(50 days)
The series of device 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 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, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP) invasive blood pressure (IBP), body temperature, Cardiac Output (CO ), oxygen concentration (FiO2), carbon dioxide concentration (CO2 and EtCO2), and respiratory rate, CO2 and EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including NJO, Halothane, Isoflurane, 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 will be available for use by medical personnel on patients within a medical facility including adults, children and infants.
The ECAPS 12 interpretive ECG software program of the device is limited for use with patients age 3 years to adult. The interpretation is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis and is not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.
Prescription Use Only
Common names for the BSM-5130A device include Bedside Monitor, Patient Monitor, Cardiac Monitor and Vital Signs Monitor and Anesthesia monitor. The device has been classified as Class III per Cardiovascular Device Classification Panel under 21 CFR Part 870.1025, "Physiological Patient Monitor with Arrhytmia Detection and Alarms" as MHX and under 21 CFR 870.2340. "ECG Analysis System" as LOS. Functions of the device have also been classified as Class II by the Anesthesiology Device Classification Panel and the General Hospital and Personal Use Classification Panel as follows: under 21 CFR 870.2300, "Cardiac Monitor (including cardiotachometer and rate alarms)" per DRT: under 21 CFR 870.2700, "Oximeter" per DQA; under 21 CFR 870.1130, "Noninvasive Blood Pressure Measurement System" per DXN; under 21 CFR 870.1110 and 21 CFR 870.1100, "Blood Pressure Computer and Alarm" per DSK and DSJ; under 21 CFR 880.2910, "Thermometer. Electronic, Clinical" per FLL; under 21 CFR 868.2375, "Breathing Frequency Monitor" per BZQ; under 21 CFR 868.1720, "Oxygen Gas Analyzer" per CCL; under 21 CFR 868.1400, "Carbon Dioxide Gas Analyzer" per CCK; under 21 CFR 870.2910, "Radio Frequency Physiological Signal Transmitter" per DRG.
The provided text is a 510(k) premarket notification for the NIHON KOHDEN AMERICA, INC. BSM-5130A Series Bedside Monitor. It includes information about the device's indications for use, classification, and predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
The text does state: "The BSM-5130A series Bedside Monitor was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of the results confirmed that the device performed within specifications."
This indicates that internal performance testing and software validation were conducted, but no details about the specific acceptance criteria or the results of these tests are provided.
§ 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.