SHELHIGH NO-REACT DURA SHIELD

K982101 · Shelhigh, Inc. · GXQ · May 2, 2000 · Neurology

Device Facts

• Record ID: K982101
• Device Name: SHELHIGH NO-REACT DURA SHIELD
• Applicant: Shelhigh, Inc.
• Product Code: GXQ · Neurology
• Decision Date: May 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.

Device Story

Shelhigh No-React® Dura Shield is a glutaraldehyde-fixed bovine pericardium sheet treated with the No-React® detoxification process. Provided sterile in 2% benzyl alcohol solution in a glass jar. Used by neurosurgeons during neurosurgical procedures to close the dura mater. Material exhibits high tensile strength, shrink temperature, and suture retention; reapproximates well around suture holes; soft and pliable for implantation. Detoxification process enhances biocompatibility compared to conventional glutaraldehyde-treated patches. Serves as a permanent implant to facilitate dural closure.

Clinical Evidence

Bench testing and animal studies only. Physical/mechanical testing confirmed equivalent performance to predicates. Animal study comparing Shelhigh No-React® patch to conventional glutaraldehyde-treated patches demonstrated higher levels of biocompatibility and cytocompatibility for the subject device.

Technological Characteristics

Glutaraldehyde-fixed bovine pericardium membrane; No-React® detoxification process; provided in 2% benzyl alcohol solution; sterile; soft, pliable sheet form factor. No electronic, software, or energy-based components.

Indications for Use

Indicated for use as a dura substitute for closure of dura mater during neurosurgery.

Regulatory Classification

Identification

A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

Predicate Devices

• Dura Guard (Bio-vascular)
• Shelhigh No-React® pericardial Patch (Shelhigh Inc.)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains a sequence of characters and numbers. The sequence starts with a lowercase letter 'k', followed by the numbers '982101'. There is a period before the letter 'k'.

# Class II 510(K) Summary

Shelhigh No-React® Dura Shield

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

#### l. Proprietary and Common Name:

Patch is the Shelhigh No-React®Dura Shield Proprietary name: Common name : Dura Substitute

## II. Regulatory Class:

Class II device

# III. Intended Use

The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.

## V. Product Description

The Shelhigh No-React® dura Substitute is a glutaraldehyde fixed sheet of bovine pericardium.rinsed with the detoxification process No-React®. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar. 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.

## VI. Substantial Equivalence

It is substantially equivalent to the Dura Guard®manufactured ny Bio-vascular and identical to the Shelhigh No-React® pericardial Patch manufactured by Shelhigh Inc..

## VII. Comparison with Predicate Device

The Shelhigh No-React® Dura Shield like the Shelhigh No-React®pericardial patch and like the Dura quard is a glutaraldehyde cross-linked bovine pericardium membrane which exhibits substantially equivalent

{1}------------------------------------------------

physical/mechnical properties as measured by suture retention, tensile strength, and shrink temperature. The only difference is the addition of the detoxification process No-React®.

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

#### Nonclinical / Animal Tests VIII.

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.

#### IX. Conclusions

The non clinical /Animal testing data showed that the Shelhigh No-React® 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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 symbol, represented by three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2000

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

K982101 Re: Trade Name: No-React® Dura Shield Regulatory Class: II Product Code: GXQ Dated: February 28, 2000 Received: March 7, 2000

Dear Dr. Gabbay:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your booker by (2) 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 Continer 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 (1 remains 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 (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.

{3}------------------------------------------------

#### Page 2 - Shlomo Gabbay, MD

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,

bmux R. bochner.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page _ 1_of __ 1__

510(k) Number (if known): 长ያያረ | o |

Device Name: Shelhigh No-React® Dura Shield Indications For Use:

The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use __

(Optional Format 1-2-96)

Irma R. Kocher.

(Division Sign-Off) (Division Sign-Orr)
Division of General Restorative Devices 510(k) Number K98210