The Salumedica™ Nerve Cuff with Salubria™ biomaterial is a flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury. The Salubria™ Norve Cuff is designed to be an interface between the nerve and its bed and to create a conduit for axonal growth across a nerve gap. The SaluMedica™ Nerve Cuff is available in sizes of 2, 5, and 10 mm inner diameters. Each Nerve Cuff is provided sterile, hydrated in saline for presentation onto the operative field.

AI/ML Overview

The provided text describes the SaluMedica™ Nerve Cuff and its non-clinical evaluation for a 510(k) submission. It does not contain information about a study involving a device and its acceptance criteria in the way a medical AI/software device would. The tests described are for a physical medical device (a nerve cuff), focusing on its physical and biological properties.

Therefore, many of the requested categories for AI/software device evaluations are not applicable. I will extract the relevant information regarding the non-clinical tests performed for this physical device where possible.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Acceptable biocompatibility for use as a permanently implanted device.	Testing completed to verify acceptable biocompatibility.
Dimensional Analysis	Dimensions within specified tolerances following electron beam sterilization.	Dimensions were within specified tolerances following exposure to electron beam sterilization.
Compression and Rebound	(1) Withstand compressive forces > 0.25N without collapsing. (2) Re-open after removal of sufficient compressive forces to collapse the cuff.	(1) Can withstand compressive forces greater than 0.25N without collapsing. (2) Will re-open following removal of compressive forces.
Suture Retention Strength	Sufficient strength to resist suture pull-out under loads exceeding those anticipated in the intended use environment.	Has sufficient strength to resist suture pull-out under loads exceeding those anticipated.
Shelf-Life	Maintenance of functional integrity following accelerated aging equivalent to six months of real-time aging.	Maintained functional integrity following accelerated aging equivalent to six months of real-time aging.
Simulated Clinical Environment	Device design meets the needs of the user.	The device meets the needs of the patient and physician.

Based on the provided text, the following information is not applicable as the document describes a physical medical device (nerve cuff), not an AI/software device or diagnostic tool typically evaluated with such metrics:

Sample size used for the test set and the data provenance: Not applicable. The tests were for physical and biological properties of the nerve cuff, not a dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device refers to established material science and biological standards, not expert consensus on diagnostic images or outputs.
Adjudication method: 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.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a physical device, ground truth would be established scientific principles and measured physical/biological properties, not expert consensus on data interpretation.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Køø2ø98

1. General information

Correspondents to the File a. David Ku, M.D., Ph.D. President and CEO SaluMedica™
Submitter's Name and Address b. SaluMedica™, L.L.C. 112 Krog Street Suite 4 Atlanta, Georgia 30307 Phone: (404) 589-1727 FAX: (404) 589-1737
c. Device Generic Name Nerve Cuff
Device Trade Name ਕੁੱਝ SaluMedicaTM Nerve Cuff
Equivalent Devices e. Fastube™ Nerve Cuff and silicone nerve cuffs

2. Device Description

The Salumedica™ Nerve Cuff with Salubria™ biomaterial is a flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury.

The Salubria™ Norve Cuff is designed to be an interface between the nerve and its bed and to create a conduit for axonal growth across a nerve gap.

The SaluMedica™ Nerve Cuff is available in sizes of 2, 5, and 10 mm inner diameters. Each Nerve Cuff is provided sterile, hydrated in saline for presentation onto the operative field.

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3. Intended Use

The SaluMedica™ Nerve Cuff with SalubriaTM Biomaterial is intendcd for use in repair of peripheral nerve discontinuities and where gap closure can be achieved by flexion of the extremity.

4. Non-Clinical Test Summary

Summary of Testing presented in 510(k)

As part of the Pre-market Notification (510(k)) submission, non-clinical evaluation of the SaluMedica™ Nerve Cuff included the following:

Biocompatibility Testing a...
Testing was completed to verify that the SaluMedica Nerve Cuff with Salubria Biomaterial has acceptable biocompatibility for use as a permanently implanted device.

b. Dimensional Analysis

Dimensional analysis was completed to verify that the dimensions of the SaluMedica M Nerve Cuff were within specified tolerances following exposure to electron beam sterilization processing.

c. Compression and Rebound Analysis

Compression and rebound analysis was completed to verify that the SaluMedica [M Nerve Cuff (1) can withstand compressive forces greater than 0.25N without collapsing, and (2) will re-open following removal of compressive forces sufficient to collapse the nerve cuff.

d. Suture Retention Testing

Suture retention strength testing was completed to verify that the SaluMedica ?M Nerve Cuff has sufficient strength to resist suture pull-out under loads exceeding those anticipated in the intended use environment.

Shelf-Life Testing e.

Accelcrated aging and testing was completed to verify maintenance of functional integrity of the SaluMedica™ Nerve Cuff following accelerated aging equivalent to six months of real-time aging.

f. Evaluation of Nerve Cuff in a Simulated Clinical Environment The SaluMedica™ Nerve Cuff was evaluated in the indicated covironment to

demonstrate that the design of the device meets the needs of the user.

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Currently no known FDA cleared nerve cuffs are available for commercial sale. Nonclinical evaluation as outlined above is intended to show that the SaluMedica Nerve Cuff meets the device design criteria based on the aide of information gained from medical professionals, literature reviews, and discussions with FDA reviewers. The device conforms to dimensional specifications, remains open during implantation even if compressed is capable of retaining suture material, and has a shelf life of six months based on accelerated aging testing. Further, evaluation of the SaluMedica Nerve Cuff in a Simulated Clinical Environment establishes that the device meets the needs of the patient and physician.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2000

David N. Ku, M.D., Ph.D. President and CEO Salumedica, L.L.C. 112 Krog Street, Suite 4 Atlanta, Georgia 30307

K002098 Re:

Trade Name: SaluMedica™ Nerve Cuff Regulatory Class: II Product Code: JXI Dated: September 22, 2000 Received: September 25, 2000

Dear Dr. Ku:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - David N. Ku, M.D., Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a promained from a classification for your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark n Milkenn

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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K002098

K002098 510(k) NUMBER:

SaluMedica™ Nerve Cuff DEVICE NAME:

INDICATIONS FOR USE:

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 (Per 21 CFR 801.109)

OR
Over-The-Counter-Use
(Optional Format)

Mark N Milkman
for
(Division Sign-Off)

Division of General Restorative Devices 002098 510(k) Number _

A-1

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).