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510(k) Data Aggregation

    K Number
    K173703
    Device Name
    Sonata Sonography-Guided Transcervical Fibroid Ablation System
    Manufacturer
    Gynesonics, Inc.
    Date Cleared
    2018-08-15

    (254 days)

    Product Code
    KNF,ITX,IYO
    Regulation Number
    884.4160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K121858,K061153,K110020
    Why did this record match?
    Reference Devices :

    K121858, K061153, K110020

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

    The Sonata® Sonography-Guided Transcervical Fibroid Ablation System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

    Device Description

    The Sonata System provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing, without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments.

    AI/ML Overview

    The provided text describes the acceptance criteria and the clinical study results for the Gynesonics Sonata® Sonography-Guided Transcervical Fibroid Ablation System.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance (Sonata System)
    Co-primary Efficacy Endpoint: Reduction in Menstrual Blood Loss (MBL) at 12 months
    Success criterion: Lower Confidence Limit (LCL) ≥ 45% (referring to ≥ 50% Reduction in PBAC and PBAC
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