The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Device Description

NeuraGen® 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve discontinuities. NeuraGen® 3D Nerve Guide Matrix provides a protective environment for peripheral nerve repair after injury, and is designed to isolate and protect the nerve and to create a conduit for axonal growth across a nerve gap. NeuraGen® 3D is composed of bovine Type I collagen conduit and a porous inner matrix comprised of collagen and glycosaminoglycan (chondroitin-6-sulfate). When hydrated, NeuraGen® 3D Nerve Guide Matrix is an easy to handle, soft, pliable, non-friable, collagen conduit containing a porous three-dimensional matrix. NeuraGen® 3D Nerve Guide Matrix is supplied sterile, non-pyrogenic, for single use in a variety of sizes.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "NeuraGen® 3D Nerve Guide Matrix." It focuses on demonstrating substantial equivalence to a previously marketed predicate device and does not involve AI/ML performance testing. Therefore, many of the requested elements for AI/ML device studies are not applicable.

Here's an analysis based on the provided text, highlighting which sections are not relevant to this type of submission:

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

Not applicable in the context of an AI/ML device's performance through a diagnostic or predictive study. This submission is for a physical medical device (nerve guide matrix) and its performance is evaluated through material properties, biological safety, and equivalence to a predicate device.

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

Not applicable. This is not an AI/ML study involving a test set of data. The "test" mentioned is a viral inactivation study of the device material.

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)

Not applicable. No ground truth establishment by experts for a test set of data is described. The viral inactivation study uses laboratory measurements and established protocols.

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

Not applicable.

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.

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

Not applicable.

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

Not applicable. The "truth" in this context is the efficacy of the viral inactivation process, measured by accepted scientific methods in a laboratory setting.

8. The sample size for the training set

Not applicable. There is no training set for an AI/ML algorithm.

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

Not applicable.

Information Relevant to the K163457 Submission of the NeuraGen® 3D Nerve Guide Matrix:

The submission focuses on demonstrating substantial equivalence to a predicate device (K130557) and ensuring the safety of the device material.

Acceptance Criteria and Reported Performance (from the document):

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Substantial Equivalence	Same design, material, and chemical composition as predicate device (K130557). Same manufacturing and processing.	The NeuraGen® 3D Nerve Guide Matrix has the same design, material, and chemical composition, and manufacturing/processing as the predicate device (K130557).
Biological Safety (Viral Inactivation)	Conformance to ISO 22442-3 (Validation of the elimination and/or inactivation of viruses and TSE agents) and FDA Recognition Number 15-47.	Viral inactivation study resulted in a six log reduction of the viral titers through combined enzymatic and alkali treatment processes.

Study Details Related to the Viral Inactivation Test:

Sample Size Used for Test Set: The document mentions "a validated scaled down process that is representative of all Integra LifeSciences Corporation's collagen products." This implies a representative sample of the material was used for the viral inactivation study. The exact number of samples for the study is not specified in the provided text.
Data Provenance: Not explicitly stated, but assumed to be laboratory testing conducted by the manufacturer or a contract research organization.
Ground Truth Establishment: The "ground truth" for viral inactivation is established by internationally recognized standards (ISO 22442-3) and regulatory guidance, using established laboratory methods to measure viral titers before and after processing.
Qualifications of Experts: Not specified, but personnel conducting such studies would be trained in virology and laboratory safety protocols.

Conclusion stated in the document:

The NeuraGen® 3D Nerve Guide Matrix is substantially equivalent to the current marketed device (NeuraGen® 3D Nerve Guide Matrix, K130557). The viral inactivation study's results do not change the intended use or fundamental scientific technology of the device and do not raise new issues of safety or effectiveness.

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. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

January 6, 2017

Integra LifeSciences Corporation Gabriella Green Regulatory Affairs Specialist 311 Enterprise Dr. Plainsboro, NJ 08536

Re: K163457

Trade/Device Name: NeuraGen® 3D Nerve Guide Matrix Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: December 8, 2016 Received: December 9, 2016

Dear Ms. Green:

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) K163457

Device Name NeuraGen® 3D Nerve Guide Matrix

Indications for Use (Describe)

The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

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

NeuraGen® 3D Nerve Guide 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:

Gabriella Green Regulatory Affairs Associate

Date the Summary was prepared: December 8, 2016

Name of the device:

Trade name:	NeuraGen® 3D Nerve Guide Matrix
Common Name:	Nerve Guide Matrix
Classification Name:	21 CFR 882.5275: Nerve Cuff, Class II
Product Code:	JXI

Substantial Equivalence:

NeuraGen® 3D Nerve Guide Matrix is substantially equivalent in function and intended use to the predicate device detailed in Table 2-1.

510(k)Number	ProductCode	Trade Name	Manufacturer
K130557	JXI	NeuraGen® 3D Nerve Guide	Integra LifeSciencesCorporation

Table 2-1: Substantial Equivalent

Device Description:

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NeuraGen® 3D Nerve Guide Matrix is supplied sterile, non-pyrogenic, for single use in a variety of sizes.

Indication for Use:

The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Summary of Technological Characteristics:

NeuraGen® 3D Nerve Guide Matrix has the same design, material, and chemical composition, as the predicate device (K130557). The manufacturing and processing are exactly the same.

Testing and Test Results:

A viral inactivation study was conducted to demonstrate that NeuraGen® 3D Nerve Guide Matrix demonstrates 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 NeuraGen® 3D Nerve Guide Matrix.

Conclusion:

The NeuraGen® 3D Nerve Guide Matrix is substantially equivalent to the current marketed device, NeuraGen® 3D Nerve Guide Matrix. There have been no modifications to the design or manufacturing of the NeuraGen® 3D Nerve Guide Matrix that resulted in this filing. 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

§ 882.5275 Nerve cuff.

(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).