Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)

The Codman Libertís EVD Catheter with Bactiseal® and Endexo® Technology is a ventricular catheter used to access the brain's ventricles and drain cerebrospinal fluid (CSF) to reduce intracranial pressure. The catheter is impregnated with two antimicrobial drugs (rifampicin and clindamycin hydrochloride) via Bactiseal treatment and incorporates an Endexo polymer surface modifier to reduce thrombus formation and bacterial adhesion.

Key changes include addition of the Endexo surface-modifying polymer additive to the silicone base; enlarged inlet holes on the smaller 1.5 mm catheter (model 821761) to maintain equivalent performance; addition of numerical depth markings and circumferential bands; different ink formulation for marking adherence; modified trocar and stylet designs for usability; and a shift from steam sterilization to electron-beam radiation sterilization with new packaging (PETG tray, nylon/LDPE barrier, nitrogen-filled pouches) to protect antibiotic integrity.

Testing followed ASTM F647, ISO 7197 (catheter evaluation); ASTM F2503 (MRI compatibility); ASTM F1980 and ISO 11607-1 (shelf life); ISO 10993-1 (biocompatibility); and internal performance, mechanical, antimicrobial efficacy, and usability validation methods.

The proposed device has identical intended use and basic functionality to the predicate (Bactiseal EVD Catheter Sets, K233448). Although multiple design and material changes were made, they are characterized as incremental improvements or manufacturing optimizations—larger inlet holes maintain equivalent surface area, Endexo is a passive polymer additive that does not introduce new mechanisms of action, and electron-beam sterilization achieves the same sterility assurance level (SAL 10⁻⁶) as steam sterilization. Comprehensive bench testing confirmed performance equivalence pre- and post-aging, antimicrobial efficacy is maintained, and biocompatibility is demonstrated. Because no new safety or effectiveness questions are raised and performance specifications are preserved, the device remains substantially equivalent despite the modifications.