The Medtronic® Model 3998 Specify™ Lead is indicated in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach to chronic pain alleviation.

Device Description

The Medtronic Specify Model 3998 Lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end. At the proximal end of each lead body are the lead contacts, which fit into a Medtronic in-line, four-conductor connector. The Model 3998 lead can be used with any Medtronic products that have two in-line connectors, including: The Mattrix system, Model 3272 receiver; The Bifurcated Y-extension, Model 7498, which can be used with the Itrel or Xtrel system.

AI/ML Overview

In the provided text, Medtronic, Inc. describes the Medtronic® Specify™ Model 3998 Lead for Implanted Spinal Cord Stimulation and its comparison to predicate devices, focusing on demonstrating substantial equivalence rather than meeting specific performance acceptance criteria for a new type of device.

Therefore, the response below is adapted to reflect that the study primarily aims to show substantial equivalence through various performance tests against existing predicate devices, rather than meeting predefined numerical acceptance criteria against clinical performance metrics.

Description of Acceptance Criteria and Proving Device Meets Criteria:

The Medtronic® Specify™ Model 3998 Lead is intended to be substantially equivalent to existing Medtronic Spinal Cord Stimulation leads. Therefore, the "acceptance criteria" are based on demonstrating comparable performance and characteristics to these predicate devices rather than independent, predefined numerical thresholds for clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category (Demonstrating Substantial Equivalence)	Reported Device Performance (Medtronic® Specify™ Model 3998 Lead)
Product Labeling	Substantially equivalent to existing Medtronic SCS leads.
Intended Use	Same intended use as many current Medtronic SCS leads: management of chronic pain of the trunk and limbs.
Physical Characteristics (Materials)	Materials used are identical to predicate device leads.
Physical Characteristics (Structure)	Consists of two lead bodies attached to a paddle with eight stimulating electrodes, functionally equivalent to two current Medtronic leads combined.
Anatomical Sites	Placed within an epidural space of the spinal cord, same as existing Medtronic SCS leads.
Performance - Paddle Flex Testing	Indicated flex characteristics equal to other currently available Medtronic leads.
Performance - Tensile Strength Testing	Indicated adequate strength to perform its intended use.
Performance - DC Resistance Testing	Indicated adequate connections exist.
Performance - Cross Circuit Impedance Testing	Concluded isolation to be adequate.

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

The document does not specify a distinct "test set" in the context of clinical data or patient samples. The performance testing described (paddle flex, tensile strength, DC resistance, cross-circuit impedance) appears to be laboratory-based engineering testing performed on the Model 3998 lead itself and possibly comparing its properties to predicate devices.

Sample Size: Not explicitly stated for each test (e.g., number of leads tested).
Data Provenance: The tests are described as having been performed by Medtronic, Inc. This suggests internal laboratory testing rather than data from external clinical sites or specific countries. The data is not described as retrospective or prospective clinical data but rather engineering test results.

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

Not applicable. This type of information is typically related to clinical studies or performance evaluations where expert review or consensus establishes a "ground truth" (e.g., for diagnostic accuracy). The provided text describes engineering performance testing against physical and electrical properties, not clinical ground truth established by medical experts for a test set.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (e.g., 2+1, 3+1) refer to a process where multiple experts review and reach a consensus on a diagnosis or outcome, usually in clinical trials. The tests described are engineering evaluations.

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

No, an MRMC comparative effectiveness study was not done. The document does not describe any clinical studies involving human readers or their improved performance with or without AI assistance. The focus is on the substantial equivalence of the device's physical and electrical properties to predicate devices.

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

Not applicable. This device is a medical lead, not an algorithm or AI system, so "standalone" performance in that context is not relevant. The performance testing refers to the physical and electrical functioning of the lead itself.

7. The Type of Ground Truth Used:

The ground truth for the engineering performance tests is based on established engineering specifications, material properties, and functional requirements for implantable medical devices of this type, as well as comparison to the measured properties of predicate devices. For example, "adequate strength" for tensile testing would be determined by predefined engineering standards for the device's intended use.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The product is a physical medical lead.

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

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

Summary

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Image /page/0/Picture/0 description: The image shows the word "Medtronic" in a bold, sans-serif font. To the right of the word is a square logo. The logo contains a stylized image of a face.

