Aqua Medical RF Vapor Ablation System

The Aqua Medical RF Vapor Ablation System is a catheter-based device that delivers heated water vapor generated by radiofrequency energy to coagulate and ablate bleeding and non-bleeding lesions in the gastrointestinal tract, including the esophagus. It is indicated for treatment of conditions such as esophageal ulcers, Mallory-Weiss tears, arteriovenous malformations, Barrett's esophagus, and other GI lesions in adult patients.

The device consists of an RF generator with graphical user interface and syringe pump, disposable single-use catheters (7F inner diameter, 10.5F outer sheath, 145-210 cm length), and saline delivery tubing. Key modifications include minor software changes, device modifications, addition of a new circumferential catheter size, and a shift from time-based to energy level-based treatment control.

Not stated in this summary.

The device demonstrates substantial equivalence through bench testing showing that modified circumferential catheters produce ablation depths substantially equivalent to predicate catheters across evaluated dose ranges. Hardware verification testing (fatigue cycling, joint forces, sliding forces) and lean beef tissue testing confirmed equivalent thermal performance and physical integrity under simulated-use conditions. The modifications do not introduce new safety or effectiveness concerns, and the addition of 'ablation' to the indication is supported by the demonstrated equivalent mechanism of action to the predicate device.