DURAGEN PLUS DURAL GRAFT MATRIX

K032693 · Integra Lifesciences Corp. · GXQ · Sep 30, 2003 · Neurology

Device Facts

• Record ID: K032693
• Device Name: DURAGEN PLUS DURAL GRAFT MATRIX
• Applicant: Integra Lifesciences Corp.
• Product Code: GXQ · Neurology
• Decision Date: Sep 30, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DuraGen Plus™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.

Device Story

DuraGen Plus™ is an absorbable, soft, white, pliable, nonfriable, porous collagen matrix used as a dural substitute for the repair of dural defects. The device is supplied sterile and nonpyrogenic for single-use application. It is intended for use by surgeons during neurosurgical procedures to facilitate dural repair. The matrix acts as a scaffold for tissue regeneration. It is applied directly to the dural defect site.

Clinical Evidence

No clinical data; substantial equivalence is supported by physical property testing.

Technological Characteristics

Absorbable collagen matrix; porous, pliable, nonfriable form factor; supplied sterile and nonpyrogenic; single-use.

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

• DuraGen® Dural Graft Matrix (K982180)

Submission Summary (Full Text)

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510(k) Summary DuraGen Plus™ Dural Graft Matrix Integra LifeSciences Corporation

# KO32693

Confidential

# DuraGen Plus™ Dural Graft Matrix 510(K) SUMMARY

#### Submitter's name and address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

### Contact person and telephone number:

Diana M. Bordon Manager, Regulatory Affairs, [phone]

August 29,2003 Date:

#### Name of the device:

| Proprietary Name: | DuraGen Plus™ |
|----------------------|-------------------------------------|
| Common Name: | Dural Graft Matrix |
| Classification Name: | Dura Substitute, Product Code 84GXQ |
| | Class II |
| | Regulation Number 882.5910 |

#### Substantial Equivalence:

DuraGen Plus™ Dural Graft Matrix is substantially equivalent in function and intended use to the currently marketed DuraGen® Dural Graft Matrix (K982180).

#### Intended Use:

DuraGen Plus™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.

#### Device Description:

DuraGen Plus™ Dural Graft Matrix, is an absorbable implant for repair of dural defects. DuraGen Plus™ is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen Plus™ is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

#### Conclusion:

Valid scientific evidence through physical property testing provide reasonable assurance that DuraGen Plus™ Dural Graft Matrix is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 2003

Ms. Diana M. Bordon Manager, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K032693 Trade/Device Name: DuraGen Plus™ Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXQ Dated: August 29, 2003 Received: September 3, 2003

Dear Ms. Bordon:

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 - Ms. Diana M. Bordon

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/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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

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K032693

## INDICATIONS FOR USE

510(k) Number:

Device Name: DuraGen Plus™ Dural Graft Matrix

Indications for Use:

DuraGen Plus™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.

Meriam C. Provost

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

510(k) Number K032693

(PLEASE DO NOT WRITE BEI.OW 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)

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