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510(k) Data Aggregation

    K Number
    DEN220025
    Device Name
    Phagenyx System
    Manufacturer
    Phagenesis Limited
    Date Cleared
    2022-09-16

    (150 days)

    Product Code
    QQG,OOG
    Regulation Number
    874.5950
    Type
    Direct
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Phagenyx System is a neurostimulation device delivering electrical stimulation to the oropharynx, to be used in addition to standard dysphagia care, as an aid to improve swallowing in patients with severe dysphagia post stroke.

    Device Description

    The Phagenyx System comprises; a sterile single-patient use catheter (PNX-1000) and a Base Station (EPSB3). The catheter is a two-part fine bore that is introduced nasally and extends down as far as the patients' stomach. It incorporates two bipolar ring electrodes on its outer surface to deliver the electrical stimulation. It also incorporates a feeding tube to facilitate delivery of nutrition or hydration. The Base Station has a touch screen user interface that facilitates the optimization of stimulation levels for treatment and stores patient and treatment information.

    AI/ML Overview

    The provided text describes a medical device, the Phagenyx System, and its regulatory information, design, nonclinical/bench studies, and clinical information, including summaries of several studies. However, the document does not contain specific acceptance criteria for an AI/algorithm's performance or describe a study designed to validate the AI's performance against such criteria.

    The information primarily focuses on the device itself (hardware, electrical specifications, biocompatibility, sterility, safety, usability, and its clinical effectiveness in treating dysphagia). It does not describe an AI/algorithm or its performance, ground truth establishment, sample sizes for AI training/testing, or expert adjudication relating to an AI's output.

    Therefore, I cannot fulfill your request as it pertains to AI/algorithm acceptance criteria and performance studies based on the provided text. The prompt asks to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" when referencing an AI/algorithm, but the provided text does not discuss an AI/algorithm within the Phagenyx System.

    If you are interpreting "device" as a broader term that could encompass an AI component not explicitly detailed, please clarify. However, based solely on the provided text, no such information on AI/algorithm performance or its validation study exists.

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