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510(k) Data Aggregation

    K Number
    K203137
    Device Name
    Venue Fit
    Manufacturer
    GE Medical Systems Ultrasound and Primary Care Diagnostics,
    Date Cleared
    2020-12-29

    (70 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Reference Devices :

    Venue (K180599), Versana Premier (K200138), Vivid iq (K200708), LOGIQ e (K133533), LOGIQ e (K151028),

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

    The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, thyroid), VascularPeripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

    Device Description

    Venue Fit is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis. The Venue Fit is a compact, portable system with a small footprint. The system can be hand carried using the integrated handle, placed on a horizontal surface (if kickstand is attached), attached to a mobile cart or mounted on the wall. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time with full functionality and scanning.

    The Venue Fit utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability. supporting all standard acquisition modes. Some transducers are compatible with OEM biopsy kits to support needle-guidance procedures.

    The system has the capability for displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

    Venue Fit is capable of wired or wireless internet connection and a barcode reader is available to be used as an input device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory available for the customer is a roller bag.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification submission for a medical device (Venue Fit ultrasound system).

    It primarily focuses on:

    • Regulatory information: FDA letter, indications for use, and a 510(k) summary.
    • Device description: Explaining the Venue Fit's features, intended use, and technical specifications.
    • Comparison to predicate devices: Highlighting similarities and differences with previously cleared GE ultrasound systems.
    • Non-clinical tests: Listing the safety and performance standards the device complies with (e.g., acoustic output, biocompatibility, electrical safety).
    • A statement explicitly saying: "The subject of this premarket submission, Venue Fit, did not require clinical studies to support substantial equivalence."

    Therefore, there is no information regarding:

    • Acceptance criteria for AI/algorithm performance.
    • Results of a study proving the device meets acceptance criteria (as no clinical studies were required).
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number of experts, their qualifications, or adjudication methods for ground truth.
    • MRMC studies or effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth for training was established.

    This document indicates that the device's substantial equivalence was demonstrated through non-clinical testing and comparison to predicate devices, rather than a clinical study involving AI performance metrics.

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