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Soloist™ Single Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

The Soloist™ Single Needle Electrode is a disposable, monopolar, electrosurgical device. The device consists of an electrode tip, an insulated delivery needle with handle, and cable. The Soloist™ Single Needle Electrode is connected to Boston Scientific radiofrequency (RF) generator so that energy passes into the electrode tip and heats the surrounding tissue. The device is also compatible with and may be used in conjunction with the Boston Scientific Coaccess™ Introducer.

This document is a 510(k) summary for the Soloist™ Single Needle Electrode and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It is not equivalent to clinical trial data showing the device's performance against pre-defined acceptance criteria.

The information provided only demonstrates that the device is substantially equivalent to a predicate device, the LeVeen™ Needle Electrode. It outlines the general information, intended use, device description, and a summary of substantial equivalence.

Therefore, I cannot provide the requested information, which typically comes from performance studies or clinical trials with defined acceptance criteria.

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