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510(k) Data Aggregation

    K Number
    K020881
    Device Name
    MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
    Manufacturer
    SCIENCE INCORPORATED
    Date Cleared
    2002-03-27

    (9 days)

    Product Code
    FRN,MEB
    Regulation Number
    880.5725
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K010824
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Science Incorporated Personal Infusor Local Pain Management Procedural Kit is intended to provide continuous infusion of physician-prescribed local anesthetic medications directly into the intraoperative site of a patient for management of postoperative pain. Medication is delivered percutaneously, through the infusor's administration line, which is attached to a catheter.

    The Personal Infusor is portable and is suitable for use by ambulatory patients.

    The Personal Infusor is intended for single use only.

    The Personal Infusor is not intended for rapid infusion, intravenous or intra-arterial drug infusion, for the delivery of blood, blood products, lipids, or fat emulsions, or for use by patients with a history of allergic reactions to anesthetics.

    Device Description

    The Science Incorporated Personal Infusor Local Pain Management Procedural Kit consists of a Personal Infusor provided in a kit with medical device components including a catheter set, catheter introducer, 60 mL syringe, dressings and accessories. Each of the additional medical device components is purchased in finished form and is packaged with the Personal Infusor in the Personal Infusor Local Pain Management Procedural Kit.

    The Personal Infusors provided in the Personal Infusor Local Pain Management Procedural Kit will be offered in three volume / flow rate configurations.

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria and the study that proves the device meets them, as requested in your prompt. The document is primarily a 510(k) summary and the FDA's substantial equivalence letter for a medical device (Personal Infusor Local Pain Management Procedural Kit). It describes the device, its intended use, and its predicate device, but it does not include details on performance studies, acceptance criteria, or ground truth establishment.

    Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, or MRMC studies.

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