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The Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (02), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.

The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.

The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.

A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia detection function is intended for child, adolescent, and adult patients.

Device Description

The Nihon Kohden Life Scope® G5 and Life Scope® G7 Bedside Monitoring System are an LCD touchscreen bedside monitoring system. These bedside monitors are installed near the patient and are intended to display the patient's vital signs such as ECG (basic and 12 lead), NIBP, temperature, SpO2, respiration, and CO2 and generate alarms from the bedside monitor. Additional parameters can be measured such as arrhythmia detection, ST elevation, and Train of Four (TOF) measuring parameters. Apnea and arrhythmia can also be monitored. The configuration of the bedside monitor can be adapted by the health care professionals to meet the clinical setting requirements.

The bedside monitoring systems require both a core unit and an input unit. The input unit interprets the electrical impulses from the patient's body and transfers this data into the core unit. The core unit calculates the electrical impulses. Each monitor has a color display and is intended for one patient. The intended populations are all patient populations under the care of health professionals.

The bedside monitor is designed so the operator can directly touch the screen from the operator position. Other optional accessories can also be used with the bedside monitor to add other parameters, allowing it to be used in a wide range of sites, such as operating rooms and intensive care units (ICU). The bedside monitor can also be connected to a network to communicate with central monitors and other Nihon Kohden devices.

The Life Scope® G5 Bedside Monitoring System consists of two models, those models are offered in two sizes:

CSM-1501 bedside monitoring with core unit (CU) model CU-151R: 12.1-inch . display
CSM-1502 bedside monitoring with core unit (CU) model CU-152R: 15.6-inch . displav

The Life Scope G7 Bedside Monitoring System consists of two models, those models are offered in two sizes:

CSM-1701 bedside monitoring with core unit (CU) model CU-171R: 15.6-inch . displav
CSM-1702 bedside monitoring with core unit (CU) model CU-172R: 19.0-inch . display

The Life Scope G7 Bedside Monitoring System consists of an input unit and a data acquisition unit with either the CU-171R or the CU-172R core unit.

AI/ML Overview

Here is an analysis of the acceptance criteria and supporting study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on establishing substantial equivalence to a predicate device rather than defining specific performance-based acceptance criteria for novel claims. The acceptance criteria are implicitly derived from the predicate device's specifications and compliance with recognized standards. Therefore, the "reported device performance" is essentially a statement of "identical" or "below" (meaning lower capacity/resolution but deemed not to affect safety/effectiveness) compared to the predicate.

Characteristic	Acceptance Criteria (from Predicate)	Subject Device (Life Scope G5/G7) Performance	Comparison
General	Identical to CSM-1901 (K201949)	Identical to CSM-1901 (K201949) in Classification Panel, Regulation Number, Classification Name, Regulatory Class, Product Code, Patient Population, Setting, End-User, Biocompatibility, Shelf Life, Patient Contact, Single-Use.	Identical
Indications for Use	Monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. Monitor ECG to generate alarms when arrhythmia exists. Monitor heart rate, pulse rate, SpO2, NIBP, IBP, body temperature, BIS, CO, O2, CO2, EtCO2, respiratory rate, inspired/expired anesthetic gases. Display patient data from external devices. Generates audible/visual alarms when a measured rate falls outside preset limits. For trained medical personnel, all patient populations (adult, neonate, infant, child, adolescent). A-fib detection, ST measurement, QTc/QRSd monitoring for adult; Arrhythmia detection for child, adolescent, adult.	Identical to Predicate K201949. Patient population for each ECG analysis functionality clarified.	Identical
ECG
QTc/QRSd Monitoring	Yes (Spot-Check)	Yes (Spot-Check) and Continuous monitoring (Automatically started when ECG monitoring begins).	Below (Predicate had only spot-check, subject device adds continuous, but deemed not to affect safety/effectiveness)
Arrhythmia Recall Files	20,000 files	16,384 files	Below (16,384

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