Arterial Pressure Monitoring Set/Tray

The Arterial Pressure Monitoring Set/Tray is a sterile, single-use diagnostic intravascular catheter kit designed for continuous arterial blood pressure monitoring and blood sampling in adult and pediatric patients. It comprises a pressure monitoring catheter, wire guide, entry access needle, and syringe, inserted percutaneously via the Seldinger technique into arteries such as the radial, femoral, or distal aorta. Different catheter sizes (2.5 to 5.0 French) accommodate patients from birth through adults, with age-specific indications for each size.

The subject device is technologically identical to its predicate devices (K180846 and K180792) in all material, design, and performance aspects except for a change in marker ink formulation from UVA Ink (Color #1 Black) to UVA Ink (TPC 980 Black Ink). Both the primary and secondary predicates used identical catheter shaft materials (polyethylene, ethylene-vinyl acetate, polyurethane), single-lumen straight-tip design, stainless steel wire guides, EtO sterilization, and Tyvek-lidstock tray packaging with 10⁻⁶ sterility assurance level.

The device was evaluated for biocompatibility in accordance with the ISO 10993 series. An additional ink legibility performance test was conducted to verify the new marker ink meets design requirements. No electrical safety, electromagnetic compatibility, or software testing was required, as the device contains no electrical components or software.

Substantial equivalence is established because the subject device is identical to the primary (K180846) and secondary (K180792) predicate devices in intended use, indications for use, and all technological characteristics except the marker ink. The change to TPC 980 Black Ink was validated through biocompatibility testing per ISO 10993 and ink legibility performance testing, demonstrating that the new formulation maintains equivalent performance and does not alter the device's safety or effectiveness profile.