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510(k) Data Aggregation

    K Number
    K162110
    Device Name
    CORGRIP NG/NI Tube Retention System
    Manufacturer
    CORPAK MedSystems, Inc. a Division of Haylard Health
    Date Cleared
    2016-09-15

    (48 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K133599
    Why did this record match?
    Device Name :

    CORGRIP NG/NI Tube Retention System

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

    The CORGRIP Nasogastric/Nasointestinal (NGNI) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal or displacement of the tubes for adult patients.

    Device Description

    The CORGRIP NG/NI Tube Retention System is an accessary to prevent unwanted displacement or removal of nasogastric/nasojejunal tubes for adult patients by retaining the tube to the patient's nasal septum. The device consists of three main components: insertion (delivery) catheter, retrieval catheter, and tube clamp.

    The catheters are placed in either nare of the patient and the clinician maneuvers the catheters to connect the magnets at the back of the patient's nasal septum. Both catheters have a flexible tip to aid in magnet connection. Once connection is made the magnet on the insertion catheter is pulled through the nare by the retrieval catheter. Both catheters are then removed from each nare until the ends of the umbilical tape are exiting either nare. The umbilical tape is then secured to the feeding tube with the provided clamp.

    The proposed device adds the option of a 14, 16 and 18 Fr clamp.

    AI/ML Overview

    The provided text describes a medical device, the CORGRIP NG/NI Tube Retention System, and its performance data. However, it does not describe an acceptance criteria table or a study proving that an AI device meets acceptance criteria. The document is a 510(k) premarket notification for a physical medical device, not an AI or software as a medical device (SaMD) product.

    Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details based on the provided text.

    The closest relevant information from the document pertains to the performance testing of the physical clamps of the CORGRIP NG/NI Tube Retention System. Here's what can be extracted about that, structured to clarify that it's not AI-related:

    1. Acceptance Criteria and Reported Device Performance (for the physical device's clamps):

    Acceptance Criteria (Design Requirements for clamps)Reported Device Performance
    Visual inspections metAll clamps and materials met or exceeded design requirements.
    Tether grip strength metAll clamps and materials met or exceeded design requirements. (Specific values for "met or exceeded" are not provided in the document, only the general statement of compliance.)
    Tube grip strength metAll clamps and materials met or exceeded design requirements.
    Tube occlusion metAll clamps and materials met or exceeded design requirements.

    For the remaining AI-specific questions, the information is NOT available in the provided document:

    1. Sample size used for the test set and the data provenance: Not applicable as this is a physical device, not an AI device tested on data. The clamps were tested in a laboratory setting with "Covidien Salem Sump™ Dual Lumen Stomach Tubes." No specific sample size for these tubes is mentioned.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical clamp involves engineering and mechanical testing, not clinical expert consensus.
    3. Adjudication method: Not applicable.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This device does not involve human readers interpreting images with or without AI assistance.
    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used: For the physical clamp testing, the "ground truth" would be established engineering and design specifications for grip strength, occlusion, etc., measured through lab tests.
    7. The sample size for the training set: Not applicable (no AI training set).
    8. How the ground truth for the training set was established: Not applicable (no AI training set).
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