(130 days)
This blood pressure monitor (Model: FC-BP20), FC-BP201, FC-BP211, FC-BP220, FC-BP221) is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.
The subject device, Wrist Electronic Blood Pressure Monitor, is an automatic noninvasive blood pressure monitor which can be driven by AAA alkaline battery, DC3V. It uses an inflatable cuff which is wrapped around the patient's wrist to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy. The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor. The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The unit also calculates an average reading based on the values of the latest 3 times measurement. This blood pressure monitor has the function of blood pressure classification according to WHO recommendation, which is convenient for you to judge whether your blood pressure is normal or not. This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips. The device detects an Irregular Heart Beat (IHB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values. The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results through Bluetooth LE4.2 to paired Bluetooth-enabled device (FC-BP200, FC-BP210, FC-BP220 and FC-BP221 applied). There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically. No operation for 2 minute the device will shut down automatically. The device includes model FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221. Six models are identical in terms of software design, cuff type and measurement range. The schematic circuit diagram are identical in all models except for model FC-BP220. Six models PCB layout are different because of different appearance (such as structure, buttons layout, etc.) and function.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Wrist Electronic Blood Pressure Monitor (K231367):
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than a full clinical study report. Therefore, some of the requested information, particularly regarding the internal workings of the "AI" (which appears to be an oscillometric method, not AI in the modern sense) and detailed expert qualifications, is limited.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard ISO 81060-2:2018) | Reported Device Performance |
|---|---|
| Accuracy within ±5 mmHg | Meets requirements of ISO 81060-2:2018 within the ±5 mmHg |
Study Details:
-
Sample size used for the test set and the data provenance:
- Sample Size: 130 subjects.
- Data Provenance: The document states "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement." It does not specify the country of origin, but given the manufacturer's location (Shenzhen, China) and the correspondent's location (Shanghai, China), it's highly probable the study was conducted in China.
- Retrospective or Prospective: Prospective, as it involved "actual clinical trial" with volunteers.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The ground truth method was "Auscultation applied as gold standard with the qualified calibrated mercurial sphygmomanometer." This implies trained medical professionals (e.g., doctors or nurses) were performing these measurements, but their specific qualifications or number are not detailed.
-
Adjudication method for the test set:
- Not explicitly described. The text mentions "Auscultation applied as gold standard" and comparison with the subject device. It doesn't detail if multiple auscultation readings were taken and adjudicated.
-
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 was not an MRMC comparative effectiveness study involving human readers and AI assistance. This study was a clinical validation of an automated non-invasive sphygmomanometer against a gold standard, not an AI-assisted diagnostic study. The "AI" mentioned in the request refers to a modern interpretation of AI; this device uses the "oscillometric method" which is an automated algorithm but not typically categorized as advanced AI in the context of diagnostic image interpretation or complex decision support.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance test described is essentially a standalone algorithm performance test. The device (algorithm) measures blood pressure independently, and its readings are compared to the gold standard (auscultation). The device is an automated non-invasive sphygmomanometer.
-
The type of ground truth used:
- Expert consensus (indirectly): The primary ground truth was "Auscultation applied as gold standard with the qualified calibrated mercurial sphygmomanometer." Auscultation is performed by human operators. While not explicitly stated as "expert consensus" in terms of multiple experts reaching agreement after individual assessments, it relies on human expert measurement as the reference.
-
The sample size for the training set:
- The document does not provide information about a separate training set. For devices like automated blood pressure monitors, the underlying oscillometric algorithms are typically developed and refined using extensive datasets during their engineering phase, but this information is not part of the clinical validation study cited here. The ISO 81060-2:2018 standard focuses on clinical validation, not algorithm development.
-
How the ground truth for the training set was established:
- Not applicable/Information not provided, as no training set details are given in this document.
§ 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).