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510(k) Data Aggregation

    K Number
    DEN170024
    Device Name
    AQUABEAM System
    Manufacturer
    PROCEPT BioRobotics Corporation
    Date Cleared
    2017-12-21

    (248 days)

    Product Code
    PZP
    Regulation Number
    876.4350
    Type
    Direct
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AOUABEAM System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.

    Device Description

    The AQUABEAM System is a personalized image-guided prostate tissue removal system that uses a high-velocity water jet to resect and remove a predetermined volume of tissue. The AQUABEAM System is comprised of nine main components along with accessories: AQUABEAM Conformal Planning Unit, AQUABEAM Console, AQUABEAM Motorpack, AQUABEAM Roll Stand, AQUABEAM Foot Pedal, AQUABEAM Handpiece Articulating Arm, AQUABEAM TRUS Articulating Arm, AQUABEAM Handpiece, and AQUABEAM Scope.

    AI/ML Overview

    The AQUABEAM System is a fluid jet system for prostate tissue removal intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia (BPH). The device cuts tissue using a pressurized fluid jet and can image the treatment area or pairs with an imaging modality to monitor treatment progress.
    The provided text details the acceptance criteria and the study that proves the device meets these criteria. The study, named WATER, was a prospective, multicenter, international double-blinded randomized clinical trial comparing the AQUABEAM System (Aquablation) to transurethral resection of the prostate (TURP).

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are derived from the "Special Controls" section, which outlines the performance data required to establish safety and effectiveness. The reported device performance is extracted from the "Safety Results" and "Efficacy Results" sections of the WATER clinical study.

    Acceptance Criteria (Special Controls)Reported Device Performance and How It Meets the Criteria
    1. Clinical performance testing must evaluate:WATER Clinical Study Results:
    a. All adverse events associated with the device;- Primary Safety Endpoint: Occurrence of Clavien-Dindo persistent grade 1 or grade 2 or higher perioperative complications at 3 months.
    • Aquablation (25.0%) vs. TURP (40.0%).
    • Rate difference: -15.0% (95% CI: -29.2 to -1.0%).
    • UCL (-1.0%)
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