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510(k) Data Aggregation

    K Number
    K242860
    Device Name
    Type 5 Integrating Indicator for Steam (CSPN-15)
    Manufacturer
    True Indicating, LLC
    Date Cleared
    2025-01-17

    (119 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    True Indicating, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes. 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. Minimum Stated Values as determined in a resistometer: SV121°C/16.5 min., SV132°C/2.0min. SV134°C/1.4 min. SV135°C/1.2 min.
    Device Description
    The True Indicating Chemical Indicator for Steam CSPN-15 consists of a white polyester substrate with acrylic adhesive married to a paper substrate. The paper substrate (with acrylic adhesive) has True Indicating water-based steam indicating ink, ISPN-01 (pink to dark brown/black), and general artwork printed. After printing, the top layer of the Type 5 Integrating Indicator strip is covered with a clear colorless polyester laminate with acrylic adhesive. The Integrating Indicators have been designed for Steam sterilization processes, ensuring the effectiveness of sterilization by monitoring all critical process variables (time, temperature and steam). The pink indicating ink was developed to turn to dark and conceal the word "NOT" when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of a 105 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer).
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