Pressio 3 Multi-parameter Neuromonitoring System

The Pressio® 3 Multi-parameter Neuromonitoring System is an invasive intracranial pressure (ICP) monitoring device used in neuro-intensive care units and neurosurgical departments. It measures and displays ICP values, waveforms, and intracranial temperature (ICT) when connected to compatible Pressio® catheter kits, and can also calculate cerebral perfusion pressure (CPP) and cerebral autoregulation indices when MAP data is obtained from a patient bedside monitor.

The Pressio® 3 replaces two separate connectors on the Pressio® 2 with a unified PSO-MPM01 extension cable, allowing compatible patient monitor cables (PSO-MCPxx and PSO-MCT2-y) to be plugged in. The device adds new software functions for displaying P2/P1 compliance ratios, CPP calculation and pressure time dose display, CPP threshold monitoring, and PRx (Pressure Reactivity Index) for cerebral autoregulation assessment. All core ICP and ICT measurement and monitoring functions remain substantially similar to the predicate.

IEC 60601-1:2005/AMD1:2012/AC1:2014/A2:2020 (general electrical safety), IEC 60601-1-2:2014/A1:2020 (EMC), IEC 60601-1-8:2006+A1:2012+A11:2017/A2:2020 (alarm systems), IEC 80601-2-49:2018 (multifunction patient monitors), ISO 80601-2-56:2017/A1:2020 (clinical thermometers), IEC 62304:2006+A1:2015 (software life cycle), ISO 10993-1:2020 (biocompatibility), and ISO 15223-1:2021 (labeling symbols).

The Pressio® 3 is substantially equivalent to the predicate Pressio® 2 ICP Monitor (K162108) because both devices share the same manufacturer, classification, product code, intended use (continuous invasive ICP monitoring in neuro-intensive care), compatible catheter systems, and core measurement functions. The Pressio® 3's enhancements—enhanced software features for CPP, compliance, and autoregulation monitoring, and connector redesign—do not alter the fundamental ICP/ICT measurement technology or the device's safety and effectiveness profile relative to the predicate.