The Smith & Nephew Adaptor Cable has been designed as an accessory device to the Smith & Nephew Electrothermal Spine System and will provide the option of bipolar energy distribution. The subject device is designed to be used with Smith & Nephew Electrothermal generators, Radiofrequency (RF) denervation probes, and cannulae to create RF heat lesions for the treatment of pain. This configuration eliminates the need of a grounding pad, allowing for return of the delivered energy via a secondary non-active RF probe.

AI/ML Overview

This is a 510(k) summary for a medical device that is an adaptor cable, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design features and intended use, rather than clinical performance or AI/ML model metrics.

Summary

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083528

510k Summary of Safety and Effectiveness

Submitted By:	Smith & Nephew, Inc.1450 Brooks RoadMemphis, TN 38116
Date:	November 26, 2008
Contact Person:	Kim P. Kelly, Director, Regulatory AffairsTel: (901) 399-6566 Fax: (901) 399-1557
Proprietary Name:	Smith & Nephew Adaptor Cable
Common Name:	Accessory, Electrosurgical cutting and coagulationdevice

Classification Name and Reference:

21 CFR 878.4400,Electrosurgical cutting and coagulation device and accessories - Class II

Device Product Code and Panel Code: GEI

Device Description:

Intended Use:

The Smith & Nephew Adaptor Cable is intended for connecting a Smith & Nephew Radiofrequency Denervation Probe to Smith & Nephew RF Lesion Generators.

Technological Characteristics:

The Smith & Nephew Adaptor Cable is similar to legally marketed devices in that they share similar indications for use and incorporate similar technological characteristics.

Substantial Equivalence Information:

When compared to the predicate device listed below, substantial equivalence is based on similarities in design features and overall indications for use:

Neurotherm NT 1000 RF Lesioning System K052878 .
Stryker RF Parallel Bipolar Adapter Cable K061660 .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2009

Smith & Nephew, Inc. % Ms. Kim P. Kelly Director, Regulatory Affairs 1980 Nonconnah Boulevard Memphis, Tennessee 38132

Re: K083528

Trade/Device Name: Smith & Nephew Adaptor Cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 26, 2008 Received: November 28, 2008

Dear Ms. Kelly:

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. Kim P. Kelly

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millican

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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Premarket Notification Indications for Use Statement

510(k) Number (if known):

083528

Device Name:

Smith & Nephew Adaptor Cable

Indications for Use:

The Smith & Nephew Adaptor Cable is intended for connecting a Smith & Nephew Radiofrequency Denervation Probe to Smith & Nephew RF Lesion Generators.

Prescription Use:

OR .

Over-The-Counter

(Per 21 CFT 801.109)

(PLEASE DO NOT WHITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRHL Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.