(247 days)
Not Found
No
The device description and performance studies focus on the biological material and mechanical properties of the dural substitute, with no mention of AI or ML.
No.
The device is a dural substitute for the repair of dura mater, which is a structural repair rather than a therapeutic treatment.
No
Explanation: The device is a dural substitute for surgical repair, not for diagnosing medical conditions. It is an implantable matrix used to replace or repair dura mater.
No
The device description clearly states it is a biological matrix made from human cadaver skin, processed, sterilized, and packaged for implantation. This is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a dural substitute for the repair of dura mater." This describes a surgical implant used directly in the body to replace or repair tissue.
- Device Description: The description details a biological matrix derived from human skin, processed for implantation. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The LifeCell Dural Substitute Matrix does not fit this description.
N/A
Intended Use / Indications for Use
LifeCell Dural Substitute Matrix is indicated as a dural substitute for the repair of dura mater.
Product codes
GXQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dura mater
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).
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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
(908) 947-1114 Phone: Facsimile: (908) 947-1095
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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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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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