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510(k) Data Aggregation

    K Number
    K102059
    Device Name
    AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Date Cleared
    2010-10-08

    (78 days)

    Product Code
    FET
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K083155
    Why did this record match?
    Device Name :

    AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017

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

    This camera head has been designed to be used with the CV-180 EXERA II video system center or OTV-S7Pro VISERA Pro video system center, endoscopes, light sources, video monitors and other ancillary equipment for endoscopic diagnosis and treatment.

    Device Description

    AUTOCLAVABLE CAMERA HEAD OTV-Y0017 is an imaging device used with specified Olympus video system center, light source, endoscope, and other ancillary equipment for observation of endoscopic image on a video monitor.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (AUTOCLAVABLE CAMERA HEAD OTV-Y0017) and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

    This document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device. It focuses on comparing the new device's technological characteristics, intended use, and general specifications to an already approved device. The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or if different, these differences do not raise new questions of safety and effectiveness.

    Therefore, I cannot provide the requested information from the given text. The text does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for a test set, data provenance, or details of a study methodology.
    3. Number and qualifications of experts for ground truth establishment.
    4. Adjudication methods.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect sizes, or human reader improvement with AI assistance.
    6. Details of a standalone algorithm-only performance study.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The document states, "OTV-Y0017 is basically identical to the predicate device except for a change to the intended use (expanding beyond the bladder, urethra and kidney), specifications and method of sterilization." This indicates that the primary argument for approval is substantial equivalence rather than a new performance study against specific acceptance criteria.

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