DELPHI System

The DELPHI System is a bipolar radiofrequency electrosurgical device used for coagulation, ablation, and hemostasis during arthroscopic surgery. It consists of a generator (DELPHI II), footswitches, power cable, and single-use bipolar electrodes (DELPHI PLUS or DISCORE) that deliver RF energy at 100 kHz to cut and coagulate tissue.

The device operates at 100 kHz output frequency with ablation voltage 100–275.68 Vrms and coagulation voltage 63–100 Vrms. It is Class I electrically isolated equipment with Type BF applied part protection, uses wired footswitch control, and is sterilized by EO gas. Multiple wand configurations offer different shaft lengths (110–380 mm), handle lengths, distal bend angles (15°–90°), and shaft diameters to accommodate various surgical approaches.

IEC 60601-1:2005 (general safety requirements), IEC 60601-2-2:2017 (high-frequency surgical equipment), IEC 60601-1-2:2014 (electromagnetic compatibility and disturbances), and ISO 14971 (risk management).

The DELPHI System shares identical indications for use, rated input voltage, output frequency, electrical protection classification, and compliance with all applicable IEC and ISO standards as the predicate ArthroCare Coblation device (K220563). Although output voltage ranges differ slightly (100–275.68 vs. 100–314 Vrms for ablation), the subject device's output falls entirely within the predicate's range and tolerance. Differences in wand geometry and sterilization method do not affect safety or effectiveness, as they merely provide clinicians additional configuration options without changing the fundamental mechanism or performance of tissue ablation and coagulation.