MESO WOUND MATRIX

• K Number: K112888
• Device Name: MESO WOUND MATRIX
• Manufacturer: KENSEY NASH CORPORATION
• Date Cleared: 2012-02-10 ( 133 days)
• Product Code: KGN
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K094061 , K061711
• Predicate For: K141738 , K231937

Intended Use

Meso Wound Matrix is a resorbable porcine mesothelium derived product intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears), and draining wounds.

The device is intended for one time use.

Device Description

Meso Wound Matrix is composed of porcine collagen from peritoneum tissue. It is an absorbent, white to off- white material supplied as sheet. The device is packaged sterile in a double-layer package.

AI/ML Overview

The provided text is a 510(k) summary for the Meso Wound Matrix and an FDA letter confirming substantial equivalence. It does not present a study or acceptance criteria for device performance as typically understood for AI/software-as-a-medical-device (SaMD) products. Instead, it focuses on the device's technological characteristics, biocompatibility, and substantial equivalence to a predicate device based on regulatory requirements for a wound dressing.

Therefore, many of the requested items, such as acceptance criteria table with reported performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone performance, are not applicable or available in this document. This document is related to a traditional medical device (wound dressing), not an AI/SaMD product.

However, I can extract information relevant to the regulatory approval process as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the device's efficacy in terms of wound healing. The "performance data" section rather lists types of tests conducted for regulatory compliance.

   Acceptance Criteria Category	Reported Device Performance (Summary)
   Biocompatibility	Passed tests according to ISO 10993-1:2003
   	- Cytotoxicity
   	- Sensitization
   	- Systemic Toxicity
   	- Sub-Chronic Toxicity
   	- Genotoxicity
   	- Implantation
   	- Pyrogenicity
   	- Hemocompatibility
   Hydration	Testing conducted; no specific results or criteria provided
   Animal Testing	Testing conducted; no specific results or criteria provided
   Viral Inactivation	Testing conducted; no specific results or criteria provided
   Technological Characteristics	"Technologically identical to the cleared KN ECM Surgical Patch (K094061)"
   Material	Composed of porcine collagen from peritoneum tissue
   Sterility	Packaged sterile

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/SaMD product with a "test set" in the context of algorithm evaluation. The document mentions "animal testing" but does not specify sample sizes or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm's performance is not relevant for this type of device submission. Regulatory decisions are based on the demonstrated characteristics and equivalence to predicate devices, assessed by FDA reviewers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the "Performance Data" sections (biocompatibility, hydration, animal, viral inactivation), the "ground truth" would be the established scientific and regulatory standards for each test type (e.g., specific endpoints for biocompatibility, histological findings in animal studies, viral load reduction for inactivation studies). No single "ground truth" like pathology or outcomes data is explicitly detailed here for a classification task. The primary ground for approval is Substantial Equivalence to a legally marketed predicate device, based on material, intended use, and technological characteristics.

8. The sample size for the training set: Not applicable. This is not an AI/ML product that uses a "training set."

9. How the ground truth for the training set was established: Not applicable. No training set is involved.

Summary

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FEB 1 0 2012

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510(k) Summary

Submitted by:	Kensey Nash Corporation735 Pennsylvania DriveExton, PA 19341
Contact Person:	Lori Burns, MS, RACManager, Regulatory AffairsPh: [phone]Fax: [phone]
Date Prepared:	February 8, 2012
510(K) #:	K112888
Device:
Trade Name:	Meso Wound Matrix
Common/Usual Name:	Wound Dressing

ನ ound Dressing Proposed Classification: KGN, unclassified

Device Description:

Meso Wound Matrix is composed of porcine collagen from peritoneum tissue. It is an absorbent, white to off- white material supplied as sheet. The device is packaged sterile in a double-layer package.

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Intended Use: Meso Wound Matrix is intended for the management of topical wounds including:

• Partial and full thickness wounds .
• . Pressure ulcers
• . Venous ulcers
• Diabetic ulcers .
• Chronic vascular ulcers .
• Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound . dehiscence )
• Trauma wounds(abrasions, lacerations, second-degree burns and skin tears) .
• Draining wounds .
• Tunneled/ undermined wounds .

Predicate Device:

Manufacturer	Device	510(k)
Cook Biotech, Inc.	Oasis Wound Matrix	K061711

Technological Characteristics:

Meso Wound Matrix is technologically identical to the cleared KN ECM Surgical Patch (K094061). Like KN ECM Surgical Patch, Meso Wound Matrix consists of terminally sterilized processed lyophilized porcine peritoneum provided in various sizes and packaged in a double layer package.

Performance Data:

Meso Wound Matrix has undergone biocompatibility, hydration, animal, and viral inactivation testing. The following biocompatibility tests were conducted on the finished device according to the requirements of ISO 10993-1:2003, Biological evaluation of medical devices - Part 1:Evaluation and testing. : Cytotoxicity, Sensitization, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemocompatibility.

Substantial Equivalence:

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K112888
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Based on the material, biocompatibility, bench, and animal testing, and the proposed device labeling, Meso Wound Matrix is substantially equivalent to the identified predicate device in terms of intended use, technological characteristics and principles of operation pursuant to section 510(k).

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

FEB 1 0 2012

Kensey Nash Corporation % Ms. Lori Burns, MS, RAC Manager, Regulatory Affairs 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K112888

Trade/Device Name: Meso Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: January 30, 2012 Received: February 01, 2012

Dear Ms. Burns:

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. Lori Burns, MS, RAC

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/ReportalToblem/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.

.fda.gov/MedicalDevices/ResourcesforIndustry/ucm.htm

Sincerely yours.

Sincerly, yours,

Mark Milliken

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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K112888
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Indications for Use

510(k) Number (if known): K112888

Device Name: Meso Wound Matrix

Indications for Use:

Meso Wound Matrix is a resorbable porcine mesothelium derived product intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears), and draining wounds.

The device is intended for one time use.

Prescription Use X (Part 21 CFR 801 Subpart D)

. AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kucera for MXM

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112855

Regulation Number and Section

N/A