VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

The VERAFEYE System is an intracardiac echocardiography imaging device consisting of an 11-French single-use catheter and an ultrasound console. It provides real-time 2D and 3D ultrasound visualization of cardiac anatomy, valves, great vessels, and other cardiac devices during minimally invasive procedures in adult patients. The device is intended for imaging guidance only, not treatment delivery, during cardiac interventional procedures.

The VERAFEYE Imaging Catheter uses a 64-channel segmented aperture ultrasound transducer operating at 5.25 MHz, compared to the predicate's 192-channel array. The catheter is 11 French (3.7 mm) outer diameter with 95 cm insertable length, slightly smaller than the predicate's 12.5 French. Both use identical imaging modalities (2D B-mode and 3D), ultrasound energy, EtO sterilization, and biocompatible materials compliant with ISO 10993-1. The console supports identical software features including volume ICE package, measurements, and Windows 10 operating system.

Testing referenced includes UL 60601-1 (medical device safety), IEC 60601-2-37 (diagnostic ultrasound safety), AIUM/NEMA UD-2 and UD-3 (acoustic output measurement and thermal/mechanical indices), ISO 10993-1 (biocompatibility), ISO 11135 (EtO sterilization), ISO 11607-1 and 11607-2 (packaging), IEC 62304 (software lifecycle), and IEC 62366 (usability).

Both devices are diagnostic intracardiac catheters with identical intended use, identical principles of operation (ultrasound-based intra-luminal visualization for imaging guidance), and comparable technological characteristics including imaging modality, sterilization method, materials, and console features. Although the VERAFEYE catheter has fewer transducer channels (64 vs. 192) and smaller diameter (11F vs. 12.5F), these represent minor design variations that do not raise new safety or effectiveness questions. Bench, laboratory, and electrical safety testing demonstrated no adverse differences, and the device complies with the same safety and performance standards as the predicate, supporting substantial equivalence.