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510(k) Data Aggregation

    K Number
    K213360
    Device Name
    SleepCheckRx
    Manufacturer
    Date Cleared
    2022-07-05

    (266 days)

    Product Code
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    ResApp Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sleep CheckRx is indicated to record a patient's respiratory pattern during sleep for the purpose of pre-screening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults (≥ 22 years of age) with suspected possible sleep breathing disorders. Results can be used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.
    Device Description
    SleepCheckRx is a software application used by healthcare providers to pre-screen adults at home for the risk of Obstructive Sleep Apnea (OSA). The application is accessed via a compatible smartphone and uses the device's inbuilt microphone to record breathing and snore sounds while the user is asleep, over a minimum duration of 6 hours. This audio recording, in conjunction with basic information about the user, is analyzed by locked machine learnt software algorithms to provide a risk assessment of the presence of OSA. Prior to use, the patient installs SleepCheckRx on a compatible smartphone and activates the application by entering a code issued to their Healthcare Professional (HCP) through a secure cloud server portal. The patient enters basic information including date of birth, biological sex, height, weight, and neck circumference. The patient is also required to answer a STOP-Bang questionnaire. The phone is placed on a nightstand as directed, and when the user is ready to go to sleep, they initiate the software that begins a recording. SleepCheckRx then captures breathing and snore sounds continuously throughout the night until the user stops the recording once they have awoken in the morning (a minimum of 6 hours of recording is required). In the event of a successful recording, SleepCheckRx provides the user with a binary outcome of either 'Minimal to Mild Risk of OSA' (AHI<15) or 'Moderate to Severe Risk of OSA' (AHI ≥15). SleepCheckRx requires a healthcare professional (HCP) to access a secure cloud server portal to provide the patient with an access code to use the app downloaded from the Apple App Store. The results of the patient's recording and the STOP-Bang questionnaire are shared with the patient and the HCP, for the HCP to then determine if further investigation and evaluation is required.
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