DuraGen® Secure Dural Regeneration Matrix is an absorbable implant for the repair of dura mater. This absorbable, sutureless onlay graft is comprised of a porous, highly purified collagen matrix and a thin layer of hydroxypropyl methyl cellulose (HPMC). HPMC is a non-cytotoxic, non-immunogenic, biocompatible plant-derived cellulose-based material. The addition of HPMC results in a dural graft which reduces the potential for the product to migrate, slide or displace during the surgical procedure, such as during irrigation of the surgical site or in a standing pool of fluid, without the use of sutures.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DuraGen® Secure Dural Regeneration Matrix. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a novel functionality. Therefore, the requested information elements related to performance metrics, statistical studies, expert adjudication, and training/test set details are not applicable in the context of this regulatory document.

However, I can extract the relevant information concerning the device, its intended use, and the single test result mentioned:

Device & Indications for Use:

Device Name: DuraGen® Secure Dural Regeneration Matrix
Indications for Use: Indicated as a dura substitute for the repair of dura mater.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Viral Inactivation	Six log reduction of viral titers demonstrated through a viral inactivation study conforming to ISO 22442-3.

Study Details:

Sample size used for the test set and data provenance: Not applicable. The "test set" in this context refers to the samples used in the viral inactivation study. The document states "These processes were performed in a validated scaled down process that is representative of all Integra LifeSciences Corporation's collagen products," but does not specify the sample size for this specific study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a laboratory study assessing viral inactivation, not an expert-driven performance evaluation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This device is not an AI-based diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the viral inactivation study was the measured reduction in viral titers following the specified treatment processes, evaluated against the standards of ISO 22442-3.
The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm or a training set in that context.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three abstract human profiles facing to the right, suggesting a focus on people and health.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2017

Integra LifeSciences Corporation Yara Hamid Regulatory and Quality Associate 311 Enterprise Dr. Plainsboro, NJ 08536

Re: K163456

Trade/Device Name: DuraGen® Secure Dural Regeneration Matrix Regulation Number: 21 CFR 882.5910 Regulation Name: Dura Substitute Regulatory Class: Class II Product Code: GXQ Dated: December 8, 2016 Received: December 9, 2016

Dear Ms. Yara Hamid:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Michael J. Hoffmann -S

Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163456

Device Name

DuraGen® Secure Dural Regeneration Matrix

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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2. 510(k) SUMMARY

DuraGen® Secure Dural Regeneration Matrix

Submitter's name and address:

Integra LifeSciences Corporation

311 Enterprise Drive

Plainsboro, NJ 08536 USA

Telephone: 609-275-0500

Cell: 609-275-5363

Contact person and telephone number:

Yara Hamid

Regulatory and Quality Associate

Date the Summary was prepared: November 11, 2016

Name of the device:

Proprietary Name:	DuraGen® Secure Dural Regeneration Matrix
Common Name:	Dura Substitute
Classification Name:	Dura substitute
Product Code:	GXQ
Regulation:	Class II, under 21 CFR 882.5910

Substantial Equivalence:

DuraGen® Secure Dural Regeneration Matrix is substantially equivalent in function and intended use to the predicate device detailed in Table 2-1.

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510(k) Number	Product Code	Trade Name	Manufacturer
K120600	GXQ	DuraGen® SecureDural RegenerationMatrix	Integra LifeSciencesCorporation

Table 2-1- Substantial Equivalence Table

Device Description:

Indication for Use:

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

Summary of Technological Characteristics:

DuraGen® Secure Dural Regeneration Matrix has the same design, material, and chemical composition, as the predicate device (K120600). The manufacturing and processing are exactly the same and have no changed.

Testing and Test Results:

A viral inactivation study was conducted to demonstrate that DuraGen® Secure Dural Regeneration Matrix demonstrates continued conformance to ISO 22442-3 Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents, FDA Recognition Number 15-47, through the combined enzymatic treatment and alkali treatment processes. These processes were performed in a validated scaled down process that is representative of all Integra LifeSciences Corporation's collagen products. The viral inactivation study resulted in a six log reduction of the viral titers. The results of the testing did not raise any new issues of safety or effectiveness compared to DuraGen® Secure Dural Regeneration Matrix.

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Conclusion:

The DuraGen® Secure Dural Regeneration Matrix is substantially equivalent to the current marketed device, DuraGen® Secure Dural Regeneration Matrix. There have been no modifications to the design or manufacturing of the DuraGen® Secure Dural Regeneration Matrix that resulted in this filing, and the results of the viral inactivation study do not change the intended use or fundamental scientific technology of the device, and do not raise any new issues of safety or effectiveness.

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).