BioBlanket™ Surgical Mesh 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, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvice floor, hernias, suture line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one time use.

Device Description

DioBlanket™ Surgical Mesh is comprised of a single layer porous, cross-linked collagen patch that is supplied sterile and for one-time use.

AI/ML Overview

The provided text describes a submission for a 510(k) premarket notification for the BioBlanket™ Surgical Mesh. This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices, and as such, it focuses on demonstrating equivalence rather than establishing novel performance criteria through clinical trials designed to prove efficacy or specific performance metrics against acceptance criteria.

Therefore, the document does not contain the following information:

A table of acceptance criteria and reported device performance.
Sample size used for a test set or its provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Details on a standalone (algorithm only) performance study.
The type of ground truth used for a test set (expert consensus, pathology, outcomes data).
Sample size for a training set.
How ground truth for a training set was established.

Instead, the document states:

Performance Data:
"BioBlanket™ Surgical Mesh was subjected to biocompatibility, integrity, in-vitro and invivo performance tests. The device passed the requirements of all tests."

This statement indicates that the device underwent a set of pre-defined tests (biocompatibility, integrity, in-vitro, and in-vivo) and met their respective requirements. However, the specific acceptance criteria for these tests and the detailed results are not provided in this summary. The focus is on demonstrating that the device is "substantially equivalent in terms of intended use, technological characteristics, performance and material" to previously cleared predicate devices.

Summary

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Kensey Nash

AUG 1 5 2005

KO43259

510(k) Summary

Submitted by:	Kensey Nash Corporation55 East Uwchlan AvenueExton, PA 19341
Contact Person:	Deborah A. Racioppi, RA Compliance ManagerPh: 610-594-4389 Fax: 610-524-0265
Date Prepared:	November 23, 2004
510(k) #:
Device:Trade Name:Common/Usual Name:Proposed Classification:	BioBlanket™ Surgical MeshSurgical Mesh, Tissue Repair BiomaterialSurgical Mesh21 CFR Part 878.3300 (79 FTM) Class II

Device Description:

DioBlanket™ Surgical Mesh is comprised of a single layer porous, cross-linked collagen patch that is supplied sterile and for one-time use.

Intended Use:

BioBlanket™ Surgical Mesh 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, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the of the floor, hernias, suture line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one time use.

Substantial Equivalence:

In terms of Section 510(k) substantial equivalence, BioBlanket™ Surgical Mesh is similar to the predicate collagen-based surgical mesh devices listed below previously cleared for commercial distribution. The BioBlanket™ Surgical Mesh is substantially equivalent in terms of intended use, technological characteristics, performance and material.

Manufacturer	Device	510(k)	ProCode
Kensey Nash Corp.	BioBlanket™ Surgical Mesh	K041923	FTM
Organogenesis, Inc.	FortaFlex™ Surgical Mesh	K020049	FTM
DePuy, Inc.	Restore® Orthobiologic Soft Tissue Implant	K031969	FTM

Performance Data:

BioBlanket™ Surgical Mesh was subjected to biocompatibility, integrity, in-vitro and invivo performance tests. The device passed the requirements of all tests.

610-524-0188

KENSEY NASH CORPORATION, 55 EAST UWCHI AN AVF , EXT ()N, PA 19(3) 1

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the words "HUMAN SERVICES - USA" and "DEPARTMENT OF" written around the top and bottom, respectively.

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

June 16, 2014

Ms Deborah Racioppi Regulatory Affairs Compliance Manager, RAC Kensey Nash Corporation 55 Eeast Uwchlan Avenue Exton, Pennsylvania 19341

Re: K043259

Trade/Device Name: BioBlanket™ Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OXB, OXE, OXH, OWY, PAI, PAJ Dated: June 30, 2005 Received: July 1. 2005

Dear Ms. Racioppi:

This letter corrects our substantially equivalent letter of August 15, 2005.

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 Deborah Racioppi

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 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 Statement

510(k) Number (if known): KOU3 259

BioBlanket™ Surgical Mesh Device Name:

Indications for Use; -- · ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

Prescription Use X (Per 21 CFR 801 Subpart D) 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)

Barbara Brielund for Mark Wilkerson
signature sign here

Division of General, Restorative and Neurological Devices

S.I. (2005) N: K043259

002

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.