(76 days)
Not Found
No
The summary describes a disposable cannula for use with a radiofrequency generator, and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is described as creating heat lesions for pain relief, which is a therapeutic intervention.
No
The device is described as creating heat lesions for pain relief, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a disposable cannula, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radiofrequency (RF) heat lesion procedures for relief of pain." This is a therapeutic procedure performed directly on a patient, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Device Description: The device is a cannula designed to deliver RF energy to create heat lesions within the body. This is a surgical/interventional tool, not a diagnostic reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on laboratory results.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) for a therapeutic purpose.
N/A
Intended Use / 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K870028, Radionics TIC Cannula
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 Avenue | |
| Burlington, MA 01803 | |
| Establishment Registration Number: | 1219140 |
| Contact Person: | Amy LaForte, Ph.D. |
| (617) 272-1233 | |
| 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 | |
| (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.
1
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.