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510(k) Data Aggregation

    K Number
    K031681
    Device Name
    STERISIL ANTIMICROBIAL TUBING AND BOTTLE
    Manufacturer
    STERISIL
    Date Cleared
    2003-10-30

    (153 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The treated article controls the growth of bacteria, fungus, and algae providing the antimicrobial surface is regenerated with the continuous use of a Sterisil water pre-treatment product. The Sterisil treated article is intended to be used with distilled, deionized, or reverse osmosis water. Efficacy for tap water has not been determined. This product is not intended to provide sterile water.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Sterisil® Antimicrobial Tubing and Bottle). It confirms that the device is substantially equivalent to a predicate device and can be marketed.

    This document does not contain any information regarding:

    • Acceptance criteria for performance.
    • Results of a study proving the device meets acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts.
    • Adjudication methods.
    • MRMC comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used or how it was established.

    Therefore, I cannot fulfill your request based on the provided input. The letter focuses on regulatory clearance, not on detailed study performance metrics.

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