Reusable 3 Button Fingerswitch Wand

The Soniquence Reusable 3 Button Fingerswitch Wand is an accessory handpiece for electrosurgical procedures that connects to a Soniquence RF Generator and monopolar electrodes. It provides three-button finger-activated control (CUT, BLEND, HEMO modes) with visual indicators to allow surgeons to activate different waveforms for resection, dissection, incision, and hemostasis in soft tissue surgery without manipulating the generator front panel.

The subject device uses an aluminum alloy housing with silicone rubber activation buttons and polyphenylsulfone button covers, compared to the disposable predicate which uses ABS for all housing and button components. Both operate on RF energy with identical 3-meter cable length, button switch activation method, and internal printed circuit board electronics. The subject device uses silicone cable insulation versus PVC in the predicate, and undergoes pre-vacuum sterilization versus ethylene oxide sterilization for the disposable predicate.

IEC 60601-1 and IEC 60601-2-2 for electrical safety and high-frequency surgical equipment; ISO 10993 series (10993-5, 10993-10, 10993-11, 10993-23) for biocompatibility; USP-NF General Chapters 151 for pyrogen testing; ISO 17664-1:2021 and ISO 17665:2024 for sterilization validation; AAMI TIR12:2020 and ANSI/AAMI ST98:2022 for device reprocessing and cleaning validation; ASTM F3208-20 for cleaning method validation.

The subject device is substantially equivalent because it has identical intended use, operating mechanism, energy source, cable length, and modes (monopolar Cut, Blend, HEMO) as the predicate devices K183611 and K212222. Material differences (aluminum alloy housing instead of ABS) and sterilization method differences do not raise new safety or effectiveness questions, as both configurations passed identical safety and biocompatibility testing standards. Non-clinical testing confirmed the device meets all applicable electrical safety and performance standards without requiring clinical data.