EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)

The EHL probe (SCDG-AS, SCDG-BS, SCDG-CS) is a sterile, single-use electrohydraulic lithotripsy device designed to fragment biliary stones in the bile duct. It delivers low-energy electrical pulses through a connection to the TCS-B3-II electrohydraulic lithotripter, generating hydraulic shock waves in saline to disintegrate bile duct stones.

Both the subject device and predicate (EL27-Compact, K230488) use identical electrohydraulic shock wave mechanisms for stone fragmentation with biocompatible materials and single-use sterile design. The subject device is dimensionally smaller in total length, energy output line, electrode length, and probe diameter, but maintains identical structural composition, similar materials, and the same energy delivery mechanism with validated equivalent performance.

ISO 10993-1 (biocompatibility), ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 10993-11 (biocompatibility testing), IEC 61846 (shock wave characterization and pressure attenuation), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC requirements), ASTM F1980 (aging/durability testing).

The subject device is substantially equivalent because it employs the identical electrohydraulic lithotripsy mechanism as the predicate, uses the same biocompatible materials and sterilization method (ethylene oxide), and achieves equivalent performance through bench testing including shock wave efficacy, stone fragmentation, tissue perforation, and electrical safety. Although dimensionally smaller, the minor dimensional differences do not compromise functionality given identical structural composition and validated performance equivalence, thus raising no new safety or effectiveness questions.