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510(k) Data Aggregation

    K Number
    K214057
    Device Name
    STATIM 6000B Vacuum Autoclave
    Manufacturer
    SciCan Ltd.
    Date Cleared
    2022-03-31

    (94 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STATIM 6000B Vacuum Autoclave

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

    The STATIM 600B are dynamic air removal (pre-vacuum) table-top steam sterilizers that are intended for use by a healthcare provider to sterilize medical products by means of pressurized steam.

    The STATIM 6000B are suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATIM 6000B has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such in incomplete sterlization and/or damage to the autoclave.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a steam sterilizer (autoclave). It does not contain information about an AI/ML powered device, its acceptance criteria, or the study used to validate its performance. The document focuses on establishing substantial equivalence for the sterilizer, specifying its indications for use, and providing a table of sterilization cycles, temperatures, times, and load descriptions.

    Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a different type of medical device.

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