Electrohydraulic Lithotriptor (TCS-B3-II)

The Electrohydraulic Lithotriptor (TCS-B3-II) is a compact, table-top medical device that generates high-voltage electric pulses transmitted through a disposable EHL probe to create hydraulic shock waves in saline, fragmenting biliary stones into smaller pieces that can be naturally passed or removed endoscopically. It is intended for use with Potent Medical disposable electrohydraulic lithotripsy probes for disintegration of concretions in the bile duct and is for prescription use only.

Both the TCS-B3-II and predicate device (EL27-Compact, K230488) generate high-voltage electric pulses to produce hydraulic shock waves, are table-top units controlled via foot switch with adjustable power settings, and provide single pulse and continuous pulse modes. Key differences are the TCS-B3-II features an advanced touch screen interface (versus simpler interface) and is lighter and more portable, though these differences do not affect safety or effectiveness.

IEC 61846 (electrohydraulic shock wave parameters and pressure attenuation), IEC 60601-1 (General Requirements for Basic Safety), and IEC 60601-1-2 (EMC Requirements). Bench testing included stone fragmentation, shockwave pressure attenuation, and acoustic characterization. Software underwent verification and validation per FDA guidance and was classified as basic documentation level.

The TCS-B3-II is substantially equivalent because it shares identical intended use (biliary stone fragmentation), core operating principles (high-voltage pulse generation producing hydraulic shock waves), and reliance on compatible disposable EHL probes as the predicate EL27-Compact. Performance and safety testing demonstrates comparable functionality across all operational modes and power settings. The technological differences (touch screen interface and portability) are enhancements that do not introduce new questions of safety or effectiveness and do not alter the fundamental mechanism or clinical performance of the device.