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510(k) Data Aggregation

    K Number
    K182362
    Manufacturer
    Date Cleared
    2019-05-23

    (266 days)

    Product Code
    Regulation Number
    868.1400
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    MaxCap Ped and MaxCap Neo

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

    The Maxtec MaxCap Neo and MaxCap Ped are indicated to provide a semi-quantitative visualization of the CO2 in the patient airvay. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.

    Patient Population: MaxCap Neo is intended for use with neonates and infants 250g to 6kg. MaxCap Ped is intended for use with pediatric patients 1kg to 15kg

    Environment of Use: Hospital, sub-acute, pre-hospital, transport.

    Device Description

    The proposed MaxCap Neo and MaxCap Ped are comprised of several components:

    • . Housing with standard 15 mm / 22 mm fittings to connect to the ventilator assist device and a face mask or endotracheal tube
    • . Colorimetric litmus media which has been treated with chemical to detect the presence of CO2 by a change in pH
    AI/ML Overview

    The Maxtec MaxCap Neo and MaxCap Ped devices are semi-quantitative CO2 detectors that use a colorimetric, pH-sensitive dye to visualize CO2 in a patient's airway. The devices are intended for use as an adjunct in patient assessment.

    Here's an analysis of the acceptance criteria and study information provided:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly state "acceptance criteria" for each performance metric, but rather lists specifications and performance data for the proposed devices and compares them to predicate and reference devices. We can infer the acceptance criteria from the context of these comparisons and discussions of "similar" or "lower" than predicates.

    Feature / Acceptance Criteria (Inferred)Reported Device Performance (MaxCap Neo and MaxCap Ped)
    Color change accuracyTested and performed
    Color change response timeTested and performed
    Drop testTested and performed
    Duration of UseUp to 6 hours
    Flow Resistance / Back PressureMaxCap Neo: 5.0% CO2 - Yellow
    Means of communicating meaning of color changesMatching Colored Label on the Outside of the device
    Means of detecting patient exhalationColor change
    Breathes to effect color change
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