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510(k) Data Aggregation

    K Number
    K955248
    Device Name
    U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    1996-05-21

    (188 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Percutaneous endoscopic gastrostomy (PEG) has become the method of choice for patients, both adults and children, unable to take nutrition through normal means, yet, have a functional gastrointestinal tract.

    Device Description

    A U.S.E. PULL PEG Tray includes all necessary products (eg. silicone feeding tube, bolster, feeding adapter, etc.) and accessory products (eg. lubricating jelly, disposable hemostat, grasping snare) to complete the endoscopic gastrostomy.
    A U.S.E. GUIDEWIRE PEG Tray includes all necessary products (eg. silicone feeding tube, bolster, feeding adapter, etc.) and accessory products (eg. lubricating jelly, disposable hemostat, grasping snare) to complete the endoscopic gastrostomy.

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided text is a "Summary and Certification" for two different Percutaneous Endoscopic Gastrostomy (PEG) trays (PULL PEG Tray and Guidewire PEG Tray).

    Here's a breakdown of what the document does include:

    • Device Overview: Describes the purpose and components of the PULL PEG Tray and Guidewire PEG Tray, stating they are used for percutaneous endoscopic gastrostomies.
    • Contraindications: Lists conditions for which PEG procedures are not suitable (e.g., massive ascites, sepsis, inability to transluminate the stomach).
    • Manufacturing Overview: Briefly outlines U.S.E.'s manufacturing processes and quality assurance based on good manufacturing practices and MIL-STD-9858.
    • Bibliography: Provides a list of scientific articles related to Percutaneous Endoscopic Gastrostomy.

    The document does not include:

    • Acceptance Criteria: There are no specific performance metrics or thresholds defined for the device's acceptable performance.
    • Device Performance: No data or results from any study demonstrating how the device performs against any criteria are reported.
    • Study Design Details: Information typically found in a study (like sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is entirely absent.

    Therefore, I cannot provide the requested table or study details based on the input. The text focuses on describing the device and its general context within medical procedures, not on proving its effectiveness through defined performance measures and studies.

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