ClaveQS™ Bag

The ClaveQS™ Bag is an empty EVA container with an integral Clave connector and administration set ports designed for compounding and administering parenteral solutions. Medication is transferred in and out using aseptic technique, with the Clave offering neutral displacement and microbial ingress prevention for up to 400 activations over seven days.

The ClaveQS™ Bag comes in two configurations with either one add port plus one spike port, or two add ports, compared to the predicate SmartSite Bag which has one add port and one spike port. Both devices use the same sterilization method (irradiation to SAL 10^-6), are single-use only, and share the same general empty bag and port design, though materials of construction differ.

ISO 10993-1:2018 for biocompatibility testing, ISO 15747 for IV container performance, ANSI/AAMI CN27 and ISO 8536-4 for Clave port performance, ISO 80369-7 for compatibility, and USP <788> for infusate compatibility. Testing also included assembly integrity and CHG disinfectant cap compatibility.

The subject device is substantially equivalent to the predicate SmartSite Bag because both share the same intended use for administration of IV solutions using aseptic technique, employ identical sterilization methods, are designed for single-use, and biocompatibility testing demonstrates equivalent safety. Minor differences in port configuration and materials do not affect the fundamental ability to administer fluids aseptically.