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    K Number
    K172529
    Device Name
    Vivaer ARC Stylus
    Manufacturer
    Aerin Medical, Inc.
    Date Cleared
    2017-12-05

    (106 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K162810
    Why did this record match?
    Device Name :

    Vivaer ARC Stylus

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

    The Vivaer ARC Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue, in the internal nasal valve area.

    Device Description

    The Vivaer ARC 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 electrodes and a temperature sensor that allows for monitoring of tissue temperature during RF energy delivery. 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.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    Device Performance (Non-Clinical)System responsivenessMet all performance testing requirements.
    Effectiveness for clinical useMet all performance testing requirements.
    Adequate shaft strength (Force load testing)Verified.
    Thermocouple accuracy and response time (water bath immersion)Efficacy supported.
    Tissue heating time (using representative soft tissues of the nasal airway)Efficacy supported.
    Comparable thermal lesion volumes to predicate deviceShowed that the Vivaer ARC Stylus creates thermal lesion volumes comparable to the predicate device.
    Device Safety (Non-Clinical)Biocompatibility (AAMI/ANSI/ISO 10993-1 (2009/(R) 2013))Demonstrated through testing.
    Sterilization validation (ANSI/AAMI/ISO 11135:2014 and ISO 10993-7:2008)Performed in accordance with standards.
    Electrical safety (IEC 60601-1:2005/A1:2012 and IEC 60601-2-2:2009)Demonstrated through testing.
    Electromagnetic compatibility (IEC 60601-1-2:2007/AC:2010)Performed according to standard.
    Packaging validation (Transit testing, visual inspection, accelerated aging, gross leak detection, seal strength testing in accordance with ASTM D4169-14, D4332-14, F1980-07(2011), F2096-11, F88/F88M-15)Met all acceptance criteria.
    Long-term safety and healing in nasal tissue (in vivo canine study)Treatment resulted in durable change of submucosal gland population, no significant fibrosis, tissue contraction, or cartilage degeneration after 6 months. Healing process complete or near-complete at 6 months. Supports long-term safety.
    Clinical EfficacyPrimary Efficacy Endpoint: Statistically significantly greater than 15-point improvement in mean NOSE score from baseline to 26 weeks post-procedure.Met. Mean NOSE score decreased 55 points (SD 21) from baseline to 26 weeks (paired t-test, p
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