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510(k) Data Aggregation

    K Number
    K965017
    Device Name
    REGIONAL ANESTHESIA TRAYS
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-03-14

    (88 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    REGIONAL ANESTHESIA TRAYS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SIMS' Regional Anesthesia Trays are used to administer to a patient regional or local anesthesia.

    Device Description

    Regional Anesthesia Trays cover a broad product range, including; Continuous Epidural, Single Shot Epidural, Spinal, Nerve Block, Pediatric Epidural, and Combined Spinal/Epidural Trays. These trays are a compilation of the preparatory and surgical components required for administering anesthesia. The trays may include components such as: needles, syringes, filters, catheters, gloves, gauze sponges, drapes, The components are placed into a plastic tray, wrapped in CSR wrap, sealed, and sterilized by ethylene oxide.

    The trays are available in standard component configurations or can be customized to meet the needs of an individual user. All componentry supplied in these kits are from an approved list of components which are legally marketed devices.

    AI/ML Overview

    This submission does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a 510(k) summary for Regional Anesthesia Trays, focusing on demonstrating substantial equivalence to predicate devices and outlining the device's characteristics and intended use.

    Specifically, the document states:

    • "There were no nonclinical or clinical tests submitted with this submission." and "There were no nonclinical or clinical tests submitted with this submission:".
    • It mentions "Testing of the epidural catheter connector was performed in accordance with BS 6196. Performance testing of the proposed modification to the epidural catheter connector demonstrates that it performed equal to or better than our current epidural catheter connector." However, this is a summary statement about testing a component (epidural catheter connector) and the standard it followed (BS 6196), not a detailed study description for the entire Regional Anesthesia Tray device, nor does it provide specific acceptance criteria or performance metrics.

    Therefore, I cannot extract the requested information regarding acceptance criteria or a study that proves the device meets them from the provided text.

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