LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190356
    Device Name
    ClariFix
    Manufacturer
    Arrinex, Inc
    Date Cleared
    2019-02-26

    (11 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K162608
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ClariFix Device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

    Device Description

    The ClariFix Device is a handheld, single patient-use, disposable cryosurgical device used for the destruction of tissue during surgical procedures, including with chronic rhinitis. The device consists of a Handle attached to a Cannula with a Cryoprobe at the distal end. The ClariFix Device is provided sterile to the user. The device is provided with a 10mL nitrous oxide Canister.

    To perform cryosurgery, the ClariFix Device is removed from the sterile packaging and a nitrous oxide Canister is inserted into the Handle. A Canister Cap is then tightened onto the Handle, which pierces the Canister. The cryogen is held in the Handle until the user opens a mechanical valve that allows cryogen to flow down the Cannula into the Cryoprobe.

    The Cryoprobe is placed into contact with the target tissue via direct visualization. The Cannula can be rotated to ensure proper positioning. Once the Cryoprobe is in the desired position, cryosurgery can start.

    The Cryoprobe is held in contact with the target location during cryosurgery. As cryogen flows into the Cryoprobe, the liquid partially evaporates and the inside of the Cryoprobe cools to

    AI/ML Overview

    This FDA 510(k) summary document for the ClariFix Device (K190356) does not describe an AI/ML medical device. It pertains to a cryosurgical unit and accessories. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for training and testing, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI performance cannot be extracted from this document, as these concepts are not applicable to the device described.

    The document focuses on demonstrating substantial equivalence to a predicate device (Arrinex, Inc., ClariFix Device K162608) by showing similar intended use, indications for use, and technological characteristics. The performance data mentioned are related to device functionality and safety (e.g., temperature reproducibility, leakage, mechanical integrity, shelf-life, sterilization) rather than the performance of an AI algorithm in diagnosis or prediction.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1