LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

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

    (266 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K173974
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    | Acceptance Criteria (Binary Output: Minimal to Mild Risk of OSA (AHI

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1