SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE

K034012 · Smith & Nephew, Inc. · GXI · Mar 16, 2004 · Neurology

Device Facts

• Record ID: K034012
• Device Name: SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
• Applicant: Smith & Nephew, Inc.
• Product Code: GXI · Neurology
• Decision Date: Mar 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew RF Denervation Probes and Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

Device Story

The Smith & Nephew RF Denervation Probes and Cannulae are medical instruments used in radiofrequency (RF) heat lesion procedures to provide pain relief. The system consists of a temperature-sensing electrode (probe) and a disposable cannula. The probe is designed for reuse, while the cannulae are provided sterile for single use and are available in various sizes and tip configurations. The device is intended to be used in conjunction with an RF lesion generator, such as the Smith & Nephew Electrothermal 20S Spine System Generator. During a procedure, the probe is inserted through the cannula to deliver RF energy to target tissue, creating a heat lesion. The healthcare provider monitors the procedure via the generator's interface. The device is used in a clinical setting by trained medical professionals.

Clinical Evidence

Bench testing only. The device meets electrical safety requirements per UL 60601-1 and IEC 60601-1 standards when used with the Smith & Nephew Electrothermal 20S Spine System Generator.

Technological Characteristics

Temperature-sensing electrode probe and disposable cannula. Designed for use with RF lesion generators. Complies with UL 60601-1 and IEC 60601-1 electrical safety standards. Probes are reusable; cannulae are single-use, sterile, and available in multiple sizes/tip configurations.

Indications for Use

Indicated for patients requiring RF 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

• Radionics Racz-Finch Electrode (K870028)
• Radionics RFK Needles (K980430)

Reference Devices

• Radionics Disposable RF Cannulae (K980430)

Submission Summary (Full Text)

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MAR 1 6 2004

Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA

978 749 1000 978 749 1599 Fax www.smith-nephew.com We are smith&nephew

Page ① of 2

## SECTION IN

K 034012

## 510{k} SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Date Prepared: December 23, 2003

A. Submitter's Name: Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road

Andover, MA 01810

| <b>B. Company Contact:</b> | |
|-------------------------------|--------------|
| Karen Provencher | |
| Regulatory Affairs Specialist | |
| Phone: | 978-749-1365 |
| Fax: | 978-749-1443 |

- C. Device Name

| Trade Name: | Smith & Nephew RF Denervation Probes<br>Smith & Nephew RF Cannulae |
|----------------------|--------------------------------------------------------------------|
| Common Name: | Probe, Radiofrequency Lesion |
| Classification Name: | Radiofrequency Lesion Probe |

## D. Predicate Devices

The Smith & Nephew RF Denervation Probes & RF Cannulae are substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution: Radionics Racz-Finch Electrode and RFK Needles (K870028 and K980430).

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Page ② of ②

- Description of Device ப்
The Smith & Nephew RF Denervation Probe is a temperature sensing electrode designed for use in radiofrequency lesion procedures. The RF Denervation Probe is used with a disposable Smith & Nephew RF Cannula. The Smith & Nephew RF Denervation Probe is packaged non-sterile for reuse. Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations. The RF Cannulae are packaged sterile for single use.

- Intended Use F.
The Smith & Nephew RF Denervation Probes and Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

- G. Comparison of Technological Characteristics
The Smith & Nephew RF Denervation Probes & RF Cannulae are substantially equivalent in design, materials, function and intended use to the following devices cleared for commercial distribution:

- Radionics Racz-Finch Electrode K870028 .
- Radionics Disposable RF Cannulae K980430 .
- H. Summary Performance Data

The Smith & Nephew RF Denervation Probes & RF Cannulae meet the requirements of electrical safety standards for UL 60601-1 and IEC 60601-1 when use in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is an abstract image of an eagle.

MAR 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Provencher Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K034012

Trade/Device Name: Smith & Nephew RF Denervation Probes & RF Cannulae Regulation Number: 21 CFR 882.4725; 21 CFR 882.4400 Regulation Name: Radicfrequency lesion probe, Radiofrequency lesion generator Regulatory Class: II Product Code: GXI, GXD Dated: December 23, 2003 Received: December 24, 2003

Dear Ms. Provencher:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Karen Provencher

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K034012 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Smith & Nephew RF Denervation Probes & RF Cannulae Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Smith & Nephew RF Denervation Probes and Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

Prescription Use __ X_ (Per 21 CFR 801 Subpar! D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart Cl

(Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number_ /< 03 40 / 2