The Collagen Nerve Cuff is designed to be a flexible, resorbable and semipermeable tubular membrane matrix to provide a protective environment for peripheral nerve repair after injury and to create a conduit for axonal growth across a nerve gap.

AI/ML Overview

The Collagen Nerve Cuff is a medical device intended for the repair of peripheral nerve discontinuities. The following outlines the acceptance criteria and the study that supports the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Safety: Device is safe for implantation.	Biocompatibility: The Collagen Nerve Cuff is biocompatible based on FDA recommended tests and meets ISO 10993 requirements for biocompatibility testing.
Effectiveness: Effective for bridging nerve gaps and guiding axonal growth in peripheral nerve repair procedure under the proposed conditions of use.	Literature Review (Animal Studies): Twenty years of animal studies using nerve conduits demonstrated the efficacy of peripheral nerve repair using resorbable and non-resorbable biocompatible nerve conduits. Literature Review (Clinical Data): Existing literature demonstrated the efficacy of peripheral nerve repair using resorbable and non-resorbable biocompatible nerve conduits.
Technical Characteristics: Device is resorbable, flexible, suturable, biocompatible, cell occlusive, and clinically manageable.	Simulated Clinical Environment Studies: Mechanical and physical characteristics were evaluated, demonstrating adequate mechanical and physical properties for peripheral nerve repair. (Biocompatibility is also covered under safety.)
Substantial Equivalence: The Collagen Nerve Cuff is substantially equivalent to predicate devices.	Comparison to Predicate Devices: The overall submission concludes that the device is substantially equivalent to the NeuroGen™ Nerve Guide [510(k) #K011168], SaluMedica™ Nerve Cuff [510(k) #K002098], and Fastube™ Nerve Cuff [510(k) #K850785].

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

Test Set: The primary evidence supporting the device's performance for this 510(k) relies on a literature review of animal and human studies.
- Animal Data: "animal studies over the past twenty years using nerve conduit have been reviewed." The specific sample size (number of animals, number of studies) is not provided.
- Clinical Data: "The results reported in the literature demonstrated efficacy of peripheral nerve repair using resorbable and non-resorbable biocompatible nerve conduits." The specific sample size (number of patients, number of studies) is not provided.
- Data Provenance: The document does not specify the country of origin of the data for the literature review. The studies are retrospective, as they involve the review of existing published literature.
Simulated Clinical Environment Studies: These were performed to evaluate mechanical and physical characteristics. No specific sample size (e.g., number of cuffs tested) is provided.

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

For the literature reviews (animal and clinical data), the "ground truth" implicitly comes from the findings and conclusions of the researchers who conducted those original studies. The 510(k) summary itself does not detail how many experts retrospectively reviewed and established the ground truth from the existing literature, nor does it specify their qualifications.
For the simulated clinical environment studies, the "ground truth" is based on objective measurements of mechanical and physical properties. This typically involves technical experts in materials science or biomedical engineering, but their number and qualifications are not specified in this document.

4. Adjudication Method for the Test Set

Given that the primary evidence comes from a literature review and simulated clinical studies rather than a prospective clinical trial with a defined test set of patients, a formal adjudication method (e.g., 2+1, 3+1) for clinician review of patient outcomes is not applicable or described in this 510(k) summary. The summary relies on the conclusions drawn by the authors of the original studies in the literature and the results from the simulated clinical environment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done for this device submission. The submission relies on a review of existing literature and simulated clinical testing, not a study comparing human readers with and without AI assistance. The device is a physical implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical implant (nerve cuff), not a software algorithm or AI-based system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Literature Review (Animal and Clinical): The ground truth for effectiveness is derived from the published results and conclusions of scientific studies in the literature on nerve repair using conduits. This would include histological observations, functional recovery assessments, and potentially patient outcomes reported in those studies.
Biocompatibility: Ground truth is established through standardized biocompatibility testing (e.g., ISO 10993) where specific biological responses are measured against predefined acceptable limits.
Simulated Clinical Environment: Ground truth for technical characteristics is based on objective measurements of physical and mechanical properties (e.g., tensile strength, flexibility, permeability) against design specifications deemed adequate for the intended use.

8. The Sample Size for the Training Set

Not applicable. This device submission does not involve a machine learning algorithm that requires a "training set." The evidence for the device's safety and effectiveness comes from a review of existing scientific literature, biocompatibility testing, and simulated clinical environment studies.

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

Not applicable. As there is no training set for a machine learning algorithm, the establishment of ground truth for such a set is not relevant to this submission.

Summary

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SEP 2 1 2001

KO12814

510 (k) Summary of Safety And Effectiveness

Applicant name and address:

Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, NJ 07417

Contact person and telephone number:

Shu-Tung Li, Ph.D. President & CEO Tel: (201) 405-1477

Date of summary:

Device generic name:

Device trade name:

Substantial Equivalence:

August 20, 2001

Collagen Nerve Cuff

None

NeuroGen™ Nerve Guide [510(k) #K011168] SaluMedica™ Nerve Cuff [510(k) #K002098] Fastube™ Nerve Cuff [510(k) #K850785]

Description of the device:

Intended Use of the Device

The Collagen Nerve Cuff is intended for use in repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Technical Characteristics

The Collagen Nerve Cuff is designed for the repair of peripheral nerves. Specifically, the device is designed to be resorbable, flexible, suturable, biocompatible, cell occlusive, and clinically manageable.

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Summary of Biocompatibility Studies

The Collagen Nerve Cuff is biocompatible based on the test recommended by the FDA and meets the ISO 10993 requirements for biocompatibility testing.

Performance Characteristics

a. Animal Data

The animal studies over the past twenty years using nerve conduit have been reviewed and have demonstrated the efficacy of peripheral nerve repair using resorbable and nonresorbable biocompatible nerve conduits .

b. Summary of Clinical Data

The results reported in the literature demonstrated efficacy of peripheral nerve repair using resorbable and non-resorbable biocompatible nerve conduits.

c. Simulated Clinical Environment

The mechanical and physical characteristics of the Collagen Nerve Cuff were evaluated in simulated clinical environment studies. The results of the studies demonstrated that the Collagen Nerve Cuff has adequate mechanical and physical characteristics for peripheral nerve repair.

Conclusion

The results of biocompatibility testing, summary of published results of animal and human studies from the literature research, simulated clinical studies, and the comparison of Collagen Nerve Cuff with other predicate devices, we conclude the following.

The Collagen Nerve Cuff is safe for implantation as demonstrated by the 1. biocompatibility studies.

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The Collagen Nerve Cuff is effective for bridging nerve gaps and guiding the 2. axonal growth in peripheral nerve repair procedure under the proposed conditions of use.
The Collagen Nerve Cuff is substantially equivalent to the predicate devices. 3.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

SEP 2 1 2001

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Shu-Tung Li President and CEO Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K012814

Trade/Device Name: Collagen Nerve Cuff Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: August 21, 2001 Received: August 22, 2001

Dear Dr. Li:

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 -Dr. Shu-Tung Li

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Susan Walter, MD

Celia M. Witten, Ph.D., M.D. ల్లు Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND D.O.

f/t:HFZ-410:MAdjodha:dlw:09-18-01

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510(k) Number (if known): KO 2814

Device Name: Collagen Nerve Cuff

Indications for Use:

Collagen Nerve Cuff is intended for use in repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109)

Over-The-Counter Use

S.N.

(Optional Format 1-2-96)

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

510(k) Number_KO12814

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).