Venclose digiRF Generator (VCRFG1)

The Venclose digiRF Generator is a radiofrequency energy delivery system with touchscreen control used to treat varicose veins by endovascularly coagulating blood vessels. It works with either the EVSRF Catheter (for superficial vein reflux) or Maven Catheter (for perforator and tributary vein reflux) to deliver temperature-controlled RF energy that causes irreversible vein occlusion, fibrosis, and resorption.

The subject device differs from predicate devices only in software modifications. All other technological characteristics remain substantially equivalent, including intended use, indications for use, performance characteristics, target population, fundamental scientific technology, operating principle (resistive radiofrequency ablation), and packaging configuration.

Not stated in this summary. The document references the FDA Guidance document 'Design Control Guidance for Medical Device Manufacturers' (dated March 11, 1997) and internal risk assessment procedures, but does not cite specific ISO, IEC, or ASTM consensus standards.

The software modifications to the digiRF Generator do not alter its fundamental mode of action, performance characteristics, or clinical application. Software verification and validation testing demonstrated that the modified generator performs comparably to the legally marketed predicate devices (K160754 and K211806) and maintains the same safety and efficacy profile, while the catheters themselves remain unchanged from their previously cleared versions.