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510(k) Data Aggregation

    K Number
    K974798
    Device Name
    STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    1998-03-20

    (88 days)

    Product Code
    LIF
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SteriChek™ Residual Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.

    Device Description

    The device is made up of a 0.20 square inch off-white reagent pad that is chemically treated to detect peroxide in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.

    AI/ML Overview

    The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics in the way a typical medical device study would describe. The document is a 510(k) Safety and Effectiveness Summary for the SteriChek™ Residual Peroxide Reagent Strips.

    This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study against defined acceptance criteria.

    However, based on the information provided, we can infer some aspects and highlight what is missing:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Inferred from intended use)Reported Device Performance (Inferred/Stated)
    Detection of peroxide in waterChemically treated pad detects peroxide
    Measurement of peroxide concentrationPad changes color relative to amount of peroxide
    Ability to detect levels < 1.0 ppmUsed as a rapid screening method to detect levels of less than 1.0 ppm
    Quantitative estimation 0-10 ppmUsed as a quantitative method to allow estimation of peroxide concentration between 0 and 10 ppm
    Color blocks calibrated to ppmColor blocks on label are calibrated in terms of peroxide concentration in parts per million (ppm)
    Performance identical to predicate device"ETS will manufacture the SteriChek™ Residual Peroxide Reagent Strips using the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device..."
    Same test principles as predicate"...the change in formulation provides for different color development but follows the same test principles as the predicate device."
    No new safety/effectiveness questions arising from technological characteristics"The SteriChek™ Residual Peroxide Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions."

    Missing Information:

    • Specific numerical acceptance thresholds for accuracy, precision, sensitivity, or specificity.
    • Quantitative data from direct comparison studies where the SteriChek™ strip's readings are compared against a gold standard or the predicate device at various concentrations.

    2. Sample size used for the test set and the data provenance:

    • Sample Size: Not specified. The document states that the new device will be manufactured using the same manufacturing and quality assurance procedures as the predicate and will be identical in performance. This implies that no new, extensive test set was generated for direct comparison within this submission.
    • Data Provenance: Not explicitly stated as a separate test set. The claim of "identical in performance" suggests reliance on the predicate device's established performance data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable/Not specified. There is no mention of human experts interpreting the results of the device for a test set, nor of defining a "ground truth" through expert consensus for a new study. The device itself produces a readily interpretable color change.

    4. Adjudication method for the test set:

    • Not applicable/Not specified. There is no mention of human interpretation requiring adjudication for a test set.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Not applicable. This device is a chemical reagent strip, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is a chemical reagent strip, not an algorithm. The "standalone" performance is the color development and its proportional intensity to peroxide concentration.

    7. The type of ground truth used:

    • For the device's function: The "ground truth" for the device's function (color change proportional to peroxide concentration) would be established by analytical chemistry methods (e.g., spectrophotometry, titration) to accurately determine peroxide concentrations in reference solutions. The document implies that the color blocks on the label are "calibrated" against such a ground truth.
    • For the submission: The "ground truth" for this 510(k) submission is the established performance and safety record of the predicate device (Serim™ Peroxide Reagent Strips). The new device aims to be substantially equivalent to this predicate.

    8. The sample size for the training set:

    • Not applicable. This is a chemical reagent strip, not a machine learning model. There is no "training set" in the context of AI.

    9. How the ground truth for the training set was established:

    • Not applicable (as above).
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