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510(k) Data Aggregation

    K Number
    K192471
    Device Name
    RHIN1 Stylus
    Manufacturer
    Aerin Medical Inc.
    Date Cleared
    2019-12-20

    (101 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K162810
    Why did this record match?
    Device Name :

    RHIN1 Stylus

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

    The RHIN I Stylus is indicated for use in otothing of the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.

    Device Description

    The RHIN1 Stylus is a handheld bipolar radiofrequency (RF) probe designed for use in otorhinolaryngology (ENT) surgery. The Stylus comprises a handle, shaft, and treatment tip. The treatment tip consists of an array of bipolar electric es and a temperature sensor that allows for monitoring of tissue temperature during RF energy delivery. The shaft is malleable to allow the user to bend the shaft in order to more easily access the desired treatment area(s). The Stylus is designed for use with the Aerin Console. It includes features to allow compatibility with and authentication by the Aerin Console. The Stylus connects to the Aerin Console via a flexible cable.

    The RHIN1 Stylus is used to treat patients experiencing chronic rhinitis. During a treatment procedure, the clinician inserts the shaft of the RHIN1 Stylus into a patient's nostril to position the treatment tip and deliver low power RF energy to the target tissue of the nasal airway. The low-power radiofrequency energy generates heat within the tissue, causing destruction of the unwanted soft tissue. The shaft of the RHIN1 Stylus is then removed from the nostril.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the RHIN1 Stylus, a radiofrequency probe for treating chronic rhinitis. While the document details the device's technical characteristics, regulatory classification, and a summary of non-clinical and clinical tests, it does not include information about an AI/algorithm-based device. Instead, the study outlined is a clinical trial assessing the effectiveness and safety of the RHIN1 Stylus itself in human subjects for a medical procedure.

    Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria for an AI/algorithm-based device cannot be extracted from this document. The document pertains to a physical medical device and its performance in a clinical setting.

    To answer your request, I would need a document describing an AI/algorithm-based medical device.

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