partial and full-thickness wounds
pressure ulcers
venous ulcers
diabetic ulcers
chronic vascular ulcers
tunneled/undermined wounds
surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery; podiatric, wound dehiscence)
trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
draining wounds

Device Description

Endoform™ Dermal Template is a wound dressing primarily composed of ovine collagen and is supplied as a sterile intact, perforated or meshed sheet ranging in size from 9cm2 to 400cm2.

AI/ML Overview

The provided text describes a 510(k) summary for the Mesynthes Limited, Endoform™ Dermal Template. It does not include information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics. Instead, it focuses on the device description, intended use, technological characteristics, and a broad statement about performance testing for substantial equivalence.

Therefore, I cannot populate the requested table and sections with specific values as the information is not present in the provided text.

Here's how I would present the absence of that information based on the given text:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the Mesynthes Limited, Endoform™ Dermal Template states that the device has undergone "extensive non-clinical testing to assess the biocompatibility and the performance of the device" and that "Endoform™ Dermal Template was shown to be safe and effective as a wound dressing." However, specific acceptance criteria, detailed study designs, and reported performance metrics are not provided in this document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against pre-defined quantitative criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided document	Not specified in the provided document beyond a general statement of "safe and effective"

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided document.
Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as no specific test set or ground truth establishment by experts is detailed in the provided document.

4. Adjudication method for the test set

Not applicable as no specific test set or adjudication process is detailed in the provided document.

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 is a wound dressing, not an AI-assisted diagnostic device. The document does not describe an MRMC study.

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

Not applicable. This is a wound dressing, not an algorithm. The document does not describe an algorithm-only performance study.

7. The type of ground truth used

Not applicable, as specific performance metrics and ground truth establishment methods are not detailed. The submission relies on demonstrating substantial equivalence to predicate devices based on material composition, device characteristics, and intended use.

8. The sample size for the training set

Not applicable. This is a wound dressing, not a machine learning model requiring a training set.

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

Not applicable. This is a wound dressing, not a machine learning model.

Summary

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JAN 8 1 2010

510(k) Summary for the Mesynthes Limited, Endoform™ Dermal Template

1. SUBMITTER/510(K) HOLDER

Mesynthes Ltd 69 Gracefield Road Lower Hutt Wellington New Zealand 5010

Contact Person Brian Ward Telephone: (+64 4) 931-3275

Date Prepared: July 10, 2009

2. DEVICE NAME

Proprietary Name: Endoform™ Dermal Template Common/Usual Name: Endoform™ Classification Name: Collagen Wound Dressing

3. PREDICATE DEVICES

피 OaSIS® Wound Matrix (Cook Biotech) (K061711, K973170, K993948)
트 UBM Lyophilized Wound Dressing (MatriStem™) (ACell) (K021637)
. Unite Biomatrix™ (Pegasus Biologics) (K071425)
. Promogran® Matrix Wound Dressing (Johnson and Johnson) (K014129)
트 IntegraTM Wound Matrix (Integra Life Sciences) (K021792)

4. DEVICE DESCRIPTION

Endoform™ Dermal Template is a wound dressing primarily composed of ovine collagen and is supplied as a sterile intact, perforated or meshed sheet ranging in size from 9cm2 to 400cm2.

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K092096 page 2/2

5. INTENDED USE

Endoform™ is supplied sterile and is intended for single use in the treatment of the following wounds:

· partial and full-thickness wounds
· pressure ulcers
· venous ulcers
· diabetic ulcers
· chronic vascular ulcers
· tunneled/undermined wounds
· surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery; podiatric, wound dehiscence)
· trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
· draining wounds

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Endoform™ Dermal Template is substantially equivalent to the predicate devices with respect to material composition, device characteristics and intended use,

7. PERFORMANCE TESTING

The Endoform™ Dermal Template has been subjected to extensive non-clinical testing to assess the biocompatibility and the performance of the device. Endoform™ Dermal Template was shown to be safe and effective as a wound dressing.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

JAN 2 1 2010

Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Room W-066-0609 Silver Spring, MD 20993-0002

Mesynthes Limited % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760

Re: K092096

Trade/Device Name: Endoform™ Dermal Template Regulatory Class: Unclassified Product Code: KGN Dated: December 21, 2009 Received: December 22, 2009

Dear Ms. McNamara-Cullinane:

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 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

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Page 2 - Ms. Mary McNamara-Cullinane, RAC

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

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):

Device Name: Endoform™ Dermal Template

Indications for Use:

The Endoform™ Dermal Template is supplied sterile and is intended for single use in the treatment of the following wounds:

� partial and full-thickness wounds
. pressure ulcers
venous ulcers
. diabetic ulcers
. chronic vascular ulcers
tunneled/undermined wounds .
. surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
. trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
draining wounds �

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause kamxm
(Division Sign Off)

Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K092096

Regulation Number and Section

N/A