MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF

• K Number: K011584
• Device Name: MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
• Manufacturer: MEDTRONIC VASCULAR
• Date Cleared: 2001-06-22 ( 30 days)
• Product Code: GZB
• Regulation Number: 882.5880
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Medtronic X-trel® and Mattrix® Neurostimulation systems are indicated as an aid in the management of chronic, intractable pain of the trunk or limbs. X-trel and Mattrix Receiver Model 3272 systems are also indicated for peripheral nerve stimulation.

Peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

Device Description

Not Found

AI/ML Overview

This FDA 510(k) summary document does not contain information on acceptance criteria or a study proving that a device meets such criteria. It is a letter from the FDA to Medtronic, Inc. notifying them that their Spinal Cord and Peripheral Nerve Stimulation Systems for Pain Relief have been found substantially equivalent to legally marketed predicate devices and can therefore be marketed.

The document includes:

• The FDA's decision on substantial equivalence for the Medtronic devices.
• The regulation numbers, regulatory class, and product codes.
• General information regarding compliance with FDA regulations.
• The approved Indications for Use for the Medtronic X-trel® and Mattrix® Neurostimulation systems.

However, it does not provide any of the specifics requested in your prompt, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size and ground truth establishment for a training set.

This document is a regulatory approval letter, not a clinical study report or a detailed technical submission.

Summary

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JUN 2 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David H. Mueller Regulatory Affairs Manager NeuroStimulation Business Medtronic, Inc. 800 53rd Avenue NE Minneapolis, Minnesota 55421-1200

Re: K011584

Trade/Device Names: Medtronic Spinal Cord and Peripheral Nerve Stimulation Systems for Pain Relief (see enclosed list) Regulation Numbers: 21 CFR 882.5880 and 21 CFR 882.5870 Regulatory Class: II Product Codes: GZB and GZF Dated: May 22, 2001 Received: May 23, 2001

Dear Mr. Mueller:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 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 devices 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 H. Mueller

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N. Milhurn

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

Enclosures

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FDA REQUIRED INDICATIONS PAGE

510(k) Number: K011584

Device Name(s): Medtronic Spinal Cord Stimulation Systems for Pain Relief and Medtronic Peripheral Nerve Stimulation Systems for Pain Relief

Indications for Use:

The Medtronic X-trel® and Mattrix® Neurostimulation systems are indicated as an aid in the management of chronic, intractable pain of the trunk or limbs. X-trel and Mattrix Receiver Model 3272 systems are also indicated for peripheral nerve stimulation.

Peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

(Please do not write below this line-continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Melkerson

ral. Restorative and Neurological Devices KO 11584

510(k) Number -

(Option Format 3-10-98)

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).