Extracorporeal Shock Wave Lithotripter (U200)

The Extracorporeal Shock Wave Lithotripter (U200) is a medical device that uses high-energy electromagnetic shock waves to fragment urinary stones in the kidney and ureter. The device generates pressure pulses up to 35 MPa focused on stone locations identified by ultrasound assistance, breaking stones into smaller pieces that can be excreted naturally.

The U200 shares similar core components with the predicate device (LM-9200 ELMA), including control console, electromagnetic shock wave generator, water transmission system, ultrasound-based localization/imaging system, patient positioning table, and comparable acoustic output characteristics. Differences exist in specific design implementations, but these do not raise new safety or effectiveness questions.

ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021 (biocompatibility); ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-36, IEC 61846 (electrical safety and electromagnetic compatibility); FDA Guidance for Software Verification and Validation; FDA Guidance for Cybersecurity in Medical Devices; IEC 61846 (shock wave characterization).

The U200 has identical indications for use as the predicate device and shares the same functional design architecture for generating and focusing shock waves on urinary stones. Clinical testing demonstrated comparable safety and effectiveness profiles, with stone fragmentation rates and treatment efficiency similar to the predicate. The differences in design details do not create new mechanisms of action or safety risks, and bench and clinical testing confirmed performance equivalence to the predicate device.