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510(k) Data Aggregation

    K Number
    K162668

    Validate with FDA (Live)

    Device Name
    Fully Automatic Electronic Blood Pressure Monitor
    Manufacturer
    ANDON HEALTH CO.,LTD
    Date Cleared
    2017-02-14

    (141 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Abbreviated
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K102939,K120672,K141984
    Predicate For
    K210770
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    KD-926 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

    Device Description

    KD-926 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

    The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-926 Fully Automatic Electronic Blood Pressure Monitor:

    No specific acceptance criteria or performance numbers are explicitly stated in the provided document. The document primarily focuses on the substantial equivalence argument, referencing standards and prior clearances.

    However, based on the mentioned standards (IEC 80601-2-30), we can infer the implied performance criteria that the device must meet to conform to these standards.

    Inferred Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:

    Given the nature of the submission (510(k) for a blood pressure monitor) and the referenced standards, the primary acceptance criteria would revolve around the accuracy of blood pressure and pulse rate measurements.

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Inferred from IEC 80601-2-30)Reported Device Performance (Implied)
    Accuracy of Systolic Blood Pressure: Mean difference and standard deviation between device and reference standard within specified limits (e.g., typically ≤ ±5 mmHg mean difference and ≤ ±8 mmHg standard deviation for individual measurements).Not explicitly stated with numerical values in the provided text for KD-926. The document states "KD-926 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards: ... IEC 80601-2-30:2009 & A1:2013." Conformance to this standard implies meeting its accuracy requirements.
    Accuracy of Diastolic Blood Pressure: Mean difference and standard deviation between device and reference standard within specified limits (e.g., typically ≤ ±5 mmHg mean difference and ≤ ±8 mmHg standard deviation for individual measurements).Not explicitly stated with numerical values in the provided text for KD-926. Conformance to IEC 80601-2-30 implies meeting its accuracy requirements.
    Accuracy of Pulse Rate: Mean difference between device and reference standard within specified limits.Not explicitly stated with numerical values in the provided text for KD-926. Conformance to IEC 80601-2-30 implies meeting its accuracy requirements.
    Safety: Compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC)."Electrical safety according test to IEC 60601-1;" "Electromagnetic compatibility test according to IEC 60601-1-2;" "None of the test demonstrates that KD-926 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness." (Implies compliance).
    Performance Characteristics (General): Compliance with IEC 80601-2-30."Safety and performance characteristics of the test according to IEC 80601-2-30." (Implies compliance).

    2. Sample size used for the test set and the data provenance

    The document states: "The cuff and algorithm of KD-926 is the same as K102939 and K120672, so we use the clinical data of K102939 and K120672 as the clinical proof of the new device."

    • Sample Size: The sample size for the clinical data used for K102939 and K120672 is not specified in the provided document.
    • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only indicates that "clinical data of K102939 and K120672" were used.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    This information is not provided in the document. For blood pressure clinical trials, ground truth is typically established by trained observers using mercury sphygmomanometers as per recognized protocols (e.g., ANSI/AAMI/ISO 81060-2). The number and qualifications of these observers are not detailed here.

    4. Adjudication method for the test set

    This information is not provided in the document. For blood pressure clinical trials, multiple observers may be used, and their readings are often averaged or assessed for agreement, but the specific adjudication method is missing.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Yes, a standalone (algorithm only) performance assessment was done. The clinical proof relies on the accuracy of the device itself (the "cuff and algorithm") against a reference standard, without human interpretation in the loop beyond initial application and reading of the reference. The device directly outputs blood pressure and pulse rate measurements.

    7. The type of ground truth used

    The type of ground truth used for validating blood pressure monitors is typically simultaneous measurements by trained observers using a reference standard device, such as a mercury sphygmomanometer or another validated oscillometric device, following an established protocol. While not explicitly stated, this is standard practice for devices conforming to IEC 80601-2-30.

    8. The sample size for the training set

    • Not applicable / Information not provided. As a standalone medical device measuring physiological parameters, it's unlikely to have a "training set" in the machine learning sense for the device's core function. The device's algorithm development involves calibration and validation against established physiological principles and clinical data, but not typically a "training set" for an AI model interpreting images or signals. The clinical data referenced (K102939 and K120672) serves as the validation/test set for the algorithm's accuracy.

    9. How the ground truth for the training set was established

    • Not applicable / Information not provided. See the explanation for point 8.
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