High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube

This device consists of five components (high pressure syringe, pressure connecting tube, spike, transfer tube, and quick fill tube) designed to work together with FDA-cleared angiographic injectors for injecting contrast media or saline during medical imaging procedures. All components are single-use, sterile devices compatible with various US-marketed injector models including Stellant, Mark V/VII, Spectris, Angiomat, OptiVantage, CT OptiOne, OPTISTAR, Dual Shot, and Empower systems.

The subject device differs from the predicate in offering: (1) an accessory prime tube for specific syringe models; (2) maximum withstanding pressures of 350 psi and 1200 psi (versus predicate's 300, 400, and 1200 psi); (3) different syringe volumes and tube lengths within comparable ranges; (4) compliance with ISO 80369-7 for Luer connectors rather than older ISO 594 standards; and (5) different patient-contact materials including PC/PP syringe barrels, PE plungers, PVC tubing without DEHP, and PP protective caps.

ISO 10993-1 (biocompatibility), ISO 11135:2014 (sterilization), ISO 10993-7 (EO/ECH residuals), ASTM F1980-21 (shelf life), ISO 11607-1:2019 (package validation), ISO 8536-4, ISO 80369-7, ISO 7886-1, ISO 7886-2, USP <85> (endotoxins), and USP <788> (particulate matter).

The subject device is substantially equivalent because it performs the same intended function as the predicate (connecting to angiographic injectors for contrast/saline injection), uses similar materials and designs, maintains comparable pressure ratings and dimensions, passes identical biocompatibility and performance testing, and differences in pressure values, component materials, and available options do not raise new safety or effectiveness questions as verified through comprehensive bench testing and standards compliance.