TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System

The TINGSN FINDERS 2 is a diagnostic ultrasound system for intracardiac and intra-luminal imaging of cardiac and great vessel anatomy in adult patients. It comprises an ultrasound console with a 17.3-inch touch screen and a disposable 10Fr intracardiac echocardiography catheter with a 64-element phased array transducer. The system supports B-mode, M-mode, Color Doppler, PW Doppler, CW Doppler, and Power Doppler imaging, and is intended for use by trained physicians in electrophysiology or catheterization laboratories.

The device operates at 4.5–9.5 MHz (narrower than the predicate's 4–10 MHz) and delivers Track 3 acoustic output. It uses a 64-channel phased array transducer identical to the predicate. The insertable catheter length is 95 cm (versus the predicate's 90 cm). Core imaging modes (B, M, Color, PW Doppler, CW Doppler, Power Doppler) match the predicate, though the predicate additionally supports Real-Time 3D (4D) and harmonic imaging. Both employ identical sterilization (ethylene oxide), 10Fr diameter, and similar deflection mechanisms.

IEC 60601-1 Edition 3.2, IEC 60601-1-2:2020, IEC 60601-2-37:2015, IEC 62359:2017, NEMA UD2:2004, ISO 10555-1:2013, ISO 10993-1:2018, ISO 14971:2019, ASTM D4169-2022, and FDA Ultrasound Guidance (February 2023). Software documentation follows FDA Guidance for Device Software Functions (June 2023).

Although the proposed device is narrower in scope (ICE-only, no 3D/4D), the predicate device (GE Vivid iq) explicitly supports ICE catheters and thus encompasses the proposed device's indications without introducing new risks. The catheter component shares identical core specifications (64-channel phased array, 10Fr, Track 3 output, same sterilization, same deflection) with the predicate SOUNDSTAR 3D catheter, differing only in slightly longer insertable length (95 vs. 90 cm) and narrower frequency band (4.5–9.5 vs. 4–10 MHz), neither of which compromises clinical safety or efficacy. Non-clinical testing and risk analysis confirm the device meets design specifications and relevant standards without introducing new failure modes.