The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair, reinforcement in plastic and reconstructive surgery, and in the urological, gynecological (excluding transvaginal repair of pelvic organ prolapse), and gastroenterological anatomy including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g., hiatal, femoral, paracolostomy, umbilical), urethral and vaginal prolapse repair (excluding transvaginal repair of pelvic organ prolapse repair, rectal prolapse repair (excluding rectocele) using an abdominal approach, reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), bladder support, and sacrocolposuspension.

The Kensey Nash ECM Surgical Patch is supplied sterile and intended for one time use.

Device Description

The Kensey Nash ECM Surgical Patch is a resorbable porcine-peritoneum-derived collagen surgical mesh intended for reinforcement of soft tissues. The device is supplied sterile in double-layer packages. The product is packaged dry (lyophilized) to be hydrated prior to use.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device, the Kensey Nash ECM Surgical Patch. This type of document is for regulatory submission and focuses on demonstrating substantial equivalence to predicate devices rather than establishing new acceptance criteria or conducting studies to prove the device meets these criteria in the same way a novel high-risk device might.

The primary "acceptance criteria" for a 510(k) submission is substantial equivalence to a legally marketed predicate device. This is demonstrated through comparisons of materials, intended use, and technological characteristics, and supported by performance testing.

Therefore, many of the requested categories for AI/clinical study reporting do not directly apply in this context. Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance/Comparison
Mechanical Equivalence to Predicate Devices	Tensile Testing: Performed with KN ECM, demonstrated equivalence to legally marketed predicate devices.
	Suture Retention: Performed with KN ECM, demonstrated equivalence to legally marketed predicate devices.
Biocompatibility (ISO 10993-1:2003 Requirements)	Passed all tests for: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity, and Hemolysis.
In Vivo Performance (Tissue Reaction & Defect Repair)	Sheep Model: Defects repaired and evaluated. Results not explicitly detailed beyond "evaluated." (Implied satisfactory for equivalency).
	Rabbit Study: Performed to evaluate tissue reactions. Results not explicitly detailed beyond "evaluated." (Implied satisfactory for equivalency, passed requirements of all tests).
Overall Substantial Equivalence to Predicate Devices	Performance Testing has confirmed that the Kensey Nash ECM Surgical Patch is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics. The FDA issued a substantial equivalence determination letter (K094061).

Additional Requested Information (and why some concepts don't apply here)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For the mechanical tests, specific sample sizes are not provided. For the in vivo studies, a "sheep model" and a "rabbit study" are mentioned, but the number of animals is not specified.
- Data Provenance: Not specified, but generally, such studies are conducted in a controlled lab or animal facility. The document doesn't mention country of origin or whether the data is retrospective/prospective, as these terms are more typically applied to human clinical data.
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 device is a surgical patch, not an AI diagnostic tool. "Ground truth" in the context of expert consensus, pathology, or outcomes data (as described further down) is not established by expert readers interpreting results, but rather through objective measurements (mechanical testing) or histological evaluation (animal studies), which would be done by trained technicians or pathologists. The document does not detail specific expert qualifications for interpreting the mechanical or animal study results.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers, typically in image interpretation or clinical diagnosis. This is not relevant to mechanical or animal biocompatibility testing of a surgical mesh.
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 physical medical device (surgical mesh), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Testing: Ground truth is based on objective, quantitative measurements of material properties (tensile strength, suture retention) compared against established standards or predicate device performance.
- Biocompatibility: Ground truth is established by standardized testing protocols (ISO 10993-1:2003) with biological endpoints (e.g., cell viability for cytotoxicity, skin reaction for sensitization).
- In Vivo Studies: Ground truth is established through histological analysis (for tissue reactions in the rabbit study) and observation/evaluation of defect repair in the sheep model, likely by animal pathologists or researchers.
The sample size for the training set
- Not Applicable: This is not an AI/machine learning device, so there is no concept of a "training set" in the sense of data used to train an algorithm.
How the ground truth for the training set was established
- Not Applicable: As above, there is no training set for this type of device.

In summary, the Kensey Nash ECM Surgical Patch demonstrated "acceptance criteria" by showing substantial equivalence to predicate devices through various established mechanical and biocompatibility tests, as well as in vivo animal studies. The device passed the requirements of all tests conducted. This approach is standard for 510(k) premarket notifications.

Summary

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Image /page/0/Picture/0 description: The image shows the DSM logo. The logo consists of a circular graphic on the left and the text "DSM" on the right. Below the text "DSM" is the tagline "BRIGHT SCIENCE. BRIGHTER LIVING.". The circular graphic is made up of three curved shapes that overlap each other.

510(k) Summary

Submitted by:	Kensey Nash Corporation dba DSM Biomedical735 Pennsylvania DriveExton, PA 19341
Contact Person:	Lori Burns, MS, RACManager Regulatory AffairsPh: (484) 713-2100Fax: (484) 713-2903
Date Prepared:510(K) #:	June 13, 2014K094061
Device:
Trade Name:	Kensey Nash ECM Surgical Patch
Common/Usual Name:	Surgical Mesh
Proposed Classification:	21 CFR 878.3300FTM, OXH, OXE, PAJ, PAG

Class II

Device Description:

Predicate Devices:

Manufacturer	Device	510(k)#
Cook, Inc.	SurgiSiS	K992159
Cook, Inc.	SurgiSiS	K034039
Cook, Inc.	SurgiSiS	K062697
Organogenesis Inc.	FortaFlex	K011025
Organogenesis Inc.	FortaFlex	K020049

Intended Use:

The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair, reinforcement in plastic and reconstructive surgery, and in the urological (excluding transvaginal repair of pelvic organ prolapse), and gastroenterological anatomy including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g., hiatal, femoral, paracolostomy, umbilical), urethral and vaginal prolapse repair (excluding transvaginal repair of pelvic organ prolapse), colon prolapse repair, rectal prolapse repair (excluding rectocele) using an abdominal approach, reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), bladder support, and sacrocolposuspension.

The Kensey Nash ECM Surgical Patch is supplied sterile and intended for one time use.

Performance Data:

Mechanical testing performed with KN ECM demonstrated equivalence of the device to legally marketed predicate devices. Mechanical test reports were completed for the following:

. Tensile Testing
HEALTH · NUTRITION · MATERIALS

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. Suture Retention
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 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 Kensey Nash ECM Surgical Patch passed the requirements of all tests.

Substantial Equivalence:

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

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

June 16, 2014

Kensey Nash Corporation d.b.a. DSM Biomedical Ms. Lori Burns Manager, Regulatory Affairs 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K094061

Trade/Device Name: Kensey Nash ECM Surgical Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM. OXE. OXH. PAG. PAJ Dated: April 29, 2010 Received: April 30, 2010

Dear Ms. Burns:

This letter corrects our substantially equivalent letter of May 18, 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 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

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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

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K094061

Device Name Kensey Nash ECM Surgical Patch

Indications for Use (Describe)

The Kensey Nash ECM Surgical Patch is supplied sterile and intended for one time use.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Krause

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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.