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K Number
K963577
Device Name
RADIONICS SLUIJTER-MEHTA CANNULA
Manufacturer
RADIONICS, INC.
Date Cleared
1996-11-21

(76 days)

Product Code
GXD
Regulation Number
882.4400
Type
Traditional
Panel
NE
Reference & Predicate Devices
K870028
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The RSM-C is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain. This is the same intended use as the SMK Cannula and TIC Cannula.

Device Description

The RSM-C Radionics Sluijter-Mehta Cannulae are insulated disposable cannulae designed for use with a Radionics Radiofrequency Lesion Generator to create heat lesions for relief of pain. These cannulae are compatible with the commercially available Radionics SMK-TC thermocouple electrodes. They are used in the same way as the commercially available Radionics SMK-C Cannulae.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. The document describes a medical device, the Radionics Sluijter-Mehta Cannula (RSM-C), and states its intended use and basis for substantial equivalence to predicate devices (SMK Cannula and TIC Cannula).

Specifically, the document focuses on:

  • General Information: Trade name, model number, manufacturer, contact, classification, predicate devices, and intended use.
  • Safety and Effectiveness Information: Stating that the labeling contains proper use and safety information, and that the device has similar intended use and technological characteristics to existing devices.

There is no mention of:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance studies.
  • Types of ground truth used.
  • Sample size for training sets or how their ground truth was established.

Therefore, I cannot fulfill the request for this specific information based on the provided text.

§ 882.4400 Radiofrequency lesion generator.

(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).