(167 days)
KD-753, KD-738BR, KD-733 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 wrist. The cuff circumference is limited to 14cm-25cm.
KD-753, KD-738BR, KD-733 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.
The provided text describes the 510(k) premarket notification for the KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitors. The primary purpose of this submission is to demonstrate the substantial equivalence of these devices to a legally marketed predicate device (KD-7920).
The key study proving the device meets acceptance criteria is a clinical test performed in accordance with ISO 81060-2. This standard specifies requirements for the clinical validation of automated non-invasive sphygmomanometers.
Here's an organized breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for blood pressure monitors are typically defined by recognized standards such as ISO 81060-2. This standard sets forth statistical requirements for accuracy by comparing the device's measurements against a reference method (auscultation).
While the exact numerical acceptance criteria are not explicitly listed in a detailed table format within the provided document (e.g., mean difference and standard deviation), the text states that the device was verified by "meeting criteria 1 and criteria 2 of ISO 81060-2." These criteria specify the allowable differences between the device measurements and the reference measurements for systolic and diastolic blood pressure.
Table of Acceptance Criteria and Reported Device Performance (Inferred from ISO 81060-2 compliance):
| Parameter | Acceptance Criteria (Based on ISO 81060-2) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy (mean difference) | Mean difference between the device and reference method should be ≤ ±5 mmHg. (This is "Criterion 1" of ISO 81060-2:2013) | "verified by meeting criteria 1 and criteria 2 of ISO 81060-2." (Implies compliance) |
| Blood Pressure Accuracy (standard deviation) | Standard deviation of the differences between the device and reference method should be ≤ 8 mmHg. (This is "Criterion 2" of ISO 81060-2:2013) | "verified by meeting criteria 1 and criteria 2 of ISO 81060-2." (Implies compliance) |
| Pulse Rate Accuracy | Within ±5% (as stated in the comparison table on page 4) | Within ±5% (Same, as stated in the comparison table) |
Note: The exact numerical results (e.g., specific mean differences and standard deviations) from the clinical study are not provided in this 510(k) summary, only the statement that the device met the ISO 81060-2 criteria.
Study Details:
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Sample size used for the test set and data provenance:
- Sample Size: 85 patients (40 males and 45 females).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, clinical validation according to ISO standards usually implies a prospective study conducted in a clinical setting.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- The standard auscultation method was used as the reference blood pressure measurement. ISO 81060-2 requires two trained observers to perform the auscultatory measurements simultaneously and independently, or in a specific sequence, and their readings are averaged to establish the reference (ground truth).
- The text does not specify the number of experts or their exact qualifications (e.g., "radiologist with 10 years of experience"). However, for auscultation in such a study, the experts would typically be medical professionals trained and experienced in blood pressure measurement using the auscultation method.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The text states, "same sequential method was chosen." In the context of ISO 81060-2, the "sequential method" typically refers to the procedure where the test device and the reference (auscultation) measurements are performed one after another on the same subject. The standard generally requires two independent observers for auscultation, with their readings averaged or adjudicated if they differ beyond a certain threshold. The specific details of adjudication (e.g., 2+1) are not provided, but it's implied that the methodology adheres to the standard's requirements for establishing a reliable reference.
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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. This is a study validating the accuracy of an automated non-invasive blood pressure monitor against a reference standard. It is not an MRMC study designed to evaluate how human readers (e.g., radiologists interpreting images) improve with AI assistance. Therefore, no effect size for human reader improvement is applicable or provided.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "clinical test" described evaluates the accuracy of the automated blood pressure device itself (the "algorithm only" in a broader sense of an automated device) in comparison to a human-performed reference standard (auscultation). While a human applies the cuff and initiates the measurement, the blood pressure reading itself is generated by the device's internal algorithm. The study assesses the device's output independently, which parallels a "standalone performance" evaluation for an automated medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by the standard auscultation method (reference blood pressure monitor measuring), performed by medical professionals (experts). This falls under expert-derived reference standard/ground truth.
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The sample size for the training set:
- Not applicable / Not provided. The clinical study described in the 510(k) summary is for validation (test set performance), not for training. Blood pressure monitors like these are typically designed and calibrated during their development phase, which would involve internal testing and potentially specific datasets. The 510(k) submission focuses on the final performance validation.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As mentioned above, the text describes the validation study, not the development or training phase of the device.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).