Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)

The N10, N12, N15, N10MPro, N12MPro, and N15MPro are multi-parameter patient monitors for healthcare facilities that continuously monitor, display, and alarm on multiple physiological parameters including ECG (3/5/12-lead), arrhythmia analysis, ST-segment analysis, heart rate, respiration, temperature, SpO2, blood pressure (non-invasive and invasive), cardiac output, CO2, and for the MPro models, anesthesia gases, bispectral index, respiration mechanics, and neuromuscular transmission monitoring. They are intended for adult, pediatric, and neonatal patients in hospital settings only, not for home use, transport, or MRI/CT environments.

The subject devices support 3, 5, and 12-lead ECG with arrhythmia detection, ST segment and QT analysis, and heart rate variability (HRV), compared to the predicate's support for 3, 5, 6, and 12-lead. They restrict arrhythmia analysis, BIS monitoring, and COMEN SpO2 to adults only (a subset of predicate use). Battery capacity is smaller (2500–5000 mAh vs. 4500–5600 mAh predicate), and they include Masimo Rainbow SpO2 capability (MPro models only) and Respironics mainstream CO2 modules, which the predicate does not offer.

Devices tested against ANSI/AAMI ES60601-1:2005, IEC 60601-1-2 Edition 4.1, IEC 60601-1-6 Edition 3.2, ANSI/AAMI IEC 62366-1:2015, IEC 60601-2-25, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-34, ISO 80601-2-56, ISO 80601-2-61, ISO 80601-2-55, IEC 62304, IEC 81001-5-1, ANSI/AAMI EC57:2012 for ECG algorithms, ISO 14971 risk management, and biocompatibility per ISO 10993-1.

The subject devices are substantially equivalent to the predicate BeneVision N series (K213799) because they provide the same intended use (multi-parameter patient monitoring in healthcare facilities), employ the same or very similar measurement principles and technologies, and meet or exceed the predicate's performance specifications. The differences (additional HRV parameter, Masimo Rainbow SpO2 support, restricted use indications) are minor and do not raise new safety or effectiveness questions. Performance testing confirms equivalence, and leveraged clinical data from previously cleared subsystem modules (Masimo, Nellcor, Respironics, COMEN) supports safety and efficacy of these monitoring functions.