The Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as a patch for closure of the patient's pericardium after open heart surgery, The patch may be tailored during surgery to meet the surgeon's needs.

The Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as an intracardiac patch for open heart surgery, as well as to close intercavitary defect, and enlarge the aortic root . The patch may be tailored during surgery to meet the surgeon's needs.

Device Description

The Shelhigh No-React® Pericardial patch is a glutaraldehyde fixed sheet of bovine pericardium, rinsed with the detoxification process No-React®. The device is provided sterile in benzyl alcohol solution. The material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable making it convenient to implant.

The material exhibits excellent biocompatibility. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldhyde processed bovine pericardium has a long history of success as a permanently implanted material.

AI/ML Overview

The provided text describes a medical device, the Shelhigh No-React® Pericardial Patch, and its substantial equivalence to a predicate device for 510(k) clearance. However, it does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the requested metrics for a clinical/performance study.

The document focuses on demonstrating substantial equivalence primarily through non-clinical (physical/mechanical properties) and animal testing, rather than human clinical trials with defined acceptance criteria and performance metrics.

Here's a breakdown of the available information based on your request, and where the information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Physical/Mechanical Properties:	Substantially equivalent to predicate device.
- Suture retention	- Equivalent performance.
- Tensile strength	- Equivalent performance.
- Shrink temperature	- Equivalent performance.
- Flexibility	- Identical.
- Wall thickness	- Identical.
- Shapes and sizes	- Identical.
Biocompatibility:	Higher level of biocompatibility. Demonstrated in animal study comparing to conventional glutaraldehyde treated patch.
Cytocompatibility:	High level of cytocompatibility. Demonstrated in non-clinical/animal testing compared to conventional glutaraldehyde treated and stored.
Safety and Effectiveness:	No new questions of safety and effectiveness compared to the predicate device due to the detoxification process.

2. Sample size(s) used for the test set and the data provenance

Test Set Sample Size: Not specified in terms of number of animals or specific measurements.
Data Provenance: Animal study. The country of origin for the animal study is not specified, but the submission is to the US FDA. The study is prospective in the sense that it was conducted specifically to support this regulatory submission.

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

Not applicable/Not provided. The "ground truth" for physical/mechanical properties would be direct measurements. For biocompatibility, it's evaluated through animal study outcomes, not expert consensus interpreting data.

4. Adjudication method for the test set

Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are typically used for interpreting results in human clinical trials or image-based studies where expert consensus is needed. The non-clinical and animal studies described here would rely on objective measurements and pathological assessment.

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. This device is a pericardial patch, not an AI or image-reading device. Therefore, MRMC studies are not relevant.

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

No. This device is a physical implantable medical device, not an algorithm.

7. The type of ground truth used

Physical/Mechanical Properties: Direct laboratory measurements (e.g., tensile strength, suture retention force, temperature at which shrinkage occurs).
Biocompatibility/Cytocompatibility: Histopathological evaluation of tissue response in animal models, and potentially in vitro cell culture assays for cytocompatibility.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a "training set." The materials used for manufacturing and testing are described, but not as a training set.

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

Not applicable, as there is no "training set."

Summary of what the document does provide regarding acceptance criteria and studies:

The document primarily addresses substantial equivalence by comparing the Shelhigh No-React® Pericardial Patch to a predicate device (Shelhigh pericardial patch #K964467). The "acceptance criteria" can be inferred from this comparison:

Physical/Mechanical Properties: The device must demonstrate "substantially equivalent physical/mechanical properties" as measured by suture retention, tensile strength, and shrink temperature, and "identical flexibility, wall thickness, shapes and sizes" to the predicate.
Biocompatibility: The device must demonstrate acceptable biocompatibility, and ideally, higher level of biocompatibility as a result of the "No-React®" detoxification process, without raising new questions of safety and effectiveness.

The study that "proves" these criteria are met is described as:

Nonclinical/Animal Tests: These tests demonstrated that the Shelhigh No-React® patch shows:
- Substantially equivalent physical/mechanical properties to the predicate.
- A higher level of biocompatibility and high level of cytocompatibility when compared with conventional glutaraldehyde-treated and stored material.

The document concludes that the differences (the addition of the No-React® detoxification process) do not pose new questions of safety and effectiveness, thus qualifying it as substantially equivalent.

Summary

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K974/914

Class II 510(K) Summary Shelhigh No-React® Pericardial Patch

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

Proprietary and Common Name: 1.

The proprietary name of the Pericardial Patch is the Shelhigh No-React® Pericardial Patch. The common name is: Pericardial Patch.

II. Regulatory Class:

Class II device

lll. Intended Use

IV. Product Description

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V. Substantial Equivalence

It is substantially equivalent to the Shelhigh pericardial patch #K964467 manufactured by Shelhigh Inc..

VI. Comparison with Predicate Device

The Shelhigh No-React® Pericardial patch like the Shelhigh pericardial patch is a glutaraldehyde cross-linked bovine pericardium membrane which exhibits substantially equivalent physical/mechnical properties as measured by suture retention, tensile strength, and shrink temperature. They both have identical flexibility wall thickness shapes and sizes and both are stored in bezyle alcohol. The only difference is the addition of the detoxification process No-React®.

Extensive validation of the effectiveness of the Patch with the detoxification process, No-React® indicates that these differences do not pose new questions of safety and effectiveness.

VII. Nonclinical / Animal Tests

Physical/Mechanical test information is discussed above . An animal study was conducted to evaluate Shelhigh No-React® vs. the conventional glutaraldehyde treated patch, the Shelhigh No-React® patch shows higher level of biocompatibility.

VIII. Conclusions

The non clinical /Animal testing data showed that the Shelhigh No-React® pericardial patch has high level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage. The Shelhigh No-React® performance in a substantially equivalent to the predicate device and there were no significant differences between the two devices which pose new questions of safety and effectiveness.

Page 2 of 2 of Summary

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol, composed of three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 1998

Shlomo Gabbay, M.D., . Chief Scientific Officer Shelhigh, Inc. P.O. Box 884 Millburn, New Jersey 07041

Re: K974914 and MAF-927 Shelhigh No React® Patch Trade Name: Requlatory Class: II Product Code: DXZ Dated: February 20, 1998 February 26, 1998 Received:

Dear Dr. Gabbay:

This letter corrects our substantially equivalent letter of May 4, 1998, regarding the incorrect classification and product code.

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 general controls provisions of the Act include the Act. requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II www (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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In

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Page 2 - Shlomo Gabbay, M.D.

addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in 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 requlations.

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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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Page _ 1_of _1

510(k) Number (if known): K974914_____________________________________________________________________________________________________________________________________________

Device Name: Shelhigh No-React® Pericardial Patch ____________________________________________________________________________________________________________________________

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number

Prescription Use(Per 21 CFR 801.109)
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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).