Break Wave

The Break Wave is an extracorporeal shock wave lithotripter designed to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper and lower regions). It uses a portable ultrasound-guided system with piezoelectric therapy probes to deliver acoustic pulses that break stones into fragments that can pass spontaneously, without requiring patient sedation.

The device maintains similar core characteristics to its predicate: focused acoustic waves for non-invasive stone fragmentation, high voltage generator, multiple piezoelectric therapy probes for variable stone depths, direct skin coupling, and continuous ultrasound imaging/localization. Minor technological differences include decreased probe diameter, addition of a fourth therapy probe, introduction of RFID licensing technology, minor user interface updates, optional mechanical arm components, and an optional external display kit for patient viewing.

IEC 60601-1 (basic safety and essential performance), IEC 60601-1-2 (electromagnetic compatibility), IEC 61846 (shock wave lithotripsy special controls), IEC 60601-2-36 (shock wave lithotripsy electrical safety), IEC 62366 (usability), and IEC 62304 (software verification and validation).

The Break Wave is substantially equivalent to its predicate device (K252913) because it has the same intended use for fragmenting kidney and ureteral stones, maintains similar technological characteristics and operating principles, and the minor design differences (probe diameter, fourth probe, RFID technology, interface updates, and optional accessories) do not raise new or different questions of safety or effectiveness as demonstrated by non-clinical testing consistent with predicate device standards.