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    K Number
    K030230
    Device Name
    AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)
    Manufacturer
    AVITA CORPORATION
    Date Cleared
    2003-05-23

    (121 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K012310
    Why did this record match?
    Device Name :

    AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)

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

    The device is noninvasive and provide systolic, diastolic blood pressure and pulse rate(heart rate) measurements by using an inflating cuff which is wrapped around the wrist. All values can be read out in one LCD panel. The device is indicated for use by people over 15 years old in home use.

    Device Description

    AVITA BPM1 Series Wrist Type Blood Pressure Meter is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual).

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the AVITA BPM1 Series Wrist Type Blood Pressure Meter:

    Acceptance Criteria and Device Performance

    The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly suggests that the device's performance needs to be "statistically and clinically acceptable" when compared to an auscultatory method. It also states adherence to several standards.

    Acceptance Criteria CategorySpecific Criteria (Implicit/Standard-based)Reported Device Performance
    Accuracy/PerformanceClinical repeatability acceptable (compared to auscultatory method)Demonstrated clinical repeatability that is "statistically and clinically acceptable."
    Operating SpecificationsConformance to applicable standardsConforms to EN-1060-1, EN-1060-3, ANSI/AAMI SP-10.
    SafetyConformance to applicable standardsConforms to IEC 60601-1.
    EMC (Electromagnetic Compatibility)Conformance to applicable standardsConforms to IEC 60601-1-2.
    Substantial EquivalenceSimilar intended use & technological characteristics to predicate. No new questions of safety/effectiveness.Demonstrated substantial equivalence to HL-168D Wrist Blood Pressure Monitor (K012310) with no new questions of safety or effectiveness.

    Study Information

    1. Sample size used for the test set and the data provenance:

      • Test Set Sample Size: Not explicitly stated in the provided text.
      • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It is referred to as a "comparison study" and "clinical testing."

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

      • Not applicable as the ground truth was established by an auscultatory method, which is a direct measurement standard, not an expert consensus for image interpretation.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

      • Not applicable, as it was a direct comparison study to a standard measurement method (auscultatory), not an expert interpretation scenario requiring adjudication.

    4. 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 an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.

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

      • Yes, the performance study effectively evaluates the device in a standalone manner, as it functions automatically to measure blood pressure and rate. The comparison is between the device's reading and the auscultatory method.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • The ground truth used was the auscultatory method, which is considered a traditional gold standard for blood pressure measurement.

    7. The sample size for the training set:

      • Not applicable. This device is a measurement instrument, not an AI/machine learning model that requires a training set in the conventional sense. Its function is based on established oscillometric principles.

    8. How the ground truth for the training set was established:

      • Not applicable, as there is no training set in the context of an AI/ML model for this device. Its design and validation rely on engineering principles and comparison to established measurement methods.
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