LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K050414
    Device Name
    PLIX
    Manufacturer
    RESPIRONICS, INC.
    Date Cleared
    2005-04-11

    (52 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K993220
    Why did this record match?
    Device Name :

    PLIX

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

    The PLOX is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside and outside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

    Device Description

    The PLOX is a double walled vacuum insulated cryogenic vessel designed to hold approximately 1 pound of liquid oxygen at a pressure of 22 psig with heat exchange tubing, relief valves and a pneumatic conserving device housed in a plastic enclosure. Oxygen is stored under low pressure in its liquid state where the pressure is limited by the pressure relief valve. The liquid oxygen is converted to near ambient temperature gaseous oxygen through a system of tubes and warming coils for delivery to patients requiring supplemental oxygen by a single lumen cannula. The PLOX is a mechanical device and does not contain any electronics or software. The PLOX is designed to be refiled from industry standard liquid oxygen stationary units already cleared and in the marketplace.

    The PLOX provides three modes of operation: conserve mode, continuous mode, and off mode.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device (PLOX - Portable Liquid Oxygen System). It includes information about the device description, indications for use, and a letter from the FDA confirming substantial equivalence to a predicate device.

    However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

    The information provided only describes the device itself and its regulatory approval status. Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1