Asurys Fluid Management System

The Asurys Fluid Management System is an electromechanical console with single-use sterile cassettes used during endourological procedures to manage fluid delivery to patients. It delivers irrigation fluid through a peristaltic pump in modes compatible with various urological endoscopes, supporting procedures including ureteroscopy, percutaneous nephrolithotomy, cystoscopy, and benign prostatic hyperplasia treatment.

The Asurys uses a peristaltic pump for pressure generation like the predicate, but differs in maximum pump pressure (300 mmHg in Standalone/LVE Lite modes; 600 mmHg transient in LVE mode), pump pressure range (30–450 mmHg in LVE mode versus 30–300 mmHg for predicate), compatible fluids, operating modes, and adds a new flush feature. It removes fluid deficit monitoring, waste collection, and heating functions present in the predicate.

ISO 10993 series (biocompatibility), ISO 11137-1 and -2 (sterility), IEC 60601-1 and 60601-2 series (electrical safety and EMC), ASTM D4169, D4332, F2096, F1886, F88, D5276, D6344 (packaging and shipping), ASTM F1980 (shelf life aging), and FDA guidance on software validation and cybersecurity.

The subject device has the same intended use as the predicate (fluid irrigation in endourological procedures) and uses the same peristaltic pump technology. Differences in maximum pressure, operating modes, compatible fluids, and addition of the flush feature do not raise different safety or effectiveness questions, as confirmed by comprehensive non-clinical testing including biocompatibility, performance, electromagnetic compatibility, and comparative bench testing showing similar intraluminal pressures and flow rates to marketed devices.