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    K Number
    K120299
    Device Name
    SRS ENDOSCOPIC STAPLING SYSTEM
    Manufacturer
    MEDIGUS, LTD.
    Date Cleared
    2012-05-18

    (108 days)

    Product Code
    ODE
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K013860,K023234,K031262,K071553,K071651
    Why did this record match?
    Reference Devices :

    K013860

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

    The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease (GERD) in patients who require and respond to pharmacological therapy.

    Device Description

    The Medigus SRS is an Endoscopic Stapling System. The device consists of the following components and accessories:

    • . The flexible endoscope combines a video camera, ultrasound sensor (range finder) and a stapler mechanism. The distal end of the endoscope is capable of retroflexion. The system enables creation of an endoluminally anterior partial fundoplication by stapling together the soft tissue of the fundus (upper part of the stomach) and the esophagus.
    • The endoscopy suite includes the ISL (Insufflation, Suction and Light) console and the CCU . (Camera Control Unit) console.
    • The associated accessories include: .
      • Irrigation bottle with liquids for irrigation of the camera lens l
      • Suction canister for extracting liquids during the procedure .
      • . Silicon tubes for connecting the ISL and other accessories to the endoscope
      • . Disposable air filter of the suction ISL input channel
      • I Overtube for protecting patient's pharynx
    AI/ML Overview

    The acceptance criteria and study proving the device meets them are detailed below, based on the provided text for the Medigus' SRS Endoscopic Stapling System (K120299).

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    SafetySerious Adverse Events (SAEs)- Ten patients with a total of ten SAEs reported.
    - Four 'mild' (pain, fever), three 'moderate' (pneumothorax, pneumomediastinum, pneumoperitoneum - all resolved spontaneously), two 'severe' (esophageal perforation requiring drainage, suicidal thoughts - non-device/procedure related).
    - One SAE (GI bleeding with transfusion) unclassified in intensity.
    - Six SAEs considered related (one definitely, others possibly); three not related.
    - Median time from procedure to SAE for related events: 1.5 days.
    - No operations or re-operations needed for SAEs.
    - SAE and overall safety profile similar to EsophyX predicate device (two perforations, one bleeding reported).
    Adverse Events (AEs)- Postoperative pain/discomfort: 33%.
    - Postoperative nausea: ~10%.
    - Sore throat: 21%.
    - AEs were mild or insignificant in most cases.
    - Number of AEs similar to EsophyX and Plicator (e.g., 3 cases of fever vs. 3 for EsophyX; 32% chest pain vs. 17% for Plicator; 21% sore throat vs. 15% for Plicator, 8% for EsophyX).
    EfficacyImprovement in GERD-HRQL score (Primary Endpoint)- 75% of patients had a >50% improvement in their GERD-HRQL score off PPI at six months compared to baseline.
    - Study met primary endpoint with 95% confidence level.
    - Median score reduction of 23.0 units (from 29.0 to 6.0), representing 79.3% improvement. This is almost identical to EsophyX (79.2%) and slightly better than Plicator (76.0%).
    Reduction in Acid Exposure (Secondary Endpoint)- Median percent of time pH
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