PhotonBlade 3; PhotonBlade 3 Smoke Evacuation

The PhotonBlade 3 is a monopolar radiofrequency electrosurgical device with integrated LED illumination for cutting and coagulating soft tissue across multiple surgical specialties including general, plastic, ENT, orthopedic, neurological, and breast surgery. The PhotonBlade 3 Smoke Evacuation variant additionally includes integrated smoke evacuation tubing for removal of surgical smoke when connected to a smoke evacuation system.

Both the subject and predicate devices are identical in technological design: monopolar RF energy delivery, LED-based illumination, integrated smoke evacuation (for the smoke evacuation model), sterile single-use design with EtO sterilization, coated stainless steel blade, and external communicating device contact <24 hours per ISO 10993-1. No physical design changes were made between subject and predicate.

ISO 10993-1 (biocompatibility limited contact testing); IEC 60601 (electrosurgical generator compliance); ISO standards referenced for sterilization validation. Specific bench testing was conducted ex vivo on polyurethane-insulated CIED leads using various power settings, modes, and orientations to assess lead damage via visual inspection and impedance measurement.

The subject devices add an electrophysiology implant indication (for CIED implantation, upgrade, and revision) to the predicate's existing cleared uses. This new indication falls within the predicate's established intended use of cutting and coagulating soft tissue; no new technological characteristics or device modifications are required. A systematic literature review of 64 publications and 7 full-text manuscripts demonstrated monopolar RF devices are safe and effective for electrophysiology procedures with no new or unexpected risks, and non-clinical bench testing confirmed the devices can contact CIED leads safely under specified settings without insulation breach.