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    K Number
    K120441
    Device Name
    GETINGE 700HC-E SERIES STEAM STERILIZER
    Manufacturer
    GETINGE SOURCING LLC
    Date Cleared
    2012-05-31

    (108 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K103504
    Why did this record match?
    Device Name :

    GETINGE 700HC-E SERIES STEAM STERILIZER

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

    The Getinge 700HC-E Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The 700HC-E Series Steam Sterilizer is available in 3 models differentiated by chamber length; 733HC-E 39 inch chamber, 733HC-E 53 inch chamber and 733HC-E 61 inch chamber.

    Device Description

    The Getinge 700HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 700HC-E Series Steam Sterilizer is 733HC-E. The model 733HC-E is available in 3 chamber sizes; 39 inches long (21.5 cu ft), 53 inches long (29.3 cu ft) and 61 inches long 33.7 cu ft).

    The 733HC-E Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 22 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.

    AI/ML Overview

    The acceptance criteria for the Getinge 700HC-E Series Steam Sterilizer are based on the ability to achieve sterilization of various loads under specified cycle parameters, and dryness of the load where applicable. The study proving the device meets these criteria involved comprehensive performance testing conforming to industry standards.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Getinge 700HC-E Series Steam Sterilizer are implicitly defined by the successful demonstration of:

    • Achieving a sterility assurance level (SAL) of at least 10^-6.
    • Complete kill of biological indicators (BIs).
    • Moisture retention within specified limits for fabric and wrapped instrument packs.
    • Successful Bowie-Dick test for air removal.
    • Maintaining steady-state thermal conditions within the chamber.
    • Water loss not exceeding 50ml for liquid loads.

    The reported device performance, demonstrated through validation testing against these criteria, confirmed that the sterilizer performs as intended.

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Sterility AssuranceSterility Assurance Level (SAL) of at least 10^-6Achieved SAL of at least 10^-6 for all validated cycles.
    Microbiological EfficacyComplete kill of biological indicators (BIs)Complete BI kill demonstrated across all validated cycles.
    Temperature ProfileSteady-state thermal conditions consistent with predicated SAL in the loadDemonstrated by empty chamber testing.
    Fabric PacksMoisture retention
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