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    K Number
    K231418
    Device Name
    ENDOGATOR™ Hybrid Irrigation Tubing
    Manufacturer
    Medivators
    Date Cleared
    2023-08-14

    (90 days)

    Product Code
    OCX
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K102855
    Why did this record match?
    Device Name :

    ENDOGATOR™ Hybrid Irrigation Tubing

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

    The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.

    Device Description

    The ENDOGATOR™ HYBRID Irrigation Tubing device contains a threaded cap and tubeset designed to be attached to sterile water bottles. The proximal end of the irrigation tubing includes the threaded bottle cap for attachment to a sterile water bottle. The bottle cap has three tubes attached, one for receiving CO2 (and air in the case of Pentax SKU's), one coaxial tube which has an inner lens rinsing uptake tube surrounded by an air/CO2 delivery tube, and one for delivering water for irrigation which interfaces with an irrigation pump. The water delivery tubes, both irrigation as well as lens rinsing include backflow check valves.

    AI/ML Overview

    The provided text describes the ENDOGATOR™ Hybrid Irrigation Tubing, a device for providing irrigation and supplying air/CO2 during GI endoscopic procedures. It compares this device to a predicate device (Universal Irrigation Solution Hybrid, K102855).

    Here's a breakdown of the acceptance criteria and study information provided:

    1. Table of acceptance criteria and the reported device performance

    TestingRequirementsReported Device Performance
    Water Flow RateLensing Flow Rate must be no lower than 10% of Predicate after calling for water for 20 secondsPass
    Insufflation Air & CO2 FlowAir & CO2 Flow Rate must be no lower than 10% of the predicatePass
    Backflow TestThe backflow valve must withstand at least 10 PSIPass
    Lens Rinsing Flow RateLensing Flow Rate must be no lower than 10% of predicate after calling for water for 20 secondsPass
    Durability of glue bonded connectionsThe bonded connections must meet or exceed 10 lbs of axial pull force and must maintain strength and durability requirements after being subjected to 2X EtO sterilization.Pass

    Biocompatibility Testing:

    • Requirements: Evaluated in accordance with ISO 10993-1:2018 for "Surface - Mucosal Membrane" with a contact duration of "Limited (
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