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510(k) Data Aggregation

    K Number
    K234145
    Device Name
    ViSiGi 3D Gastric Sizing Tube
    Manufacturer
    Boehringer Laboratories
    Date Cleared
    2024-01-26

    (28 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Special
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K222880,K130483
    Why did this record match?
    Device Name :

    ViSiGi 3D Gastric Sizing Tube

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

    ViSiGi 3D is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, and to serve as a sizing guide.

    Device Description

    VISIG1® 3D is a non-sterile, single patient use device comprises a tube with a closed, rounded tip, and holes at the distal end. The tubes are supplied in three separate diameters: 32 French, 36 French, and 40 French. The proximal end of ViSiGi® 3D includes an integral suction regulator and vented On/Off slide valve. The device is supplied packaged in a sealed, labeled, poly bag. A squeeze bulb with an integral pressure gauge that can connect to the proximal end of the ViSiGi® 3D tube is an optional component compatible with the ViSiGi® 3D.

    AI/ML Overview

    The medical device in question is the Boehringer Laboratories ViSiGi® 3D Gastric Sizing Tube. The Special 510(k) submission (K234145) is for adding "to test for leaks" to the indications for use.

    Here's an analysis of the provided text in relation to your request:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document does not explicitly state formal "acceptance criteria" for the safety and effectiveness of the device for the added indication. Instead, it mentions that "Performance Data was collected to support the risk assessment associated with the addition of 'to test for leaks' to the indications for use." The performance data focused on accessory compatibility and functionality rather than the device's ability to detect leaks itself.

    Acceptance Criteria (Inferred from study scope)Reported Device Performance
    Bulb CompatibilityNot explicitly detailed, but implied to be compatible for the functionality testing, as the device is specified to be "compatible with the ViSiGi® 3D"
    Bulb Functionality (e.g., pressure generation)Not explicitly detailed, but implied to be functional for its intended purpose of supporting leak testing, as it was considered in the risk assessment.

    Important Note: The current submission for K234145 is a Special 510(k). This type of submission is used when a modification to a legally marketed device does not require a new 510(k) submission, meaning the changes are well-defined and do not significantly affect the safety or effectiveness of the device. In this case, the change is only to expand the indications for use. The manufacturer is essentially leveraging the existing clearance (K130483) of the primary predicate device and the fact that a similar indication ("to test for leaks") is included in a reference device (K222880, Endolumik Fluorescence Guided Gastric Calibration Tube). They argue that the existing technological characteristics are sufficient for this added indication.

    Therefore, the "studies" conducted for this specific submission focused on demonstrating that the modification (addition of a new indication) does not alter the fundamental safety and effectiveness of the existing device design.

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

    The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance data cited ("Bulb Compatibility" and "Bulb Functionality") appears to be internal verification of accessory functionality rather than a clinical study with patient data.

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

    The document does not mention the use of experts to establish ground truth for a test set. This type of assessment is typically used for AI/ML-based devices or image interpretation, which is not the primary focus of this device's change in indication.

    4. Adjudication Method for the Test Set:

    No adjudication method is mentioned as there's no indication of a test set with multiple interpretations requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    No MRMC study was conducted or referenced. This device is not an AI/ML-based diagnostic tool where human reader performance with and without AI assistance would be relevant.

    6. Standalone (Algorithm Only) Performance:

    No standalone algorithm performance study was conducted. The device is a physical gastric sizing tube, not a software algorithm. The "performance data" mentioned (bulb compatibility and functionality) relates to the physical accessories and their mechanical function, not an algorithm.

    7. Type of Ground Truth Used:

    No external ground truth (like pathology or outcomes data) is mentioned as being specifically used for evaluating the "to test for leaks" indication. The submission relies on the established safety and effectiveness of the device for its existing indications and the technological similarity to a predicate device that already includes the "to test for leaks" indication.

    8. Sample Size for the Training Set:

    No training set is mentioned. This is not an AI/ML device that requires a training set.

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

    Not applicable, as there is no training set mentioned.

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