RFG-3CF

K965182 · Radionics, Inc. · GXD · Mar 12, 1997 · Neurology

Device Facts

• Record ID: K965182
• Device Name: RFG-3CF
• Applicant: Radionics, Inc.
• Product Code: GXD · Neurology
• Decision Date: Mar 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To create lesions during neurosurgical lesion procedures.

Device Story

Radiofrequency lesion generator; used in neurosurgery to coagulate/lesion nervous tissue and stimulate nerve cells for electrode placement. Input: user-selected stimulation parameters (pulse amplitude, duration, frequency). Operation: delivers radiofrequency energy; provides constant voltage or constant current stimulation modes. Output: RF energy for lesioning; audio/visual indicators for system status. Operated by neurosurgeons/clinicians in clinical settings. Benefits: precise tissue lesioning and guided electrode positioning. Safety features: power-up self-tests for software/LEDs; watchdog timer for software monitoring/rebooting.

Clinical Evidence

Bench testing only. System and unit testing results verify accuracy and reliability of the RFG-3CF, including validation of new self-test routines and watchdog timer functionality.

Technological Characteristics

Radiofrequency lesion generator; constant voltage and constant current stimulation modes; stimulation frequency up to 200 Hz; audio/visual indicators; power-up self-test routines; watchdog timer for software monitoring.

Indications for Use

Indicated for neurosurgical patients requiring tissue lesioning or coagulation; used by clinicians to create lesions in nervous tissue and stimulate nerve cells to assist in electrode placement.

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

• Radionics RFG-3C Lesion Generator
• Fischer Neuro N50 System
• Leksell Neuro Generator, LNG 30-T
• Grass Instruments' Stimulator Model S5 with Constant Current Unit, Accessory Model CCU1

Submission Summary (Full Text)

{0}

Radionics RFG-3CF Lesion Generator
K965182

# Appendix 1

MAR 12 1997

## Summary of Safety and Effectiveness

### General Information

| Classification: | Class II |
| --- | --- |
| Common Name | Radiofrequency Lesion Generator |
| Device Trade Name: | RFG-3CF |
| Intended Uses | To create lesions during neurosurgical lesion procedures. |
| Predicate Device: | Radionics RFG-3C Lesion Generator; Fischer Neuro N50 System; Leksell Neuro Generator, LNG 30-T; Grass Instruments' Stimulator Model S5 with Constant Current Unit, Accessory Model CCU1 |
| Establishment Name and Address: | Radionics, Inc.
22 Terry Avenue
Burlington, MA 01803 |
| Contact Name and Phone: | Amy J. LaForte, Ph.D. |
| | [phone] |
| Establishment Registration Number: | 1219140 |
| Performance Standard | None established under Section 514. |

### Substantial Equivalence Determination

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

#### Safety Summary

The Radionics RFG-3CF lesion generator is a modification of the RFG-3C lesion generator. The stimulator feature has been modified to include a constant current mode and the stimulation parameter specification for frequency has been increased to 200 Hz. The system and unit testing results provided in this premarket notification verify that the RFG-3CF is accurate and reliable. Audio and visual indicators and displays inform the user regarding the proper function of the RFG-3CF. In addition, new self-tests routines have been included to check the software and front panel LEDs upon power-up. In addition, a watchdog timer has been added which will shut down the RFG-3CF and re-boot the software, if the software was not functioning properly.

#### General Safety and Effectiveness Concerns

The device labeling contains instructions for use. It includes indications for use, cautions, warnings and error conditions as well as general instructions for the proper operation of the device. This information promotes safe and effective use of the device.

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

The RFG-3CF, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available Radionics RFG-3C, Fischer Neuro 50, and Leksell LNG 30-T generators. Like these devices, the RFG-3CF is a radiofrequency lesion generator used to coagulate or lesion nervous tissue. In addition, the stimulator feature of the RFG-3CF has the same intended use and technological characteristics as the that of the predicate devices mentioned as well as the Grass Stimulator with Constant Current Unit. The stimulator feature is used to stimulate nerve cells to aid in the placement of electrodes. The stimulator is the major feature modification of the RFG-3CF from the RFG-3C. In the RFG-3CF, the user may choose

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Radionics RFG-3CF Lesion Generator

from constant voltage or constant current stimulation. The user may also select the stimulator parameters such as pulse amplitude, duration and frequency. Radionics believes that the information and testing provided in this premarket notification clearly describe the modifications to the RFG-3CF (from the RFG-3C) and demonstrate that it is equivalent to the mentioned commercially marketed predicate devices.

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