SteriHub™ Disinfecting Device and Protective Cover

The SteriHub Disinfecting Device and Protective Cover is a single-use sterile cap containing 70% isopropyl alcohol (IPA) designed to actively disinfect needleless connectors through mechanical scrubbing (twisting back and forth ten times) while delivering IPA. After disinfection, it provides a physical barrier against contamination for up to 7 days and can be used in home or healthcare facility settings.

The subject device uses active mechanical scrub disinfection with an HDPE ribbed housing, thermoplastic element, and LDPE core filled with 70% IPA, compared to the predicate PureHub's passive soak method using a polyester urethane sponge. Both deliver 70% IPA, maintain a 7-day protective barrier, and target the same microbial organisms, though the subject device is tested against six organisms while the predicate includes seven (with the addition of Acinetobacter baumannii in the predicate).

ISO 13485 (Design controls, Nonconforming product, Corrective and preventative action), ISO 10993 series (Biocompatibility: cytotoxicity, hemolysis, sensitization, irritation, acute systemic toxicity, subacute toxicity, pyrogenicity), USP <85> (LAL Endotoxin), USP 788 (Particulate Testing), and Guinea Pig Maximization Test for sensitization.

The subject and predicate devices share identical intended use (disinfect needleless connectors and provide a 7-day barrier using 70% IPA), regulatory classification, and product code. While the subject uses active scrub disinfection versus the predicate's passive soak, this is comparable to the legally marketed reference device Site-Scrub (K112791), and performance testing demonstrates >4 log reduction against all target organisms. Differences in internal materials and design have been validated through comprehensive performance, microbiological, biocompatibility, and particulate testing, establishing that the subject device is as safe and effective as the predicate with no new safety or effectiveness questions.