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510(k) Data Aggregation

    K Number
    K033954
    Device Name
    SHAPE LOCKING ENDOSCOPIC OVERTUBE
    Manufacturer
    USGI MEDICAL, INC.
    Date Cleared
    2004-03-19

    (88 days)

    Product Code
    FED,FDF
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K023902
    Why did this record match?
    Device Name :

    SHAPE LOCKING ENDOSCOPIC OVERTUBE

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

    The USGI Shape Locking Endoscopic Overtube is intended to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.

    Device Description

    The USGI Shape Locking Endoscopic Overtube is an endoscopic accessory designed to provide external support to an endoscope without hindering its flexibility and maneuverability. It is an overtube guide that can conform to any bend configuration of the scope and then be shape locked in that form. In the "shape locked" configuration, the scope can be further advanced or withdrawn repeatedly. The USGI Shape Locking Endoscopic Overtube is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The Shape Locking Tube is constructed from multiple nested links that are held together by four cables. Applying tension to the cables squeezes the links together. The friction between links maintains their relative positions, allowing the practitioner to "lock in" a shape.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to USGI Medical, Inc. regarding their Endoscopic Sheath. It primarily focuses on the device's substantial equivalence to a previously cleared predicate device (K023902).

    Here's an analysis of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Functional Equivalence to Predicate DeviceBench testing demonstrates that the devices are functionally equivalent.
    Biocompatibility of Patient-Contacting MaterialsAll components that come in direct contact with the patient have a long history of use in medical devices and are biocompatible.
    Performance as Intended (Mechanical & Functional)Mechanical and functional bench testing demonstrate that the USGI Shape Locking Endoscopic Overtube performs as intended.

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

    The document does not specify a "test set" in the context of an AI/algorithm-based device. The testing described is bench testing of the physical device. Therefore, information regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this context. The document refers to the device itself and its components.

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

    This information is not applicable as the document describes a physical medical device and its mechanical/functional performance, not an AI or algorithm-based diagnostic tool requiring expert ground truth for interpretation.

    4. Adjudication Method for the Test Set

    This information is not applicable for the reasons stated in point 3.

    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

    This information is not applicable. The device is a physical endoscopic overtube, not an AI or algorithm that assists human readers.

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

    This information is not applicable as the device is a physical medical device, not an algorithm.

    7. The Type of Ground Truth Used

    For the biocompatibility aspect, the ground truth is established by the "long history of use in medical devices" of the materials, implying a track record of safety and acceptance as biocompatible.

    For the mechanical and functional performance, the ground truth is based on the device's ability to "perform as intended" as demonstrated by bench testing. This refers to engineering and design specifications rather than clinical ground truth (like pathology or outcomes data).

    8. The Sample Size for the Training Set

    This information is not applicable as the document describes a physical medical device, not an AI or algorithm that requires a training set.

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

    This information is not applicable for the reasons stated in point 8.

    In summary, the provided document describes a 510(k) submission for a physical medical device, the USGI Endoscopic Sheath. The acceptance criteria and testing focus on the device's physical and functional performance, as well as the biocompatibility of its materials, by demonstrating substantial equivalence to a predicate device through bench testing. The concepts of AI/algorithm performance, training/test sets, expert ground truth, and MRMC studies are not relevant to this document.

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