WARD-CSS (v1.2.x)

WARD-CSS is a clinical decision support system that remotely integrates, analyzes, and displays continuous vital sign data from medical devices via mobile and web applications for non-pediatric hospitalized patients in non-critical care units. It uses standardized rules based on scientific and clinical evidence to detect and alert healthcare professionals to clinically relevant vital sign deviations, while explicitly not replacing current monitoring practices or clinical judgment.

WARD-CSS has the same product code (MWI), regulation (870.2300), intended users (healthcare professionals), patient population (hospitalized adults, non-ICU), monitoring role (adjunctive), vital signs monitored (heart rate, oxygen saturation, respiration rate, temperature, blood pressure), platforms (mobile and web apps), and algorithm type (threshold-based) as the predicate Capsule Surveillance System. Both use direct detection from vital sign data with 1-minute monitoring resolution.

Software Testing per IEC 62304 and Human Factors per IEC 62366-1 were performed to demonstrate safety based on current industry standards.

WARD-CSS is substantially equivalent because it shares identical intended use and indications for use with the predicate device—both are clinical decision support systems using standardized rules to alert clinicians to relevant vital sign deviations in hospitalized adult patients without replacing clinical judgment. The technological characteristics are identical across product code, regulation, vital signs monitored, platforms, algorithms, and alert mechanisms. WARD-CSS demonstrated superior performance by reducing alert numbers by 97.8% compared to threshold-only monitoring through time duration filters and alert prioritization logic, which represents an improvement rather than a new safety concern, and clinical testing on 794 patients confirmed safety across medical and surgical cohorts.