DUREPAIR DURA REGENERATION MATRIX

K052211 · Medtronic Neurosurgery · GXQ · Sep 14, 2005 · Neurology

Device Facts

• Record ID: K052211
• Device Name: DUREPAIR DURA REGENERATION MATRIX
• Applicant: Medtronic Neurosurgery
• Product Code: GXQ · Neurology
• Decision Date: Sep 14, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Durepair is 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 in various sizes, the device is trimmed and sutured by a neurosurgeon during surgical procedures. It serves as a scaffold to facilitate dural regeneration. The device is intended for clinical use in an operating room setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material identity to the predicate device.

Technological Characteristics

Collagen-based implant; supplied as a sterile, trimmable sheet. No specific ASTM standards or electronic components described.

Indications for Use

Indicated for the repair of the dura mater in patients requiring dural reconstruction.

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)

Submission Summary (Full Text)

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# KOSzz11

#### 7. 510(k) Summary

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 307.87.

| Address of Manufacturer: | TEI Biosciences Inc.<br>7 Elkins Street<br>Boston, MA 02127<br>[phone]<br>[phone] (fax)<br>ERN 3004170064<br><br>Lyophilization Services of New England, Inc.<br>One Sundial Ave., Suite 112<br>Manchester, NH 03103<br>ERN 1225991 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | August 10, 2005 |
| 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) |

Description: The Durepair Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Du epair is supplied sterile in sheet form in a variety of sizes to be trimmed and sutu red by the surgeon to meet the individual patient's needs.

Intended Use: Durepair is a dura subs titute 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.

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KOSZZ11

2/2

Technological Comparison: Medtronic Ne រrosurgery submits that the collagen
t and comparison anasification, fundamental scientific technological attitibutes, Technological Comparison: Nedronic Ne irosurgery submiss matributes, device
material, sourcing specification, fundamerial scientific technological attributes, device rechnique intended use of the device are the same as the previously reviewed
Iabeling, and the intended use of the device are the same as the previously reviewed hateling, and the intended use of the device are the same as the provinces of the morgery
and cleared Durepair. Based upon the summary above, Medicological product haboling and determines substantial equivalence, surently marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

SEP 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052211

Trade/Device Name: Durepair® Dura Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXQ Dated: August 10, 2005 Received: August 16, 2005

Dear Mr. Henderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) premained is substantially equivalent (first indications referenced above and nave cetermined a vices and a sevices marketed in interstate for use stated in the electosule) to legally management date of the Medical Device American be and Food. Days commerce proof to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require appears appear al controls provisions of the Act. The r ou may, merciolo, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations on may be subject to submittenal connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the OULS announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advised that I Dri of ibseants of our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally it collar statures and regaranents and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quanty bytvelles (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) I his letter will anow you to ocgin manceing your antial equivalence of your device to a legally premarket nothication. The PDA midning of backantial vour 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 Pairt 801), please If you desire specific advice for your active of your access note the regulation entitled, contact the Office of Comphanes at (217) =if =ation" (21CFR Part 807.97). You may obtain "Misbranding by reference to premantee so premantee for from the Division of Small other general information on your responsible in the toll-free number [phone] or Manufacturers, micritational and Octass http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Barbara Buchud
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Mark N. Melkerson Acting 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

### Indicati >ns 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Otfice of Device Evaluation (ODE)

Barbara Buchholz for Myivi

Division Sign-Off) Offision big
Division of General, Restorative, and Neurological Devices

510(k) Number K052211