The Shelhigh No-React® VascuPatch™ is a made of glutaraldehyde fixed bovine pericardium, rinsed with the detoxification process No-React®. It is stored in 2% Benzyl alcohol like the Shelhigh No-React® pericardial patch. The material exhibits good tensile strength, shrink temperature, excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.

AI/ML Overview

This document is a 510(k) summary for the Shelhigh No-React® VASCUPATCH™, specifically addressing its substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the context of device performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested categories cannot be filled directly from the provided text. The document focuses on demonstrating that the new device is "substantially equivalent" to existing, legally marketed devices based on material properties and intended use.

Here's an attempt to answer the questions based only on the provided text, with clear indications where the information is not present:

Acceptance Criteria and Study for Shelhigh No-React® VASCUPATCH™

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Non-Clinical/Animal Tests:
Cytocompatibility	Shelhigh No-React® patch shows higher level of biocompatibility compared to conventional glutaraldehyde treated patch.
Material/Physical/Mechanical Properties:
Suture retention	Exhibits substantially equivalent properties to predicate device.
Tensile strength	Exhibits substantially equivalent properties to predicate device.
Shrink temperature	Exhibits substantially equivalent properties to predicate device.
Flexibility	Identical to predicate device.
Wall thickness	Identical to predicate device.
Storage solution	Stored in bezyle alcohol, identical to predicate device.

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified. The document mentions "An animal study," but does not provide details on the number of animals or samples used.
Data Provenance: The animal study was conducted to compare the Shelhigh No-React® patch with a conventional glutaraldehyde treated patch. No country of origin is specified. This was a nonclinical/animal test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The study described is an animal study evaluating material properties and biocompatibility, not an assessment requiring expert interpretation of diagnostic images or clinical outcomes in humans to establish "ground truth."

4. Adjudication method for the test set:

Not applicable. As noted above, this was an animal study of material properties and biocompatibility, not a study requiring adjudication of expert interpretations.

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:

Not applicable. This device is a cardiovascular patch, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a cardiovascular patch.

7. The type of ground truth used:

For the animal study on biocompatibility, the "ground truth" would be established through histological analysis, cellular assays, and potentially macroscopic observation of the animal tissue responses to the implanted materials.
For the physical/mechanical properties, the "ground truth" is based on standardized laboratory testing methods for suture retention, tensile strength, and shrink temperature.

8. The sample size for the training set:

Not applicable. This is a medical device (cardiovascular patch), not a machine learning algorithm requiring a training set in the conventional sense.

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

Not applicable. (See #8)

Summary of Device Equivalence from the Document:

The provided text describes the Shelhigh No-React® VASCUPATCH™ as being substantially equivalent to a predicate device (Knitted MiniCrimp Vascupatch manufactured by Meadox Medical, Inc. #K905496) and identical to another currently manufactured device (Shelhigh No-React® pericardial patch K974914). The equivalence is based on:

Material: Glutaraldehyde fixed bovine pericardium, rinsed with No-React® detoxification process.
Physical/Mechanical Properties: Substantially equivalent suture retention, tensile strength, and shrink temperature. Identical flexibility, wall thickness, and storage in benzyl alcohol.
Intended Use: Repair of carotid endarterectomy and vascular patch grafting.
Biocompatibility: An animal study showed higher cytocompatibility for the Shelhigh No-React® vs. conventional glutaraldehyde treated patches.

Summary

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OCT 28 1998

Class II 510(K) Summary Shelhigh No-React® VASCUPATCH™

This summary of the 510(k) information is being submitted as required by section 807.92(a).

Proprietary and Common Name: 1.

Shelhigh No-React® VascuPatch™ Proprietary name:

Common name: Cardiovascular patch

II. Regulatory Class:

Class II device

III. Intended Use

For repair of carotid endarterectomy and vascular patch grafting.

Product Description IV.

V. Substantial Equivalence

The Shelhigh No-React® VascuPatch™ is equivalent to the Knitted MiniCrimp Vascupatch manufactured by Meadox Medical, Inc. #K905496 and identical to the Shelhigh No-React® pericardial patch K974914 currently manufactured by Shelhigh Inc.

VI. Comparison with Predicate Device

The Shelhigh No-React® VascuPatch™, like the Shelhigh No-React® pericardial patch is a glutaraldehyde cross-linked bovine pericardium membrane which

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exhibits substantially equivalent physical/mechnical properties as measured by suture retention, tensile strength, and shrink temperature. They both have identical flexibility, wall thickness and both are stored in bezyle alcohol.

VII.Nonclinical / Animal Tests

An animal study was conducted to evaluate Shelhigh No-React® vs. the conventional glutaraldehyde treated patch, the Shelhigh No-React® patch shows higher evel of biocompatibility.

VIII. Conclusions

The non clinical /Animal testing data showed that the Shelhigh No-React® VascuPatch™. has higher level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage. The VascuPatch™ is identical to the Shelhigh No-React® pericardial patch, thus is substantially equivalent to the predicate device.

Page 2 of 2 of Summary

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of a human figure. The figure is composed of three curved lines that form the shape of a person in motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

OCT 28 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shlomo Gabbay, M.D. Chief Scientific Advisor Shelhigh, Inc. P.O. Box 884 Millburn, NJ 07041

Re : K982810 Shelhigh No-React® VASCUPATCH™ Regulatory Class: II Product Code: DXZ Dated: July 15, 1998 Received: August 11, 1998

Dear Dr. Gabbay:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. All references to the No-React® treatment or to animal studies regarding said treatment in the labeling or promotional materials/advertisements must be immediately followed by a statement that no clinical data are available which evaluate the long term impact of the detoxification treatment in humans.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Shlomo Gabbay, M.D.

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of of 1 _

510(k) Number (if known): 长982810

Device Name: Shelhigh No-React® VASCUPATCH™ Indications For Use:

For repair of carotid endarterectomy and vascular patch grafting.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) V2

Selli Camper le (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_ ≤ 98 28 1(2

V Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).