Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)

The Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter is a reprocessed intravascular ultrasound catheter intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy during cardiac interventional procedures in adult patients. It is used for imaging guidance only, not treatment delivery, and allows physicians to steer the catheter tip to optimize tissue visualization.

The subject device is a reprocessed version of the predicate device with identical technological characteristics, materials, and fundamental scientific technology. Both devices are 10F catheters with 64-element phased array transducers offering four-way tip deflection, compatible with ACUSON, Vivid I, and Vivid q console systems. Each reprocessed catheter is tracked and removed from service once maximum reprocessing cycles are reached.

Not stated in this summary.

Substantial equivalence is established because the predicate device models (K170263 AcuNav Diagnostic Ultrasound Catheter 8F and 10F) include the exact same device models as the subject devices. The only difference is that the subject devices have undergone reprocessing. Comprehensive non-clinical testing—including functional performance, electrical safety, cleaning validation, biocompatibility, sterilization validation, and shelf-life studies—demonstrated that the reprocessed devices maintain equivalent performance to the predicate. Since the physical devices, indications for use, and technological characteristics are identical to the predicate, and functional testing confirms equivalence after reprocessing, substantial equivalence is supported.