Medeor Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications; and for reinforcement of the soft tissues, which are repaired by suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.

The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

The device is intended for single use only.

Device Description

The purpose of this submission is to add hydration with autologous bodily fluids to the labeling of the Medeor Matrix device. Medeor Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues where weakness exists. The device is supplied sterile in double-layer peel-open packages. The device is packaged either dry or hydrated with saline. The device can be hydrated with saline or autologous bodily fluids prior to implantation.

AI/ML Overview

Acceptance Criteria and Device Performance Study

This document describes the acceptance criteria and the study that demonstrates the Medeor™ Matrix device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Biocompatibility	Must meet requirements of ISO 10993-1:2003 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemolysis).	The Medeor Matrix surgical mesh passed the requirements of all tests conducted according to ISO 10993-1:2003, including: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemolysis.
Viral Inactivation	Appropriate levels of viral inactivation.	Manufacturing methods were tested by an independent laboratory to assure appropriate levels of viral inactivation.
Mechanical Testing	Not explicitly stated in the provided text, but implied to be sufficient for soft tissue reinforcement.	Mechanical test reports were completed for: - Tensile Testing - Suture Retention. The device passed the requirements of all tests.
Hydration Testing	Not explicitly stated, but implied to allow for hydration with various fluids.	Hydration testing was performed using various hydration fluids. The device passed the requirements of all tests.
In Vivo Performance	Not explicitly stated, but implied to demonstrate appropriate tissue repair and reaction in animal models.	The device was evaluated in two in vivo studies: - Defects were repaired and evaluated in a sheep model. - A rabbit study was performed to evaluate tissue reactions. The device passed the requirements of all tests.
Substantial Equivalence	Demonstrated equivalence to predicate devices (Medeor™ Matrix (K091499) and KN ECM Surgical Patch (K094061)) in materials, intended use, and technological characteristics.	Performance Testing confirmed that Medeor Matrix is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify exact sample sizes for each test within the performance data section. However, it indicates the following studies were conducted:

Biocompatibility Tests: The tests were conducted "on the finished device," implying a sufficient number of samples for each specific test mandated by ISO 10993-1:2003.
Mechanical Tests (Tensile Testing, Suture Retention): Samples of the Medeor™ Matrix were used for these tests.
Hydration Testing: Samples were tested with "various hydration fluids."
In Vivo Studies:
- Sheep Model: Defects were repaired and evaluated in a sheep model. The specific number of sheep is not provided.
- Rabbit Study: A rabbit study was performed to evaluate tissue reactions. The specific number of rabbits is not provided.

Data Provenance:
The data was generated through laboratory testing and animal studies. The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, implying the data would be acceptable to U.S. regulatory standards. All studies appear to be prospective in nature, as they were specifically conducted to evaluate the device's performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the test set in the context of human interpretation or review. The evaluation of the device relied on standardized laboratory tests (biocompatibility, mechanical, hydration) and animal models (in vivo studies). The "ground truth" for these tests would be the established scientific and engineering principles, and the interpretation of results would be by qualified laboratory personnel and researchers, rather than a panel of clinical experts adjudicating cases.

4. Adjudication Method for the Test Set

Not applicable. The reported studies (biocompatibility, mechanical, in vivo) are objective tests with predefined pass/fail criteria based on scientific standards and observations, not on expert consensus or adjudication of subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted. This type of study typically involves human readers evaluating medical images or data, with and without AI assistance, to measure improvements in diagnostic accuracy or efficiency. The Medeor™ Matrix is a surgical mesh, not an AI-powered diagnostic device, so such a study would not be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not conducted. The Medeor™ Matrix is a physical medical device, not a software algorithm. Therefore, "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

The ground truth for the various tests was based on:

Established Industry Standards: For biocompatibility, adherence to ISO 10993-1:2003.
Inherent Material Properties: For mechanical testing (tensile strength, suture retention) and hydration properties, the measurements are objective.
Biological Response: For viral inactivation and in vivo studies (sheep model for repair, rabbit study for tissue reactions), the ground truth was the observable biological outcomes and whether they met safety and performance expectations.

8. Sample Size for the Training Set

Not applicable. The Medeor™ Matrix is a physical surgical mesh and not an AI/machine learning model. Therefore, there is no "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

Kensey Nash

14103787

FEB - 7 2011

510(k) Summary

Submitted by:	Kensey Nash Corporation735 Pennsylvania DriveExton, PA 19341484-713-2100
Contact Person:	Lori Burns, MS, RACSr. Regulatory Affairs SpecialistPh: (484) 713-2186Fax: (484) 713-2903
Date Prepared:510(K) #:	January 31, 2011K103787
Device:
Trade Name:	Medeor™ Matrix
Common Name:	Surgical Mesh
Proposed Classification:Product Code	21 CFR 878.3300, Class IIFTM
Predicate Device:	Medeor™ Matrix (K091499) - Kensey Nash CorporationKN ECM Surgical Patch (K094061) - Kensey Nash Corporation

Device Description:

Intended Use:

Medeor™ Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications, and for reinforcement of the soft tissues,

1-800-524-1984

{1}------------------------------------------------

Kensey Nash

which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.

Medeor Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

Medeor Matrix is intended for one time use.

Technological Characteristics:

There have been no changes to the design or manufacturing process of Medeor Matrix (K091499). Medeor Matrix is substantially equivalent to KN ECM Surgical Patch (K094061) with respect to its design, intended use and technological characteristics.

Performance Data:

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, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemolysis.

The manufacturing methods have been tested by an independent laboratory to assure appropriate levels of viral inactivation.

Mechanical test reports were completed for the following:

. Tensile Testing
. Suture Retention

Hydration testing was performed using various hydration fluids.

The device was evaluated in two in vivo studies; defects were repaired and evaluated in a sheep model and a rabbit study was performed to evaluate tissue reactions.

The Medeor Matrix surgical mesh passed the requirements of all tests.

Substantial Equivalence:

Performance Testing has confirmed that Medeor Matrix is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

June 16, 2014

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

Re: K103787

Trade/Device Name: Medeor™ Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXB, OXE, OXH, OWY Dated: December 22, 2010 Received: December 27, 2010

Dear Ms. Burns:

This letter corrects our substantially equivalent letter of February 7, 2011.

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{3}------------------------------------------------

Page 2 - Ms. Lori Burns

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{4}------------------------------------------------

Kensev Nash

Indications for Use Statement

510(k) Number: K103787

Medeor TM Matrix Device Name:

Indications for Use:

The device is intended for single use only.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dain D. Kainebe MXM

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

510(k) Number K103787

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.