EchoNavigator R5.0

EchoNavigator R5.0 is software that assists interventionalists and surgeons in treating cardiovascular diseases by displaying live X-ray and ultrasound (echo) images simultaneously during procedures. The software receives live images from compatible X-ray and ultrasound systems, determines the echo probe position relative to the X-ray system using a software algorithm, and displays the echo images overlaid with or alongside the X-ray images to guide device and catheter navigation.

EchoNavigator R5.0 uses the same underlying operating principle as the predicate device (R4.0): receiving live X-ray and echo images, calculating probe position through software algorithms, and displaying synchronized images side-by-side or fused. The new R5.0 version adds M-TEER device detection and overlay functionality using artificial intelligence to visualize therapy device shape, trajectory, and orientation in real time, along with UI harmonization with the EPIQ ultrasound system.

IEC 62304 (software lifecycle), IEC 62366-1 (usability engineering), IEC 82304-1 (health software safety), ISO 14971 (risk management), ISO 15223-1 (symbols), ISO 20417:2021 (labeling), UL ANSI 2900-1/2-1 (cybersecurity), IEC 81001-5-1 (health IT security). FDA guidance documents on 510(k) evaluation, device software functions, cybersecurity, AI-enabled devices, and human factors were also applied.

EchoNavigator R5.0 is substantially equivalent to predicate EchoNavigator R4.0 because they share the same indications for use, technological operating principles, and safety profile. All core features and algorithms remain identical; only the new M-TEER device detection feature using AI and UI harmonization were added. Non-clinical verification and validation testing, including algorithm testing on 72 patient datasets with ≤5mm positional accuracy and ≤10° orientation accuracy, demonstrated the device meets acceptance criteria and does not raise new safety or effectiveness concerns.