Break Wave

The Break Wave is an extracorporeal shock wave lithotripter designed to fragment urinary stones in the kidney and ureter non-invasively. It uses piezoelectric acoustic waves focused by a lens to break stones into small fragments that can pass spontaneously, with real-time ultrasound imaging guidance for stone localization and treatment monitoring.

The Break Wave uses lower amplitude, longer duration acoustic pulses and a higher pulse rate than the predicate device. It features a smaller therapy probe head with an acoustic lens for focusing, can be hand-held or mounted on a mechanical arm, couples directly to the patient's skin without a water membrane, and does not require an integrated table or water circulation system.

IEC 60601-1, IEC 60601-1-2 (electrical safety and EMC); IEC 61846 and IEC 60601-2-36 (SWL special controls); ANSI AAMI ST98:2022 (reprocessing); ISO 10993-1 (biocompatibility); IEC 62366 (usability); IEC 62304 (software verification and validation).

The Break Wave has the same intended use as the predicate device (Piezolith 3000) and maintains similar primary system components and function. Non-clinical and clinical data demonstrate that technological differences do not introduce new safety or effectiveness questions; clinical study showed 70% success rate with adverse events consistent with known lithotripsy risks and no clinically significant hematoma, sepsis, or arrhythmia events.