RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)

K980430 · Radionics, Inc. · GXI · Mar 16, 1998 · Neurology

Device Facts

• Record ID: K980430
• Device Name: RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)
• Applicant: Radionics, Inc.
• Product Code: GXI · Neurology
• Decision Date: Mar 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SC-C, RFK-DS, and RFK-DB cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

Device Story

Insulated disposable cannulae used with Radionics Radiofrequency Lesion Generator; creates heat lesions for pain relief. SC-C models compatible with SMK-TC thermocouple electrodes; RFK-DS and RFK-DB models compatible with RFK-TC thermocouple electrodes. Used by physicians in clinical settings for RF procedures. Device provides physical access for electrode placement to target tissue; heat generated by connected lesion generator creates therapeutic lesion. Benefits include disposable design for patient safety.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to predicate devices.

Technological Characteristics

Insulated disposable cannulae; medical grade heat-shrinkable tubing insulation; compatible with Radionics thermocouple electrodes (SMK-TC, RFK-TC).

Indications for Use

Indicated for patients undergoing radiofrequency heat lesion procedures for pain relief.

Regulatory Classification

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.

Predicate Devices

• RSM-C Cannula (K963577)
• SMK-C Cannula (K870028)

Submission Summary (Full Text)

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# APPENDIX A: Summary of Safety and Effectiveness

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980430 MAR 16 1998

SC-C, RFK-DS, RFK-DB 510(k) PMN

January 30, 1998

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K980430

| General Information<br>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.<br>22 Terry Avenue<br>Burlington, MA 01803 |
| Establishment Registration Number: | 1219140 |
| Contact Person: | William Rittman<br>[phone] |
| Classification / Panel: | Class II / Neurology |
| Predicate Devices: | RSM-C Cannula (K963577);<br>SMK-C Cannula (K870028). |
| Intended Use: | The SC-C, RFK-DS and RFK-DB are intended for use in<br>radiofrequency (RF) heat lesion procedures for relief of<br>pain. This is the same intended use as the RSM-C Cannula<br>and SMK-C Cannula. |
| Performance Standard: | No applicable performance standards have been issued<br>under section 514 of the Food, Drug, and Cosmetic Act. |
| Sterilization Site: | STS<br>7500 W. Henrietta Road<br>PO. Box 349<br>Rush, NY 14543<br>[phone] |

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# General Information (Continued from page A-1)

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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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<br>(Per 21 CRF 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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(Division Sign-Off)

Division of General Restorative Devices

| (K) Number | K980430 |
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