TephaFLEX Melt blown Matrix is intended to reinforce soft tissue where weakness exists in patients undergoing surgical procedures that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Description

The TephaFLEX Meltblown Matrix is a resorbable construct prepared from poly-4-hydroxybutyrate (P4HB) and is provided either non-dyed or dyed with D&C Violet No. 2. It is a porous, fibrous structure composed of thin P4HB fibers that result in a non-woven mesh like fabric. It is provided in single sheets of varying widths, lengths and shapes ranging from 1x1 to 10x14 inches.

AI/ML Overview

This document describes the TephaFLEX® Meltblown Matrix, a resorbable surgical mesh, and its substantial equivalence to predicate devices, rather than an AI-powered device. Therefore, many of the requested categories related to AI device performance are not applicable.

Here's the information that can be extracted and a clear indication of what is not applicable based on the provided text:

Acceptance Criteria and Device Performance for TephaFLEX® Meltblown Matrix

1. A table of acceptance criteria and the reported device performance

The document establishes "substantial equivalence" to predicate devices as the primary acceptance criterion. Performance is evaluated through comparative mechanical testing and in vivo animal testing against these predicates. While specific quantitative acceptance criteria values are not explicitly stated, the conclusion is that the new device is "Substantially Equivalent" to the predicates.

Characteristic	Acceptance Criterion (Based on Predicate Devices)	Reported Device Performance (TephaFLEX® Meltblown Matrix)
Suture Pullout Strength	Substantially Equivalent to predicate devices (TephaFLEX® Mesh, Cook Biodesign Surgisis, MAST Biosurgery Surgi-Wrap)	Substantially Equivalent
Tensile Strength	Substantially Equivalent to predicate devices (TephaFLEX® Mesh, Cook Biodesign Surgisis, MAST Biosurgery Surgi-Wrap)	Substantially Equivalent
Burst Strength	Characterized comparably to predicate devices	Data collected determined product to be substantially equivalent
Tear Resistance Strength	Characterized comparably to predicate devices	Data collected determined product to be substantially equivalent
In vivo Strength Retention	Characterized via subcutaneous implantation study comparable to predicate devices	Data collected determined product to be substantially equivalent
Biocompatibility	In compliance with applicable parts of FDA's Class II Special Controls Guidance Document for Absorbable Poly(hydroxybutyrate) Surgical Suture	Performed and in compliance
Absorption Profile	Essentially complete within 12-18 months (similar to TephaFLEX Mesh and MAST Biosurgery's Surgi-Wrap)	Absorption essentially complete within 12-18 months

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Mechanical testing, biocompatibility testing, and in vivo animal testing" were performed. However, specific sample sizes for these tests are not provided. The provenance of the data (country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This relates to AI interpretation or expert consensus on clinical data. For this device, "ground truth" would be established through physical and biological testing parameters, likely overseen by engineers, material scientists, and animal study veterinarians. The document does not specify the number or qualifications of individuals involved in generating or interpreting these test results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for evaluating the physical properties of a surgical mesh.

5. 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 document describes a medical device (surgical mesh), not an AI algorithm. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This document describes a medical device (surgical mesh), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on standardized mechanical property measurements and in vivo animal study observations, compared against the performance of legally marketed predicate devices. This is a scientific and engineering ground truth, not a clinical ground truth established by expert consensus, pathology, or outcomes data in humans.

8. The sample size for the training set

Not applicable. This document describes a medical device, not an AI algorithm. Therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of medical device.

Summary

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K130326 page 1/3

tepha

840 Memorial Drive Cambridge. MA 02139 tel: (617) 995-5400 fax: (617) 995-5401

MAY 0 7 2013

Section IX 510(k) Summary (April 18, 2013)

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® Melt blown Matrix
Sponsor:	Tepha, Inc.99 Hayden Avenue, Suite 360Lexington, MA 02421
Contact Person:	Mary P. LeGraw, V.P., Regulatory AffairsTelephone: 781-357-1709Fax: 781-357-1701E-mail: legraw@tepha.com
Device Classification Name:	CFR §878.3300Surgical Mesh - Product Code: OOD
Classification:	According to Section 13 of the Federal Food, Drug and Cosmetic Act, thedevice classification is Class II, Performance Standards.
Predicate Devices:	TephaFLEX Surgical Mesh - K113723Cook Biodesign Surgisis Tissue Graft - K062696Gore Bio-A Tissue Reinforcement - K033671MAST Biosurgery Surgi-Wrap - K031995, K050332Please see the attached Substantial Equivalence table comparing the
Device Description:	TephaFLEX Meltblown Matrix to the predicate devices.The TephaFLEX Meltblown Matrix is a resorbable construct preparedfrom poly-4-hydroxybutyrate (P4HB) and is provided either non-dyed ordyed with D&C Violet No. 2. It is a porous, fibrous structure composed ofthin P4HB fibers that result in a non-woven mesh like fabric. It isprovided in single sheets of varying widths, lengths and shapes rangingfrom 1x1 to 10x14 inches.
Indications for Use:	TephaFLEX Meltblown Matrix is intended to reinforce soft tissue whereweakness exists in patients undergoing surgical procedures that requirethe addition of a reinforcing or bridging material to obtain the desiredsurgical result.
Safety and Performance:	The P4HB material used to manufacture the TephaFLEX melt blownmatrix is in compliance with the applicable parts of FDA's Class II SpecialControls Guidance Document: Absorbable Poly(hydroxybutyrate)Surgical Suture Produced by Recombinant DNA Technology.Mechanical testing, biocompatibility testing, and in vivo animal testingwas performed based on recommendations identified in the FDA surgicalmesh guidance document: The Guidance for the Preparation of a Pre-

