(114 days)
Truly Automatic Wrist Blood Pressure Monitor ,Models DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
The devices features include irregular pulse rhythm detection during measurement. and display a warning signal with the reading once the irregular heartbeat is detected.
Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
Truly Automatic Wrist Blood Pressure Monitor DW series are single-mounted devices of the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to wrist circumfernan approximately between 135 and 220 mm, includes the inflatable bladder and nylon shell. All models of the wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by two AAA alkaline batteries.
The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Truly Automatic Wrist Blood Pressure Monitor DW series:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states the accuracy acceptance criteria for both pressure and pulse rate measurements.
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (Pressure) | ± 3 mmHg | ± 3 mmHg (Stated as "No change, all same" compared to predicate device K014141, which had this accuracy) |
| Accuracy (Pulse) | ± 5% | ± 5% (Stated as "No change, all same" compared to predicate device K014141, which had this accuracy) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the measurement methods are "No change, all same" as the predicate devices, implying that their performance is expected to be similar.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any tests performed specifically for this device. Blood pressure monitor studies typically compare device readings against reference measurements taken by trained professionals using a mercury sphygmomanometer, but this specific information is absent.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Blood pressure monitors are typically assessed for agreement with a gold standard, not for their impact on human reader performance.
6. Standalone (Algorithm Only) Performance Study
Yes, implicitly. The listed "Accuracy Pressure" and "Accuracy Pulse" of ±3 mmHg and ±5% respectively are standalone performance metrics of the device's algorithm and hardware, without human intervention in the measurement process itself, beyond initiation. The document states that the calibration and measurement algorithms are the same ("No change, all same") as the predicate device K014141, which itself would have undergone standalone performance testing to meet its accuracy claims.
7. Type of Ground Truth Used
The document inherently refers to the auscultatory method as the ground truth. It states, "Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer." While not explicitly detailed for this specific device's testing, the standard for validating oscillometric blood pressure monitors involves comparing their readings against those obtained by trained observers using a mercury sphygmomanometer (auscultatory method).
8. Sample Size for the Training Set
The document does not provide any information about the sample size used for a training set. This is typical for oscillometric blood pressure monitors, which often rely on well-established algorithms that may have been developed and validated over many years, rather than requiring re-training on new data for each new device model. The document states the measurement algorithm is "No change, all same" as the predicate.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for a training set was established. Given that the measurement algorithm is stated as "No change, all same" as the predicate device (Digibio Digital Blood Pressure Monitor, Model D11), it implies that the core algorithm was previously established and validated with a ground truth likely derived from the auscultatory method. The only detail provided is on the irregular heartbeat detection algorithm, where it refers to a "Software validation report I-5. Algorithm description 4. Determination method of irregular heartbeat," which would presumably detail its development and validation, but this report is not included.
§ 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).