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510(k) Data Aggregation

    K Number
    K240929
    Device Name
    Sleep Apnea Notification Feature (SANF)
    Manufacturer
    Apple Inc.
    Date Cleared
    2024-09-13

    (162 days)

    Product Code
    QZW
    Regulation Number
    868.2378
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K192469
    Why did this record match?
    Device Name :

    Sleep Apnea Notification Feature (SANF)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sleep Apnea Notification Feature (SANF) is a software-only mobile medical application that analyzes Apple Watch sensor data to identify patterns of breathing disturbances suggestive of moderate-to-severe sleep apnea and provides a notification to the user. This feature is intended for over-the-counter (OTC) use by adults age 18 and over who have not previously received a sleep apnea diagnosis and is not intended to diagnose, treat, or aid in the management of sleep apnea. The absence of a notification is not intended to indicate the absence of sleep apnea.

    Device Description

    The Sleep Apnea Notification Feature (SANF) is an over-the-counter mobile medical application (MMA) intended to identify patterns of breathing disturbances suggestive of moderate-to-severe sleep apnea and provide a notification to the user. SANF is intended to run on compatible iOS (e.g. iPhone, iPad) and Apple Watch platforms. Users set up SANF and view their health data on the iOS platform. Prior to use, users must undergo educational onboarding. SANF uses accelerometer sensor data collected by the Apple Watch to calculate breathing disturbance values while a user is asleep. Breathing disturbances describe transient changes in breathing patterns, such as temporary breathing interruptions.

    Breathing disturbance data is analyzed in discrete, consecutive 30-day evaluation windows, If patterns consistent with moderate-to-severe sleep apnea are identified within the 30-day evaluation window, the user is notified. SANF provides visualizations depicting the user's breathing disturbance data over various time scales. SANF is not intended to provide instantaneous measurements. Instead, once activated, SANF runs opportunistically in the background receiving signals from Apple Watch sensors for processing.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study details for the Sleep Apnea Notification Feature (SANF), based on the provided FDA 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    MetricAcceptance Criteria (Stated Goal)Reported Device Performance (95% CI)
    SensitivityOptimized for high specificity given SANF is designed as an opportunistic detection feature.66.3% [62.2%, 70.3%] for moderate-to-severe sleep apnea (AHI ≥ 15)
    SpecificityOptimized for high specificity given SANF is designed as an opportunistic detection feature.98.5% [98.0%, 99.0%] for normal-to-mild sleep apnea (AHI
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