The Shelhigh No-React® PneumoPledgets strips are glutaraldehyde fixed sheet of bovine pericardium. They are held on the stapler by a unique design of a loop on the anterior part of the PneumoPledgets. It holds the strip by inserting the pointed edge of the staple into the loop. The posterior part (if needed) is held by an "O" ring made of pericardium as well. The PneumoPledgets. strips are customized to fit all sizes and types of staples. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar.

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 describes a 510(k) premarket notification for the Shelhigh No-React® PneumoPledgets, a Class II medical device. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria. Therefore, the information provided does not align directly with the typical structure of an AI/software-based device study.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a physical medical device (bovine pericardial patch), not an AI/software device. Its performance is evaluated through physical/mechanical properties and biocompatibility, not typical AI metrics like sensitivity, specificity, or AUC. The "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Suture Retention	Substantially equivalent to predicate devices.
Tensile Strength	Substantially equivalent to predicate devices.
Shrink Temperature	Substantially equivalent to predicate devices.
Flexibility	Identical to Shelhigh pericardial patch (predicate).
Wall Thickness	Identical to Shelhigh pericardial patch (predicate).
Shapes and Sizes	Identical to Shelhigh pericardial patch (predicate). Customization to fit all sizes and types of staples.
Biocompatibility	Higher level of biocompatibility than conventional glutaraldehyde-treated patches. High level of cytocompatibility compared to conventional glutaraldehyde treated and storage. Detoxification process ("No-React®") validated to not pose new safety/effectiveness questions. Bovine pericardial material has a long history of success as a permanently implanted material.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The study conducted was an animal study, not a human clinical trial. The text refers to "an animal study" without specifying the number of animals.
Data Provenance: The study was an "animal study." No information on the country of origin. It would be considered prospective in the context of comparing the new device against conventional treatment in the animal model.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of device and study. The evaluation of biocompatibility in the animal study would likely be performed by veterinary pathologists or toxicologists, but no details are provided. This is not an image-based diagnostic AI device requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The animal study would involve direct observation and potentially histological analysis by trained personnel, not adjudication among human readers as in an AI study.

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 is a physical medical device, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used

The ground truth for the animal study was based on direct biological and histological observations and measurements of biocompatibility in the animal model. This would include parameters like tissue reaction, inflammation, and potential adverse effects compared to the control group (conventional glutaraldehyde treated patch).

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The device's manufacturing process and materials are established through engineering design, material science, and prior experience with similar glutaraldehyde-treated bovine pericardium.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for an AI model. The "ground truth" for the device's design and manufacturing relies on established biological and material science principles for medical implants, including understanding the properties of bovine pericardium and the effects of glutaraldehyde processing. The "No-React®" detoxification process was validated to improve biocompatibility.

Summary

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K981756

2 1608 AUG

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.

Shelhigh No-React® PneumoPledgets Proprietary name:

Pledget (pericardial Strips) Common name:

II. Regulatory Class:

Class II device

III. Intended Use

To reinforce the soft tissue of the lung, thereby sealing or reducing air leak that occurs during pulmonary surgery.

IV. Product Description

The material exhibits good tensile strength, shrink temperature excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant.

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V. Substantial Equivalence

The Shelhigh No-React® PneumoPledgets. is equivalent to the Peri-Strips® manufactured by Bio-Vascular K940205 and the Shelhigh No-React® pericardial patch K974914 and #K964467 currently manufactured by Shelhigh Inc.

VI. Comparison with Predicate Device

The Shelhigh No-React® PneumoPledgets. 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.

Nonclinical / Animal Tests VII.

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® PneumoPledgets. 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.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a bird or eagle, with three curved lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG ર વિવેત્ક

Shlomo Gabbay, M.D. Chief Scientific Officer Shelhigh. Inc. 67-71 East Willow Street Millburn, New Jersey 07041

Re: K981756 Trade Name: Shelhigh No-React Pneumopledgets Regulatory Class: II Product Code: FTL Dated: Mav 12, 1998 Received: May 18, 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 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.

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 Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug 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 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.

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Page 2 - Dr. Shlomo Gabbay

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) 594-4595. 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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative 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): K981756

Device Name: Shelhigh No-React® PneumoPledgets.

Indications For Usc:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The devicc is intended for use to reinforced the soft tissue of the lung, thereby sealing or reducing air leak that occur during pulmonary surgery.

(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 General Restorative Devices
510(k) Number	K981756

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use
----------------------	--

(Optional Format 1-2-96)

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.