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510(k) Data Aggregation

    K Number
    K232445
    Device Name
    CSF-4 (CSF-4)
    Manufacturer
    CardiacSense
    Date Cleared
    2024-05-02

    (262 days)

    Product Code
    DPS, DQA, DXH
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CardiacSense

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CSF-4 is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The ECG signal is for quality checks of the data and for manual interpretation of heart rate. The CSF-4 also measures, records and displays pulse rate. The CSF-4 is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2). The CSF-4 is for adult patients and health-conscious individuals in hospitals, clinics, long-term care facilities, and homes. The CSF-4 is a prescription device and should be used under the care of a physician. CSF-4 does not provide any alarms. It is not intended for pediatric use or use in critical care settings. The device is not intended to provide outputs during periods of motion.
    Device Description
    The CSF-4 is a non-invasive system comprised of software, hardware and mechanical components that enables the user to measure electrocardiography (ECG) and oxygen saturation of arterial hemoglobin (SpO2), as well as measuring pulse rate using photoplethysmography (PPG). CSF-4 is a single-patient use, wearable monitoring device that collects intermittent data of physiological parameters, when little to no motion is detected. The CSF-4 is comprised of 3 main components; - 1) CS Watch 3 with CSF-4 Watch firmware ("Watch"): The CS Watch 3 is a wrist worn device embedded with non-invasive sensors. The watch includes firmware that activates the sensors, synchronizes the data sampled by the sensors, processes the data, stores the processed data in nonvolatile memory, and provides the data to the user. The processed data is transferred to the Mobile App via a secured BLE communication channel. In addition, the watch sends real-time raw data signals to the Mobile App. - 2) CSF-4 Mobile Application ("Mobile App"): The Mobile App works on both Android OS and iOS. The mobile app communicates with the watch via BLE and to the Cloud App via HTTPS, thus acting as the watch gateway to the cloud application. The Mobile App caches the processed data from the watch and transfers it to the cloud application. It allows the user to conveniently view the measurement results and real time raw data. The Mobile App provides the user with the capability of creating an on-demand report and sharing it using 3rd party sharing applications. - 3) CSF-4 Cloud Application ("Cloud App"): The Cloud App securely stores the user and processed data over designated databases. It provides the mechanism of creating and sending periodical reports which are sent to the user's email both automatically and on-demand.
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    K Number
    K221260
    Device Name
    CSF-3
    Manufacturer
    CardiacSense
    Date Cleared
    2023-01-06

    (249 days)

    Product Code
    DPS, DAT, DQA, DXH
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CardiacSense

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CSF-3 is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The ECG signal is for quality checks of the data and for manual interpretation of heart rate. The CSF-3 is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2). The CSF-3 is for adult patients and health-conscious individuals in hospitals, clinics, long-term care facilities, and homes. The CSF-3 is a prescription device and should be used under the care of a physician. CSF-3 does not provide any alarms. It is not intended for pediativ use or use in critical care settings.
    Device Description
    The CSF-3 is a non-invasive system consisting of software, hardware and mechanical components that enables the user to measure electrocardiography (ECG) and oxygen saturation of arterial hemoglobin (SpO2). The CSF-3 consists of 3 main components: 1) CS Watch 3 with CSF-3 Watch firmware ("Watch"): The Watch is a wrist worn device embedded with non-invasive sensors. The Watch includes firmware that activates the sensors, synchronizes the data sampled by the sensors, processes the data, stores the processed data in non-volatile memory, and provides the data to the user. The processed data is transferred to the Mobile App via a secured BLE communication channel. In addition, the watch sends realtime raw data signals to the Mobile App. 2) CSF-3 Mobile Application ("Mobile App"): The Mobile App works on both Android OS and iOS. The Mobile App communicates with the Watch via BLE and to the Cloud App via HTTPS, thus acting as the Watch gateway to the Cloud App. The Mobile App caches the processed data from the Watch and transfers it to the Cloud App. It allows the user to conveniently view the measurement results and real time raw data. The Mobile App provides the user with the capability of creating an on-demand report and sharing it using 3rd party sharing applications. 3) CSF-3 Cloud Application ("Cloud App"): The Cloud App securely stores the user and processed data over designated databases. It provides the mechanism of creating and sending periodical reports which are sent to the user's email both automatically and on-demand.
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