TEPHAFLEX COMPOSITE MESH by TEPHA, INC.

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.

Device Description

The TephaFLEX composite mesh is comprised of a layer of TephaFLEX knitted mesh with a layer of TephaFLEX film on one of its sides. The mesh is prepared from size 5-0 monofilament P4HB fiber and the film is a solid sheet of P4HB material. The knitted mesh side of the construct allows for tissue in growth while the film side provides a layer that physically separates the knitted mesh from underlying tissue and organ surfaces during the wound healing period to minimize tissue attachment to the mesh in case of direct contact with the viscera.

AI/ML Overview

This document describes the safety and effectiveness of the TephaFLEX Composite Mesh through a 510(k) premarket notification. The study primarily relies on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for a novel AI or diagnostic device. As such, many of the requested categories for AI/diagnostic studies are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The device, TephaFLEX Composite Mesh, is seeking substantial equivalence to existing predicate devices (TephaFLEX Surgical Film and TephaFLEX Surgical Mesh). The acceptance criteria are implicitly based on demonstrating comparable mechanical properties and in vivo biological responses to these predicate devices. The "reported device performance" is the conclusion that the device meets substantial equivalence.

Performance Metric	Acceptance Criteria (Implicit - based on predicate devices)	Reported Device Performance
Burst Strength	Comparable to predicate devices	Characterized; data supported substantial equivalence
Suture Pull-out Strength	Comparable to predicate devices	Characterized; data supported substantial equivalence
Tensile Strength	Comparable to predicate devices	Characterized; data supported substantial equivalence
Tear Resistance Strength	Comparable to predicate devices	Characterized; data supported substantial equivalence
Long-term (78 weeks) In Vivo Strength	Comparable to predicate devices (demonstrated via subcutaneous implantation)	Characterized; data supported substantial equivalence
Histological Assessments (up to 78 weeks)	Comparable to predicate devices (demonstrated via subcutaneous implantation in vivo to assess tissue response and integration/degradation)	Characterized; data supported substantial equivalence

Study Conclusion: "The mechanical and in vivo data collected determined the mesh to be substantially equivalent to the predicate devices."

Additional Requested Information:

Since this is a submission for a surgical mesh, not a software-driven AI or diagnostic device, many of the requested categories pertaining to AI/ML device studies are not directly applicable.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of an algorithmic test set. The testing involved in vitro mechanical tests and in vivo animal studies.
- Data Provenance: The in vivo testing was an "implantation study with histological assessments out to 78 weeks." This implies prospective animal studies conducted to gather safety and performance data. The country of origin for these studies is not specified but would typically be conducted in the country where the manufacturer is located or specialized contract research organizations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of device performance testing for a surgical mesh. "Ground truth" here refers to established scientific methods for mechanical testing and histopathological assessment, which are typically performed by trained technicians and pathologists, not "experts" establishing truth for an AI algorithm.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments in diagnostic studies. The mechanical and histological assessments are objective measurements or standard interpretations.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic or interpretation device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical properties: Standardized mechanical testing procedures (e.g., burst strength, tensile strength, tear resistance) with specific metrics being the "ground truth."
- For in vivo response: Histological assessments (pathology) from animal implantation studies out to 78 weeks were used to evaluate tissue ingrowth, inflammation, degradation, and other biological responses.
The sample size for the training set:
- Not applicable, as this is not an AI/ML device requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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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: (781) 357-1700 fax: (781) 357-1701

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.99 Hayden Avenue, Suite 360Lexington, MA 02421Telephone: 781.357.1700Fax: 781.357.1701
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,the device classification is Class II, Performance Standards.
Predicate Devices:	Tepha, Inc. - TephaFLEX Surgical FilmTepha, Inc. - TephaFLEX Surgical Mesh
Indications for Use:	TephaFLEX composite mesh is intended to be used wherevertemporary wound support is required, to reinforce soft tissues whereweakness exists or for the repair of hernia or other fascial defectsthat require the addition of a reinforcing or bridging material to obtainthe desired surgical result. This includes, but is not limited to thefollowing procedures: repair of colon and rectal prolapse (excludingrectocele) using an abdominal approach, sacral colposuspension andreconstruction of the pelvic floor using an abdominal approach(excluding transvaginal repair of pelvic organ prolapse). The filmside of the device may help minimize the potential for tissueattachment to the mesh in case of direct contact with the viscera.
Device Description:	The TephaFLEX composite mesh is comprised of a layer ofTephaFLEX knitted mesh with a layer of TephaFLEX film on one ofits sides. The mesh is prepared from size 5-0 monofilament P4HBfiber and the film is a solid sheet of P4HB material. The knitted meshside of the construct allows for tissue in growth while the film sideprovides a layer that physically separates the knitted mesh fromunderlying tissue and organ surfaces during the wound healingperiod to minimize tissue attachment to the mesh in case of directcontact with the viscera.
Safety and Performance:	Mechanical and in vivo animal testing was performed based onrecommendations identified in the FDA surgical mesh guidancedocument: 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: (781) 357-1700 fax: (781) 357-1701

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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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 (800) 638-2041 or (301) 796-7100 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:

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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Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.