Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair® is supplied sterile in sheet form in a variety of sizes to be trimmed and; sutured or onlayed by the surgeon to meet the individual patient's needs.

AI/ML Overview

The provided text is a 510(k) summary for the Durepair® Dura Regeneration Matrix, a collagen implant for dura mater repair. It outlines the device's description, indications for use, and a statement of substantial equivalence to predicate devices (Dura-Guard® and DuraGen™).

However, the document does not contain information about:

Acceptance criteria in terms of specific performance metrics or thresholds.
A "study" describing device performance against such criteria.
Sample sizes for test sets or training sets.
Data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or type of ground truth.

The document states that "Safety of the Durepair® device to the predicate products was demonstrated in biocompatibility studies in accordance with ISO 10993, in vitro testing, animal studies, and clinical data." This vaguely mentions "clinical data" but provides no details about the design, results, or specific metrics from these studies that would allow for an evaluation of acceptance criteria or performance.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, or detailed study information based solely on the provided text. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results that would typically include such metrics.

Summary

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

JUL 27 2004

41000

510(k) Summary

This 510(k) summary for Dura Regeneration Matrix is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitted by:

Medtronic Neurosurgery 125 Cremona Drive Goleta, CA 93117

Contact Person:

Jeffrey Henderson Vice President, Quality & Requlatory Affairs Tel: (805) 968-1546 Ext. 1770 or 1-800-826-5603 Fax: (805) 968-9336

Date Prepared:

April 16, 2004

Device Information:

Proprietary name:	Durepair® Dura Regeneration Matrix
Classification name:	Dura substitute
Device classification:	Class II (21CFR882.5910)

Device Description:

Indications for Use:

Durepair® is indicated as a dura substitute for the repair of the dura mater.

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

KO411e C

Statement of Substantia! Equivalence:

Durepair® is substantially equivalent in function and intended use to:

PredicateDevices	Manufacturer	510(k) Number
Dura-Guard®	Bio-Vascular	K982282
DuraGen™	Integra Life Sciences	K982180

Summary of Technological Characteristics:

Safety of the Durepair® device to the predicate products was demonstrated in biocompatibility studies in accordance with ISO 10993, in vitro testing, animal studies, and clinical data.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 2004

Mr. Jeffrey Henderson Vice President, Quality & Regulatory Affairs Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117-5500

Re: K041000

Trade/Device Name: Durepair® Dura Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: II Product Code: GXQ Dated: June 18, 2004 Received: June 21, 2004

Dear Mr. Henderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mr. Jeffrey Henderson

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for 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}------------------------------------------------

K041000

Indications for Use

510(k) Number (if known):

Device Name:

Durepair® Dura Regeneration Matrix

Indications for Use:

Durepair® is indicated as a dura substitute for the repair of the dura mater.

Muriam C. Provost

Division Sign-Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Medtronic Neurosurgery Durepair® 510(K) 04/16/04

Regulation Number and Section

§ 882.5910 Dura substitute.

(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).