BioBlanket™ Surgical Mesh is indicated for use in general surgical procedures for reinforcement of soft tissue where weakness exists and for the repair of ruptured or damaged soft tissues. The device is supplied sterile and is intended for one time use.

Device Description

BioBlanket™ is comprised of a single layer porous, cross-linked collagen patch that is supplied sterile in the form of a pad. This pad will be available in 2 different sizes, 5 cm x 5 cm and 5 cm x 10 cm, both with a 1.0 mm ± 0.25 mm thickness.

AI/ML Overview

The provided text describes a 510(k) submission for the BioBlanket™ Surgical Mesh. However, it does not contain specific acceptance criteria, detailed study designs, or performance data beyond a general statement that the device passed required tests.

Therefore, I cannot populate the table or answer most of your questions based on the provided input. The document is primarily focused on seeking clearance for the device by demonstrating substantial equivalence to a predicate device, rather than presenting detailed performance study results against specific criteria.

Here's what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in document	BioBlanket™ was subjected to biocompatibility, integrity and performance tests. The device passed the requirements of all tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. 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 as this document does not describe a study involving expert-established ground truth for a test set in the way one would for diagnostic or AI-driven devices. The "performance data" mentioned refers to engineering and biocompatibility tests, not clinical studies with human review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

No MRMC study was mentioned. This device is a surgical mesh, not an AI-driven diagnostic tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "biocompatibility, integrity and performance tests," the ground truth would likely be established by pre-defined engineering standards, material specifications, and biological response criteria, rather than expert consensus on clinical images or pathology.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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510(k) Summary 23

Submitted by:

Kensey Nash Corporation 55 East Uwchlan Avenue Exton, PA 19341 USA

Contact:

Deborah A. Racioppi Telephone: 610-594-4389 Facsimile: 610-524-0265

Date: July 9, 2004

Device:

Trade name: Common/Usual Name: Classification Name: Regulatory Class:

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

Predicate Device:

The device is similar to predicate collagen-based surgical mesh devices previously cleared for commercial distribution. The relevant predicate device is Organogenesis' FortaFlex™, which was cleared by FDA under 510(k) number K011025.

Statement of Substantial Equivalence:

BioBlanket™ is substantially equivalent to the predicate device, having similar intended use, technological characteristics, performance and material.

Intended Use:

Device Description:

Performance Data:

BioBlanket™ was subjected to biocompatibility, integrity and performance tests. The device passed the requirements of all tests.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

SEP = 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Deborah A. Racioppi Regulatory Affairs Specialist Kensey Nash Corporation 55 East Uwchlan Avenue Exton, Pennsylvania 19341

Re: K041923

K041925
Trade/Device Name: BioBlanket™ Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: July 15, 2004 Received: July 16, 2004

Dear Ms. Racioppi:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 IQK) prematics is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have delemined the devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug. commerce prior to May 28, 1976, the chance with the provisions of the Federal Food, Drug, devices that have been reclassified in accounted with approval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses approvisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements for annual misbranding and general controls provisions of the Act merade requirement of the magainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (secadove) miro cities and regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA In may be subject to such additional controller. Extrement of the 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In additi be found in the Code of Federal Regarations, our device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles or a sublics with other requirements of the Act
that FDA has made a determination that your device complies with of act that FDA has made a determination that your as reserved by other Federal agencies. You must or any Federal statutes and regulations daminities to: registration and listing (21 l
comply with all the Act's requirements, including, but not limited to: ret comply with all the Act STEquilements, moradice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the olectronic CFR Part 807), labeling (21 CFR Part 807), good manage (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Deborah A. Racioppi

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter waitication. The FDA finding of substantial equivalence of your device to a legally premaince motion a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you a the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kensey Nash Corporation 510(k) Application: BioBlankel The Surgical Mesh

Section IV - Statement of Intended Use

Indications For Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: BioBlanket™ Surgical Mesh

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Prescription Use OT Use___________________________________________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109)

Please do not write below this line - Use another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

iriam C. Provost

on Sign-Of (Division of General, Restorative, and Neurological Devices

510(k) Number K041923

రం

September 7, 2004

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.