DURAGEN II DURAL REGENERATION MATRIX

K043427 · Integra Lifesciences Corp. · GXQ · Jan 12, 2005 · Neurology

Device Facts

• Record ID: K043427
• Device Name: DURAGEN II DURAL REGENERATION MATRIX
• Applicant: Integra Lifesciences Corp.
• Product Code: GXQ · Neurology
• Decision Date: Jan 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DuraGen II Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.

Device Story

DuraGen II is an absorbable, porous collagen matrix designed for the repair of dural defects. It features a mechanically strengthened collagen component to improve handling. The device is supplied sterile and nonpyrogenic for single use. It is applied by surgeons during neurosurgical procedures using either an onlay or suturing technique, depending on clinical requirements. By providing a scaffold for dural regeneration, the matrix facilitates the repair of the dura mater, potentially benefiting patients by restoring dural integrity.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Absorbable, porous collagen matrix with a mechanically strengthened collagen component. Supplied sterile, nonpyrogenic, in double peel packaging. Single-use device.

Indications for Use

Indicated for the repair of dura mater in patients requiring a dura substitute.

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 Plus Dural Regeneration Matrix (K032693)

Submission Summary (Full Text)

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JAN 12 2005

K043427
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# DuraGen II Dural Regeneration 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]

December 10, 2004 Date:

# Name of the device:

| Proprietary Name: | DuraGen II |
|----------------------|-------------------------------------------------------------------------------|
| Common Name: | Dural Regeneration Matrix |
| Classification Name: | Dura Substitute, Product Code 84GXQ<br>Class II<br>Regulation Number 882.5910 |

### Substantial Equivalence:

DuraGen II Dural Regeneration Matrix is substantially equivalent in function and intended use to the currently marketed DuraGen Plus™ Dural Regeneration Matrix (K032693).

#### Intended Use:

DuraGen II Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.

## Device Description:

DuraGen II Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGen II Dural Regeneration Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. DuraGen II Dural Regeneration Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes. DuraGen II Dural Regeneration Matrix may be applied using either onlay or suturing technique depending on clinical need and surgeon preference.

#### Conclusion:

Valid scientific evidence through physical property testing provide reasonable assurance that DuraGen II Dural Regeneration 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 circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2005

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

Re: K043427

Trade/Device Name: DuraGen II Dural Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXQ Dated: December 10, 2004 Received: December 13, 200

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/industry/support/index.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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# Indications for Use

K043427 510(k) Number (if known):

Device Name: DuraGen II Dural Regeneration Matrix

Indications For Use:

DuraGen II Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

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**510(k) Number** k043427
B.1