QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)

QMAPP® is a physiological/hemodynamic monitoring system intended for use by professional healthcare providers in cardiology, cardiac catheterization, electrophysiology, and radiology. The system displays and analyzes surface ECG, respiration, invasive pressures, pulse oximetry (SpO2), end-tidal CO2 (EtCO2), fractional flow reserve (FFR), non-invasive blood pressure (NiBP), body temperature, cardiac output, and intra-cardiac ECG. It provides clinical data acquisition, medical image/data processing, analytical assessment, and patient/procedural data management including documentation, logging, reporting, trending, storing, and exporting data.

The QMAPP® system comprises three units: an Amplifier, Live Monitoring CPU, and optional Reporting CPU connected via Ethernet. Key technical specifications include 24-bit ECG resolution at 2-32 kHz sampling frequency, heart rate range of 15-300 bpm with ±2% accuracy, NiBP oscillometric measurement (15-260 mm Hg, ±5 mm Hg accuracy), SpO2 capability (1-100%), IBP measurement (±2 mm Hg or ±1% accuracy), cardiac output via thermo dilution and FICK method, and intra-cardiac ECG with 8, 16, or 32 bipolar channels. The system integrates third-party FDA-cleared modules for SpO2 (Covidien Nellcor K083325), NiBP (CAS Medical Systems K150620), and EtCO2 sensors and operates standalone or networked via HL7/DICOM protocols.

AAMI/ANSI EC 60601-1:2005/(R)2012 with amendments, IEC 60601-1-2:2014 (EMC), IEC 60601-2-27:2016 (ECG monitoring), IEC 80601-2-30:2018 (non-invasive sphygmomanometers), IEC 60601-2-34:2011 (invasive blood pressure), ISO 80601-2-56:2017 (clinical thermometers), and ISO 80601-2-61:2017 (pulse oximeter equipment). Testing included bench testing for measurement accuracy, electromagnetic compatibility, electrical safety, mechanical safety, software verification and validation, and usability testing.

QMAPP® is substantially equivalent to its predicate devices (primary: K170032 QMAPP®; secondary: K131497 McKesson Cardiology Hemo) because it maintains the same intended use (physiological/hemodynamic monitoring in cardiac procedures), design principle (multi-parameter monitoring via integrated amplifier and CPUs), and performs identical monitoring functions with comparable or improved technical specifications. The substantially equivalent table demonstrates that all key monitoring parameters—ECG, heart rate, respiration, NiBP, SpO2, IBP, cardiac output, temperature, and intra-cardiac ECG—match or exceed predicate specifications. Non-clinical bench testing and standards compliance verify safety and performance parity, with no differences raising new safety or effectiveness concerns.