HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece

The HYDROS™ Robotic System is engineered for precise, image-guided resection of prostatic tissue in BPH patients using a robotically controlled fluid jet (Aquablation) with integrated ultrasound and cystoscopy. Its methodology includes optional AI-assisted surgical planning and has demonstrated comprehensive safety and performance in non-clinical evaluations.

The HYDROS™ Robotic System, developed by PROCEPT BioRobotics, is designed for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). The system consists of three primary components: the HYDROS™ Robotic System itself (which includes a tower, touchscreen interfaces, software, motorpack, robotic arms, and foot pedal), the reusable HYDROS™ TRUS Probe for biplane transrectal ultrasound imaging, and the single-use sterile HYDROS™ Handpiece with an integrated digital CMOS scope. The core technology involves a fluid jet system for prostate tissue removal, a procedure referred to as Aquablation, which is robotically controlled and guided by real-time ultrasound and cystoscopic visualization. The system features integrated ultrasound and cystoscopy capabilities, dual monitor displays for the surgeon and staff, touchscreen interaction, optional network/cloud connectivity, and an AI-powered planning tool called FirstAssist AI™ to assist in defining treatment parameters. The HYDROS™ Robotic System and its components have undergone extensive non-clinical performance testing, including simulated use and cadaver studies, to validate its design and performance. This testing regime demonstrated compliance with numerous international and FDA standards covering aspects such as usability, electromagnetic compatibility, basic safety, wireless functionality, sterilization (EtO for the handpiece), biocompatibility for patient-contacting parts, packaging, shelf-life, reliability, labeling, reprocessing for reusable elements, and the performance of its imaging, software (including AI/ML), and cybersecurity features. All reported non-clinical bench tests were successfully passed. The system differentiates itself from its predicate, the AQUABEAM® Robotic System, through its integrated imaging, updated surgeon interface, AI planning assistance, and connectivity features, while maintaining the core fluid jet ablation technology.

AI Regulatory Concerns

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• Q1. How does the FirstAssist AI™ feature specifically enhance surgical planning accuracy and efficiency for prostate tissue resection compared to purely manual methods?; What are the quantitative performance metrics from the cadaver and simulated use studies that substantiate the HYDROS™ system's efficacy and safety for prostate tissue removal via Aquablation?; Considering the system's network and cloud connectivity, what are the specific cybersecurity protocols implemented beyond standard risk management to ensure data integrity and patient privacy, especially if remote diagnostics or software updates are envisioned?; How does the image quality and diagnostic capability of the integrated HYDROS™ TRUS Probe and CMOS scope compare to the previously utilized third-party ultrasound and cystoscopy systems in guiding the Aquablation procedure?; What is the anticipated learning curve for urologists to achieve proficiency with the HYDROS™ Robotic System, including the effective use of the FirstAssist AI™ and mastering the nuances of the robotic controls for precise tissue ablation?