LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252913

    Validate with FDA (Live)

    Device Name
    Break Wave
    Manufacturer
    Sonomotion, Inc.
    Date Cleared
    2026-01-12

    (122 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    18 - 120
    Reference & Predicate Devices
    K072538
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Break Wave device is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper and lower ureter).

    Device Description

    The Break Wave device is designed for the extracorporeal fragmentation of calculi located in the kidney and ureter. The primary components include a diagnostic ultrasound imaging workstation, imaging probe(s), high voltage signal generator, and piezoelectric acoustic source (therapy probe).

    The generator controls and drives the therapy probe, which delivers the acoustic pulses required for breaking stones. A lens is used to focus the acoustic waves to the target stone, creating stresses within the stone that result in stone fracture. Repeated application of the acoustic waves breaks the stone into small fragments that can pass spontaneously.

    The imaging workstation and associated ultrasound imaging probe provide the user interface and real-time image guidance for the Break Wave procedure. The imaging and therapy probe are coaxially aligned, with the imaging probe docking into the housing of the therapy probe. The probe assembly is designed to couple directly to the patient's skin and be held in place with a mechanical arm or hand-held. Since the therapy probe has a fixed focus, multiple therapy probes are included to target stones over a range of skin-to-stone distances.

    The Break Wave device is a portable lithotripter the size of a diagnostic ultrasound system, and the user operates the device similarly to operating a diagnostic ultrasound system. The user applies ultrasound coupling gel to the therapy/imaging probes, places the probe assembly against the patient's skin, and scans the abdomen to locate the stone(s) using standard ultrasound imaging techniques. Once the stone is identified and positioned within the target zone, the operator presses and releases the foot pedal to activate therapy. The operator monitors the fragmentation of the stone in real-time via the coaxial aligned imaging probe. The operator has the option to stop the therapy at any time by pressing and releasing the foot pedal a second time. Treatment may continue with up to 30 minutes of therapy. The device can be used without the need for patient sedation.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1