XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set

The XABO Catheters are antibiotic-impregnated silicone catheters used for cerebrospinal fluid (CSF) shunting in patients requiring fluid drainage from the brain or spinal cord. The system includes ventricular catheters (18–25 cm length), peritoneal catheters (60–120 cm length), and associated components like stylets and deflectors, designed to work with existing Miethke shunt systems.

The XABO Catheters are manufactured from barium sulfate-filled silicone elastomer impregnated with clindamycin hydrochloride and rifampicin for controlled release. Ventricular catheters feature 1.2 mm inner diameter, 2.5 mm outer diameter, with 16 proximal flow holes and length markers at 1 cm intervals. Peritoneal catheters have open tips and can be trimmed to length. Performance characteristics including zone of inhibition, drug content, drug release kinetics, and crush resistance are substantially equivalent to the predicate device.

ISO 7197 (catheter performance specifications), ISO 10993-1 (biocompatibility evaluation and risk management), ASTM F2052, ASTM F2213, ASTM F2182, ASTM FF2119 (MRI safety testing), and ASTM F2503 (MRI conditional assessment). Testing confirmed the deflector is MR Conditional in 3-Tesla systems.

The XABO Catheters are substantially equivalent because they have the same indications for use (CSF shunting), identical dimensions, tip configurations, and design features as the Medtronic ARES predicate device. Comparative performance testing demonstrates that both devices have the same technological characteristics and meet the same performance specifications. The antibiotic impregnation, material composition, and articulation with existing Miethke shunt systems are substantially equivalent in design, function, and principles of operation.