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    K Number
    K232327
    Device Name
    Endorail
    Manufacturer
    Endostart s.r.l.
    Date Cleared
    2024-03-15

    (225 days)

    Product Code
    ODC
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K183057,K111760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Endostart s.r.l.

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

    ENDORAIL is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope (i.e. an endoscope with an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization) during endoscopy of the large intestine.

    Device Description

    ENDORAIL is a colonoscopy add-on device developed to be used without any modification to colonoscopes and peripheral devices currently utilized. It is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. The device works as a magnetic anchor that allows the operator to guide the colonoscope and to straighten colon curves and loops. ENDORAIL includes a Balloon Guide that can be introduced, when needed, through the endoscope instrument channel during the colonoscopy, if this procedure becomes challenging. The system does not require to be premounted and does not interfere with the normal colon examination process. The Balloon Guide is advanced beyond the colonoscope tip where the balloon is filled with a ferromagnetic fluid and magnetically anchored to a magnetic Handpiece placed on the patient's abdomen. Once anchored, the colonoscope can be easily straightened and guided along the device, allowing a fast and safe inspection of the entire colon. Once the challenging segment of the colon is resolved, or the colonoscopy procedure is completed, the Balloon Guide can be retrieved.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Primary Endpoints)Reported Device Performance (ENDORAIL)
    Efficacy: Colonoscopy incompletion rate ≤ 10% in long-lasting colonoscopies.0% colonoscopy incompletion rate. All 100% of patients successfully completed the colonoscopy.
    Safety: No increase in colonoscopy serious adverse events (SAEs) (i.e., absence of any device-related SAEs).No AE/SAE, no abnormal findings, and no overall change in the health status of any patient undergoing colonoscopy with ENDORAIL were observed in the study.

    Study Details

    2. Sample Size and Data Provenance

    • Test Set Sample Size: 38 patients were enrolled and included in the statistical analysis.
    • Data Provenance: Prospective, multi-center clinical trial conducted in Italy, Germany, and Belgium.

    3. Number of Experts and Qualifications for Ground Truth (Test Set)

    The document does not explicitly state the number of experts used to establish the ground truth for the test set cases or their specific qualifications beyond being "specialized medical staff" and "Principal Investigators" at the trial centers. However, the study involved:

    • Principal Investigator: Prof. Alessandro Repici (IRCCS Humanitas Research Hospital, Milan, Italy)
    • Principal Investigator: Prof. Helmut Neumann (GastroZentrum Lippe, Germany, affiliated with Universität Mainz)
    • Principal Investigator: Prof. Raf Bisschops (University Hospitals Leuwen, Belgium)

    These individuals are implied to be highly qualified gastroenterologists or endoscopists.

    4. Adjudication Method for the Test Set

    The document does not describe a formal adjudication method for the test set cases, such as "2+1" or "3+1." The evaluation of outcomes (completion rate, adverse events) was directly reported as observed during the clinical study.

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

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was a single-arm interventional study.

    6. Standalone Algorithm Performance

    This section is not applicable as ENDORAIL is a physical accessory to an endoscope, not a software algorithm or AI-driven device intended for standalone performance.

    7. Type of Ground Truth Used

    The ground truth for the acceptance criteria (colonoscopy completion and adverse events) was based on clinical observation and outcomes data from the prospective clinical trial. Colonoscopy completion was defined as caecal intubation being achieved. Adverse events were observed and classified by medical staff.

    8. Sample Size for the Training Set

    This section is not applicable. As ENDORAIL is a physical medical device accessory and not a machine learning algorithm, there is no "training set" in the context of AI/ML. The device's design and functionality were developed and validated through non-clinical testing and then evaluated in a clinical trial.

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

    This section is not applicable as there is no training set for a physical device.

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