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510(k) Data Aggregation

    K Number
    K132003
    Device Name
    WINX SLEEP THERAPY SYSTEM
    Manufacturer
    APNICURE, INC.
    Date Cleared
    2014-06-13

    (347 days)

    Product Code
    OZR
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K111549
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.

    Device Description

    The Winx Sleep Therapy System consists of four (4) main components and two (2) sizing methods. The components are: a small electronic bedside console, a soft polymer mouthpiece, a flexible polymer tube that connects the mouthpiece to the console, and a physicians' software application (Winx Data Management Software) that allows clinicians to download usage data from the console and generate patient usage reports. The sizing methods include: a sizing template and an iPhone sizing application (Winx Mouthpiece Sizing Application). The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.

    AI/ML Overview

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

    Acceptance Criteria and Device Performance for Winx Sleep Therapy System (Winx+ Mouthpiece)

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided 510(k) summary focuses on demonstrating substantial equivalence of the Winx+ mouthpiece to the predicate Winx mouthpiece, rather than setting entirely new, independent acceptance criteria for the Winx+ system. However, specific performance targets and safety metrics were evaluated.

    Clinical Performance Acceptance Criteria (derived implicitly from non-inferiority claims):

    Performance MetricAcceptance Criteria (for Winx+ to be non-inferior to Winx)Reported Device Performance (Winx+ Mouthpiece)
    Effectiveness (Primary Endpoint):
    Clinical Success Rate (First Night)Non-inferiority to Winx mouthpiece, defined as AHI reduction of >50% compared to control PSG AND treatment AHI 50% and treatment AHI 50% (comparing treatment PSG to control PSG) and a treatment AHI of
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