PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-

The PeritX™ Peritoneal Catheter System is a sterile, single-use indwelling catheter system for long-term drainage of symptomatic ascites (fluid buildup in the abdomen) in adults. It includes catheters, drainage kits, valve kits, access kits, and supplemental insertion supplies that enable home management of malignant and non-malignant ascites when medical therapy has failed or is not tolerated.

The subject device is substantially equivalent to the predicate in intended use, patient population, catheter-to-accessory interface, catheter materials, catheter design, mechanism of action, fundamental scientific technology, patient contact duration, and sterilization method. The primary difference is the addition of a new vacuum-initiated drainage kit accessory, the PeritX™ Drainage Kit, which did not exist in the predicate device.

ISO 14971:2019 (Medical Devices – Application of Risk Management to Medical Devices) was used to guide the internal risk assessment and determine which non-clinical tests to perform.

The device demonstrates substantial equivalence because the PeritX™ Drainage Kit accessory performs the same intended function (draining fluid from the peritoneal cavity) as existing drainage methods supported by the predicate device. Non-clinical testing confirmed that the new kit's technological characteristics and performance metrics—including tensile strength, volume capacity, leakage resistance, and sterilization—are comparable to the predicate device and maintain equivalent safety and effectiveness. Since the kit uses the same catheter interface and materials as the predicate system and adds only a vacuum-initiated collection option (functionally similar to other drainage methods already cleared for use), it does not introduce new safety risks or fundamentally alter the device's mechanism of action.