MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE

K071300 · Smith & Nephew, Inc. · GXI · Jul 20, 2007 · Neurology

Device Facts

• Record ID: K071300
• Device Name: MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
• Applicant: Smith & Nephew, Inc.
• Product Code: GXI · Neurology
• Decision Date: Jul 20, 2007
• 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

Device consists of temperature-sensing radiofrequency (RF) lesion probe and disposable RF cannulae; used in RF heat lesion procedures for pain relief. Probe is non-sterile/reusable; cannulae are sterile/single-use. System operates in conjunction with Smith & Nephew Electrothermal 20S Spine System Generator. Physician inserts probe through cannula to target tissue; generator delivers RF energy to create heat lesion. Output is thermal energy for tissue ablation. Used in clinical settings by physicians to manage pain.

Clinical Evidence

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

Technological Characteristics

Temperature-sensing electrode probe; disposable cannulae in various sizes/tip configurations. Electrical safety per UL 60601-1 and IEC 60601-1. Compatible with Smith & Nephew Electrothermal 20S Spine System Generator. Probe is reusable; cannulae are single-use.

Indications for Use

Indicated for patients undergoing 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

• Smith & Nephew RF Denervation Probes & RF Cannulae (K034012)

Submission Summary (Full Text)

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JUL 2 0 2007

Ko7/300

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

w.smith-nephew.com

We are smith&nephew

Page 1 of 2

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.

## Smith & Nephew RF Denervation Probes & RF Cannulae Traditional 510(k)

Date Prepared: May 8, 2007

# A. Submitter's Name:

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

### B. Company Contact:

Kathy Reddig Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

### C. Device Name

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

### D. Predicate Devices

The Smith & Nephew RF Denervation Probe is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew RF Denervation Probes & RF Cannulae (K034012).

#### E. Description of Device

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 Cannulae. The Smith & Nephew Denervation Probe is packaged non-sterile for reuse. The Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations, and are packaged sterile for single use.

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#### F. Intended Use

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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 and Nephew RF Denervation Probes & RF Cannulae are substantially equivalent in design, materials, function and intended use to the following device cleared for commercial distribution:

- Smith & Nephew RF Denervation Probes and RF Cannulae -- K034012

# H. Summary Performance Data

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2007

Smith & Nephew, Inc. % Ms. Kathy Reddig, RAC Regulatory Consultant 150 Minuteman Road Andover, Massachusetts 01810

Re: K071300

Trade/Device Name: Smith & Nephew RF Denervation Probes & RF Cannulae Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: July 2, 2007 Received: July 3, 2007

Dear Reddig:

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 (OS) 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. Kathy Reddig, RAC

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/industry/support/index.html.

Sincerely yours,

Mark A. Milburn

Mark N. Melkerson 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

510(k) Number (if known):

Ko. 7/300

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

Indications For Use:

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

Mark N Milferson

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

510(k) Number

Prescription Use ________x (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)