SHELHIGH NO-REACT PERICARDIAL PATCHES

K974914 · Shelhigh, Inc. · DXZ · Jun 3, 1998 · Cardiovascular

Device Facts

• Record ID: K974914
• Device Name: SHELHIGH NO-REACT PERICARDIAL PATCHES
• Applicant: Shelhigh, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Jun 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Device is glutaraldehyde-fixed bovine pericardium sheet; processed with No-React® detoxification; stored in benzyl alcohol solution. Used by cardiac surgeons during open heart surgery; patch tailored intraoperatively to meet surgical requirements. Provides tissue patch for pericardial closure, intercavitary defect closure, and aortic root enlargement. Benefits patient through biocompatible, soft, pliable material with high tensile strength and suture retention; reapproximates well around suture holes. No-React® process enhances biocompatibility compared to conventional glutaraldehyde-treated patches.

Clinical Evidence

No human clinical data provided. Evidence consists of physical/mechanical bench testing and animal studies comparing the No-React® patch to conventional glutaraldehyde-treated patches. Animal study results demonstrated higher levels of biocompatibility and cytocompatibility for the No-React® device.

Technological Characteristics

Glutaraldehyde-fixed bovine pericardium membrane; No-React® detoxification process; stored in benzyl alcohol solution. Material properties include high tensile strength, shrink temperature, and suture retention. Soft, pliable form factor for surgical tailoring.

Indications for Use

Indicated for patients undergoing cardiac surgical procedures requiring an intracardiac patch, closure of intercavitary defects, or enlargement of the aortic root.

Regulatory Classification

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.

Predicate Devices

• Shelhigh pericardial patch (K964467)

Submission Summary (Full Text)

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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

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.

#### IV. Product 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] 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:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| Prescription Use<br>(Per 21 CFR 801.109) | <span></span> |
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OR

| Over-The-Counter Use | |
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| | (Optional Format 1-2-96) |