MOVIVA® Hybrid Ablation Probe

MOVIVA is a flexible, sterile, single-use monopolar probe that combines hydrosurgery and argon plasma coagulation (APC) in one instrument for endoscopic procedures. It delivers pressurized fluid to create a protective cushion beneath tissue, then ablates the lifted tissue using argon plasma energy. The device is indicated for argon plasma coagulation and ablation of the mucosa with or without lesions, and for needle-free injection and tissue-selective hydrodissection to lift mucosa.

MOVIVA has a 2.4 mm diameter, 1.9 meter shaft length, and 5000 Vp maximum electrical load capacity, matching the predicate HybridAPC probe. Both deliver monopolar high-frequency electrical current via ionized argon plasma and high-pressure water jet (1–80 bar). Key differences are MOVIVA's protruding electrode design (to optimize injection success), new switch enclosure design, shaft color, and plug design—none affecting safety or effectiveness.

Testing complied with 21 CFR 820.30 (design controls), FDA Guidance on Electrosurgical Devices (March 9, 2020), IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2 (electrical safety and EMC), ISO 10993-1 (biocompatibility), ISO 11135 (sterilization validation with SAL 10⁻⁶), ISO 10993-7 (EO residuals), ISO 11607-1 (packaging/shelf-life), and ASTM F 1980 (accelerated aging).

MOVIVA has the same intended use, fundamental design, substantially equivalent performance characteristics, and same energy source (argon plasma and pressurized water jet) as the predicate HybridAPC probe. Bench testing including side-by-side tissue testing, functional verification, and biocompatibility/sterilization validation demonstrated that design modifications do not raise new or different safety or effectiveness questions. Therefore, MOVIVA is substantially equivalent to the predicate device.