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510(k) Data Aggregation

    K Number
    K090009
    Device Name
    THD SLIDE ONE
    Manufacturer
    THD SPA
    Date Cleared
    2009-01-28

    (26 days)

    Product Code
    JAF,REG
    Regulation Number
    892.1540
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K070815,K081429
    Why did this record match?
    Device Name :

    THD SLIDE ONE

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

    The THD Slide One Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler system, placed inside the THD Evolution Doppler device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a THD proctoscope, sutures and a needle holder included in the THD Kits.

    The THD Slide One is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

    Device Description

    The THD Slide One consists of the THD Evolution Doppler device and the THD Slide One Kt. The THD Evolution Doppler device is an 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler is used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation. The THD Slide One Kit is a sterilized surgical kit comprised of a proctoscope, needle holder, knot tightener, sutures and Doppler probe. The kits used for the surgical treatment could be the THD Slide One kit or one of the kits already cleared by THD/G.F .; the THD kit that was included in the THD Submission (K070815) or the THD Slide (K081429)

    AI/ML Overview

    The provided text describes a 510(k) summary for the THD Slide One, a nonfetal ultrasonic monitor. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance metrics.

    The document primarily focuses on:

    • Administrative details: Submitter, contact persons, summary preparation date, device names, classification, and predicate devices.
    • Device description: Components of the THD Slide One system (THD Evolution Doppler device and THD Slide One Kit) and their function.
    • Indications for Use: What the device is intended for (surgical treatment of second and third-degree hemorrhoids using Doppler-guided Transanal Hemorrhoidal Dearterialization technique).
    • FDA Clearance Letter: Confirmation of substantial equivalence to a predicate device and permission to market.

    Therefore, it is impossible to provide the requested information as the input text does not contain any data related to acceptance criteria, device performance studies, or ground truth establishment.

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