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    K Number
    K141879
    Device Name
    BELIMED STEAM STERILIZER MST-H
    Manufacturer
    SAUTER AG
    Date Cleared
    2015-06-17

    (341 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K021223
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K021223

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

    The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

    Device Description

    The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version. The sterilizers are equipped with Pre-vacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles.

    AI/ML Overview

    The provided document describes the Belimed Steam Sterilizer MST-H, not an AI-powered device. Therefore, the questions related to AI-specific criteria (such as effect size of human readers with AI assistance, standalone algorithm performance, number of experts for ground truth, training set information, or a multi-reader, multi-case study) are not applicable.

    The document details the acceptance criteria (performance requirements) for the steam sterilizer and summarizes the studies proving it meets these criteria through non-clinical validation.

    1. A table of acceptance criteria and the reported device performance

    The document presents performance criteria and verified results implicitly throughout the "EFFECTIVENESS" and "NONCLINICAL COMPARISON TO PREDICATE DEVICE" sections by referencing compliance with ANSI/AAMI ST8:2013 and specific outcomes. Here's a structured table:

    Acceptance Criteria / Performance RequirementReported Device Performance (Belimed Steam Sterilizer MST-H)
    Biological Performance (Sterility Assurance Level - SAL)SAL of 10⁻⁶ reduction (through achievement of no growth at half cycle with validation loads), complying with AAMI ST8:2013. Verified for PreVac 270 cycles (fabric), PreVac and Gravity instrument cycles, and liquid cycle.
    Moisture Retention (Fabrics)
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