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    K Number
    K111519
    Device Name
    STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Date Cleared
    2012-10-03

    (489 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K103219
    Why did this record match?
    Device Name :

    STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202

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

    STERRAD® SEALSURE® Chemical Indicator Tape (PN 14202) is a process indicator (ISO 11140-1:2005) intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems. The color of the STERRAD® SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.

    Device Description

    STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems. The color of the STERRAD® SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the STERRAD® SEALSURE® Chemical Indicator Tape, based on the provided text:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Chemical Indicator FunctionalityPassed
    Tape Adhesion StrengthPassed
    End Point / Post Processing Color StabilityPassed
    BiocompatibilityPassed
    Shelf lifePassed

    Study Details

    • Sample Size for Test Set: Not explicitly stated in the provided text.
    • Data Provenance (Test Set): Not explicitly stated in the provided text.
    • Number of Experts for Ground Truth (Test Set): Not applicable. This device is a chemical indicator, not an AI or diagnostic device requiring expert interpretation for ground truth.
    • Qualifications of Experts (Test Set): Not applicable.
    • Adjudication Method: Not applicable.
    • Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not conducted as the device is a chemical indicator, not a diagnostic or AI-assisted tool for human readers.
    • Effect Size of Human Readers with vs. without AI Assistance: Not applicable.
    • Standalone (Algorithm Only) Performance Study: Not applicable. The device's performance is intrinsically linked to its chemical reaction, not an algorithm.
    • Type of Ground Truth Used: The ground truth for the "Chemical Indicator Functionality" and "End Point / Post Processing Color Stability" would be based on the intended color change (red to gold or lighter) upon exposure to a specific sterilization cycle (hydrogen peroxide). "Tape Adhesion Strength" and "Biocompatibility" would have their own established pass/fail criteria from material science and safety testing. "Shelf life" would be determined by remaining functional over time.
    • Sample Size for Training Set: Not applicable. This is a physical chemical indicator, not an AI model that requires a training set.
    • How Ground Truth for Training Set was Established: Not applicable.
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