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    K Number
    K022876
    Device Name
    MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
    Manufacturer
    INTERNATIONAL BIOMEDICAL, INC.
    Date Cleared
    2002-09-11

    (12 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K854065
    Why did this record match?
    Device Name :

    MODIFICATION TO INFANT LIFE SUPPORT MODULE-20

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

    The "Infant Life Support Module - 20" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring is usually present. The system is to be operated by trained medical technical personnel. Intended use of the modified (K022876) and predicate device ( K854065) are identical.

    Device Description

    The "Infant Life Support Module - 20" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring is usually present.

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the "Infant Life Support Module-20," a neonatal transport incubator. While it mentions the device name, regulation information, and indications for use, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    Specifically, the document lacks:

    • A table of acceptance criteria and reported device performance.
    • Details on sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
    • Information regarding a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
    • The type of ground truth used, training set sample size, or how ground truth for a training set was established.

    This document is a regulatory approval letter, confirming the device's substantial equivalence to a predicate device, and thus permitting its marketing. It does not include the technical study details that would typically be found in a performance study report or a summary thereof.

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