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510(k) Data Aggregation

    K Number
    K123996
    Device Name
    RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Date Cleared
    2013-04-09

    (104 days)

    Product Code
    DXQ,PRE
    Regulation Number
    870.1120
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K120125
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GE CRITIKON blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems. The RADIAL-CUF is intended for use with automated oscillometric NIBP devices to measure radial arterial pressure on the forearm. The RADIAL-CUF is available in adult size only. The device is non-sterile and is semi-disposable (may be single-patient use or optional limited reuse). The cuff is intended for use in patients whose upper arm circumference is greater than 40cm or in patients where currently marketed GE CRITIKON upper arm cuffs cannot be used, due to excess width of the cuff or conical shape of the upper arm. The forearm cuff is intended to be placed on the patient's forearm with circumference ranging from 26cm -36cm. The devices are not designed, sold or intended for use except as indicated.

    Device Description

    The RADIAL-CUF is a Non-Invasive Blood Pressure cuff that incorporates an inflatable non-distensible bladder, sized to encircle a patient's forearm. Connection tubing allows air to flow in and out of the cuff for inflation and deflation. Inflation allows for the occlusion of the Radial artery. The RADIAL-CUF facilitates the measurement of automated non-invasive blood pressure (NIBP).

    AI/ML Overview

    Here's a summary of the acceptance criteria and study detailed in the provided 510(k) K123996 for the RADIAL-CUF Non-Invasive Blood Pressure Cuff:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    ANSI/AAMI/ISO 81060-2:2009 Standard for NIBP AccuracyThe GE CRITIKON RADIAL-CUF meets the ISO 81060-2 accuracy standards.
    Specifically, the study compared noninvasive systolic, diastolic, and mean blood pressures to invasive data using the requirements detailed in the ISO 81060-2 standard.The results demonstrate success for both the DASH 4000 with SuperSTAT NIBP algorithm and the CARESCAPE V100 with Classic NIBP algorithm when used with the RADIAL-CUF.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not explicitly state the exact sample size for the clinical study. It mentions "a set of studies using the new cuff design was undertaken using subjects who fit the special population demographic requirements."

    • Sample Size: Not explicitly stated.
    • Data Provenance: Prospective clinical testing. The country of origin is not specified but implicitly in the US, as it's a US FDA submission. The study aimed to measure NIBP in "special populations."

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    Not applicable. The ground truth was established by direct physical measurement (invasive radial arterial blood pressure), not by expert opinion.

    4. Adjudication Method for the Test Set

    Not applicable. The ground truth was established by direct physical measurement (invasive radial arterial blood pressure), not by expert consensus or adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC study was not done. The study focused on the accuracy of the device itself against invasive measurements, and on comparing the new cuff to a marketed upper arm cuff used on the forearm. It did not involve multiple human readers evaluating cases with and without AI assistance.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    Yes, a standalone performance evaluation was conducted. The study assessed the accuracy of the RADIAL-CUF combined with two different GE NIBP algorithms (SuperSTAT and Classic NIBP) against invasive blood pressure measurements. This evaluates the device-algorithm combination's performance without direct human interpretation influencing the measurement itself beyond initial cuff placement and device operation.

    7. The Type of Ground Truth Used

    The ground truth used was invasive radial arterial blood pressure. This was collected continuously using a GE DASH 4000 device.

    8. The Sample Size for the Training Set

    The document does not report on a training set size. This submission describes a medical device (a blood pressure cuff) and its performance, implying an evaluation of its accuracy and function with existing NIBP algorithms. It does not detail the development or training of a new AI algorithm for NIBP measurement. The NIBP algorithms (SuperSTAT and Classic NIBP) referenced were pre-existing.

    9. How the Ground Truth for the Training Set Was Established

    As no training set for a new AI algorithm is discussed, this information is not applicable.

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