(247 days)
LifeCell Dural Substitute Matrix is indicated as a dural substitute for the repair of dura mater.
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) peel-pouch and an outer foil pouch.
The provided text describes a 510(k) premarket notification for the "LifeCell Dural Substitute Matrix." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive, de novo clinical trials with predefined acceptance criteria.
Therefore, the concept of specific "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a new clinical trial with statistical endpoints is not explicitly detailed in this document. The submission focuses on showing that the new device is as safe and effective as existing, legally marketed predicate devices.
However, based on the provided information, we can infer how performance was assessed for equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) based on substantial equivalence, there are no specific numerical acceptance criteria like sensitivity/specificity thresholds. Instead, the acceptance is based on demonstrating that the device performs similarly to the predicate devices in terms of its intended function and safety.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent to predicate devices for dural substitution. | "The mechanical... testing has demonstrated that the LifeCell Dural Substitute Matrix will meet its intended function as a dura substitute." |
| Preclinical Animal Testing Performance: Equivalent to predicate devices for dural substitution. | "The... preclinical animal testing has demonstrated that the LifeCell Dural Substitute Matrix will meet its intended function as a dura substitute." |
| Clinical Performance: Adequate as a dura substitute, similar to predicate devices. | "Clinical data has shown that it is an adequate dura substitute used for the repair of dura mater." |
| Technological Characteristics: Similar to predicate devices (biological material, processed allograft, sterilization, packaging, rehydration, revascularization/repopulation post-implantation). | "The LifeCell Dural Substitute Matrix... is made from donated human cadaver skin... processed to remove cells and freeze-dried... terminally sterilized... 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." (This aligns with description of predicate devices as also being from biological material). |
| Safety and Effectiveness: As safe and effective as the predicate devices (Integra LifeSciences' DuraGen® Dural Regeneration Matrix and Bio-Vascular's DuraGuard® Dural Repair Patch). | "The LifeCell Dural Substitute Matrix is as safe and effective as the DuraGen Dural Regeneration Matrix and the DuraGuard Dural Repair Patch." and "Performance data demonstrates that the LifeCell Dural Substitute Matrix is as safe and effective as the predicate devices." |
Study Information (Inferring from "Performance Data"):
The document mentions "Performance Data" which includes "mechanical," "preclinical animal testing," and "clinical data." This suggests a combination of studies were conducted, but specific details about each study are limited.
2. Sample size used for the test set and the data provenance:
- Mechanical and Preclinical Animal Testing: The specific sample sizes are not provided in this summary.
- Clinical Data: The specific sample size for the clinical data is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The term "clinical data has shown" suggests some form of observational or compiled data, but details are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the 510(k) summary. For devices of this nature, "ground truth" often refers to histological analysis or clinical outcomes adjudicated by physicians, but no specifics are mentioned here.
4. Adjudication method for the test set:
This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study is not applicable to this device. This device is a dural substitute (a physical implant), not an AI-powered diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This question is not applicable to this device, as it is a physical implant, not an algorithm.
7. The type of ground truth used:
Based on the nature of the device (dural substitute), the "ground truth" would likely involve:
- Histology/Pathology: For preclinical animal studies (e.g., tissue integration, inflammatory response, dural regeneration, presence/absence of cells).
- Clinical Outcomes Data: For human application (e.g., absence of CSF leak, infection, adverse reactions, successful dural repair as observed surgically or symptomatically).
- Mechanical Testing Results: For physical properties.
- The exact methods for establishing "ground truth" are not detailed in the summary.
8. The sample size for the training set:
- Not applicable/Not provided. This device is a biologic implant, not an AI algorithm that requires a training set. The "clinical data" and "preclinical animal testing" are likely related to validation/performance assessment rather than training a model.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, there is no "training set" for this type of device.
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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.
Page ( of (
§ 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).