LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990401
    Device Name
    FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER
    Manufacturer
    FUKUDA DENSHI USA, INC.
    Date Cleared
    1999-10-15

    (248 days)

    Product Code
    IYO,ITX,IYN
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K922208,K955543,K925582
    Predicate For
    K033209
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to be used for applications in fetal. abdominal, intraoperative (defined as the abdominal region and periphery), pediatric, small organ (defined as thyroid, breast and testes), cardiac, transrectal, transvaginal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either from the surface of the skin, transrectally, transvaginally or intraoperatively. The UF-5800A incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-5800A with optional Doppler (UF-5800DU) is a prescription device intended to by used by or on the order of a physician or similarly qualified health care professional. The UF-5800 is intended to be used in a doctor's office and all hospital environments; ER ICU, CCU, OR, etc. This device is intended to be use on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.

    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (Abdominal region and periphery), Pediatric, Small Organ (thyroid, breast, and testes), Cardiac, Transrectal, Transvaginal, Peripheral Vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

    Device Description

    The model UF-5800 is a portable, General Purpose Ultrasound Scanning System. The unit will be marketed as the UF-5800A General Purpose Ultrasound Scanner without Doppler. The addition of the optional UF-5800DU Doppler unit will add black and white Doppler capability to the UF-5800A. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on its gray scale monitor. The resulting information is displayed in M-mode, B-Mode, Doppler (both CW and pulsed) modes, or in combinations of modes on the system's 7 inch diagonal video monitor as a 16 level grayscale or black and white image.

    AI/ML Overview

    The Fukuda Denshi FF sonic model UF-5800A is a general-purpose ultrasound scanner with an optional Doppler unit (UF-5800DU). Here's an analysis of its acceptance criteria and the study that proves it meets those criteria, based on the provided document.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Fukuda Denshi FF sonic model UF-5800A are primarily based on demonstrating substantial equivalence to predicate devices and adherence to established safety and performance standards. The "reported device performance" section directly addresses how the device meets these criteria through various tests.

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    Substantial EquivalenceThe device must be as safe, as effective, and perform as well as or better than the legally marketed predicate devices (Fukuda Denshi models UF-4500 and UF-3500, and Medison SonoAce 4800). This includes technological characteristics not raising new safety/efficacy issues.Laboratory testing was conducted to validate and verify that the UF-5800A and UF-5800DU "met all design specifications and is substantially equivalent to the currently marketed FUKUDA DENSHI models UF-4500 and UF-3500 as well as the Medison SonoAce 4800." The technological characteristics, including the microprocessor, linear and convex probes (same as predicate Fukuda Denshi devices), and acceptance of sector and CW Doppler probes (similar to Medison SonoAce 4800), were deemed not to raise new safety or efficacy issues.
    Environmental SafetyCompliance with environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document.Environmental testing, as per the specified FDA guidance document, was performed. (Specific results are not detailed in this summary, but the conclusion states "demonstrate that the device is as safe...").
    Acoustic OutputDerated acoustic output limits must be below the maximums established for Track 1 devices as listed in the "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 30, 1997. Specific limits provided in the table:
    • Peripheral Vessel: ISPTA3
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1