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510(k) Data Aggregation

    K Number
    K080809
    Device Name
    IEC MEDSIGHT AND MEDBRIGHT
    Manufacturer
    INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
    Date Cleared
    2008-08-11

    (143 days)

    Product Code
    FET,CFR,GCT
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K974391,K983279,K023659,K003325,K983566,K994090,K070266,K962595,K983628,K905376
    Why did this record match?
    Device Name :

    IEC MEDSIGHT AND MEDBRIGHT

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

    The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes. MedSIGHT is a color, television camera system (supplies image) and MedBRIGHT is a xenon/halogen light source system (supplies light). Both can be used with all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope) and it is designed for surgical procedures.

    Device Description

    The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes.

    The IEC MedSIGHT is a endoscopic color camera system and used in a variety of endoscopic surgical procedures (orthopedic, laparoscopic, urologic, sinuscopic, plastic, ... ) to capture and visualize the image from the endoscope on a monitor. The system consists of a control unit and a video head. The cable of the video head connects to the control unit. The video head connects to all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope).

    The IEC MedBRIGHT is a endoscopic light source system and used with all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope) to provide light for a high visual and photographic clarity for color rendition. The system consists of a control unit and a fiber optic cable. The fiber optic cable connects on one site with the control unit and the other side it connects to the endoscope.

    All these components are designed, constructed and intended to be operated exclusivelv as a unit.

    AI/ML Overview

    The provided document is a 510(k) summary for the IEC MedSIGHT and MedBRIGHT, an endoscopic camera and light source system. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication methods.

    The document focuses on:

    • Submitting entity and manufacturer information.
    • Device names and classification.
    • Indications for Use.
    • Device description.
    • A list of predicate devices used for substantial equivalence.
    • A brief statement on safety, largely referencing biocompatibility and similarity to predicate devices.
    • The FDA's letter of clearance.

    Therefore, I cannot provide the requested information from this document. The document primarily establishes substantial equivalence to legally marketed predicate devices, rather than detailing analytical or clinical performance studies with specific metrics and acceptance criteria.

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