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510(k) Data Aggregation

    K Number
    K172356
    Device Name
    BladderScan Prime PLUS System
    Manufacturer
    Verathon Incorporated
    Date Cleared
    2017-09-15

    (43 days)

    Product Code
    IYO,ITX
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K153101
    Why did this record match?
    Device Name :

    BladderScan Prime PLUS System

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

    The BladderScan® PRIME PLUS system is an ultrasound device intended to be used for measuring urine volume of the bladder non-invasively.

    Device Description

    The BladderScan" PRIME PLUS system provides non-invasive measurement of urinary bladder volume. The system calculates the bladder volume using patented neural network technology. Volume measurements made with this technology are based on a more complex, multifaceted image of the bladder.

    Bladder volume, directional aiming with real-time feedback, battery status and usage rate indicators are displayed on the LCD display. The system operates using a battery which includes a charging cradle.

    AI/ML Overview

    The provided text describes the Verathon BladderScan® PRIME PLUS system, an ultrasound device for non-invasive measurement of bladder urine volume. However, the document explicitly states that "The BladderScan® PRIME PLUS System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means that a study proving the device meets acceptance criteria was not conducted or provided in this submission for the purpose of demonstrating substantial equivalence. Instead, the submission relies on the device's technological characteristics being substantially equivalent to a predicate device (BladderScan® PRIME System K153101).

    Therefore, I cannot provide details about acceptance criteria and a study that proves the device meets them because such a study was not required for this 510(k) submission and is not described in the provided text.

    The closest information available regarding performance is the "Measurement Accuracy" listed under the "Technological Characteristics and Performance" comparison table on page 6, which states:

    • Verathon BladderScan® PRIME PLUS System (This submission):
      • 0-100 mL = ±7.5 mL
      • 100-999 mL = ±7.5%
    • Predicate Verathon BladderScan® PRIME System (K153101):
      • ±15% ±15mL

    This indicates that the new device has improved measurement accuracy compared to its predicate. However, this table is a
    comparison of specifications, not a result of a new clinical study.

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