(40 days)
Not Found
No
The summary describes a simple medical device (cannulae) used in conjunction with a radiofrequency generator. There is no mention of AI, ML, image processing, or any data-driven analysis that would suggest the use of such technologies. The device description focuses on its physical characteristics and compatibility with existing equipment.
Yes
The device is described as being used to create heat lesions for the relief of pain, which is a therapeutic purpose.
No.
The device is described as a cannula used in RF heat lesion procedures for pain relief, indicating a therapeutic rather than diagnostic purpose.
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 "RF heat lesion procedures for the relief of pain." This is a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is a "disposable RF Cannulae" designed to "create heat lesions for relief of pain" using a radiofrequency lesion generator. This describes a surgical or interventional tool used in vivo.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on bodily specimens.
The device is clearly intended for a therapeutic intervention performed directly on a patient, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The SC-C, RFK-DS and RFK-DB are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain. This is the same intended use as the RSM-C Cannula and SMK-C Cannula.
The SC-C, RFK-DS, and RFK-DB cannulae are indicated for use in RF heat lesion procedures for the relief of pain.
Product codes (comma separated list FDA assigned to the subject device)
GXI, GXD
Device Description
The SC-C, RFK-DS and RFK-DB Radionics disposable RF Cannulae are insulated disposable cannulae designed for use with a Radionics Radiofrequency Lesion Generator to create heat lesions for relief of pain.
The SC-C cannulae are compatible with the commercially available Radionics SMK-TC thermocouple electrodes. They are used in the same way as the commercially available Radionics RSM-C and SMK-C cannulae. The RFK-DS and RFK-DB are compatible with the commercially available RFK-TC thermocouple electrode . They are used in the same way as the commercially available Radionics RSM-C and 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.
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
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).
0
APPENDIX A: Summary of Safety and Effectiveness
್ಕಾ ಸಾಮಾನ್ಯ
980430 MAR 16 1998
SC-C, RFK-DS, RFK-DB 510(k) PMN
January 30, 1998
1
| General Information
| I. | |
|---|---|
| Proprietary Trade Name: | Radionics Disposable RF cannulae |
| Model Numbers: | SC-C, RK-DS, RFK-DB |
| Common Name: | Disposable cannula for radiofrequency electrode |
| Manufacturing Facility Address: | Radionics, Inc. |
| 22 Terry Avenue | |
| Burlington, MA 01803 | |
| Establishment Registration Number: | 1219140 |
| Contact Person: | William Rittman |
| (781) 272-1233 | |
| Classification / Panel: | Class II / Neurology |
| Predicate Devices: | RSM-C Cannula (K963577); |
| SMK-C Cannula (K870028). | |
| Intended Use: | The SC-C, RFK-DS and RFK-DB are intended for use in |
| radiofrequency (RF) heat lesion procedures for relief of | |
| pain. This is the same intended use as the RSM-C Cannula | |
| and SMK-C 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 |
i
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2
General Information (Continued from page A-1)
The SC-C, RFK-DS and RFK-DB Radionics disposable RF Cannulae are insulated disposable cannulae designed for use with a Radionics Radiofrequency Lesion Generator to create heat lesions for relief of pain.
The SC-C cannulae are compatible with the commercially available Radionics SMK-TC thermocouple electrodes. They are used in the same way as the commercially available Radionics RSM-C and SMK-C cannulae. The RFK-DS and RFK-DB are compatible with the commercially available RFK-TC thermocouple electrode . They are used in the same way as the commercially available Radionics RSM-C and SMK-C cannulae.
3
Safety and Effectiveness Information Supporting the Substantial Equivalence II. Determination
A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.
General Safety and Effectiveness Concerns
Radionics Disposable RF Cannula (SC-C, RFK-DS and RFK-DB ) 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
Radionics Disposable RF Cannula (SC-C, RFK-DS and RFK-DB ) addressed in this premarket notification has similar intended use and technological characteristics as the commercially available Radionics RSM-C cannulae (K963577) and SMK-C cannulae (K870028). The insulating material is widely used as a medical grade heat shrinkable tubing and bicompatibility has been performed on Radionics SC-C10 Cannula.
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 1998
Mr. William J. Rittman III ·Vice President Radionics, Incorporated 22 Terry Avenue 01803 Burlington, Massachusetts
Re: K980430 Radionics Disposable RF Cannulae Trade Name: (SC-C, RFK-DB, RFK-DS) Requlatory Class: II Product Code: GXI and GXD January 30, 1998 Dated: February 4, 1998 Received:
Dear Mr. Rittman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with .... the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Mr. Rittman
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally rinaing or easone device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene origo or ocmprises as ("Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
6
510(k) NUMBER (IF KNOWN): K980430
Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS DEVICE NAME:
INDICATIONS FOR USE:
. - - -
ب
The SC-C, RFK-DS, and RFK-DB cannulae are indicated for use in RF heat lesion procedures for the relief of pain.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(Per 21 CRF 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
(Division Sign-Off)
Division of General Restorative Devices
| (K) Number | K980430 |
|---|---|
| ------------ | --------- |