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510(k) Data Aggregation

    K Number
    K062005
    Device Name
    PORTEX EPIDURAL CATHETER
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Date Cleared
    2006-10-18

    (93 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K992471
    Predicate For
    K080140
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Epidural Catheter is indicated for the injection of local anesthetics into the epidural space. The duration of use should not exceed 72 hours.

    Device Description

    The epidural catheter is made of flexible, nylon tubing. The catheters have a yellow radiopaque stripe. The catheter may be closed-ended with eyes or open-ended with a finished tip. The catheter has a marked tip with a single mark at 5cm from tip with 1cm increments, up to 15cm. The 10cm mark is indicated by two marks, 15cm by three marks, and 20mm by four marks.

    The catheter is available in 20g (O.D. 1.05 mm/ I.D. 0.52 mm) or 21G (O.D. 0.83 mm/ I.D. 0.41 mm) sizes. The catheters have a nominal length of 36 inches.

    AI/ML Overview

    The provided document is a 510(k) summary for the Portex® Epidural Catheter. It outlines the device description, indications for use, and a summary of testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain detailed information regarding specific acceptance criteria for performance metrics, nor does it describe a study with specific performance results to prove the device meets such criteria.

    The document states:

    "All materials used in the fabrication of the Epidural Catheter were evaluated through biological qualification safety tests as outlined in ISO 10993-1 Part 1 "Biological Evaluation of Medical Devices". Design control activities have been completed and the results indicate that the subject device is safe and effective."

    This statement indicates that testing was performed, but it does not provide the specific performance data, acceptance criteria, or the methodology of the study related to acceptance criteria as requested in your prompt.

    Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory compliance through substantial equivalence to a predicate device and biological safety testing, rather than a detailed performance study with defined acceptance criteria and corresponding results.

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