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.

AI/ML Overview

The provided text is a 510(k) premarket notification for Radionics Disposable RF Cannulae. For devices of this nature, the acceptance criteria are generally based on substantial equivalence to predicate devices. There are no direct performance metrics, such as sensitivity, specificity, or image quality, that are usually reported for such accessories. Instead, the "study" demonstrating that the device meets criteria is primarily a comparison of technological characteristics and intended use to previously cleared devices.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate Devices)	Reported Device Performance (as described in the 510(k))
Intended Use Equivalence: Device must have the same intended use as predicate devices.	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 (K963577) and SMK-C Cannula (K870028).
Technological Characteristics Equivalence: Device must have similar design, materials, and operational principles as predicate devices.	The Radionics Disposable RF Cannula (SC-C, RFK-DS and RFK-DB) has similar 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.
Safety: Device must demonstrate safety comparable to predicate devices.	Labeling contains instructions for proper use, including a description, directions for use, and applicable safety information. "These instructions ensure safe and effective use of the device when followed by the physician."
Biocompatibility: Materials used must be biocompatible.	Biocompatibility has been performed on Radionics SC-C10 Cannula. (It's implied that this applies to the materials used in the new devices as well).
Compatibility: New cannulae should be compatible with existing equipment (e.g., electrodes, generators).	The SC-C cannulae are compatible with the commercially available Radionics SMK-TC thermocouple electrodes. The RFK-DS and RFK-DB are compatible with the commercially available RFK-TC thermocouple electrode. They are designed for use with a Radionics Radiofrequency Lesion Generator.

2. Sample size used for the test set and the data provenance

The document does not describe a test set, clinical study, or data provenance in the traditional sense of a clinical trial for device performance. The demonstration of safety and effectiveness for these accessories is based on a comparison to predicate devices, material biocompatibility, and intended use as an accessory to an existing procedure. There are no quantitative performance metrics (like accuracy, F1-score, etc.) typically associated with AI/diagnostic devices that would require a "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As described above, there was no "test set" and no ground truth establishment by experts in the context of device performance as one might expect for a diagnostic or AI device. The expertise involved would be in the design, manufacturing, materials science, and regulatory interpretation to establish equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no test set or clinical data requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a disposable cannula for radiofrequency heat lesion procedures, not an AI-assisted diagnostic or therapeutic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical accessory, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of performance metrics. The "ground truth" for this 510(k) submission is the existence and established safety and effectiveness of the predicate devices (RSM-C Cannula K963577 and SMK-C Cannula K870028). The new devices are deemed substantially equivalent to these already-cleared devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of medical accessory.

Summary

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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

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K980430

General InformationI.
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 AvenueBurlington, 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 inradiofrequency (RF) heat lesion procedures for relief ofpain. This is the same intended use as the RSM-C Cannulaand SMK-C 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

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General Information (Continued from page A-1)

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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.

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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.

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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

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510(k) NUMBER (IF KNOWN): K980430

Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS DEVICE NAME:

INDICATIONS FOR USE:

. - - -

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)
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(Division Sign-Off)

Division of General Restorative Devices

(K) Number	K980430
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Regulation Number and Section

§ 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).