PowerWire® 14 Radiofrequency Guidewire Kit

The PowerWire 14 Radiofrequency Guidewire Kit is a sterile, single-use device that delivers radiofrequency energy to create a channel through totally occluded peripheral blood vessels 3 mm or greater in diameter, including vessels with stents. It consists of an insulated core wire with an active tip at the distal end and connects via a connector cable to a radiofrequency generator at the proximal end.

The subject device shares the same fundamental insulated core wire design with active tip as the predicate but differs in overall length, wire outer diameter (0.014 inches), and materials used. It is available in both 190 cm and 300 cm lengths with straight and angled distal configurations, and is sterilized using ethylene oxide.

Testing followed FDA guidance on Coronary, Peripheral, and Neurovascular Guidewires; ISO 10993-1 for biocompatibility; IEC 60601-1 and IEC 60601-2-2 for electrical safety; and internal Baylis Medical Technologies specifications.

The subject device is substantially equivalent because it shares identical intended use, mechanism of action, and operating principle with the predicate device—both use controlled radiofrequency energy delivered in monopolar mode to vaporize tissue and create channels in vascular occlusions. Although the subject device differs in length, wire diameter, and materials, comprehensive bench validation, electrical, biocompatibility, and mechanical testing demonstrate performance equivalent to the predicate across various vessel sizes with and without stents, and these dimensional differences do not raise different safety or effectiveness questions.