ASEPT® Glide Peritoneal Drainage System

The ASEPT Glide Peritoneal Drainage System is an indwelling catheter that drains accumulated fluid from the abdomen in patients with symptomatic, recurrent ascites (malignant or non-malignant) that does not respond to medical management. For non-malignant ascites, use is limited to adults intolerant or resistant to maximum medical therapy and refractory to large volume paracentesis who are not candidates for shunt placement.

The device consists of an indwelling ASEPT Glide Peritoneal Catheter and ASEPT Drainage Kit. The catheter features a surface modification applied from the distal tip to the polyester cuff. The technological design features including intended use, design, materials, drainage function and method, and fundamental scientific technology were compared to the predicate device.

Biocompatibility was tested in accordance with ISO 10993 standards. Device sterilization process was validated in accordance with ISO 11135:2014. Bench testing was performed on the catheter and replacement valve.

The subject device demonstrates substantial equivalence through identical intended use (drainage of refractory ascites), comparable design and materials, equivalent drainage function and method, and the same fundamental scientific technology as the predicate ASEPT Peritoneal Drainage System (K221779). Bench testing, biocompatibility testing per ISO 10993, and sterilization validation per ISO 11135:2014 confirmed the device performs as well or better than the legally marketed predicate.