Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

The Venclose digiRF Generator is an energy delivery system that works with the EVSRF Catheter to treat superficial vein reflux. It uses temperature-controlled radiofrequency energy to heat and permanently close incompetent veins through resistive ablation, causing the vein to scar and eventually resorb.

The subject device is substantially equivalent to predicate devices in intended use, indications for use, performance characteristics, target population, fundamental scientific technology, operating principle, and packaging configuration. The only difference is a software modification to the generator.

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

The modified digiRF Generator maintains all substantial technological characteristics of the predicate devices (K160754 and K250068), including the same intended use, indications, performance criteria, target population, and fundamental RF ablation technology. Software verification and validation testing demonstrated that the technological characteristics and performance criteria of the modified generator are comparable to and perform as safely and effectively as the legally marketed predicate devices.