(61 days)
The Smith & Nephew Adaptor Cable is intended for connecting a Smith & Nephew Radiofrequency Denervation Probe to Smith & Nephew RF Lesion Generators.
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.
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.
§ 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.