DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE

K061487 · Collagen Matrix, Inc. · GXQ · Jun 26, 2006 · Neurology

Device Facts

• Record ID: K061487
• Device Name: DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
• Applicant: Collagen Matrix, Inc.
• Product Code: GXQ · Neurology
• Decision Date: Jun 26, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Collagen Dura Substitute Membranes are indicated for use as a dural substitute for the repair of dura mater.

Device Story

DuraMatrix™ Collagen Dura Substitute Membranes are white, nonfriable, conformable, resorbable membrane matrices; engineered from highly purified type I collagen derived from bovine Achilles tendon. Device mimics thickness of native dura; flexible to conform to defect site contours. Supplied sterile, non-pyrogenic, for single use. Used by surgeons during neurosurgical procedures to repair dura mater. Provides a scaffold for tissue repair; benefits patient by facilitating dural closure.

Clinical Evidence

Effectiveness supported by a large-scale animal study and clinical study of the equivalent product. Safety evaluated via biocompatibility testing per FDA Blue Book Memorandum G95-1 and ISO 10993-1.

Technological Characteristics

Resorbable membrane matrix; material: highly purified type I collagen from bovine Achilles tendon. Form: conformable, nonfriable sheet. Biocompatibility: ISO 10993-1 compliant. Sterilization: sterile, non-pyrogenic.

Indications for Use

Indicated for use as a dural substitute for the repair of dura mater in patients requiring such surgical intervention.

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

• DuraMatrix™ Collagen Dura Substitute Membrane (K040888)

Submission Summary (Full Text)

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K061487 Page 1/2

### 510(k) Summary of Safety and Effectiveness

| Applicant Name and Address: | Collagen Matrix, Inc.<br>509 Commerce Street<br>Franklin Lakes, New Jersey 07417 | JUN 26 2006 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Peggy Hansen, RAC<br>Director, Clinical, Regulatory, and Quality Assurance<br>Tel: [phone]<br>Fax: [phone] | |
| Date of Summary: | May 30, 2006 | |
| Device Common Name: | Collagen Dura Substitute Membranes | |
| Device Trade Name: | DuraMatrix™ Collagen Dura Substitute Membranes | |
| Device Classification Name: | Dura substitute<br>Class II<br>882.5910<br>GXQ | |
| Predicate Device(s): | DuraMatrix™ Collagen Dura Substitute Membrane,<br>K040888 | |

#### Description of the Device

The Collagen Dura Substitute Membrane are white, nonfriable, conformable, resorbable, membrane matrices engineered from highly purified type I collagen derived from bovine Achilles tendon. The devices have thicknesses similar to that of native dura. They are flexible and conform to the contours of the defect site. The Collagen Dura Substitute Membranes are supplied sterile, non-pyrogenic, in various sizes, and for single use only.

#### Intended Use

The Collagen Dura Substitute Membranes are indicated for use as a dural substitute for the repair of dura mater.

# Summary/Comparison of Technical Characteristics

Collagen Dura Substitute Membranes and their predicate have similar technological characteristics. In particular, the Collagen Dura Substitute Membrane and its predicates are similar with respect to intended use, material, form, sizes, thickness, physical integrity, pore structure and conformability.

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K061487

# Safety

Collagen Dura Substitute Membrane equivalent has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

# Effectiveness

The results of a large-scale animal study and clinical study of the equivalent product support the effectiveness of using a membrane material as a dura substitute in the repair of dura mater. The characteristics of the modified Collagen Dura Substitute Membranes meet the design requirements for an effective dura substitute.

# Conclusion

The results of the in vitro product characterization studies show that the device modifications of the Collagen Dura Substitute Membrane are safe and substantially equivalent to the original device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines representing hair or clothing.

JUN 26 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Collagen Matrix, Inc. c/o Peggy Hansen, RAC Director, Clinical, Regulatory, and Quality Assurance 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K061487

Trade/Device Name: DuraMatrix™ Collagen Dura substitute Membranes Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: June 7, 2006 Received: June 8, 2006

Dear Ms. Hansen:

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 idecations 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 1 clity. general controls pro sions of the Act include requirements for annual registration, isting 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. In the way 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. Younny of 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 lectronic product radiation control provisions (Sections 531-542 of the Actil 11 CFR 100-0.000.

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#### Page 2 - Peggy Hansen

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 vours

Oabara Bneem

Mark Melkerson 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

| 510(k) Number (if known): | K061487 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: DuraMatrix™ Collagen Dura Substitute Membranes

Indications for Use:

DuraMatrix™ Collagen Dura Substitute Membranes are indicated as dural substitutes 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)

Cladia, Philip, Joseph
(Doris, Sister)

Div neral, Restorative. and Neurological Devices

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510(k) Number