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Image /page/1/Picture/1 description: The image shows the word "tepha" in a bold, sans-serif font. A curved line underlines the word, starting from the left side of the 't' and extending to the right side of the 'a'. The text is black against a white background.

840 Memorial Drive Cambridge, MA 02139 tel: (617) 995-5400 fax: (617) 995-5401

market Notification Application for a Surgical Mesh. Specifically, comparative burst strength, suture pull-out strength, tensile strength and tear resistance strength was characterized. In vivo strength retention was characterized via a subcutaneous implantation study. The mechanical and in vivo data collected determined the product to be substantially equivalent to the predicate devices.

Conclusion:

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

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Substantial Equivalence Comparison Tabl

Characteristic	Indications for Use	Material	Thickness	Dyed, Non-dyed	Size	Performance ResultsSuture PulloutTensile Strength	Absorption Profile	Packaging	Sterilization
Tepha, Inc.Proposed TephaFLEX®Melt blown Matrix	The TephaFLEX melt blownmatrix is intended toreinforce soft tissue insurgical procedures thatrequire the addition of areinforcing or bridgingmaterial to obtain the desiredsurgical result.	Poly-4-hydroxybutyrate(P4HB)	~ 1 mm	Non-dyed & Dyed (D&CViolet #2)	Single sheet sizes of: 1x2through 10 X 12 inches	SubstantiallyEquivalent	Absorption essentiallycomplete within 12-18months	Foil packaging withremovable Tyvek header	Ethylene Oxide (EO)
Tepha, Inc.Predicate TephaFLEX®MeshK113723	The TephaFLEX mesh isintended to reinforce softtissue where weakness existsin patients requiring soft tissuerepair or reinforcement inplastic and reconstructivesurgery, or for the repair ofhernia or other fascial defectsthat require the addition of areinforcing or bridging materialto obtain the desire surgicalresult.	Poly-4-hydroxybutyrate(P4HB)	~0.6 mm	Non-dyed & dyed (D&C Violet#2)	Single sheet sizes of: 1x2through 12x14 inches	SubstantiallyEquivalent	Absorption essentiallycomplete within 12-18 months	Foil packaging with removableTyvek header	Ethylene Oxide (EO)
Cook BiotechSurgisisK062696	Surgisis is Intended forimplantation to reinforce softtissue. The device isintended for one-time use.	Porcine small intestinalsubmucosa	Nominal thickness rangingfrom 0.04 mm to 0.7 mm	Non-dyed	Single sheet size of: 2x3through 7x10 cm	Substantially Equivalent	Unknown	Inner pouch contained inouter bag composed ofpolymer film lined paper	Ethylene Oxide
GoreBio-A TissueReinforcementK033671	Bio-A Tissue Reinforcementis intended for use in thereinforcement of soft tissue.Examples of applicationswhere the Bio-A may beused include, but are notlimited to, hernia repair (innon-load bearingapplications), muscle flapreinforcement, and generaltissue reconstruction	Poly(glycolide: trimethylenecarbonate) copolymer	~ 2 mm	Unknown	Available in single sheetsand preformed, three-dimensional shapes.	Not tested	Biobsorption process shouldbe complete by the end ofsix months (labeling)	Unknown,	Ethylene Oxide (EO)
MAST Biosurgery, Inc.Surgi-WrapK031955, K050332	SurgiWrap MAST BioresorbableSheet is to be used wherevertemporary wound support isrequired, to reinforce soft tissueswhere weakness exists in theurological, gynecological orgastroenterological anatomy, or forthe repair of hernia or other fascialdefects that require the addition of areinforcing or bridging material toobtain the desired surgical result.This includes, but is not limited tothe following procedures:pubourethral support and bladdersupport, urethral and vaginalprolapse repair, colon and rectalprolapse repair, reconstruction ofthe pelvic floor and sacralcolposuspension. The absorbableprotective film minimizes tissueattachment to the device in case ofdirect contact with the viscera.	Polylactic acid (PLA)	20 - 1000 microns	Undyed	Single sheet sizes of25mm x 25mm to 500mm x 500mm	SubstantiallyEquivalent	Absorption complete between 12-18months depending on design.	Tyvek film pouch in individualcardboard box	Electron beam irradiation

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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

May 7, 2013

Re: K130326

Trade/Device Name: TephaFLEX® Meltblown Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OOD Dated: April 18, 2013 Received: April 23, 2013

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. Ilsting 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

Peter D. Rumm-S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Unknown

Device Name: . TephaFLEX® Melt blown Matrix

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)

Page 1 of 1

David Krajūsēs-S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130326

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.