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510(k) Data Aggregation

    K Number
    K212788
    Device Name
    Seer Home
    Manufacturer
    Seer Medical Pty Ltd
    Date Cleared
    2022-06-16

    (288 days)

    Product Code
    GWQ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Seer Medical Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The electroencephalographic system Seer Home is intended to acquire, display, and store the electro-physiological signals of the patient's brain obtained by placing electrodes on the patient scalp. The Seer Home is intended to be used for such studies as electroencephalograph (EEG) and video EEG recording to aid in diagnosis of neurological disorders. The Seer Home does not draw any diagnostic conclusions. Seer Home is not intended for use as life support equipment such as vital signs monitoring in intensive care units. Seer Home is only to be used under the direction and supervision or EEG technologist or clinician.
    Device Description
    The Seer Medical - Seer Home is an ambulatory electroencephalograph system designed to be used at the patient's home for up to week-long studies. The ambulatory EEG recorder (called "Seer Sense" or "Wearable") is worn around the patient shoulders. The Wearable has a single cable exiting from the bottom of the device and is routed inline to 3 disposable ECG electrodes which are positioned on the chest for ECG recording. Exiting from the rear of the Wearable is single flexible cable which has a junction at the top of the patient's head connected to the 22 EEG electrodes (disposable) which are positioned in the international '10-20' system for EEG recording. The Wearable records the EEG and ECG signals and wirelessly transmits them to a nearby "Seer Sight Video Monitoring Hub" in the patient's house. The Video Monitoring Hub has two roles, first to store the wireless data from the wearable, and the second is to record video from an in-built camera that is synchronized to the EEG/ECG data. The use of the recorded video data provides additional information to the physician (such as body movement artifacts) to assist in diagnosis in the neurological conditions. At the end of the study period (up to a week) the Wearable and Hub are returned back to the clinic for data download. The Seer Cloud Platform software downloads the data, stores the data, displays the EEG/ECG signals and video for reviewers to interpret, make annotations, and produce reports. The Seer Home is intended to be used by qualified operators or physicians trained in the interpretation of EEG/ECG signals and visual cues of patient movements - and is viewed as a part of a range of assessments used by Neurologists to assist in making diagnosis of neurological conditions. The accessories used with the Seer Home are disposable EEG electrodes, disposable ECG electrodes, Transport/Carry case, Medical Grade Power Adapter, IFU, and Rechargeable Batteries.
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