The Medtronic Model 7495 Extension Kit is intended for use with implanted spinal cord or peripheral nerve stimulation systems for the treatment of chronic, intractable pain.

Device Description

The Medtronic Model 7495 extension kit is used with spinal cord and peripheral nerve stimulation systems to connect stimulation leads to the implanted receiver of externally powered (RF) systems. The extension provides an electrical path to allow stimulation to be delivered to the target site.

AI/ML Overview

I am sorry, but based on the provided text, I cannot extract the detailed information requested regarding acceptance criteria and a study proving device performance as it pertains to a modern AI/ML medical device submission.

The document is a 510(k) summary for the Medtronic Model 7495 Extension Kit, dated January 11, 1999. This is a medical device from nearly 25 years ago, and the regulatory requirements and types of studies conducted for such devices pre-date the widespread use of AI/ML in medical diagnostics and the associated sophisticated performance evaluation criteria.

Here's what I can provide based on the document:

Device Type: This is an extension kit for spinal cord and peripheral nerve stimulators, essentially an electrical connector component. It is a physical, hardware device, not an AI/ML-driven diagnostic or therapeutic tool.
Regulatory Pathway: It's a 510(k) submission, indicating a claim of substantial equivalence to a predicate device.
Performance Evaluation Approach: The document explicitly states:
- "Performance of the Model 7495 extension is not affected by the modifications in accessories provided with the extension kit. The design of the extension remains unchanged."
- "Because there is no significant change to the design of the accessory components, mechanical testing is not applicable."
- The primary "testing" mentioned is biocompatibility testing for a new material added to a connector boot.

Therefore, the specific questions related to AI/ML device performance (like sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, etc.) are not applicable to this document. The document focuses on demonstrating that minor accessory changes to an existing device do not alter its fundamental performance or safety.

Summary

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Image /page/0/Picture/0 description: The image shows the date 2/9/99 at the top. Below the date is the Medtronic logo. The logo consists of the word "Medtronic" in bold, sans-serif font, followed by a square symbol containing a stylized image.

K 9940104

800 53rd Avenue Minneapolis, MN 55421-1200 nternet: www.medtronic.com elephone: (612) 514-5000 Toll-free: 1-800-328-0810 FAX: (612) 514-5078

510(k) SUMMARY

SUBMITTER I.

Name and Address:

Medtronic, Inc. Neurological Division 800 53rd Avenue NE Minneapolis, MN 55421

Lisa L. Pritchard Contact Person:

January 11, 1999 Date of Summary Preparation:

Establishment Registration Number: 2182207

II. DEVICE NAME

Extension for Spinal Cord and Device Common or Usual Name: Peripheral Nerve Stimulators Device Trade Name: Medtronic Model 7495 Extension Kit

III. PREDICATE DEVICE

Extensions for Implanted spinal Cord Stimulation (SCS) and/or Peripheral Nerve Stimulation (PNS) for the treatment of chronic intractable pain.

IV. DEVICE DESCRIPTION

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Medtronic &

Medtronic Neurological 800 53rd Avenue NE Minneapolis, MN 55440-9087 Internet: www.medtronic.com Telephone: (612) 514-5000 Toll Free: 1-800-328-0810 FAX: (612) 514-5078

V. INDICATION FOR USE

The Model 7495 extension kit with revised accessories has the same intended use as the current Model 7495 extension kit. These extensions are intended to be surgically implanted as part of a neurostimulation system to treat chronic, intractable pain.

VI. COMPARISON TO PREDICATE DEVICE

The Medtronic Model 7495 extension kit with revised accessories is substantially equivalent to the Medtronic Model 7495 extension kit that is currently in commercial distribution.

a. Intended Use

These extensions are intended to be surgically implanted as part of a neurostimulation system to treat chronic, intractable pain.

b. Principles of Operation

The design and principle of operation of the extension in the revised kit is identical to the currently available Model 7495 extension. The extension provides an electrical path between the neurostimulator and the lead to allow stimulation to be delivered to the target site.

Device Performance C.

Performance of the Model 7495 extension is not affected by the modifications in accessories provided with the extension kit. The design of the extension remains unchanged. Design of the large wedge tip and dual carrier tip tunneling accessories also remains unchanged (these accessories are currently packaged with the Model 7498 extension kit). Changes to the connector boots to add Roman Numeral identification and radiopaque material do not change the performance or use of the connector boot.

d. Bench Testing

Because there is no significant change to the design of the accessory components, mechanical testing is not applicable. The material added to the connector boot has undergone extensive biocompatibility testing and has been determined to be biocompatible.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Ms. Lisa L. Pritchard Principal Product Regulation Manager Medtronic Neurological 800 53rd Avenue NE Minneapolis, Minnesota 55440-9087

Re: K990104 Medtronic Model 7495 Extension Kit Trade Name: Regulatory Class: II Product Codes: GZB and GZF Dated: January 11, 1999 Received: January 12, 1999

Dear Ms. Pritchard:

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 able beach in the 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 - Ms. Lisa L. Pritchard

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberroom in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed produced or mits 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) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact che promocion and liance 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,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX 2

INDICATIONS FOR USE STATEMENT

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Device Name: Model 7495 Extension Kit

Indications For Use:

The Medtronic Model 7495 Extension Kit is intended for use with implanted spinal cord or peripheral nerve stimulation systems for the treatment of chronic, intractable pain.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The Counter Use OR Prescription Use (Per 21 CFR 801.109)

Special 510(k) for Model 7495 Extension Kit Medtronic Neurological January 11, 1999

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Regulation Number and Section

§ 882.5880 Implanted spinal cord stimulator for pain relief.

(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).