Etiometry Platform (DAV 5.4 RAE 9.2)

The Etiometry Platform is a software-only ICU data aggregation and visualization system that collects physiological parameters from bedside devices and displays them for remote clinical consultation. It includes a Risk Analytics Engine that calculates four indices (IDO2, IVCO2, ACD, HLA) to provide adjunctive cardiovascular and respiratory status indicators for pediatric and adult intensive care patients, though it cannot alarm, control devices, or replace primary monitoring.

The device has identical technological characteristics to its predicate devices cleared under K223578 and K213423. The key change is that this submission unifies the predicate devices' IDO2 Index capability across both pediatric (0-12 years) and adult (18+ years) populations, whereas previously these were separated.

Not stated in this summary.

Substantial equivalence is based on identical indications for use, identical technological characteristics, and the same predicate device code (PPW). The clinical validation dataset of 4,721 data points from 779 patients met the same acceptance criteria as the predicate device—discriminatory power, range utilization, resolution/limitation, and robustness—with no adverse effects noted. The unification of the IDO2 Index across age groups represents a straightforward expansion of an already-cleared capability using the same mathematical model and validation methodology.