(18 days)
The device is 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 signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (CNIBP), invasive blood pressure (IBP), body temperature, BIS, Cardiac Output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2) and EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency.
The device is 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 signals 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, Cardiac Output (CO), oxygen concentration (FiO2), CO2 and EtCO2, respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include AG-920RA Anesthetic Agent Detection System, Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency.
The provided text is a 510(k) Premarket Notification for the NIHON KOHDEN AMERICA, INC. BSM-6000 Series Bedside Monitor. This document is a regulatory submission for premarket approval of a medical device and does not contain the details of a study with acceptance criteria and reported device performance in the format requested.
Regulatory submissions like this typically refer to compliance with recognized standards (e.g., IEC-60601-1) and internal testing to verify specifications, but they do not typically include detailed study designs, sample sizes for test sets, ground truth establishment, or comparative effectiveness with human readers as would be found in a clinical study report or peer-reviewed publication.
Therefore, I cannot provide the requested table and information based on the input text. The text states:
- "The BSM-6000 Series device was subjected to tests to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. The software validation tested the operation of the software function of the device. The results confirmed that the device performed within specifications."
This indicates that internal testing was done, but the specific acceptance criteria, reported performance, sample sizes, and other detailed study information are not present in this 510(k) summary. The purpose of this document is to demonstrate substantial equivalence to a predicate device, not to present a detailed clinical study for novel performance claims.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.