Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)

This device is a multifunctional electrosurgical pencil and disposable electrode system for general surgical cutting, coagulation, illumination, and smoke evacuation. The pencil enables surgeons to remotely conduct high-frequency electrical current from an electrosurgical unit to tissue for the desired surgical effect, with various electrode shapes available for different medical applications.

The proposed device is a monopolar electrosurgical pencil with multiple electrode configurations (blade, needle, ball, hook, etc.) and cable lengths of 2.5–3.2 m. It operates at 3 kV rated voltage, has a 5-year shelf-life, and is sterilized via ethylene oxide to achieve 10⁻⁶ sterility assurance level. Key differences from the predicate include higher voltage and longer shelf-life, but both comply with relevant electrical safety standards.

Testing complied with ISO 10993 series (biocompatibility), IEC 60601-1/1-2/2-2 (electrical safety and EMC), ASTM F1886/F88/F1929/D4169 (packaging and seal integrity), ISO 11135 (sterilization validation), USP <85>/<151> (endotoxin and pyrogen testing), and comparative thermal tissue damage testing per FDA guidance on electrosurgical devices.

The proposed device shares the same intended use, functions (cutting, coagulation, smoke removal), monopolar design, and regulatory classification as predicate K230547. Comparative performance testing showed no significant differences in thermal effects on tissue or electrical characteristics. Design differences in electrode shapes, cable length, voltage, and shelf-life do not affect safety or effectiveness because they comply with applicable standards and performance testing confirmed equivalent outcomes.