MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX

K063117 · Medtronic Neurosurgery · GXQ · Nov 3, 2006 · Neurology

Device Facts

• Record ID: K063117
• Device Name: MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
• Applicant: Medtronic Neurosurgery
• Product Code: GXQ · Neurology
• Decision Date: Nov 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Durepair Dura Regeneration Matrix is a collagen-based implant used for the repair of dura mater defects. Supplied as a sterile sheet, the device is cut and sutured by a surgeon during neurosurgical procedures to address individual patient needs. It serves as a scaffold for tissue regeneration. The device is used in clinical settings by neurosurgeons.

Technological Characteristics

Collagen-based implant; supplied as a sterile sheet; intended for surgical suturing. No electronic, software, or mechanical sensing components.

Indications for Use

Indicated for patients requiring repair of the dura mater.

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

• Durepair® Dura Regeneration Matrix (K041000)
• Durepair® Dura Regeneration Matrix (K052211)

Submission Summary (Full Text)

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K063117

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NOV - 3 2006

## 4. 510(k) Summary

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87 .

| Address of Manufacturer: | TEI Biosciences Inc.<br>7 Elkins Street<br>Boston, MA 02127<br>[phone]<br>[phone] (fax)<br>ERN 3004170064 |
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| Contact Person: | Jeffrey Henderson<br>Vice President, Quality and Regulatory Affairs<br>Medtronic Neurosurgery<br>125 Cremona Drive<br>Goleta CA, 93117<br>[phone] ext. 1773<br>Fax: [phone]<br>ERN 2021898 |
| Date: | October 12, 2006 |
| Trade or Proprietary Name: | Durepair® Dura Regeneration Matrix |
| Common Usual or Classification Name: | Dura Substitute (882.5910) |
| Predicate Device Identification: | Durepair® Dura Regeneration Matrix<br>(K041000 and K052211) |

Description: The 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 ropal. of act and sutured by the surgeon to meet the individual patient's needs.

Intended Use: Durepair is a dura substitute for the repair of the dura mater.

Intended Use of Predicate Device(s): The predicate device, Durepair, is a dura substitute for the repair of the dura mater.

Technological Comparison: Medtronic Neurosurgery submits that the collagen material, fundamental scientific technological attributes, device labeling, and the matonal, familian homal vice are the same as the previously reviewed and cleared Intenair. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Durepair product compared to the predicate and currently marketed devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

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

Re: K063117

Trade/Device Name: Durcpair® Dura Regencration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXO Dated: October 12, 2006 Received: October 12, 2006

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, 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 (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.

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.

Sincerely yours,

Neil R.S. Dohm

Mark N. Melkerson (

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## II. Statement of Indications for Use

Indications for Use

510(k) Number (if known): KO63117

Device Name: Durepair® Dura Regeneration Matrix

Indications for Use:

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

Prescription Use ﺮ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Per Division of General, Restorative, and Neurological Devices

510/12) Nimbor K 063 117