LIFECELL DURAL SUBSTITUTE MATRIX

K061208 · Lifecell Corp. · GXQ · Jan 3, 2007 · Neurology

Device Facts

• Record ID: K061208
• Device Name: LIFECELL DURAL SUBSTITUTE MATRIX
• Applicant: Lifecell Corp.
• Product Code: GXQ · Neurology
• Decision Date: Jan 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5910
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

LifeCell Dural Substitute Matrix is indicated as a dural substitute for the repair of dura mater.

Device Story

LifeCell Dural Substitute Matrix is an acellular, freeze-dried allograft human dermis used as a dural substitute. The device is implanted by a surgeon during neurosurgical procedures to repair the dura mater. Upon implantation, the matrix serves as a scaffold that is revascularized and repopulated with host cells, facilitating tissue repair. The device is supplied in a double-pouch configuration and requires rehydration prior to use. It functions as a biological patch to restore dural integrity.

Clinical Evidence

Evidence includes mechanical testing, preclinical animal testing, and clinical data demonstrating the device's adequacy as a dural substitute for the repair of dura mater.

Technological Characteristics

Biological material derived from donated human cadaver skin; processed to remove cells; freeze-dried; terminally sterilized via e-beam irradiation; packaged in double-pouch configuration (inner Tyvek, outer foil).

Indications for Use

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

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 Regeneration Matrix (K043427)
• DuraGuard Dural Repair Patch (K982282)

Submission Summary (Full Text)

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#### I. 510(K) SUMMARY

#### LifeCell Dural Substitute Matrix

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

LifeCell Corporation One Millennium Way Branchburg, NJ 08869

[phone] Phone: Facsimile: [phone]

Contact Person: Rey Librojo

Date Prepared:April 28, 2006

### Name of Device and Name/Address of Sponsor

LifeCell Dural Substitute Matrix

LifeCell Corporation One Millennium Way Branchburg, NJ 08876

## Common or Usual Name

Dura Substitute

#### Device Classification

Class II

## Regulation Number

21CFR § 882.5910

#### Product Code:

GXQ

JAN - 9 2007

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# Classification Name

Dura Substitute

# Predicate Devices

Integra LifeSciences' DuraGen® Dural Regeneration Matrix (K043427) Bio-Vascular's DuraGuard® Dural Repair Patch (K982282)

# Intended Use / Indications for Use

LifeCell Dural Substitute Matrix is indicated as a dural substitute for the repair of dura mater.

# Technological Characteristics

The LifeCell Dural Substitute Matrix, like the predicate devices made from a biological material, is made from donated human cadaver skin. The donated allograft human dermis is processed to remove cells and freeze-dried to remove moisture while preserving the general structure of the dermal matrix. The LifeCell Dural Substitute Matrix is terminally sterilized using e-beam irradiation and packaged in a double-pouch configuration. The freeze-dried matrix is rehydrated prior to implantation. After implantation, the graft is revascularized and repopulated with cells. The LifeCell Dural Substitute Matrix is packaged in a double-pouch configuration - an inner (Tyvek) peelpouch and an outer foil pouch.

# Performance Data

The mechanical and preclinical animal testing has demonstrated that the LifeCell Dural Substitute Matrix will meet its intended function as a dura substitute. Clinical data has shown that it is an adequate dura substitute used for the repair of dura mater.

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# Substantial Equivalence

The LifeCell Dural Substitute Matrix is as safe and effective as the DuraGen Dural Regeneration Matrix and the DuraGuard Dural Repair Patch. The LifeCell Dural Substitute Matrix has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The technological difference between the LifeCell Dural Substitute Matrix and its predicate devices raises no new issues of safety or effectiveness. Performance data demonstrates that the LifeCell Dural Substitute Matrix is as safe and effective as the predicate devices.

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Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle in flight, with its wings forming three curved lines. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in a circular arrangement around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LifeCell Corporation % Mr. Rey Librojo Manager, Regulatory Affairs One Millenium Way Branchburg, New Jersey 08876

JAN - 3 2007

Re: K061208

Trade/Device Name: LifeCell Dural Substitute Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXO Dated: October 13, 2006 Received: October 16, 2006

Dear Mr. Librojo:

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. Rey Librojo

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,

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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K061208

#### INDICATIONS FOR USE STATEMENT I.

K061208 510(k) Number (if known):

Device Name: LifeCell Dural Substitute Matrix

#### Indications for Use:

LifeCell Dural Substitute Matrix is indicated as a dural substitute for the repair of dura mater.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division \ Division of General, Restorative, and Neurological Devices

1208 510(k) Number.

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