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510(k) Data Aggregation

    K Number
    K242842
    Device Name
    ANNE View, Central Hub
    Manufacturer
    Sibel Health Inc.
    Date Cleared
    2025-01-08

    (111 days)

    Product Code
    MSX, DRG, KMI, MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sibel Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANNE View application is intended for the display of physiological data from the ANNE Chest and ANNE Limb devices. The application is also compatible with third-party, FDA-cleared devices for the display of noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The ANNE View application notifies healthcare professionals when physiological data fall outside selected parameters. The ANNE View application displays the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system notifies the user when the patient's position has not changed for a preset threshold of time. The ANNE View application communicates to compatible central monitoring platforms, including the Central Hub, for the display and storage of multiple patients' physiological data. The Central Hub has the ability to notify healthcare professionals when physiological data fall outside selected parameters. The ANNE View and Central Hub are intended for use by trained, qualified healthcare professionals in the clinical or home healthcare environment. The device is not intended for use on critical care patients.
    Device Description
    The ANNE View application is a bedside patient monitoring device that receives vital signs and physiological data from compatible devices for display and transmission to the Central Hub. The ANNE View application operates on the ANNE Tablet. When connected to the ANNE Chest Sensor, the ANNE View application displays electrocardiography (ECG), skin temperature, heart rate, respiratory rate, and body position data. When connected to the ANNE Limb Sensor, the ANNE View application displays photoplethysmography (PPG), SpO2, pulse rate, and skin temperature data. The ANNE View application is also compatible with optional third-party devices for SpO2, non-invasive blood pressure, and body temperature measurements. The ANNE View application alarms when physiological data are outside of the configured thresholds. When the ANNE Tablet is connected to Wi-Fi, the vital signs and physiological data are uploaded from the ANNE View application to the Central Hub. The Central Hub allows healthcare professionals to view vitals data from up to 16 beds on one screen and provides storage of up to 48 hours of data from each patient. Alarm conditions are communicated to the Central Hub from the ANNE View application for visual and audio alarms on the Central Hub.
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    K Number
    K240251
    Device Name
    ANNE Chest
    Manufacturer
    Sibel Health Inc.
    Date Cleared
    2024-06-03

    (125 days)

    Product Code
    DRG, BZQ, FLL, KMI, MWI, MWJ
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sibel Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANNE Chest is a wearable, wireless sensor intended for the measurement of electrocardioaraphy (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is intended to provide continuous physiological information as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients.
    Device Description
    The ANNE Chest Sensor is a skin-mounted, bio-integrated sensor that collects real-time biosignals including electrocardiography (ECG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, body position, fall detection, and skin temperature. The sensor communicates via Bluetooth to the Sibel SDK, which may be integrated within software applications for the display and storage of data. The ECG signal obtained by the ANNE Chest sensor is not intended for manual discrimination of any arrhythmias or cardiac conditions.
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    K Number
    K240305
    Device Name
    ANNE Limb
    Manufacturer
    Sibel Health Inc.
    Date Cleared
    2024-05-28

    (116 days)

    Product Code
    DQA, DRG, FLL
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sibel Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANNE Limb Sensor is a pulse oximeter intended for continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature. The ANNE Limb Sensor is not intended to monitor or measure SpO2 or pulse rate while the patient undergoes significant motion or is active. The ANNE Limb Sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is indicated for use as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients.
    Device Description
    The ANNE Limb sensor is a wearable, bio-integrated sensor that collects real-time biosignals including photoplethysmography (PPG) and temperature. The ANNE Limb sensor has on-device processing of raw data for the calculation of SpO2 and pulse rate. The sensor communicates via Bluetooth to the Sibel SDK, which may be integrated within software applications for the display and storage of data.
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    K Number
    K223711
    Device Name
    ANNE One
    Manufacturer
    Sibel Health Inc.
    Date Cleared
    2023-08-10

    (241 days)

    Product Code
    DRG, DQA, FLL, KMI, MWI, MWJ
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sibel Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms. heart rate, respiratory rate, function of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin temperature by qualified healthcare professionals in home and healthcare settings. ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The device is indicated for monitoring ECG waveforms and heart rate on ambulatory patients. The device is not intended to monitor or measure respiratory rate. SpO2, pulse rate, or noninvasive blood pressure while the patient undergoes significant motion or is active. ANNE One continuously monitors the orients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the pation has not changed from a preset threshold of time. The device is intended for use on general care patients who are 12 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The data from ANNE One are transmitted wirelessly for display, storage, and analysis. The device is not intended for use on critical care patients.
    Device Description
    ANNE One is a wireless monitoring platform that streams and stores real-time biosignals including electrocardiography (ECG), photoplethysmography (PPG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, SpO2, pulse rate, skin temperature, and body temperature. The ECG signal is not intended for automated arrhythmia detection or classification; rather it is intended for manual interpretation, and the automated computation of heart rate through QRS identification using the well-known Pan-Tompkins beat detection algorithm. The displayed waveform is only intended for display as a check for normal ECG rhythm. The waveform is not intended for manual discrimination of any arrhythmias or cardiac conditions. The system features two skin-mounted, bio-integrated sensors that pair with the ANNE View software application for the continuous display, storage, and analysis of vital sign measurements and physiological waveforms. The system is also compatible with optional FDA-cleared third-party devices for SpO2, non-invasive blood pressure, and body temperature measurements.
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