Device Dossier

Nephrology information system application software

Device Dossier for Nephrology information system application software (Nephrology information system application software, Class IIa, sponsor Vantive).…

Intended purpose

Sharesource Adequest is a stand-alone software application, which assists clinician calculations used in defining treatment parameters for peritoneal dialysis therapy. Sharesource Adequest is intended to calculate solute clearances and net fluid removal for individual patients, based on therapy parameters provided by the clinician. Additionally, it is intended to assist the clinician in calculating patient peritoneal membrane transport characteristics and peritoneal dialysis adequacy from data that is input into the system by the clinician. The resulting information is used by clinicians in their selection of treatment regimens for individual patients. The calculations can be used for both Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD) patients and are based on publicly available information. It is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.

TGA Public Summary