(97 days)
The Arm blood pressure monitor is used for measuring blood pressure and pulse rate. The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy.
The proposed device, Arm Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven both battery and AC power supply. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy. The measuring method for the Arm Blood Pressure Monitor is oscillation mensuration. And all values can be read out in one LCD panel. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data.The blood pressure storing 2x99 set memory value, each measurement it will automatically stored. When it stored 2x99 set memory value, the old value will be covered by the new one. It can show the latest 3 times average value. User can set the time as year, month, day, hour and minute; User can enable or disable the function of voice broadcast about measurement result: User can select the unit of the measurement: mmHg or KPa; The device has the data storage function for data reviewing, including the data of systolic pressure, diastolic pressure, pulse rate and measurement time. The device has low power indicator to indicate the states of low batteries power.
This document is a 510(k) Premarket Notification from Xuzhou Yongkang Electronic Science Technology Co., Ltd. for their Arm Blood Pressure Monitor (Model YK-BPA1). It aims to demonstrate substantial equivalence to a legally marketed predicate device.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Arm Blood Pressure Monitor are primarily derived from the ISO 81060-2:2013 standard for clinical validation of automated non-invasive sphygmomanometers.
| Criteria Category | Acceptance Criteria (Standard) | Reported Device Performance (YK-BPA1) |
|---|---|---|
| Blood Pressure Accuracy | Mean difference within +/- 5 mmHg compared to standard reference. | Meets ISO 81060-2:2013 requirements (within +/- 5mmHg) |
| Pulse Rate Accuracy | +/- 5% of reading value | +/- 5% of reading value |
| Measurement Range (BP) | Not explicitly stated as acceptance, but device range. | 20-280 mmHg |
| Measurement Range (PR) | Not explicitly stated as acceptance, but device range. | 40-199 beats/min |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 150 subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical trial data. It is implied to be a prospective study ("relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement").
3. Number of Experts and Qualifications for Ground Truth
- The document does not explicitly state the number of experts or their specific qualifications. It mentions that "Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the proposed device." This implies trained personnel were involved in taking the reference measurements, but their number and specific qualifications (beyond being "qualified") are not detailed.
4. Adjudication Method for Test Set
- The document does not specify a formal adjudication method (like 2+1 or 3+1). The ground truth was established through Auscultation using a qualified calibrated mercurial sphygmomanometer, which is a direct measurement method rather than a subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the accuracy of an automated blood pressure monitor against a gold standard, not on how it assists human readers.
6. Standalone (Algorithm Only) Performance
- Yes, the performance study effectively evaluates the standalone performance of the Arm Blood Pressure Monitor. The study validates the accuracy of the device's automated measurements against a clinical gold standard (auscultation).
7. Type of Ground Truth Used
- Clinical Measurements / Expert Consensus (Implicit): The ground truth was established through auscultation using a qualified, calibrated mercurial sphygmomanometer. This involves direct physiological measurement, performed by what are assumed to be trained and qualified personnel (implicitly, experts in taking blood pressure measurements via auscultation).
8. Sample Size for Training Set
- The document does not provide information on the sample size for a training set. This is a medical device validation, and the provided clinical data is for performance testing, not for training an AI/ML algorithm. The device described appears to be a traditional automated blood pressure monitor, not an AI-driven one.
9. How Ground Truth for Training Set was Established
- Not applicable. The document describes the validation of a standard automated blood pressure monitor, not an AI/ML-driven device that requires a training set with established ground truth.
§ 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).