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 pelvic 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

BioBlanket™ 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 document is a 510(k) summary for the Kensey Nash Corporation's BioBlanket™ Surgical Mesh. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance data derived from clinical studies with specified acceptance criteria in the same way an AI/ML device would.

Therefore, the information requested in the prompt, which is typically relevant for AI/ML device performance studies, is not explicitly available within this 510(k) summary. These include:

Acceptance criteria and reported device performance table: The document states the device "passed the requirements of all tests" but does not define specific acceptance ranges or thresholds.
Sample size and data provenance for test set: Not applicable for a device of this nature as there's no "test set" in the context of AI/ML evaluation. Pre-clinical or clinical studies for surgical meshes would involve animal or human subjects, but this detail is not provided.
Number of experts and qualifications for ground truth: Not applicable.
Adjudication method for test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone algorithm performance: Not applicable.
Type of ground truth used: For surgical meshes, "ground truth" would typically come from histological analysis, biomechanical testing outcomes, or clinical outcomes, but this is not specified.
Sample size for training set: Not applicable.
How ground truth for training set was established: Not applicable.

Instead, the document states:

"BioBlanket™ Surgical Mesh has been subjected to biocompatibility, integrity, in-vitro and in-vivo performance tests. The device passed the requirements of all tests."

This indicates that various types of non-clinical (and possibly some clinical) tests were performed, and the device met the internal requirements of those tests. However, the specific acceptance criteria and detailed results are not part of the 510(k) summary provided. Substantial equivalence is primarily based on similarity in intended use, technological characteristics, performance, and material to previously cleared devices.

Summary

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Kensey Nash Corporation 510(k) Application: BioBlanket™ Surgical Mesh

Image /page/0/Picture/1 description: The image shows the text "K061030" in large, bold font. Below this, the text "510(k) Summary" is visible, also in bold font. The text appears to be part of a document or label, possibly related to a medical device or regulatory submission.

MAY - 9 2006

Submitted by:

Kensey Nash Corporation 735 Pennsylvania Drive Exton, PA 19341

Contact Person:

Deborah A. Racioppi, RA Compliance Manager Ph: 610-594-4389 Fax: 610-524-0265 March 22, 2006

Date Prepared: 510(k) #: Device: Trade Name: Common/Usual Name: Proposed Classification:

BioBlanket™ Surgical Mesh Surgical Mesh, Tissue Repair Biomaterial Surgical Mesh 21 CFR Part 878.3300 (79 FTM) Class II

Device Description:

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

Intended 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	K043259	FTM
Kensey Nash Corp.	BioBlanket™ Surgical Mesh	K041923	FTM

Performance Data:

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the 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. Deborah A. Racioppi RA Compliance Manager 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K061030

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: April 12, 2006 Received: April 14, 2006

Dear Ms. Racioppi:

This letter corrects our substantially equivalent letter of May 9, 2006.

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. Iisting 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 A. 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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Kensey Nash Corporation 510(k) Application: BioBlanket™ Surgical Mesh

Indications For Use Statement

510(k) Number (if known): K 06/03 >

Devicc Name: BioBlanket™ Surgical Mesh

Indications for Use:

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)

el.qMDE.

Division of General, Restorative, and Neurological Devices

510(k) Number_ko61030

Page 20

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.