HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

The HYDROS Robotic System is a fluid jet-based surgical device for resecting and removing prostate tissue in males with lower urinary tract symptoms due to benign prostatic hyperplasia. It comprises three components: a robotic tower with software and motorized arms, a biplane transrectal ultrasound (TRUS) probe for imaging, and a single-use sterile handpiece with integrated digital camera that is inserted through the urethra to visualize and remove prostatic tissue.

The subject device features physician authorization enabled on the surgeon monitor or via motorpack button (versus predicate only on surgeon monitor), an updated AI model for landmark identification in the FirstAssist AI Sagittal feature, two additional reprocessing methods for the TRUS probe (CIDEX OPA and STERIS V-Pro maX sterilization), extended TRUS probe reprocessing validation (71 cycles versus 25 in predicate), and extended handpiece shelf life (24 months versus 6 months). All other specifications including operating environments, workflow steps, ultrasound integration, and cystoscope imaging parameters remain equivalent to the predicate.

Standards cited include IEC 62366-1:2015 (usability), IEC 60601 series (electrical safety and EMC), ISO 10993 series (biocompatibility), EN ISO 11135:2014 (ETO sterilization), ISO 8600 series (endoscope optical resolution), IEC 62127-1:2022 (ultrasound characterization), ASTM standards for packaging and corrosion testing, and FDA guidance documents for BPH device development, cybersecurity, software, and AI/ML in medical devices.

The HYDROS Robotic System is substantially equivalent to its predicate device (K240200) because both share identical intended use, patient population, indications, user training requirements, and core functionality for aquablation of prostate tissue. The subject device enhancements (improved AI model, additional sterilization options, extended shelf life, dual authorization pathway) represent refinements that do not alter the fundamental mechanism of action, safety profile, or performance. All non-clinical testing demonstrates pass results across system verification, electromagnetic compatibility, basic safety, sterilization, biocompatibility, software, and cybersecurity domains.