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510(k) Data Aggregation

    K Number
    K010404
    Device Name
    EXEL I.V. ADMINISTRATION SET
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2001-08-30

    (199 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K963659
    Device Name
    EXEL I.V. ADMINISTRATION SET
    Manufacturer
    EXEL INTL.
    Date Cleared
    1997-12-16

    (469 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    THIS DEVICE IS ESED FOR IMPUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria, the study details, or the device performance as requested. The document is a 510(k) clearance letter from the FDA for an "Exel I.V. Administration Set," indicating that the device has been deemed substantially equivalent to a predicate device.

    The letter discusses regulatory aspects, such as:

    1. Device Type: Exel I.V. Administration Set.
    2. Regulatory Class: II.
    3. Product Code: FPA.
    4. Indications For Use: "THIS DEVICE IS USED FOR INFUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT."
    5. FDA Clearance Date: December 18, 1997.

    However, it does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about sample sizes, data provenance, or ground truth establishment for any studies.
    • Information on expert usage, adjudication methods, or MRMC comparative effectiveness studies.
    • Specifics on standalone algorithm performance or training set details.

    This document is a regulatory approval, not a scientific study report. Therefore, I cannot fulfill your request based solely on the provided text.

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