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    K Number
    K122259
    Device Name
    BLOOD PRESSURE MONITOR WITH STETHOSCOPE
    Manufacturer
    HANGZHOU RELI-ON CO., LTD
    Date Cleared
    2012-09-24

    (59 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K081951
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Blood pressure monitor with stethoscope, Model HBPK-A is a non-automated, aneroid blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospital or at home to monitor both systolic and diastolic pressure. This device is sold with an adult D-ring cuff and suitable for use on adult.

    Device Description

    Blood pressure monitor with stethoscope, Model HBPK-A is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff, an aneroid manometer to measure pressure, and a stethoscope for detecting Korotkoff sounds.

    The Aneroid Sphygmomanometer with Stethoscope contains:

      1. Adjustable D-ring Cuff (Adult Size)
      1. Stethoscope (Attaches to the cuff)
      1. Non-stop rotary pin. 300 mmHq gauge
      1. Instruction booklet and record
      1. Carrying case

    -The Blood pressure monitor with stethoscope enables the user to monitor the pressure of flowing blood that is exerted against the arteries at highest (systolic or contraction) and lowest (diastolic or relaxation) pressure. To operate, the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the pulse of the brachial artery. After inflation of the cuff, the user does auditory monitoring with the stethoscope to evaluate systolic and diastolic pressure. The two values are usually recorded as a ratio of the two measurements: systolic over diastolic.

    AI/ML Overview

    The provided text refers to a traditional, non-automated aneroid blood pressure monitor with a stethoscope. As such, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of software-driven AI/ML devices, as typically asked for in these questions, does not directly apply here.

    However, I can extract information related to the device's performance validation based on the standards it claims to meet.

    Acceptance Criteria and Device Performance (Interpreted from Compliance to Standards)

    Acceptance Criteria CategorySpecific Criteria (from standards)Reported Device Performance
    Blood Pressure AccuracyCompliance with ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003 (Manual, electronic or automated sphygmomanometers)"The device successfully passed all the requirements within these standards." (Implies meeting accuracy requirements, though specific accuracy values are not provided)
    BiocompatibilityCompliance with ISO 10993-5 (Tests for in vitro cytotoxicity) and ISO 10993-10 (Tests for irritation and skin sensitization)"The device successfully passed all the requirements within these standards." (Implies the externally contacting components are biocompatible)
    General Safety & EffectivenessCompliance with other general controls and applicable parts of the Federal Food, Drug, and Cosmetic Act"Blood pressure monitor with stethoscope, Model HBPK-A is safe and effective as proven by compliance to consensus standards."

    Study Details (Not applicable in the AI/ML sense, but interpreted from regulatory submission)

    1. Sample size used for the test set and the data provenance: Not applicable. For a manual aneroid sphygmomanometer, "test set" in the context of AI/ML data is not relevant. The "testing" refers to physical and performance testing against the cited standards. The provenance of subjects used in any clinical validation for the ANSI/AAMI SP10 standard is not detailed in this summary.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the AI/ML sense is not relevant here. The ground truth for blood pressure measurement against which the device would be compared (if direct clinical validation data were presented, which it is not) would typically involve a reference standard measurement method performed by trained clinicians.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is for AI/ML model output disagreements, which doesn't apply to this device.

    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: Not applicable. This is not an AI-assisted device.

    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a manual device requiring human operation. There is no standalone algorithm.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for evaluating blood pressure monitors against standards like ANSI/AAMI SP10 typically involves comparison to a highly accurate reference method (e.g., intra-arterial measurement or another validated sphygmomanometer) performed by trained personnel. This document only states "compliance to consensus standards" and does not detail the specific ground truth used in the underlying studies for those standards or for this specific device's validation.

    7. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."

    8. How the ground truth for the training set was established: Not applicable.

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