Qitexio® 4-Way Stopcock (QIT014)

The Qitexio® 4-Way Stopcock is a flow control and delivery device for intravenous fluid injection into the patient's vascular system. It is designed for medium pressure injection of fluids and is specifically qualified for delivery of Lipiodol (Ethiodized Oil), an iodinated contrast imaging agent. It is single-use only and not intended for infusion.

The device has four ports (three female, one male) compared to the predicate's three ports (two female, one male). It features an L-shaped diverter that opens two neighboring ports simultaneously, whereas the predicate opens one port at a time. The subject device is made of polyamide (body and rotator) and polybutylene terephthalate (handle), differing from the predicate's polycarbonate and acetal materials. Maximum pressure rating is 550 psi versus the predicate's 500 psi (medium-pressure) or 1200 psi (high-pressure). It uses gamma irradiation for sterilization versus the predicate's ethylene oxide and has a 3-year shelf life versus up to 1 year for the predicate.

ISO 80369-7 and ISO 80369-20 (Luer connectors and pressure testing); ISO 10993-1, 10993-4, 10993-5, 10993-10, 10993-11, 10993-12, 10993-17, and 10993-18 (biocompatibility and chemical characterization); ISO 11607-1, ASTM F1980-21, and ASTM F1886/F1886M-16 (sterilization and package integrity); ISO 11137-1 and ISO 11137-2 (microbiological validation); USP <85>, <151>, and <788> (pyrogenicity and particulates); ISTA 3A-2018 (transportation); FDA Guidance on Human Factors and Usability Engineering and Intravascular Administration Sets.

Both devices share the same intended use as flow control and delivery mechanisms for IV fluids at medium pressure, are single-use and individually sterilized, and possess one male Luer with a mobile/rotating ring for secure locking. Both withstand medium pressure up to 500 psi. The material differences, additional female port, L-shaped diverter design, Lipiodol compatibility, extended shelf life, and sterilization method were evaluated through non-clinical performance testing, biocompatibility studies, and use-related risk analysis, which demonstrated these differences do not raise new safety or effectiveness concerns. The device's performance under bench testing confirms it maintains its intended function and is robust under the conditions of use.