Model 3991A Series Leads are indicated for use for epidural spinal cord stimulation (SCS) as an aid in the treatment of chronic intractable pain of the trunk and/ or limbs. All other uses are considered investigational.

Device Description

The Medtronic Model 3991a series of Transverse Tripolar™ Leads, or TTL™ leads are indicated for use for SCS for chronic intractable pain of truck or limbs, as for the Model 3982 Symmix®, Model 3883, Model 3586 and Model 3487A leads. There are three modifications in the Model 3991a series of leads from the original Model 3991C (K952459). These modifications are discussed as follows: A. Spiral-wound wires in lead body. B. Crimps and ferrules in the paddle. C. Radiopaque markers in the tips of the paddle.

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device, the Medtronic Model 3991a series of Transverse Tripolar™ Leads. This document outlines the FDA's determination of substantial equivalence and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical study report or a pre-market approval (PMA) submission.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in this document. The submission focuses on demonstrating "substantial equivalence" to predicate devices. Substantial equivalence generally means that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.
Reported Device Performance: The document mentions "bench tests on similar Model 3991C leads" and "Returned Product Analysis of one explanted lead" which led to design changes. However, specific quantitative performance metrics (e.g., failure rates, durability under specific conditions) are not provided in this summary.

2. Sample size used for the test set and the data provenance:

Not specified. The document mentions a "single device failure" from a returned product and "bench tests on similar Model 3991C leads," but no details on the sample size or provenance of these tests are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This document does not describe a study involving expert assessment or ground truth establishment in the context of device performance. The modifications were based on engineering analysis and physician recommendations for improved usability (radiopaque markers), not on expert consensus for a test set.

4. Adjudication method for the test set:

Not applicable. There is no mention of a test set requiring adjudication in this document.

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. This device is a spinal cord stimulation lead, an implantable medical device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

Not applicable in the typical sense of a diagnostic or predictive device. The "ground truth" for the device modifications appears to be:
- Engineering analysis of device failure: For the spiral-wound wires and crimps/ferrules.
- Physician feedback/clinical utility: For the radiopaque markers.

8. The sample size for the training set:

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable.

In summary, the provided document is a regulatory communication from 1997 for a medical device that predates the common use of AI in medical devices and the detailed reporting requirements for AI-enabled devices. It focuses on demonstrating substantial equivalence of design modifications to an existing product, rather than providing extensive clinical study data with acceptance criteria or performance metrics as would be expected for a novel device or AI algorithm today.

Summary

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K964172

del 3991A . K964172, Response to Questions

June 30, 1997

JUL - 3 1997

RE: 510(k) Notification: Medtronic Model 3991a, 3992a, 3993a, 3994a Leads

In order to comply with the Safe Medical Devices Act of 1990, these two pages will provide safety and effectiveness information to interested persons.

SUMMARY OF SAFETY AND EFFECTIVENESS

Medtronic considers the Model 3991a series of spinal cord stimulation leads to be substantially equivalent to the current Model 3982 Symmix lead K913993 in paddle size, the Model 3991 series of SCS leads (K952459) in paddle and electrode configuration, the Models 3487A (K923931), 3888 (K910199, K923567), and 3587A (K884948) leads for the lead body design and composition, and other commercially available spinal cord stimulation leads.

There are three modifications in the Model 3991a series of leads from the original Model 3991C (K952459). These modifications are discussed as follows:

A. Spiral-wound wires in lead body.

This change was recommended by Medtronic mechanical engineers as a result of Returned Product Analysis of one explanted lead and bench tests on similar Model 3991C leads. Hence it was done as a result of a single device failure. The new design minimizes forces being applied to the welds between lead body wires and connector rings in the proximal end of the lead, which was the site of the failure of the single returned lead.

B. Crimps and ferrules in the paddle.

This change was recommended by Medtronic mechanical engineers as the best way to have the spiral-wound wires of the lead body connect to the most lateral (edge) contacts of the paddle. Hence it was done to allow the modification a. (above) to be used.

Medtronic Neurological 800 53rd Avenue NE P.O. Box 1250 Minneapolis, MN 55440-9087 (612) 572-5000 1-800-328-0810 FAX: (612) 572-5078

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C. Radiopaque markers in the tips of the paddle.

This change was recommended by physicians so that they could best determine the orientation of the paddle relative to vertebral bones using fluoroscopy. Since the electrodes are all located in a relatively small area (10 mm x 10 mm), this helps to align certain contacts, E0, E1 and E2, transversely to the spinal cord.

Therefore, the Model 3991a TTL leads family with alternate design are substantially equivalent to current Medtronic spinal cord stimulation leads.

Sincerely,

MEDTRONIC, INC.

Neurological Division

David R. Zeller

David H. Mueller Regulatory Affairs Manager NeuroStimulation Business

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 1997

Mr. David H. Mueller Regulatory Affairs Manager NeuroStimulation Business Medtronic Neurological 800 53rd Avenue NE P.O. Box 1250 Minneapolis, Minnesota 55440-9087

Re: K964172 Trade Name: Medtronic TTL® Leads (Models 3991A, 3993A, and 3994A) Requlatory Class: II Product Code: 84GZB Dated: April 3, 1997 Received: April 4, 1997

Dear Mr. Mueller:

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 Requiations, Title 21, Farts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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Page 2 - Mr. David H. Mueller

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.

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 leqally 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Medtronic Model 3991A Lead Series

Indications For Use Statement

Model 3991A Series Leads are indicated for use for epidural spinal cord stimulation (SCS) aid in the treatment of chronic intractable pain of the trunk and/ or limbs.

All other uses are considered investigational.

Prescription Use(Per 21 CFR 801.109)
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Thomas J. Callahon

as an

(Division Sign-Off) Division of Cardiovascular, R and Neurological Devices 510(k) Number

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).