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510(k) Data Aggregation

    K Number
    K193421
    Device Name
    Smart Alarm Interface
    Manufacturer
    Date Cleared
    2020-10-30

    (326 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BoxView, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Box View Smart Alarm Interface (SAI). Model SA-01 is to provide an interface with physiological patient monitoring systems to forward information associated to an alarm event to a designated display device(s). For medical, near real time alarms, the BoxView Smart Alarm Interface, Model SA-01 is intended to serve as a parallel, redundant, mechanism to inform healthcare professionals of particular medical alarm events. The BoxView Smart Alarm Interface, Model SA-01 does not alter the primary medical devices and associated alarm annunciations. The BoxView Smart Alarm Interface. Model SA-01 is intended for use as a secondary alarm notification system. It does not replace the primary alarm function on the monitor. The BoxView Smart Alarm Interface. Model SA-01 is not intended to be used for diagnostic purposes. The Box View Smart Alarm Interface, Model SA-01 is intended for use by professional clinical personnel and relies on proper use and operation of both the communication in place at the healthcare facility and the display devices used. The BoxView Smart Alarm Interface, Model SA-01 is a software product and cannot come into physical contact with patients.
    Device Description
    The BoxView Smart Alarm Interface (SAI), Model SA-01, is a Software Medical Device (SaMD) product intended to be located on-site in the hospital, or pre-configured off site in the 'cloud' utilizing a standard Linux operating system. The primary purpose of the BoxView Smart Alarm Interface (SAI), Model SA-01 is to act as a message integrator to forward patient monitor status and alarm event information originating from a patient monitoring network. Users receive interactive, time-critical information from patient monitoring devices directly via their display devices as text, alarms or data. The BoxView Smart Alarm Interface (SAI), Model SA-01 allows caregivers to be informed of their patient's alarm conditions when they are not in the patient vicinity. The BoxView Smart Alarm Interface (SAI), Model SA-01 is an open system that is compatible with most smart phones or computers. The BoxView Smart Alarm Interface (SAI), Model SA-01 connects to the information sources through wired Ethernet connections which are part of the customer's infrastructure. The BoxView Smart Alarm Interface (SAI), Model SA-01 software acquires patient data from patient monitoring devices and allows the user to configure the system to determine which information, including alarm notifications, is delivered to which users communicators. The BoxView Smart Alarm Interface (SAI), Model SA-01 then formats the data for delivery to the display devices. The BoxView Smart Alarm Interface (SAI), Model SA-01 system is designed to forward alarm event information as the alarms are recognized by the patient monitoring network. The system is also capable of being configured to periodically forward a patient's physiological data as well. All messaging activities are recorded by the BoxView Smart Alarm Interface (SAI), Model SA-01 providing real-time activity logging for audit trail records and reporting. The BoxView Smart Alarm Interface (SAI), Model SA-01, system is a secondary alarm notification system. It does not replace the primary alarm function of the bedside monitor or telemetry monitoring system.
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