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    K Number
    K163509
    Device Name
    XprESS ENT Dilation System
    Manufacturer
    Entellus Medical, Inc.
    Date Cleared
    2017-04-05

    (111 days)

    Product Code
    PNZ,LRC,REG
    Regulation Number
    874.4180
    Type
    Traditional
    Panel
    Ear, Nose, and Throat (EN)
    Reference & Predicate Devices
    K152434
    Why did this record match?
    Device Name :

    XprESS ENT Dilation System

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

    To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

    To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach.

    Device Description

    The XprESS ENT Dilation System is intended to recreate the sinus outflow tract and dilate the Eustachian tube by transnasal balloon dilation. The XprESS device combines features of a curved suction tip and an ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device into the sinuses and Eustachian tubes using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses and Eustachian tubes within the same patient.

    The XprESS device curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS ENT Dilation System is provided sterile and for single use only.

    The Xpress ENT Dilation System includes the XprESS device, Inflation Syringe, Bending Tool, and two Extension Lines. The XprESS LoProfile and Ultra ENT Dilation Systems also include the PathAssist LED Light Fiber. The XprESS Pro ENT Dilation System also includes a Tuohy Adapter.

    AI/ML Overview

    I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is a 510(k) summary for a medical device (XprESS ENT Dilation System) and does not contain acceptance criteria or a detailed study description in the specified format.

    The document states that "The primary efficacy endpoint was met with Eustachian tube balloon dilation demonstrating superiority over medical management for improvement in ETDQ-7 symptom scores (p

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