Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)

The Shear Wave Quantificational Ultrasound Diagnostic System is a portable diagnostic ultrasound device that uses transient elastography to measure liver stiffness and tissue attenuation non-invasively. It provides 50 Hz shear wave speed measurements and ultrasound attenuation parameters, and is indicated for clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as well as general-purpose ultrasound imaging and Doppler flow analysis.

The device consists of a fibrosis scanning probe (single-element, 2.5 MHz, with external mechanical vibrator) and an imaging probe (multi-element array, 3.5 MHz) with B, CFM, PWD, and M modes. The subject device offers a broader range of M-mode applications compared to the predicate. Both fibrosis and imaging probes use piezoelectric ultrasound sources, and measurement depth is 15-85 mm. The system supports measurement and display of liver stiffness (2.0-80 kPa) and UAP (90-450 dB/m) with interquartile range reporting.

ISO 10993 series (biocompatibility, skin sensitization, irritation), IEC 60601-1 and IEC 60601-2-37 (electrical safety and essential performance), IEC 62359 (thermal and mechanical indices), IEC 62304 (software life cycle), IEC 60601-1-2 (electromagnetic compatibility), FDA guidance for diagnostic ultrasound system clearance and software validation, and IEC 62133-2 (lithium battery safety).

The subject device shares the same intended use, intended patient population, technology (transient elastography), and general design principles as the predicate. Performance parameters for liver stiffness bias and precision are similar or slightly tighter (subject: -2.1% to 3.5% bias, 0.0% to 3.8% precision vs. predicate ranging -4.7% to 3.5% bias). Similarly, UAP bias and precision are comparable. The broader M-mode application range in the subject device does not raise different safety or effectiveness questions because M-mode is widely used in ultrasound systems. All differences are slight and do not introduce new risks.