(76 days)
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.
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.
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.
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963597
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 AvenueBurlington, MA 01803 |
| Establishment Registration Number: | 1219140 |
| Contact Person: | Amy LaForte, Ph.D.(617) 272-1233 |
| Classification: | Class II |
| Predicate Devices: | SMK Cannula (K870028); andRadionics TIC Cannula (pre-amendment). |
| Intended Use: | The RSM-C is intended for use in radiofrequency (RF) heatlesion procedures for relief of pain. This is the sameintended use as the SMK Cannula and TIC Cannula. |
| Performance Standard: | No applicable performance standards have been issuedunder section 514 of the Food, Drug, and Cosmetic Act. |
| Sterilization Site: | STS7500 W. Henrietta RoadPO. Box 349Rush, NY 14543(716) 533-1672 |
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.
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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 Sluiter-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.
§ 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).