External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters

The Sophysa External CSF Drainage device consists of sterile catheters designed to temporarily drain cerebrospinal fluid (CSF) from the brain and spinal cord for up to 29 days. It includes two types: ventricular catheters inserted into the brain's ventricles and lumbar catheters inserted into the lower spine, both supplied with accessories like stylets, guidewires, and connectors to attach to external collection systems.

The ventricular catheters are 29-35 cm long with 1.5-2.3 mm inner diameter, while lumbar catheters are 90 cm long with 0.76 mm inner diameter. Both are single-use, supplied sterile, and cannot be re-sterilized. Accessories include stylets, trocars, luer-lock connectors, guidewires, Tuohy needles, and suture tabs. Ventricular catheters are MR Safe; lumbar catheters are MR Conditional due to metallic components in the compression hub. Target shelf life is 5 years.

ISO 7197, ISO 20697, ISO 20698, and ISO 11070 cited as applicable performance standards. Non-clinical testing included visual inspection, dimensional analysis, radiopacity, pressure/flow characteristics, blockage resistance, tensile and breaking strength, kink resistance, catheter fixation, corrosion resistance, and guidewire performance testing.

The proposed device operates through the identical mechanism as the predicates—inserting catheters into ventricular or subarachnoid spaces and diverting CSF into compatible collection systems. It shares the same intended use (temporary CSF drainage), single-use and sterile characteristics, and comparable dimensions and accessories to the Phoenix Neuro Catheters and Codman Lumbar Drainage predicates. The proposed device uses biocompatible materials verified through standard implantation and toxicity testing, employs ethylene oxide sterilization identically to predicates, and is designed to the same consensus standards, with only minor dimensional variations (e.g., lumbar catheter 90 cm vs. predicate 80 cm) that do not raise new safety or effectiveness concerns.