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510(k) Data Aggregation

    K Number
    K020944
    Device Name
    VORTEX VALVED HOLDING CHAMBER
    Manufacturer
    PARI INNOVATIVE MANUFACTURERS, INC.
    Date Cleared
    2002-05-09

    (45 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K992917,K930574,K900576,K900557,K884803,K872037,K822437
    Why did this record match?
    Device Name :

    VORTEX VALVED HOLDING CHAMBER

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

    Vortex is indicated for use as a spacer/valved holding chamber for use in delivery of aerosol medication with metered dose inhalers.

    Device Description

    Vortex is a new spacer/holding chamber designed to assist patients using metered dose inhalers (MDI) for aerosolized drug delivery. Vortex may provide enhanced drug delivery, ease of use and ability to clean/disinfect the device.

    Vortex is a reusable device consisting of an aluminum cylinder with an elastomeric fitting on one end to accept metered dose inhalers and a valved mouthpiece on the other end to interface with the patient. The elastomeric fitting may be removed for cleaning and/or replacement.

    Vortex will be available as a stand-alone item and will also be available packaged with a mask.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test/CharacteristicAcceptance Criteria (Vortex compared to Aerochamber)Reported Device Performance (Vortex)
    Drug Delivery (Respirable Drug)Comparable to or greater than Aerochamber.Respirable drug delivered through Vortex is "comparable to . or greater than Aerochamber."
    Fit with MDI ElbowsNot explicitly stated as a comparative criterion, but implied to fit all.Vortex "fit all MDI elbows evaluated."
    Inhalation ResistanceComparable to or less than Aerochamber, and less than 250 pascal at 30 lpm flow."Comparable to or less than Aerochamber. All results are less than 250 pascal at 30 lpm flow."
    Exhalation ResistanceComparable to or less than Aerochamber, and less than 250 pascal at 30 lpm flow."Comparable to or less than Aerochamber. All results are less than 250 pascal at 30 lpm flow."

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not specify the exact sample sizes for the "test set" (i.e., the number of devices or experimental replicates used in the non-clinical testing). It only states that "Testing to compare Vortex to Aerochamber was conducted."

    The data provenance is retrospective, as the testing was conducted for the purpose of a 510(k) submission to demonstrate substantial equivalence to an already legally marketed device. The country of origin of the data is not explicitly stated.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

    This information is not applicable as the provided document describes non-clinical performance testing of a medical device (a valved holding chamber/spacer), not a diagnostic or AI-driven system that requires expert-established ground truth. The "ground truth" here is objective physical measurements (e.g., drug delivery, resistance).

    4. Adjudication Method for the Test Set

    This information is not applicable for the same reason as point 3. Adjudication methods are typically relevant for subjective assessments or when multiple experts review the same data, which is not the case for this non-clinical performance study.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not completed/is not required to show substantial equivalence." MRMC studies typically involve human readers and clinical outcomes.

    6. If a Standalone (algorithm only without human-in-the-loop performance) was done

    This question is not applicable as the device (Vortex valved holding chamber) is a physical medical device, not an algorithm or AI system. Its performance is measured directly, not through an algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" used for this device's performance assessment was based on objective physical measurements and established testing methodologies. For example:

    • Drug delivery: Measured quantitatively according to FDA guidance.
    • Fit with MDI elbows: An objective assessment of physical compatibility.
    • Inhalation and exhalation resistance: Measured quantitatively using instruments (e.g., in pascal at a specific flow rate).

    8. The Sample Size for the Training Set

    This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The performance testing was conducted on the physical device itself.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable for the same reason as point 8.

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