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510(k) Data Aggregation

    K Number
    K972300
    Device Name
    CROSS-CHECKS P
    Manufacturer
    STERITEC PRODUCTS MFG. CO., INC.
    Date Cleared
    1998-03-25

    (279 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K921910
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cross-Checks P chemical process indicator strips are designed to be used in the Sterrad sterilizer. Cross-Checks P Process Indicator Strips will exhibit a blue to red color change when exposed to hydrogen peroxide during the dillusion phase of the Sterrad cycle. When used as directed, the Cross Checks P strips give visible confirmation that the item has been exposed to hydrogen peroxide during the Sterrad Cycle.

    Device Description

    SteriTec Cross-Checks P strips are 4" x 5/8" process indicators with indicator ink printed onto Tyvek plastic.

    AI/ML Overview

    The SteriTec Cross-Checks P process indicator strips are designed to change color from blue to red when exposed to hydrogen peroxide during the diffusion phase of the Sterrad sterilizer cycle.

    Acceptance Criteria and Device Performance:

    Exposure Time to Hydrogen PeroxideAcceptance Criteria (Expected Outcome)Reported Device Performance (Number of strips meeting criteria)
    Less than 25 minutesIncomplete color change200/200 incomplete color change (at 10 and 15 minutes)
    25 minutesPossible pass (indicating some color change, but not necessarily complete)200/200 possible pass
    30 minutesComplete color change200/200 complete color change

    Study Details:

    1. Sample Size and Data Provenance:

      • Test Set Sample Size: 200 strips were used for each of the four different exposure timings (10 minutes, 15 minutes, 25 minutes, and 30 minutes), totaling 800 strips.
      • Data Provenance: The study was conducted using a Sterrad sterilizer, implying a controlled laboratory environment rather than a retrospective analysis of field data. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a U.S. company.

    2. Number of Experts and Qualifications: Not applicable. The assessment of color change for process indicators is typically objective and determined visually, often against a reference color chart, rather than through expert interpretation.

    3. Adjudication Method: Not applicable. The color change is a direct physical observation.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not performed. This type of study is relevant for diagnostic devices requiring human interpretation.

    5. Standalone Performance: Yes, a standalone performance study was conducted. The device's color change response was evaluated directly under controlled exposure times without human intervention influencing the outcome.

    6. Type of Ground Truth: The ground truth was established by defining the expected color change (or lack thereof) at specific exposure durations to hydrogen peroxide within the Sterrad cycle. This is a direct measure of the device's functional response to the sterilizing agent.

    7. Training Set Sample Size: The document does not specify a separate training set. The study appears to be a validation study of the final product with the reported 800 strips.

    8. Ground Truth for Training Set: Not applicable, as a separate training set is not described. The performance criteria against which the device was evaluated are inherent to the intended function of a chemical process indicator.

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