Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI® Flex Needle

The Aliya EX System is an electrosurgical device that delivers high-frequency, short-duration electrical pulses (Aliya Pulsed Electric Field) through needles to ablate soft tissue. It includes the Aliya EX Generator, Aliya Needle, Aliya Electrode, and INUMI Flex Needle (an endoscopically compatible version with 160 cm working length). The system is indicated for surgical ablation of soft tissue.

The Aliya EX Generator provides two factory-preset energy settings (G10 and G20) creating ~10mm and ~20mm diameter ablation zones, respectively, compared to the predicate's single 3000V setting. The EX version adds: (1) foot switch latching to reduce physician fatigue, (2) serial port for performance data retrieval, (3) current control instead of voltage control for enhanced predictability at different impedances, and (4) boot application for improved startup. The INUMI Flex Needle is identical to its predicate but now specifies compatibility with the Aliya EX System.

IEC 60601-1, IEC 60601-1-2, and IEC 60601-4-2 (electrical safety and EMC); FDA Guidance on Off-The-Shelf Software Use and Device Software Functions; FDA Guidance on Cybersecurity in Medical Devices; FDA Premarket Notification Guidance for Electrosurgical Devices for General Surgery (March 9, 2020). Testing included ex vivo porcine tissue characterization and in vivo porcine animal studies in liver, kidney, and muscle.

The subject Aliya EX System has the same intended use (surgical ablation of soft tissue) as the predicate Aliya System. Bench and animal performance testing demonstrate that technological differences—primarily the dual energy settings and software enhancements—do not raise different safety or effectiveness questions. The device is as safe and effective as the predicate. The INUMI Flex Needle is identical to its predicate with only updated labeling for compatibility; the additional language does not alter intended use.