Clinical Efficacy and Performance.
Ablation Success Rates: Documented amenorrhea rates (e.g.,>50-60%) and a significant reduction in bleeding (e.g.,>90% patient satisfaction) at 12 months post-procedure from clinical trials or post-market surveillance.
Treatment Time: Short, standardized procedure time (e.g., typically <90 seconds for the RF energy delivery phase, total procedure time including setup and removal <5-10 minutes)
Uterine Cavity Compatibility: Stated range of uterine lengths (e.g., 6-10 cm, or 8-12 cm) and fundal width accommodation (e.g., by expandable array). Ensures applicability to a broad range of patients without requiring multiple specialized probes, reducing inventory and ensuring more patients are eligible (e.g., 4-6mm) across the entire endometrial surface, including cornual regions, as confirmed by histology or follow-up. Importance: reduced risk of incomplete alation, persistent bleeding, and need for repeat procedure.
End-point Detection: Automatic system shut-off based on reaching specific internal parameters (e.g., impedance rise, temperature plateau, complete energy delivery) that indicate successful ablation. Endures consistent, complete ablation while preventing overtreatment and relies less on user judgment, improving consistency across multiple gynecologists.
Real-time Monitoring and Feedback: Continuous, real-time display of critical parameters such as intrauterine temperature, pressure (if balloon-based), and impedance. Allows immediate detection of potential issues (e.g., perforation, inadequate tissue contact) and endures optimal ablation. System automatically terminates energy delivery and provides distinct auditory/visual alarms for abnormal conditions (e.g., uterine perforation/pressure drop, excessive temperature, high impedance, low tissue contact, power surges0. Prevents patient injury and ensures a safe procedure even with varying user experience.
Intuitive user Interface: Touchscreen interface with clear, guided prompts; minimal steps for setup and operation; single button start/stop for ablation. Can be assessed by observing average setup time for a new user (< 5 minutes) or number of steps to initiate therapy. Reduces training time for six gynecologists and support staff, minimized user errors and streamlines workflow in a busy operating room (OR).
Disposable Probe/Catheter Design: Single use, presterilized probe. Easy inserting and removal without complex maneuvers. Minimal components for assembly. Ensures sterility, eliminates reprocessing needs, and simplifies setup/takedown for faster OR turnover.
Does not have to interface with other equipment.
Minimum one-year warranty, guaranteed service response time (e.g., <24 hours for phone support, <48 hours for on-site repair), comprehensive warranty (e.g., 1-2 years) and availability of local field service engineers. Ensure rapid resolution of issues, minimizing disruption to patient scheduling.
Clear policy on software upgrades (e.g., free for the life of the product, or clear upgrade path/cost) for performance enhancements and bug fixes. Ensure system remains current and supported.
Availability of on-site training for all six gynecologists and support staff, including hands-on simulation, clinical proctoring and comprehensive user manuals/videos.
Access to clinical specialists for ongoing questions, troubleshooting and best practice sharing. Valuable resource for optimization and addressing specific case challenges for multiple users. Ensure all six surgeons are proficient and comfortable leading to consistent outcomes and reduced errors.
FDA clearance (510(k)) and/or CE mark. Confirms device meets established safety and efficacy standards.
