Radiofrequency Generator System, Cura RF Electrode

The Radiofrequency Generator System with Cura RF Electrode is an electrosurgical device that delivers radiofrequency energy for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures. The generator can deliver up to 250 W of RF power at 480 kHz and includes a peristaltic pump for electrode cooling, foot switch control, and temperature/impedance monitoring.

The subject device operates at 480 kHz ± 10%, matching the predicate frequency. It delivers up to 250 W (predicate: 200 W), supports both monopolar and bipolar modes (predicate: monopolar only), and includes temperature and impedance monitoring. The Cura RF Electrode offers three models with multiple size options (lengths 70–250 mm monopolar, 43–143 mm bipolar; active parts 5–40 mm), whereas the predicate offered two models with more limited configurations. Both use stainless steel electrodes and hydrogel neutral electrodes with identical sterilization (EO gas) and connector types (4-pin).

Testing complied with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2, IEC 60601-1-6, ISO 10993 biocompatibility series, ISO 11135 (ethylene oxide sterilization), ISO 11137-2 (radiation sterilization), ASTM F1980-16 (accelerated aging), and IEC 62304 (software validation). Ex-vivo tissue testing on liver, kidney, and muscle evaluated thermal damage zones per FDA electrosurgical device guidance.

The subject device is substantially equivalent because it uses the same fundamental RF technology at the identical frequency, serves the same indications (tissue coagulation and ablation via percutaneous, laparoscopic, and intraoperative routes), shares the same electrode materials and construction principles, and has identical safety monitoring (temperature, impedance, continuity). Although the subject device offers increased power output (250 W vs. 200 W) and adds bipolar capability, these represent enhancements rather than fundamental design changes. Ex-vivo thermal testing demonstrates comparable tissue ablation performance, and compliance with the same safety standards (IEC 60601-2-2, IEC 60601-2-18) confirms equivalent safety and effectiveness profiles relative to the predicate.