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

12971756

FEB - 3 N88

SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTER L

Name and Address:

Medtronic, Inc. 800 53rd Avenue N.E. Minneapolis, MN 55421

Lisa L. Pritchard

Contact Person:

August 29, 1997 Date of Summary Preparation:

Establishment Registration Number: 2182207

II. DEVICE NAME

Device Common or Usual Name:

Device Trade Name:

Device Classification Name:

Lead for Implanted Spinal Cord Stimulation

Medtronic® SpecifyTM Model 3998 Lead

Implanted Spinal Cord Stimulator for Pain Relief (21 CFR 882.5880)

III. PREDICATE DEVICE

Leads for Implanted Spinal Cord Stimulators for Pain Relief:

Medtronic® Model 3586 Resume® Lead .
Medtronic® Model 3587A Resume II® Lead ●
. Medtronic® Model 3982 SymMix® Lead
Medtronic® Model 3983 Lead
Medtronic® Model 3993 TTL Lead ●
Medtronic® Model 3483S Pisces-Sigma® Lead ●

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Medtronic &

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

IV. DEVICE DESCRIPTION

The Medtronic Specify Model 3998 Lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord.

The lead consists of two polyurethane lead bodies joined to one silicone rubber The lead has two parallel rows of four platinum iridium electrodes on the paddle. distal end.

At the proximal end of each lead body are the lead contacts, which fit into a Medtronic in-line, four-conductor connector. The Model 3998 lead can be used with any Medtronic products that have two in-line connectors, including:

The Mattrix system, Model 3272 receiver .
The Bifurcated Y-extension, Model 7498, which can be used with the . Itrel or Xtrel system.

INDICATION FOR USE V.

The Medtronic® Model 3998 Specify™ Lead is indicated in the management of chronic pain of the trunk and limbs, either as a sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach to chronic pain alleviation.

VI. COMPARISON TO PREDICATE DEVICES

The Medtronic Specify Model 3998 Lead is substantially equivalent to other Medtronic Spinal Cord Stimulation leads currently in commercial distribution.

a. Product Labeling
Product labeling for each of the Medtronic Spinal Cord Stimulation Leads is substantially equivalent to the proposed product labeling for the Specify Model 3998 lead.

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Medtronic &

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

b. Intended Use

The Medtronic Specify Model 3998 Lead has the same intended use as many of the current Medtronic Spinal Cord Stimulation Leads. The Medtronic Specify Model 3998 Lead is indicated in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach to chronic pain alleviation.

Physical Characteristics C.

In the existing Medtronic Spinal Cord Stimulation leads, and the Specify Model 3998 Lead, the lead consists of two lead bodies attached to a paddle containing eight stimulating electrodes. Electrically and functionally, the Model 3998 Lead is the same as two of Medtronic's current leads combined within one paddle. Medtronic, Inc., supplied an equivalence table comparing the similarities and differences within this physical structure. Materials used are identical to predicate device leads.

d. Anatomical Sites

In the existing Medtronic Spinal Cord Stimulation leads, and the Specify Model 3998 Lead, the lead is placed within an epidural space of the spinal cord.

Performance Testing e.

Medtronic, Inc., has provided descriptive data on the test plan and test results for the Specify Model 3998 Lead. These data support that the function and characteristics of the device are suitable for its intended use.

Paddle flex testing was performed which indicated the Model 3998 Specify lead to equal the flex characteristics of other currently available Medtronic leads.

Tensile strength testing was performed to evaluate the separation strength of the lead. This testing indicated the lead to have adequate strength to perform its intended use.

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Medtronic &

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

DC Resistance testing was performed to evaluate the electrode impedance. This testing indicated adequate connections exist.

Additionally, cross circuit impedance testing was performed to evaluate the effectiveness of circuit isolation. This testing concluded isolation to be adequate.

In summary, Medtronic, Inc. has provided information within the 510(k) Premarket Notification to indicate that the Specify™ Model 3998 Lead is safe and effective for its intended use in the treatment of chronic intractable pain of the trunk and limbs. Additionally, the Specify Model 3998 Lead has been shown to be comparable in terms of intended use and technological characteristics to the Spinal Cord Stimulation Leads currently in commercial distribution. The data and information provided within this 510(k) premarket notification adequately support that the Specify Model 3998 Lead is substantially equivalent to other Medtronic Spinal Cord Stimulation Leads currently in commercial distribution.

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Image /page/4/Picture/2 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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the head, body, and tail feathers. The logo is simple and recognizable, and it is often used on official documents and websites related to health and human services in the United States.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 3 1998

Ms. Lisa L. Pritchard Senior Product Regulation Manager Medtronic, Incorporated 800 53rd Avenue, NE P.O. Box 1250 Minneapolis, Minnesota 55440-9087

Re: K971756 Trade Name: Medtronic Specify Model 3998 Lead Regulatory Class: II Product Code: GZB Dated: December 10, 1997 Received: December 11, 1997

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 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 forannual 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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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

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Page 2 - Ms. Pritchard

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 legally marketed predicate device results in a classification for your device and thus, permits vour 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 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,

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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510(k) Number (if Known)

Device Name: Specify™ Model 3998 Spinal Cord Stimulation Lead

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) 510k) Num OR Over-The Counter Use

Prescription Use (Per 21 CFR 801.109)

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).