FiAPC plus probes

The FiAPC plus probes are sterile, single-use flexible probes designed for argon plasma coagulation and ablation of tissue during endoscopic procedures. They connect to compatible electrosurgical units and deliver argon plasma through a distal opening to treat various conditions in endoscopy.

The subject device adds a new probe variant with a circumferential (360-degree) opening for argon plasma delivery, compared to the predicate's axial (straight-fire) and lateral (side-fire) openings. All variants share the same 2.3 mm outer diameter, filter-integrated plug with instrument recognition, 5000 Vp electrical capacity, and 2.4 l/min gas flow rate. Materials include stainless steel, plastics, ceramics, and silver.

ISO 11135 (sterilization validation), ISO 10993-1 and 10993-7 (biocompatibility and EO residuals), ISO 11607-1 (packaging/shelf-life), IEC 60601-1, 60601-2-2, 60601-2-18, 60601-1-2 (electrical safety and EMC), IEC 62304 (software), and ASTM F1980 (accelerated aging). Tissue testing followed FDA Guidance on Premarket Notification Submissions for Electrosurgical Devices (March 9, 2020).

Although the subject device introduces a circumferential opening design not present in the primary predicate (K242044), this same beam type was already cleared in the secondary predicate (K060183). Side-by-side tissue testing demonstrated equivalent coagulation depth, coagulation area, and ignition distances compared to the predicate device. Design controls per 21 CFR 820.30 verified the design change maintained safety and effectiveness. The device shares identical intended use, fundamental design, materials, electrical specifications, gas flow, and sterilization method as its predicates, with only the tip design modification—which testing showed produces equivalent thermal and performance outcomes.