HybridAPC probe

The HybridAPC probe is a flexible, single-use endoscopic electrode that combines hydrosurgery and argon plasma coagulation (APC) in one instrument. It injects sterile saline to lift mucosa while protecting underlying tissue, then ablates the mucosa or mucosal lesions using monopolar high-frequency electrical current delivered as ionized argon plasma. It is used with the ERBEJET 2 hydrosurgical unit and compatible Erbe APC units.

The device is 1.9 meters long with a 2.3 mm outer diameter, delivers argon plasma via monopolar high-frequency current at up to 5000 Vp, and supplies high-pressure water jet at 1–80 bar with a 120 µm nozzle diameter. It is identical to the primary predicate (K143306) with no design, material, or performance changes since initial clearance. Like the secondary predicate (K060183), it is a flexible sterile single-use probe providing monopolar HF current as argon plasma, but adds waterjet capability as a safety feature.

Functional and design controls per 21 CFR 820.30; tissue testing for lifting and thermal effects; EMC and electrical safety per IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2; biocompatibility per ISO 10993-1 and FDA guidance; sterilization validation per ISO 11135 demonstrating SAL of 10⁻⁶; EO residual testing per ISO 10993-7; packaging and shelf-life per ISO 11607-1 with accelerated aging (ASTM F 1980) and real-time aging.

The subject device has identical intended use, fundamental design, and energy source as the primary predicate (K143306), with no changes since that device's clearance. The secondary predicate (K060183) shares the same basic monopolar APC design and performance; the subject device is an iteration that adds waterjet capability while maintaining equivalent APC function and performance. The broadened indications (from mucosal lesions to mucosa with or without lesions) are supported by peer-reviewed literature showing the device is safe and effective for non-lesioned mucosa with no new device-specific risks, and the reference device (Barrx, K160360) is cleared for similar indications using a comparable mode of action (HF electrical current for tissue ablation).