(78 days)
No
The description focuses on radiofrequency lesion generation and nerve stimulation with user-selectable parameters, and explicitly states that mentions of AI, DNN, or ML were not found.
Yes
The device is a radiofrequency lesion generator used to coagulate or lesion nervous tissue and stimulate nerve cells, which are therapeutic actions.
No
The device is described as a radiofrequency lesion generator used to coagulate or lesion nervous tissue, and its stimulator feature is used to stimulate nerve cells to aid in electrode placement. Neither of these functions are for diagnosis.
No
The device description explicitly states it is a "radiofrequency lesion generator" and mentions hardware components like a "stimulator feature" and "electrodes," indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To create lesions during neurosurgical lesion procedures." This is a therapeutic procedure performed directly on a patient's nervous tissue.
- Device Description: The device is described as a "radiofrequency lesion generator used to coagulate or lesion nervous tissue" and a "stimulator feature... used to stimulate nerve cells to aid in the placement of electrodes." These are all actions performed in vivo (within a living organism).
- Anatomical Site: The anatomical site is "nervous tissue," which is part of the human body.
In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform such tests; it is a surgical tool used for treatment and guidance during surgery.
N/A
Intended Use / Indications for Use
To create lesions during neurosurgical lesion procedures.
Product codes
Not Found
Device Description
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 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.
The RFG-3CF 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 from constant voltage or constant current stimulation. The user may also select the stimulator parameters such as pulse amplitude, duration and frequency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nervous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Appendix 1
MAR 1 2 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. |
| (617) 272-1233 | |
| 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
1
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 parameters such as purse anientates, but and the 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.