The Collagen Dura Substitute Membrane is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. The device has a thickness similar to that of native dura. It is flexible and conforms to the contours of the defect site. The unique conformability properties of the membrane combined with its mechanical strength allow the membrane matrix to be applied as an onlay membrane or sutured in place. The Collagen Dura Substitute Membrane is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

AI/ML Overview

This 510(k) summary describes a medical device, the DuraMatrix™ Collagen Dura Substitute Membrane, which is not an AI or software device. Therefore, many of the requested categories in the prompt, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "sample size for the training set," and "how the ground truth for the training set was established" are not applicable.

Here's an analysis of the provided text based on the other relevant categories for this type of device:

Acceptance Criteria and Device Performance Study for DuraMatrix™ Collagen Dura Substitute Membrane

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K040888 focuses on demonstrating substantial equivalence to predicate devices rather than specific quantitative performance metrics against pre-defined acceptance criteria for a novel AI or software device. The acceptance is based on the device meeting design requirements for an effective dura substitute and passing various safety and biocompatibility tests.

Category	Acceptance Criteria (Implied/General)	Reported Device Performance
Safety	Compliance with FDA Blue Book Memorandum G95-1 and ISO 10993-1 for biological evaluation of medical devices.	"The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices." This implies meeting the acceptance criteria for each test within these guidelines. Specific numerical thresholds or results are not provided in this summary.
Effectiveness (Dura Substitute)	Must meet design requirements for an effective dura substitute.	"The results of a large-scale animal study and clinical study support the effectiveness of using a membrane material as a dura substitute in the repair of dura mater. The characteristics of the Collagen Dura Substitute Membrane meet the design requirements for an effective dura substitute." Specific details of these study results are not provided in this summary.
Technological Characteristics (Comparison)	Similar to predicate devices (Dura-Guard® Dural Repair Patch, DuraGen® Dural Graft Matrix) in key characteristics.	"Collagen Dura Substitute Membrane and its predicates 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, porosity and conformability." This indicates the device met the criteria of being sufficiently similar to the legally marketed predicates.

2. Sample Size Used for the Test Set and Data Provenance

The summary mentions a "large-scale animal study and clinical study" but does not provide specific sample sizes for either.
The data provenance (country of origin, retrospective/prospective) is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of device. The "ground truth" for a dura substitute is assessed through its physiological performance and safety in animal models and clinical use.

4. Adjudication Method for the Test Set

Not applicable for this type of device.

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

Not applicable, as this is a medical implant, not an AI or software device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a medical implant, not an AI or software device.

7. The Type of Ground Truth Used

For the safety and effectiveness of a dura substitute, the "ground truth" would be established through:

Biocompatibility testing: In vitro and in vivo tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation studies) according to ISO 10993-1 and FDA G95-1 guidelines. The "ground truth" for these tests are the established biological responses that indicate safety.
Animal study outcomes: Histological analysis of tissue response, assessment of dural repair integrity, absence of adverse events like CSF leakage or infection.
Clinical study outcomes: Patient outcomes related to dural repair, absence of complications, healing, and functionality.

8. The Sample Size for the Training Set

Not applicable, as this is a medical implant, not an AI or software device that uses a training set in the computational sense. The "training" in this context would refer to the extensive R&D, material characterization, and iterative design work that precedes formal testing.

9. How the Ground Truth for the Training Set was Established

Not applicable, as this is a medical implant, not an AI or software device.

Summary

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K040888 1/2

DEC - 1 2004

510(k) Summary of Safety and Effectiveness

Applicant Name and Address:	Collagen Matrix, Inc.509 Commerce StreetFranklin Lakes, New Jersey 07417
Contact Person:	Peggy Hansen, RACDirector, Clinical, Regulatory, and Quality AssuranceTel: (201) 405-1477Fax: (201) 405-1355
Date of Summary:	April 1, 2004
Device Common Name:	Collagen Dura Substitute Membrane
Device Trade Name:	DuraMatrix™ Collagen Dura Substitute Membrane
Device Classification Name:	Dura substituteClass II8882.5910GXQ
Predicate Device(s):	Dura-Guard® Dural Repair Patch, K950956DuraGen® Dural Graft Matrix, K982180

Description of the Device

Intended Use

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

Summary/Comparison of Technical Characteristics

Collagen Dura Substitute Membrane and its predicates have similar technological characteristics. In particular, the Collagen Dura Substitute Membrane and its predicates

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K040888 2/2

are similar with respect to intended use, material, form, sizes, thickness, physical integrity, porosity and conformability.

Safety

Collagen Dura Substitute Membrane 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 support the effectiveness of using a membrane material as a dura substitute in the repair of dura mater. The characteristics of the Collagen Dura Substitute Membrane meet the design requirements for an effective dura substitute.

Conclusion

The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, large-scale animal study and clinical study show that the Collagen Dura Substitute Membrane is safe and substantially equivalent to Dura-Guard® Dural Repair Patch and DuraGen® Dural Graft Matrix.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2004

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

Re: K040888

Trade/Device Name: DuraMatrix™ Collagen Dura Substitute Membrane Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXQ Dated: October 25, 2004 Received: October 26, 2004

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 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. Peggy Hansen, RAC

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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K040888

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

DuraMatrix™ Collagen Dura Substitute Membrane is indicated for use as a dural 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)

the submit and the submit of the submit of the submit of the submit of the subsequence and

Miriam C Provost

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

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510(k) Number_K040888

Regulation Number and Section

§ 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).