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510(k) Data Aggregation

    K Number
    K243917
    Device Name
    F&P Optiflow Air/Oxygen Flow Source
    Manufacturer
    Fisher & Paykel Healthcare Ltd
    Date Cleared
    2025-07-14

    (206 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K161718,K131895
    Why did this record match?
    Reference Devices :

    K161718,K131895

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

    This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals.

    This product is not intended to be used on patients with bypassed upper airways.

    This product is not intended to be life-sustaining or life-supporting.

    This product is not intended for apneic ventilation.

    Device Description

    The F&P Optiflow Air/Oxygen Flow Source is a respiratory high flow therapy device designed to generate a flow of air and/or oxygen. The device allows selectable flow rates up to 70L/min with selectable oxygen concentrations ranging from 21% to 100%.

    The subject device is a multi-patient use prescription only device, provided in a non-sterile state. It operates at flow ranges between 0 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.

    AI/ML Overview

    The provided FDA 510(k) clearance letter and summary for the "F&P Optiflow Air/Oxygen Flow Source" is for a hardware device, a breathing gas mixer, not a software or AI-driven diagnostic device. Therefore, the majority of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI/software performance is not applicable based on the provided document.

    The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and compliance with general medical device standards. There is no information regarding AI-specific performance metrics, clinical studies involving human readers, or detailed ground truth establishment for diagnostic capabilities.

    Below is a table summarizing the general performance data found, where applicable, according to the structure requested, along with an explanation for the absence of AI-specific information.

    Acceptance Criteria and Device Performance for F&P Optiflow Air/Oxygen Flow Source

    This device is a hardware breathing gas mixer, not an AI or software-driven diagnostic tool. As such, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, human reader improvement, adjudication, ground truth for AI training/testing) are not present in this 510(k) summary. The "performance data" section primarily refers to compliance with safety, electrical, and performance standards for medical electrical equipment and gas mixers.

    1. Table of Acceptance Criteria and Reported Device Performance:
    Acceptance Criteria (from recognized standards & predicate comparison)Reported Device Performance (as per 510(k) Summary)
    Flow Rate Accuracy: +/- 10%Accuracy of +/- 10% (Identical to Primary Predicate)
    Operating Temperature Range: (Comparable to predicates)64°F to 79°F (18 °C to 26 °C)
    % Oxygen Control: 21 – 100%21 – 100% (Identical to Predicates)
    % Oxygen Control Accuracy: (Based on ISO 11195:2018)+/- 5%
    Oxygen Supply Alarm: Triggers if pressure 2 minutesAudible alarm for time, t > 2 minutes
    Disconnection Alarm: Activated in
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