Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters (8F, 8FG, 10F, 10FG) are diagnostic intravascular catheters used for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy. When used with compatible CARTO 3 EP Navigation Systems, the catheters provide location information to guide electrophysiology procedures.

The subject devices are reprocessed versions of predicate devices with identical technological characteristics: 64-element ultrasound transducers providing 2D imaging, 3D location sensors for CARTO 3 integration, and four-directional tip deflection. Models differ in shaft diameter (8F or 10F) and ultrasound system compatibility (Siemens for 8F/10F; GE for 8FG/10FG). Each catheter is reprocessed no more than one time and tracked until maximum cycle limits are reached.

Not stated in this summary.

The subject devices are substantially equivalent because they are reprocessed versions of legally marketed predicate devices (K140318 for 8F/8FG models; K112050 for 10F/10FG models) with identical indications for use, design, materials, and technological characteristics. Functional performance testing including ultrasound transducer operation, localization capability, mechanical characteristics, cleaning validation, biocompatibility, sterilization validation, and electrical safety confirmed equivalence to the predicates. The only difference—reprocessing—does not alter the fundamental design or intended function of the devices.