RADIONICS SLUIJTER-MEHTA CANNULA

K963577 · Radionics, Inc. · GXD · Nov 21, 1996 · Neurology

Device Facts

• Record ID: K963577
• Device Name: RADIONICS SLUIJTER-MEHTA CANNULA
• Applicant: Radionics, Inc.
• Product Code: GXD · Neurology
• Decision Date: Nov 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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 Story

Disposable, insulated cannula; used with Radionics Radiofrequency Lesion Generator and SMK-TC thermocouple electrodes; creates heat lesions for pain relief. Used by physicians in clinical settings. Device functions as a conduit for RF energy delivery to target tissue; provides mechanical access for electrode placement. Benefits include standardized, disposable interface for RF lesioning procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Insulated disposable cannula; compatible with Radionics SMK-TC thermocouple electrodes; designed for use with Radionics RF lesion generators. Materials consistent with predicate TIC Cannula.

Indications for Use

Indicated for patients requiring radiofrequency heat lesion procedures for pain relief.

Regulatory Classification

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.

Predicate Devices

• SMK Cannula (K870028)
• Radionics TIC Cannula (pre-amendment)

Submission Summary (Full Text)

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K963577

NOV 21 1996

# I. General Information

| Proprietary Trade Name: | Radionics Sluijter-Mehta Cannula |
| --- | --- |
| Model Number: | RSM-C |
| Common Name: | Disposable cannula for radiofrequency electrode |
| Manufacturing Facility Address: | Radionics, Inc.
22 Terry Avenue
Burlington, MA 01803 |
| Establishment Registration Number: | 1219140 |
| Contact Person: | Amy LaForte, Ph.D.
[phone] |
| Classification: | Class II |
| Predicate Devices: | SMK Cannula (K870028); and
Radionics TIC Cannula (pre-amendment). |
| 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. |
| Performance Standard: | No applicable performance standards have been issued under section 514 of the Food, Drug, and Cosmetic Act. |
| Sterilization Site: | STS
7500 W. Henrietta Road
PO. Box 349
Rush, NY 14543
[phone] |

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.

RSM-C 510(k) PMN

August 23, 1996

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## II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.

### General Safety and Effectiveness Concerns

RSM-C Radionics Sluijter-Mehta Cannula labeling contains instructions for the proper use of this device. It includes a description of the product, directions for use, and applicable safety information. These instructions ensure safe and effective use of the device when followed by the physician.

### Description of the Device and Basis for Substantial Equivalence

The RSM Sluijter-Mehta Cannula addressed in this premarket notification has similar intended use and technological characteristics as the commercially available Radionics SMK Cannula (K870028). The insulating material is the same as that on the commercially available Radionics TIC Cannula, a pre-amendment device.

RSM-C 510(k) PMN
August 23, 1996
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