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510(k) Data Aggregation

    K Number
    K103688
    Device Name
    G-PROX EZ ENDOSCOPIC GRASPER
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2011-01-14

    (28 days)

    Product Code
    OCZ,HET
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K093018
    Why did this record match?
    Device Name :

    G-PROX EZ ENDOSCOPIC GRASPER

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

    The USGI g-Prox EZ Endoscopic Grasper is intended for use in minimally Invasive procedures to facilitate tissue grasping and manipulation.

    Device Description

    The g-Prox EZ Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is available in two jaw lengths. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments. It is comprised of a polycarbonate proximal handle, flexible shaft made of medical grade polymers and distal stainless steel jaws. It has a nominal working length and outer diameter of 111 cm and 5.5 mm, respectively.

    AI/ML Overview

    This 510(k) summary (K103688) describes the g-Prox EZ Endoscopic Grasper, a sterile, single-patient-use device intended for tissue grasping and mobilization in minimally invasive procedures.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Device IntegrityNon-clinical performance testing, including bond joint strength testing, was conducted. Test data confirmed that the modified g-Prox EZ device demonstrated equivalent safety and performance to the predicate device.
    FunctionalityNon-clinical performance testing was conducted. Test data confirmed that the modified g-Prox EZ device demonstrated equivalent safety and performance to the predicate device. This likely includes the ability to grasp and mobilize tissue, and for the g-Prox EZ, specifically the ability to cut G-Cath anchor suture tails.
    In Vivo Simulated UseNon-clinical performance testing, including in vivo simulated use testing, was conducted. Test data confirmed that the modified g-Prox EZ device demonstrated equivalent safety and performance to the predicate device.
    Equivalence to Predicate Device (g-Prox Endoscopic Grasper - K093018)The g-Prox EZ Endoscopic Grasper demonstrated equivalent safety and performance to the predicate device in terms of intended use, technology, materials, and overall function. Specific comparisons include:
    • Identical shaft and distal jaw materials and sizes.
    • Identical intended use and principles of operation.
    • Identical lumen for accepting other instruments.
    • New suture cutting component in g-Prox EZ jaw. |

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

    The submission states that "Non-clinical performance testing was conducted." While it details the types of tests performed (device integrity, functionality, in vivo simulated use), it does not explicitly state the sample size for these tests or the data provenance (e.g., country of origin, retrospective or prospective). This information is typically found in the detailed test reports which are part of the full 510(k) submission but not included in this summary.

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

    This document does not describe the use of human experts to establish ground truth for the non-clinical performance testing. The evaluation focused on engineering and performance characteristics of the device itself rather than human interpretation of medical images or conditions.

    4. Adjudication Method for the Test Set

    Not applicable. This device's performance was evaluated through non-clinical engineering and functional testing, not through a process requiring expert adjudication of results.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    No, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument (grasper), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of improving human readers with AI assistance does not apply.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    Not applicable. This device is a physical surgical instrument and does not involve an algorithm or AI component in its operation. Its performance is entirely mechanical/physical, used by a human operator.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's testing was based on engineering specifications, material properties, and functional requirements. For example:

    • Device Integrity: "Ground truth" would be the predetermined acceptable limits for bond joint strength or other integrity measures.
    • Functionality: "Ground truth" would be the successful demonstration of tissue grasping, mobilization, and suture cutting (for the EZ model) according to design specifications.
    • In Vivo Simulated Use: "Ground truth" would involve successful and safe operation within a simulated biological environment, meeting predetermined performance criteria.

    8. The Sample Size for the Training Set

    Not applicable. As described in point 6, this device is a physical surgical instrument and does not involve any AI algorithms or machine learning that would require a "training set."

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

    Not applicable. As described in point 8, there is no training set for this device.

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