The SURGIS Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.

Device Description

The SURGIS Nerve Cuff is manufactured from porcine small intestinal submucosa (SIS) and is supplied in nominal tube diameters of 2, 5 and 7 mm, and a nominal length of 5 cm. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.

AI/ML Overview

Acceptance Criteria and Study for SURGISIS® Nerve Cuff

This document summarizes the acceptance criteria and the studies conducted to demonstrate that the SURGISIS® Nerve Cuff meets these criteria, based on the provided 510(k) summary (K031069).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility	Device is biocompatible	"Outcomes show the device to be biocompatible..."
Viral Inactivation	Manufacturing processes adequately disinfect the material	"...manufacturing processes to adequately disinfect the material..."
Mechanical Properties:
- Tensile Strength	Sufficient tensile strength	"...tensile strength to be sufficient..."
- Suture Retention Strength	Sufficient suture retention strength	"...as well as suture retention strength..."
- Compressive Forces	Ability to withstand compressive forces	"...ability to withstand compressive forces..."
In Vivo Performance	Promotes axonal growth and myelination	"...during in vivo use to be associated with a higher degree of axonal growth and myelination as compared to controls." (Comparison to control implies a positive, statistically significant difference or clinical relevance)
Substantial Equivalence	Similar to predicate devices in intended use, materials, and technological characteristics, and suitable for nerve cuff repair	"The SURGIS Nerve Cuff is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of 510(k) substantial equivalence as shown through in vitro and in vivo testing." and "Outcomes from the evaluation of the SURGISIS® Nerve Cuff provide evidence of its suitability for nerve cuff repair and substantial equivalency to predicate devices in terms of intended use and technological characteristics."

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

The provided 510(k) summary does not explicitly state the sample sizes used for the in vitro or in vivo test sets for the SURGISIS® Nerve Cuff, nor does it specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "extensive biocompatibility testing, viral inactivation testing, mechanical testing, and assessment of in vivo performance."

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

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for any of the tests conducted. The testing appears to be primarily laboratory-based (biocompatibility, viral inactivation, mechanical) and animal-based (in vivo performance), rather than relying on expert clinical assessment of a test set in the way an AI/CAD system might.

4. Adjudication Method for the Test Set

Not applicable. The types of tests described (biocompatibility, viral inactivation, mechanical, in vivo animal studies) do not typically involve an adjudication method by human experts in the context of establishing a clinical ground truth for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The summary describes a medical device (nerve cuff) and its performance, not an AI or CAD system. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable to this device.

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

Not applicable. This device is a physical implantable nerve cuff, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the various tests can be inferred as follows:

Biocompatibility: Established through standardized in vitro and in vivo biocompatibility testing methods, likely involving cellular responses, tissue reactions, and toxicology assessments.
Viral Inactivation: Established by validated laboratory assays to detect viral agents following the manufacturing process.
Mechanical Properties (Tensile Strength, Suture Retention, Compressive Forces): Established through standardized engineering and materials testing methods using calibrated equipment.
In Vivo Performance (Axonal Growth and Myelination): Established through histological analysis, immunohistochemistry, and potentially functional recovery assessments in an animal model, compared to control groups (e.g., empty cuff or direct repair).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set of data.

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

Not applicable, as there is no training set for this type of device.

Summary

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K03/069/R,

9. 510(K) SUMMARY

MAY 1 5 2003

Submitted By: Mark Bleyer, President Cook Biotech Incorporated 3055 Kent Avenue West Lafayette, IN 47906 (765) 497-3355 April 2, 2003

Names of Device:

SURGISIS® Nerve Cuff Trade Name: Common/Usual Name: Nerve Cuff, Nerve Sheath Proposed classification name: Nerve Cuff 21 CFR 882.5275 (84 JXI) Class II

Intended Use:

Predicate Devices:

The SURGIS Nerve Cuff is similar to predicate devices, including the SURGISS Soft Tissue Graft (K980431) manufactured by Cook Biotech Incorporated, the NeuroGen Nerve Guide (K011168) manufactured by Integra Life Sciences, the SaluBridge Nerve Cuff (K002098) manufactured by Salumedica, LLC, and the Collagen Nerve Cuff (K012814) manufactured by Collagen Matrix Incorporated.

Device Description:

Substantial Equivalence:

The SURGIS Nerve Cuff is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of 510(k) substantial equivalence as shown through in vitro and in vivo testing.

Discussion of Tests and Test Results:

The material comprising the SURGISIS® Nerve Cuff was subjected to extensive biocompatibility testing, viral inactivation testing, mechanical testing, and assessment of in vivo performance. Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, tensile strength to be sufficient as well as suture retention strength, ability to withstand compressive forces, and during in vivo use to be associated with a higher degree of axonal growth and myelination as compared to controls.

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510(k) Premarket Notification: SURGISIS® Nerve Cuff

K03/069/P2

Conclusions Drawn from the Tests:

Outcomes from the evaluation of the SURGISIS® Nerve Cuff provide evidence of its suitability for nerve cuff repair and substantial equivalency to predicate devices in terms of intended use and technological characteristics.

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Image /page/2/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 to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2003

Mr. Mark Blever President Cook Biotech, Inc. 3055 Kent Avenue West Lafayette, Indiana 47906

Re: K031069

Trade/Device Name: SURGISIS® Nerve Cuff Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve cuff Regulatory Class: II Product Code: JXI Dated: April 2, 2003 Received: April 4, 2003

Dear Mr. Bleyer:

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. Iisting 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 (OS) 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 - Mr. Mark Bleyer

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 (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) you may obtain. 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,

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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Page 1 of 1

510(k) Number (if known): K03

K031069

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Surgisis Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number K031069

Prescription Use (Per 21 CFR 801.109) ବିତା

Over-The-Counter Use (Optional Format 1-2-

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).