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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
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

§ 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).