(84 days)
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 16cm to 36cm (about 6½"-14½"), 22cm to 32cm (about 8¾"-12½"), 22cm to 42cm (about 8¾"-16½") or 22cm to 45cm (about 8¾"-17¾").
The cuff with arm circumference range of 1636cm is intended for children older than 6 years old or adults. The cuffs with arm circumference range of 2232cm or 2242cm or 2245cm, which are intended for adult population.
It is intended indoor use only.
Blood Pressure Monitor TMB-2266 is designed to measure systolic pressure, diastolic pressure and pulse rate of population at or over 3 years old by a non-invasive technique, with an inflatable cuff wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method".
The main components of the Blood Pressure Monitor include main unit and cuff. For the outer housing of the main unit, it's made of HIPS material. As for accompanying cuffs, five types of cuffs have been clinically validated to be matched with the device, suitable for population aged at or over three and with arm circumference from 16cm~45cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is medical witch power supply, PCB, thermistor, pressure pump, motor, release valve and pressure sensor.
The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ± 25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results.
An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
The provided document describes the K232713 Blood Pressure Monitor, which is a digital monitor for measuring blood pressure and pulse rate. The information below is extracted from an FDA 510(k) summary concerning the device's substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance
The device's performance acceptance criteria are primarily derived from the ISO 81060-2 standard for non-invasive sphygmomanometers. The reported performance indicates that the device met these criteria.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 81060-2:2018+A1:2020: Mean error and standard deviation of differences in systolic and diastolic pressure not beyond specified limits. | All data's mean error and standard deviation of differences in systolic and diastolic pressure is not beyond the limits set as per ISO 81060-2:2020. No adverse effect and/or complications were found in the study. This was confirmed in four clinical studies for different cuff models. |
| IEC 60601-1: Basic safety and essential performance | Compliance demonstrated through testing. |
| IEC 60601-1-2: Electromagnetic compatibility | Compliance demonstrated through testing. |
| IEC 80601-2-30: Basic safety and essential performance of automated non-invasive sphygmomanometers | Compliance demonstrated through testing. |
| IEC 60601-1-11: Requirements for medical electrical equipment and systems used in home healthcare | Compliance demonstrated through testing. |
| Biocompatibility (ISO 10993-1/5/10/23): Cytotoxicity, Sensitization, Irritation | All patient contact parts meet the requirements of ISO 10993-1/5/10/23 (cytotoxicity, sensitization, and irritation). The device is considered surface contacting for a duration of exceeding 24 hours but not exceeding 30 days. |
| Bluetooth Wireless (47 CFR Part 15, Subpart C 15.247): Compliance for wireless module | The wireless module was validated according to 47 CFR Part 15, Subpart C 15.247, demonstrating compliance. |
2. Sample Size and Data Provenance for Test Set (Clinical Studies)
- Sample Sizes:
- Study 1: 87 qualified subjects
- Study 2: 86 qualified subjects
- Study 3: 86 qualified subjects
- Study 4: 102 qualified subjects (65 adults, 37 children aged 3-12)
- Data Provenance: The document does not explicitly state the country of origin. The studies are described as "clinical studies," implying they were prospective.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document does not provide details on the number of experts or their specific qualifications for establishing the ground truth measurements during the clinical studies. However, for blood pressure monitor validation studies conforming to ISO 81060-2, trained observers are typically used to obtain reference blood pressure measurements using a validated auscultatory method.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). For ISO 81060-2 studies, it is common to have multiple observers simultaneously or sequentially measure blood pressure using a reference method, and their measurements (or an average) are used as the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human interpretation.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, the clinical studies describe the standalone performance of the blood pressure monitor, which operates autonomously to measure blood pressure and pulse rate (algorithm only). The studies evaluated the device's accuracy against a recognized reference standard (implied by ISO 81060-2).
7. Type of Ground Truth Used
The ground truth for the clinical studies was established through comparative measurements against a reference method, which for ISO 81060-2 studies typically involves simultaneous or sequential auscultatory measurements performed by trained observers.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. This is typical for medical device submissions that focus on the clinical validation of the final product and do not disclose details about internal development or machine learning training data.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established, as details about the device's internal development and training are not part of this 510(k) summary.
§ 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).