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    K Number
    K160764
    Device Name
    AirLife Autofill Humidification Chamber
    Manufacturer
    CAREFUSION 2200, INC.
    Date Cleared
    2016-08-25

    (157 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K934140
    Why did this record match?
    Device Name :

    AirLife Autofill Humidification Chamber

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

    The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to any patient using a heated humidifier. The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician. The Artofill Humidification Chamber is compatible with the Fisher and Paykel MR850 system.

    Device Description

    The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the AirLife Autofill Humidification Chamber, comparing it to a predicate device (MR290 Humidification Chamber). The document focuses on demonstrating substantial equivalence rather than a study with acceptance criteria and a detailed performance evaluation of an AI-powered device.

    Therefore, the requested information components related to AI/algorithm performance, such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.

    The document primarily evaluates the physical and functional characteristics of a medical device (humidification chamber) against recognized standards and a predicate device.

    Here's the closest representation of the requested table and related information based only on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria here are implicitly compliance with relevant medical device standards and demonstrating performance comparable to the predicate device. The "acceptance criteria" for each performance characteristic are often defined by the standard itself or by the performance of the predicate device.

    Performance CharacteristicAcceptance Criteria (Implied by Predicate/Standard)Reported Device Performance (Proposed Device)
    Humidity Output InvasiveComparable to predicate (39.2 mg/L) & BS EN ISO 8185:200939.0 mg/L
    Humidity Output Non-InvasiveComparable to predicate (24.6 mg/L) & BS EN ISO 8185:200924.3 mg/L
    Specific EnthalpyComparable to predicate (Max: 151 kJ/kg, Avg: 120 kJ/kg) & BS EN ISO 8185:2009Max: 156 kJ/kg, Avg: 117 kJ/kg
    Hazardous OutputBS EN ISO 8185:2009Not explicitly stated, assumed met
    Resistance to Flow @60L/minComparable to predicate (0.50 cmH2O) & BS EN ISO 5367:20140.40 cmH2O
    Maximum Peak FlowBS EN ISO 8185:2014Maximum continuous gas flow rate of 60 LPM in invasive mode and 120 LPM in non-Invasive mode (Comparable to predicate)
    Leakage & Maximum Operating PressureComparable to predicate (>100 mL/min for leakage, 13.2kPa for pressure) & BS EN ISO 8185:2009, BS EN ISO 5367:2014
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