilament fiber. The device provides temporary wound support and soft tissue reinforcement. The knitted mesh side facilitates tissue ingrowth, while the film side acts as a physical barrier to minimize tissue attachment to viscera. It is intended for use by surgeons in procedures such as hernia repair, pelvic floor reconstruction, and rectal prolapse repair via abdominal approach. The device functions as a mechanical scaffold for tissue healing; it does not involve electronic components, software, or automated analysis.

Clinical Evidence

No clinical data. Evidence consists of bench testing (comparative burst strength, suture pull-out, tensile strength, and tear resistance) and a long-term subcutaneous in vivo animal implantation study with histological assessments conducted out to 78 weeks to characterize strength retention.

Technological Characteristics

Composite surgical mesh composed of P4HB (poly-4-hydroxybutyrate). Structure: knitted mesh layer combined with a solid film layer. Material: size 5-0 monofilament P4HB fiber. Mechanical properties characterized by burst, suture pull-out, tensile, and tear resistance testing. Non-electronic, non-software device.

Indications for Use

Indicated for patients requiring temporary wound support, soft tissue reinforcement, or repair of hernia/fascial defects. Procedures include abdominal repair of colon/rectal prolapse (excluding rectocele), sacral colposuspension, and abdominal pelvic floor reconstruction (excluding transvaginal repair).

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 Film
• TephaFLEX Surgical Mesh

Submission Summary (Full Text)

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K10/287

Image /page/0/Picture/1 description: The image shows the logo for TEPHA MEDICAL DEVICES. The logo consists of the word "TEPHA" in large, bold, sans-serif font, with the words "MEDICAL DEVICES" in a smaller font below. To the left of the word "TEPHA" is a graphic element that appears to be an abstract design. The logo is black and white.

99 Hayden Avenue Suite 360 Lexington, MA 02421 tel: [phone] fax: [phone]

## Section X Summary of Safety and Effectiveness (Prepared July 30, 2012)

AUG 30 2010

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 Composite Mesh |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Tepha, Inc.<br>99 Hayden Avenue, Suite 360<br>Lexington, MA 02421<br>Telephone: [phone]<br>Fax: [phone] |
| Contact: | Mary P. LeGraw, V.P., Regulatory Affairs |
| Device Classification Name: | CFR §878.3300, Surgical Mesh |
| Product Code: | OOD, OTO, OW T, OXL |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act,<br>the device classification is Class II, Performance Standards. |
| Predicate Devices: | Tepha, Inc. - TephaFLEX Surgical Film<br>Tepha, Inc. - TephaFLEX Surgical Mesh |
| Indications for Use: | TephaFLEX composite mesh is intended to be used wherever<br>temporary wound support is required, to reinforce soft tissues where<br>weakness exists or for the repair of hernia or other fascial defects<br>that require the addition of a reinforcing or bridging material to obtain<br>the desired surgical result. This includes, but is not limited to the<br>following procedures: repair of colon and rectal prolapse (excluding<br>rectocele) using an abdominal approach, sacral colposuspension and<br>reconstruction of the pelvic floor using an abdominal approach<br>(excluding transvaginal repair of pelvic organ prolapse). The film<br>side of the device may help minimize the potential for tissue<br>attachment to the mesh in case of direct contact with the viscera. |
| Device Description: | The TephaFLEX composite mesh is comprised of a layer of<br>TephaFLEX knitted mesh with a layer of TephaFLEX film on one of<br>its sides. The mesh is prepared from size 5-0 monofilament P4HB<br>fiber and the film is a solid sheet of P4HB material. The knitted mesh<br>side of the construct allows for tissue in growth while the film side<br>provides a layer that physically separates the knitted mesh from<br>underlying tissue and organ surfaces during the wound healing<br>period to minimize tissue attachment to the mesh in case of direct<br>contact with the viscera. |
| Safety and Performance: | Mechanical and in vivo 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 |

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Image /page/1/Picture/0 description: The image shows the logo for TEPHA MEDICAL DEVICES. The logo is in black and white. The word "TEPHA" is in large, bold letters, and the words "MEDICAL DEVICES" are in smaller letters below. There is a design to the left of the word "TEPHA".

99 Hayden Avenue Suite 360 Lexington, MA 02421 tel: [phone] fax: [phone]

Notification Application for a Surgical Mesh. Specifically, comparative burst strength, suture pull-out strength, tensile strength and tear resistance strength was characterized. Long term in vivo strength retention was characterized via a subcutaneous in vivo implantation study with histological assessments out to 78 weeks. The mechanical and in vivo data collected determined the mesh to be substantially equivalent to the predicate devices.

Conclusion:

Based on the indications for use, technological characteristics, and safety and performance testing, the TephaFLEX composite mesh has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with three intertwined strands representing health, services, and people.

Public Health Service

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

Tepha. Incorporated % Ms. Mary P. LeGraw Vice President, Regulatory Affairs 99 Hayden Avenue, Suite 360 Lexington, Massachusetts 02421

Re: K101287

Trade/Device Name: TephaFLEX Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OOD, OTO, OWT, OXL Dated: July 16, 2010 Received: July 19, 2010

AUG 2 4 2012

Dear Ms. LeGraw:

This letter corrects our substantially equivalent letter of August 30, 2010.

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 (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 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); 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.

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Page 2 - Ms. Mary P. LeGraw

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,
Mark N. Melkerson

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): K101287

Device Name: TephaFLEX Surgical Mesh

## Indications for Use:

TephaFLEX® Composite 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: repair of colon and rectal prolapse (excluding rectocele) using an abdominal approach, sacral colposuspension and reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapsed). The film side of the device may help minimize the potential for tissue attachment to the mesh in case of direct contact with the viscera.

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)

David Kreefarman
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101267

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