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510(k) Data Aggregation

    K Number
    K193460
    Device Name
    The iNAP One Sleep Therapy System
    Manufacturer
    Somnice, Inc.
    Date Cleared
    2020-05-26

    (162 days)

    Product Code
    OZR
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K130538
    Predicate For
    K220907
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment choice.

    Device Description

    The iNAP One Sleep Therapy System consists of six (6) main components. The components are a console, a saliva container, a saliva absorbent (iNAP DryPad), a flexible polymer tubing (iNAP Tubing Set), a soft polymer oral interface (iNAP Oral Interface) and a software application for mobile devices (iNAP Care). One additional accessory is Oral Interface with Tubing, which is a combination of the Oral Interface and Tubing Set. The function of iNAP One Sleep Therapy System is developing a negative pressure gradient in the user's oral cavity, which is set as -40 mmHg.

    AI/ML Overview

    Please find below the requested information about the acceptance criteria and study proving the device meets these criteria:

    1. Table of Acceptance Criteria and Reported Device Performance

    CategoryAcceptance CriteriaReported Device Performance (iNAP One Sleep Therapy System)
    BiocompatibilityCompliance with ISO 10993-1 series for patient contact materials.All biocompatibility tests (Cytotoxicity, Skin Sensitization, Oral Mucosa Irritation, Pyrogenicity, Leechable & Extractables) passed for all relevant components (Oral Interface, Tubing Set, Oral Interface with Tubing Set).
    Bench TestingSubstantial equivalence to predicate device (Winx) in negative pressure application and maintenance.Substantially equivalent to Winx device in negative pressure application and maintenance.
    AcousticsAcoustic power
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