Clave™ Neutral-Displacement Needlefree Connectors

The Clave Neutral-Displacement Needlefree Connectors (MicroClave, NanoClave, Clave Neutron) are needle-free, bidirectional connectors with a pre-slit septum that prevents microbial ingress when not in use and allows IV fluid and blood aspiration/injection when activated with a male Luer connector. They can be used with power injectors at up to 400 psi and 10 mL/sec flow rate, and prevent microbial ingress for seven days.

The subject device body material was changed from polyester (predicate) to polycarbonate, which is the same material as other device components. The maximum pressure infusion rating was increased from 350 psi to 400 psi. New testing supports a claim that the device prevents microbial ingress for seven days rather than the three days evaluated in the predicate. Compatibility was expanded to include chlorhexidine (CHG) disinfectants and disinfectant caps.

ISO 8536-4, ISO 8536-8, ISO 8536-10, ISO 11607-1, ISO 11607-2, ISO 11137-1/A1, ISO 11137-2, ISO 80369-7, ISO 10993-1, ANSI/AAMI CN27, ANSI/AAMI ST72, USP <85>, and USP <788>.

The subject device operates on the identical principle as the predicate K100434 (neutral displacement with pre-slit septum and self-sealing mechanism). The material change to polycarbonate for the body does not introduce safety concerns per ISO 10993 biocompatibility testing. The increased pressure rating and extended microbial ingress prevention duration are supported by non-clinical testing per ANSI/AAMI CN27 and published clinical data showing reduced bloodstream infection risk. These differences do not raise new safety or effectiveness questions because the core function and mechanism remain unchanged.