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510(k) Data Aggregation

    K Number
    K964561
    Device Name
    ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
    Manufacturer
    BIOENTERICS CORP.
    Date Cleared
    1997-02-11

    (90 days)

    Product Code
    FDG
    Regulation Number
    876.4530
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    FDG

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

    The ENDOLUMINA® II Transillumination System is a medical device designed to aid in the identification of the esophagus, rectum, and other structures by transillumination during laparoscopy, thoracoscopy, or open procedures.

    Device Description

    The ENDOLUMINA II Transillumination System (EIB II) consists of a glass fiberoptic bundle inserted into a length of silicone elastomer tubing in a configuration similar to a fiberoptic cable. Attached to the cable's proximal end is a ball-shaped fitting which allows a clear, flexible, and detachable silicone tip to be attached or removed by means of a "pop-fit" connection. This tip is available in both blunt and tapered configurations. The EIB II is available in sizes ranging from 4 to 60 Fr. A light source connector/fitting is permanently attached to the distal end of the cable and is designed to be inserted into a commercially-available light source. Light generated from the light source is transmitted through the cable's fiberoptic bundle and down into the clear silicone tip, where it is deflected radially to enhance transillumination. The EIB II is supplied with one (1) cable assembly, which is supplied nonsterile and is designed to be reusable by the customer. Instructions for methods for cleaning and sterilizing the EIB II cable assembly are provided. The EIB II also contains three (3) detachable tips which are individually packaged in a double pouch system and labeled as sterile and for single use only.

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a 510(k) summary for the BioEnterics Corporation ENDOLUMINA® II Transillumination System, comparing it to a predicate device (ENDOLUMINA® I Illuminated Bougie) to establish substantial equivalence for market clearance.

    The document focuses on:

    • Description of the device: What the ENDOLUMINA II Transillumination System is, its components, and how it works.
    • Comparison to a legally marketed device: Highlighting similarities and minor differences between the ENDOLUMINA I and ENDOLUMINA II regarding design, materials, intended use, and reusability/sterilization.
    • Safety aspects: Mentioning biocompatibility testing and heat build-up evaluation.

    There is no mention of performance metrics, clinical studies, or acceptance criteria in the provided text. Therefore, I cannot generate the requested table or answer the specific questions about study design, sample sizes, ground truth, or expert involvement.

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