Argos Infinity (Rev. 1.0)

Argos Infinity is a software-as-a-medical-device designed to calculate hemodynamic parameters (cardiac output, stroke volume, systemic vascular resistance, and pulse pressure variation) from invasive radial arterial blood pressure signals obtained via hospital network data aggregation systems. It is intended for use in adult patients (18+) in operating rooms and intensive care units, deployed on a hospital network server and accessible for bedside or remote clinical monitoring.

Argos Infinity uses an identical algorithm to the predicate Argos Monitor with no changes to signal processing or calculation methods. The key differences are implementation-based: Argos Infinity is a software-as-a-medical-device deployed on a hospital network server (versus the predicate's physical monitor form), supports remote and centralized command-center monitoring in addition to bedside use, and features a multi-patient view interface alongside single-patient view. Clinical validation was performed using Philips IntelliVue and GE CARESCAPE patient monitors.

ISO 14971 (risk management), ISO 62366 (usability), IEC 62304 (medical device software lifecycle), IEC 82304 (health software lifecycle), IEC 81001 (network security), and IEC 60601-1-8 (medical device safety standards).

Argos Infinity is substantially equivalent because the underlying algorithm is identical to the predicate, clinical testing comparing cardiac output results from both devices against identical input recordings met pre-specified equivalence criteria (≤0.1 L/min or 6% bias), and independent comparison to pulmonary artery catheter thermodilution showed clinically and statistically indistinguishable performance. Differences are limited to deployment model and user interface; no new safety or effectiveness questions are raised.