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510(k) Data Aggregation

    K Number
    K202828
    Device Name
    Surgical Green Laser System
    Manufacturer
    Realton (Suzhou) Medical Technology Co., Ltd.
    Date Cleared
    2021-06-04

    (253 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K202601,K092735
    Why did this record match?
    Reference Devices :

    K202601

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

    The surgical green laser system is intended for surgical treatment of benign prostatic hyperplasia (BPH) through photoselective vaporization of the prostate (PVP).

    Device Description

    The surgical green laser system is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The device is a semiconductor pumped, Q-switched and double-frequency solid-state Nd:YAG green laser. The device has the following models according to different output laser powers: PVP-120, PVP-140, PVP-160 and PVP-180. It shall be used with the laser fibers cleared under K202601.

    The pulse rate of the device is 10kH-18kH, and pulse width of the device is 100ns-180ns.

    The surgical green laser system consists of a semiconductor-pumped controller, Laser internal circulating cooling system, electronic control system and footswitch.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device (Surgical Green Laser System) and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML powered medical device.

    The document describes a traditional medical device and its comparison to a predicate device for substantial equivalence. The "Performance testing" section (page 10) refers to tests conducted on the laser system according to IEC 60825-1:2014, optical pulse and RF Wireless performance tests, electrical safety, laser safety and electromagnetic compatibility (EMC) tests (ANSI AAMI ES60601-1, IEC 60601-2-22, IEC 60601-1-2), and software verification and validation testing. These are standard engineering and safety tests for hardware and software, not clinical performance studies for an AI/ML algorithm.

    Specifically, the document explicitly states: "Based on the similarities of the device specifications, intended use, indications for use between the surgical green laser system and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification." This confirms that there are no studies related to the clinical performance of an AI-powered device, nor acceptance criteria for such a device.

    Therefore, I cannot provide the requested information for an AI/ML powered medical device from this document.

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