CURIS II RF Generator (REF 360100-05)

The Sutter CURIS® II RF Generator is a radiofrequency electrosurgical device that provides cutting, coagulation, and hemostasis capabilities for orthopedic, arthroscopic, spinal, neurosurgical, and dermatological procedures. It operates at 4.0 MHz with maximum power outputs of 120 Watts in cut mode and 80 Watts in coagulation mode, and can deliver monopolar or bipolar energy through compatible electrodes.

The CURIS® II has slightly higher maximum power (120 W vs. 100 W in cut mode) and different impedance load specifications compared to the predicate CURIS® RF Generator. Dimensions are 313 × 166 × 408 mm (vs. 320 × 170 × 385 mm), and some operating modes were renamed or removed (e.g., BICUT 1 and BICUT 2 no longer offered). All other characteristics including frequency, mains supply, and overall PEMS/software design are substantially identical.

Testing was performed in compliance with IEC 60601-1 (electrical safety general), IEC 60601-2-2 (electrosurgical devices), IEC 60601-1-2 (electromagnetic compatibility), ISO 14971 (risk management), and IEC 62304 (software lifecycle). Thermal tissue effects testing followed FDA guidance for electrosurgical devices.

The CURIS® II is substantially equivalent to the predicate CURIS® RF Generator because both share identical intended use, product code, regulatory classification, and basic technological design. Minor differences in power output limits, physical dimensions, and operating mode availability do not raise new safety or effectiveness concerns, as verified by non-clinical performance testing showing equivalent coagulation and cutting performance to the predicate device.