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510(k) Data Aggregation

    K Number
    K221557
    Device Name
    Visera Hysterovideoscope Olympus HYF Type V
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2022-09-02

    (94 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K111425,K051645,K954451,K102379,K103264,K022445
    Why did this record match?
    Reference Devices :

    K111425, K051645, K954451, K102379, K103264

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

    VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus. Do not use the instrument for any purpose other than its intended use.

    Device Description

    This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus.

    AI/ML Overview

    The provided document does not describe an AI medical device. It is a 510(k) summary for a "VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (HYF-V)", which is a hysterovideoscope for endoscopic diagnosis within the uterus.

    The document discusses various non-clinical bench tests (e.g., thermal safety, photobiological safety, noise and dynamic range, composite durability, color performance, image intensity uniformity, resolution, direction of view, field of view), biocompatibility evaluation, sterilization/reprocessing validation, and electrical safety/EMC testing. It explicitly states that software verification and validation testing was not applicable and not performed because the HYF-V does not include any software.

    Therefore, I cannot provide details on acceptance criteria and study proving device meets acceptance criteria for an AI device based on this document. The questions regarding sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the information provided for this hysterovideoscope.

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