DURA-GUARD-DURAL REPAIR PATCH

K973706 · Bio-Vascular, Inc. · GXQ · Dec 24, 1997 · Neurology

Device Facts

• Record ID: K973706
• Device Name: DURA-GUARD-DURAL REPAIR PATCH
• Applicant: Bio-Vascular, Inc.
• Product Code: GXQ · Neurology
• Decision Date: Dec 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use as a dural substitute for the closure of dura mater during neurosurgery.

Device Story

Dura-Guard is a dural repair patch composed of bovine pericardium cross-linked with glutaraldehyde. The device is used during neurosurgery to facilitate the closure of the dura mater. The subject device incorporates antibiotic treatments not present in the original predicate. Performance is evaluated via bench testing, including burst strength, suture retention, ultimate tensile strength, and shrink temperature testing, alongside biocompatibility assessments. The device is intended for prescription use by neurosurgeons in an operating room setting.

Clinical Evidence

Bench testing only. Testing included burst strength, suture retention, ultimate tensile strength, and shrink temperature comparisons between antibiotic-treated and control samples. Biocompatibility testing was also performed. No clinical data provided.

Technological Characteristics

Dural repair patch made of bovine pericardium cross-linked with glutaraldehyde. Subjected to antibiotic treatments. Evaluated via mechanical testing (burst strength, suture retention, ultimate tensile strength, shrink temperature) and biocompatibility testing.

Indications for Use

Indicated for use as a dural substitute for the 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 (K950956)

Submission Summary (Full Text)

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5973706

Bio-Vascular, Inc.

DEC 2 4 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant Name & Address: | Bio-Vascular, Inc., 2575 University Ave., St. Paul,<br>MN 55114-1024 | |
|-----------------------------|----------------------------------------------------------------------|--|
| Contact: | Barbara Atzenhoefer, Regulatory Affairs Manager | |
| Date Prepared: | September 26, 1997 | |
| Common or Usual Name: | Dura-Guard® | |
| Device Classification Name: | Dural Repair Patch | |
| Substantial Equivilance: | Dura-Guard K950956 | |

Dura-Guard is a dural repair patch manufactured from bovine Device Description: pericardium cross-linked with glutaraldehyde.

## Statement of Intended Use:

For use as a dural substitute for the closure of dura mater during neurosurgery.

## Summary/Comparison of Technological Characteristics:

Product samples were subjected to various antibiotic treatments. Both control and test samples were subjected to burst strength, suture retention, ultimate tensile and shrink temperature testing. Results showed no significant difference between the test and control articles. Biocompatibility testing also showed no significant difference between the test and control articles. BVI believes that product subjected to antibiotics perform in a manner substantially equivalent to product not subjected to antibiotics, and that the exposure to antibiotics poses no additional questions of safety or effectiveness.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human figures are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 1997

Ms. Barbara Atzenhoefer Regulatory Affairs Manager Bio-Vascular, Inc. 2575 University Avenue Saint Paul, Minnesota 55114-1024

Re: K973706

Trade Name: Dura-Guard - Dura Repair Patch Regulatory Class: II Product Code: GXO Dated: September 26, 1997 Received: September 29, 1997

Dear Ms. Atzenhoefer:

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 requirements , as set forth in the Quality System Regulation (OS) 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 - Ms. Barbara Atzenhoefer

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,

Willy Wold

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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510(k) Number (if known): K97 3 J O _ 6

Device Name: Dura-Guard - Dural Repair Patch

#### Indications for Use:

For use as a dural substitute for the 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 X Per 21 CFR 801.109

OR

Over-The-Counter Use

Ulan will

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