DuraGen II Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGen II Dural Regeneration Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. DuraGen II Dural Regeneration Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes. DuraGen II Dural Regeneration Matrix may be applied using either onlay or suturing technique depending on clinical need and surgeon preference.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DuraGen II Dural Regeneration Matrix. The submission focuses on demonstrating substantial equivalence to a predicate device through physical property testing, rather than clinical performance data with acceptance criteria for a specific device output. Therefore, many of the requested categories regarding clinical study design and AI performance are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the format typically seen for diagnostic or AI-driven devices. Instead, it relies on demonstrating substantial equivalence through "physical property testing."

Acceptance Criteria (Implied)	Reported Device Performance
Safety	Deemed "safe and effective under the proposed conditions of use" based on valid scientific evidence.
Effectiveness	Deemed "safe and effective under the proposed conditions of use" based on valid scientific evidence.
Substantial Equivalence	"substantially equivalent in function and intended use to the currently marketed DuraGen Plus™ Dural Regeneration Matrix (K032693)" and "substantially equivalent to the predicate device" in intended use and technological characteristics.
Physical Properties	Implied to meet similar physical property profiles as the predicate device, as confirmed by "physical property testing."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "physical property testing" but does not detail the nature or scale of these tests, nor the source of any data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided and is not applicable as the submission is based on physical property testing for a dural substitute, not on expert-adjudicated clinical outcomes or diagnostic accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided and is not applicable for this type of device submission.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, especially with AI assistance, which is not the case for the DuraGen II.

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

This information is not applicable. DuraGen II is a medical implant (dural substitute), not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission appears to be derived from the physical properties and established safety/effectiveness profiles of the predicate device, as assessed through "physical property testing." There is no mention of expert consensus, pathology, or clinical outcomes data for this specific submission's "ground truth."

8. The sample size for the training set

This information is not applicable as the DuraGen II is not an AI-driven device requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for an AI model.

Summary of Device and Study Type:

The DuraGen II Dural Regeneration Matrix is a Class II medical device, essentially an absorbable implant for dural repair. The 510(k) submission primarily focuses on demonstrating substantial equivalence to an existing predicate device (DuraGen Plus™ Dural Regeneration Matrix). The evidence for this substantial equivalence is stated as "valid scientific evidence through physical property testing." This type of submission relies on showing that the new device has similar technological characteristics and intended use as a legally marketed device, and therefore can be presumed to be as safe and effective without the need for extensive new clinical trials with patient-specific outcome measures or comparative effectiveness studies against experts.

Summary

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JAN 12 2005

K043427
page 1/1

DuraGen II Dural Regeneration Matrix 510(K) SUMMARY

Submitter's name and address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

Contact person and telephone number:

Diana M. Bordon Manager, Regulatory Affairs, (609) 936-2240

December 10, 2004 Date:

Name of the device:

Proprietary Name:	DuraGen II
Common Name:	Dural Regeneration Matrix
Classification Name:	Dura Substitute, Product Code 84GXQClass IIRegulation Number 882.5910

Substantial Equivalence:

DuraGen II Dural Regeneration Matrix is substantially equivalent in function and intended use to the currently marketed DuraGen Plus™ Dural Regeneration Matrix (K032693).

Intended Use:

DuraGen II Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.

Device Description:

Conclusion:

Valid scientific evidence through physical property testing provide reasonable assurance that DuraGen II Dural Regeneration Matrix is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2005

Ms. Diana M. Bordon Manager, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K043427

Trade/Device Name: DuraGen II Dural Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXQ Dated: December 10, 2004 Received: December 13, 200

Dear Ms. Bordon:

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. Diana M. Bordon

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/industry/support/index.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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Indications for Use

K043427 510(k) Number (if known):

Device Name: DuraGen II Dural Regeneration Matrix

Indications For Use:

DuraGen II Dural Regeneration Matrix is indicated as a dura 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)

Muriam C. Provost

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

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510(k) Number K043427
B.1

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).