SHELHIGH PERICARDIAL PATCH

K964467 · Shelhigh, Inc. · DXZ · Sep 23, 1997 · Cardiovascular

Device Facts

• Record ID: K964467
• Device Name: SHELHIGH PERICARDIAL PATCH
• Applicant: Shelhigh, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Sep 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shelhigh Pericardial Patch is intended for use as a pericardial patch, and as an intracardiac patch.

Device Story

Shelhigh Pericardial Patch is a surgical implant used for repair or reconstruction of pericardial and intracardiac tissues. Device is implanted by surgeons during cardiac procedures. It serves as a structural patch to close defects or reinforce tissue. Benefits include providing a biocompatible scaffold for surgical repair. No automated processing, software, or electronic components involved.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory history and intended use.

Technological Characteristics

Pericardial tissue patch; intended for surgical implantation. No electronic, software, or complex mechanical components.

Indications for Use

Indicated for use as a pericardial or intracardiac patch in patients requiring surgical repair or reconstruction of cardiac tissues.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

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

SEP 23 1997

Re: K964467
Shelhigh Pericardial Patch (without detoxification treatment)
Regulatory Class: II
Product Code: DXZ
Dated: June 19, 1997
Received: June 25, 1997

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 (without the detoxification treatment) 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 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 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.

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Page 2 - Shlomo Gabbay, M.D.

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]. 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 [phone] or [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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870.3470 - Dx2 II - Intracardiac Patch

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510(k) Number (if known): K964467

Device Name: Shelhigh Pericardial Patch

Indications For Use: The Shelhigh Pericardial Patch is intended for use as a pericardial patch, and as an intracardiac patch.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K 964467

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)