Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)

The ES-100 and ES-300 Electrosurgical Generators are high-frequency surgical devices that deliver RF energy via surgical instruments to cut and coagulate tissue. The ES-100 provides up to 100 W output power with 6 operating modes, while the ES-300 provides up to 300 W with 10 operating modes, both supporting monopolar and bipolar functionality.

Both devices operate at 416 kHz output frequency with similar waveforms, voltage output up to 4800 V, crest factor of 6.3, and modulation up to 25 kHz. Key differences include the ES-300's higher 300 W power output versus ES-100's 100 W, different input power specifications, and additional modes in the ES-300 (soft coagulation, three bipolar modes vs. one). The modulation frequency differs from the predicate's 30 kHz specification.

IEC 60601-1:2005+A1:2012+A2:2020 (medical electrical equipment general requirements), IEC 60601-1-2:2014 (electromagnetic disturbances), and IEC 60601-2-2:2017 (high frequency surgical equipment). Bench testing evaluated output performance across multiple modes; pre-clinical testing assessed thermal damage and edge carbonization across different tissues.

The devices share identical indications for use with the predicate (Bovie IDS-310) and employ the same RF technology for cutting and coagulation. Bench testing demonstrated consistent output power trends across modes compared to the predicate. Pre-clinical thermal damage testing confirmed comparable performance in terms of injury dimensions and carbonization. Although some specifications differ (modulation frequency, input power), these differences do not raise new safety or effectiveness questions because output performance and thermal characteristics remain comparable to the legally marketed predicate device.