(326 days)
The Bernoulli Management System (MS) Software is a software application intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital-type environment. It is used to provide a secondary display of multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO2, blood pressure, cardiac output, temperature and associated derived outputs), lung ventilator, respiratory gas monitor, IV infusion.(including PCA) pump, feeding pump and related ancillary devices, and to provide remote monitoring and alarm surveillance. This application is also intended to provide primary alarm surveillance for devices where no alarm notification capability is enabled or available in low acuity MedSurg, Cardiac, General ward care areas to monitor patients who are currently not monitored. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring procedures.
The Bernoulli Management System (MS) Software is to be used under license by or on the order of a physician or licensed healthcare professional in the course of his/her professional practice.
Not Found
The provided FDA 510(k) summary (K130208) for the Bernoulli® Enterprise Software is a clearance letter and an "Indications for Use" statement. It affirms the device's substantial equivalence to a predicate device but does not contain the detailed study information or acceptance criteria requested.
Therefore, I cannot extract the specific details about the acceptance criteria or a study proving the device meets them from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on performance studies with specific statistical metrics.
§ 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.