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    K Number
    K983017
    Device Name
    MODIFICATION TO SYSTEM 83 PLUS
    Manufacturer
    CUSTOM ULTRASONICS
    Date Cleared
    1998-09-22

    (25 days)

    Product Code
    NVE,KOG
    Regulation Number
    876.1500
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO SYSTEM 83 PLUS

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

    The System 83 Plus Endoscope Washer/Disinfector is designed for the simultaneous reprocessing of up to two flexible endoscopes used in the gastrointestinal and/or pulmonary tracts. These flexible scopes may be high level disinfected when the washing/disinfection cycle of the System 83 Plus is used with the labeled contact conditions for the germicide as in the predicated device.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Custom Ultrasonics, Inc. regarding their "System 83 Plus" device. This document does not contain information about acceptance criteria for a device, a study proving it meets such criteria, or any details about AI/ML algorithm performance.

    The document primarily focuses on:

    • The FDA's determination of substantial equivalence for the "System 83 Plus" to a legally marketed predicate device.
    • Instructions for marketing the device under general controls provisions.
    • Contact information for compliance and regulatory questions.
    • The Indications for Use statement for the System 83 Plus, which describes its function as an endoscope washer/disinfector for reprocessing up to two pre-cleaned submersible endoscopes. It states that the device provides high-level disinfection when the washing/disinfection cycle meets the labeled contact conditions for the germicide, similar to the predicate device.

    Therefore, I cannot provide the requested information, such as:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes, data provenance.
    3. Number and qualifications of experts.
    4. Adjudication method.
    5. MRMC comparative effectiveness study details.
    6. Standalone performance details.
    7. Type of ground truth used.
    8. Training set sample size.
    9. Ground truth establishment for the training set.

    These details are typically found in a device's design validation studies, clinical trial reports, or specific performance testing documentation, which are not part of this FDA clearance letter.

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