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K Number
K990104
Device Name
MEDTRONIC MODEL 7495 EXTENSION KIT
Manufacturer
MEDTRONIC VASCULAR
Date Cleared
1999-02-09

(28 days)

Product Code
GZB
Regulation Number
882.5880
Type
Special
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

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.

§ 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).