NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is a diagnostic intravascular ultrasound catheter designed to evaluate vascular morphology in coronary and peripheral blood vessels by producing cross-sectional images. It operates over a 0.018-inch guidewire and is used as an adjunct to conventional angiography to visualize vessel lumen and wall structures, but is not indicated for cerebral vessels.

The NES reprocessed device has identical technological characteristics to the predicate device, including the same design, materials, chemical composition, principle of operation using a cylindrical ultrasound transducer array, energy source, and method of operation. There are no changes to claims, clinical applications, patient populations, performance specifications, or operational methods.

Not stated in this summary. The document references specific test methods (cleaning validation, sterilization validation, functional testing including visual inspection, dimensional verification, simulated use, mechanical characteristics, system compatibility, image acuity, transducer acoustic output, thermal testing, and biocompatibility testing) but does not cite specific consensus standards by designation (ISO, IEC, ASTM, etc.).

Substantial equivalence is established through testing demonstrating that the reprocessed catheter maintains performance and safety equivalent to the predicate. The test methods and acceptance criteria used are identical to those employed in the previously-cleared K200195 (reprocessed .014 IVUS model), which is a different model in the same device family with the same indications. The catheter is reprocessed only once with device-level tracking, and reprocessing is restricted to single-use only by Northeast Scientific to ensure safety.