CROMA Electrosurgical Generator (PRD-EMR-050)

The CROMA Electrosurgical Generator is a tabletop surgical power unit that delivers radiofrequency (RF) energy at 400 kHz and microwave (MW) energy at 5.8 GHz to compatible surgical instruments for cutting, coagulation, and ablation of soft tissue during endoscopic procedures. The system is explicitly not intended for cardiac procedures.

The subject device maintains identical energy inputs, outputs, principles of operation, and control console functionalities as the predicate devices. The primary change is a modernized user interface: the display was upgraded from a Vacuum Fluorescent Display (VFD) to a Liquid Crystal Display (LCD) capable of displaying alphanumeric, Chinese, and Japanese characters. The keypad membrane was aesthetically updated, and software was modified to support the new LCD and include minor updates, but RF output (396.7 kHz ± 2.0 kHz, 460 V peak), MW output (5.8 GHz ± 1 MHz, 79 V peak), and all power specifications remain identical.

IEC 60601-1 Ed. 3.2 (general electrical safety), IEC 60601-2-2 Ed. 6.0 (high-frequency surgical equipment), IEC 60601-2-6 Ed. 2.1 (RF equipment), IEC 60601-1-2:2014 (electromagnetic compatibility), and IEC 62304 Ed. 1.1 (medical device software lifecycle processes).

The device is substantially equivalent because it delivers identical RF and MW energy at the same frequencies and power levels as the predicates using the same operational principles and control functions. Although the display technology changed from VFD to LCD and software was updated to support it, these changes are purely cosmetic and functional interface improvements that do not affect energy delivery, safety characteristics, or clinical performance. Mechanical and usability testing confirmed the new interface operates correctly, and all electrical safety and EMC testing validates compliance with the same standards as the predicate.