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510(k) Data Aggregation

    K Number
    K221631
    Device Name
    Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2022-09-26

    (112 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K082720,K981543
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

    The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

    Device Description

    The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

    The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI-powered device.

    Instead, the document is a 510(k) premarket notification summary for two tracheal intubation fiberscopes/videoscopes (OLYMPUS LF-P and VISERA LF Type V). This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and non-clinical bench testing, rather than a clinical study of an AI device meeting specific performance criteria.

    Therefore, I cannot provide the requested information from the given input.

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