(121 days)
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8¾"-12½") or 22cm to 42cm (about 8¾"-16½"). It is intended for adult indoor use only.
Blood Pressure Monitor TMB-2296-BT is designed to measure systolic pressure, diastolic pressure and pulse rate of adult 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 HI-121H material. The two types of cuffs have been clinically validated to be matched with the device, suitable for adults with arm circumference from 22cm~42cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is medical switch 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 text describes the 510(k) submission for a Blood Pressure Monitor (Model TMB-2296-BT) and its substantial equivalence to a predicate device. The information focuses on regulatory compliance, non-clinical, and clinical performance data, primarily related to the accuracy of blood pressure and pulse rate measurements.
1. Table of Acceptance Criteria and Reported Device Performance
The main acceptance criteria for blood pressure monitors is typically defined by standards like ISO 81060-2. The document specifically states that the device was tested according to ISO 81060-2:2018/Amd.1:2020 and "fulfilled both validation criteria 1 and 2".
The ISO 81060-2 standard defines the following criteria:
- Criterion 1: The mean difference between the device readings and reference blood pressure (BP) measurements should be within ±5 mmHg, with a standard deviation of 8 mmHg or less.
- Criterion 2: For each subject, the difference between the device reading and the reference BP should be within 5 mmHg for at least 65% of the subjects, within 10 mmHg for at least 85% of the subjects, and within 15 mmHg for at least 95% of the subjects.
Here's a table summarizing the reported device performance against these generally accepted criteria (as defined by ISO 81060-2):
| Acceptance Criteria (ISO 81060-2) | Reported Device Performance (Study 1) | Reported Device Performance (Study 2) |
|---|---|---|
| Criterion 1 (Mean Difference & SD) | ||
| Mean difference ≤ ±5 mmHg | SBP: 0.21 mmHg, DBP: 0.66 mmHg | SBP: -1.62 mmHg, DBP: 0.12 mmHg |
| Standard deviation ≤ 8 mmHg | SBP: 2.59 mmHg, DBP: 2.12 mmHg | SBP: 2.80 mmHg, DBP: 3.01 mmHg |
| Criterion 2 (Within specified range) | ||
| Mean difference ≤ ±5 mmHg | SBP: 2.07 mmHg, DBP: 1.76 mmHg (presumably mean difference for criterion 2 check) | SBP: 2.35 mmHg, DBP: 2.60 mmHg (presumably mean difference for criterion 2 check) |
| Specific percentages (e.g., 65% within 5mmHg) | Explicit percentages not provided, but stated "fulfilled both validation criteria." | Explicit percentages not provided, but stated "fulfilled both validation criteria." |
Note: The document states "fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020," indicating that the device met the required statistical thresholds for accuracy. The provided mean differences and standard deviations are the direct results from the studies, demonstrating compliance with Criterion 1. While specific percentages for Criterion 2 are not listed, the statement of fulfillment confirms compliance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Study 1: 88 qualified subjects. From these, 262 datasets were collected.
- Study 2: 87 qualified subjects. From these, 259 datasets were collected.
- Data Provenance: Not explicitly stated regarding the country of origin. The studies are described as "clinical studies," implying a prospective design where the data was collected specifically for the validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts for establishing ground truth. For blood pressure monitor validation according to ISO 81060-2, ground truth is established by multiple independent reference measurements, typically performed by trained observers using a mercury sphygmomanometer or a validated auscultatory device. The standard requires specific training and quality control for these observers, but their specific "qualifications" (e.g., as radiologists) are not applicable or mentioned. The primary focus is on the accuracy of the reference measurements, not expert interpretation.
4. Adjudication Method for the Test Set
The document does not explicitly describe an "adjudication method" in the context of expert review, as ISO 81060-2 validation primarily relies on direct comparison of the device's readings against a set of rigorously collected reference measurements. Multiple readings are taken per subject, and statistical analyses (mean difference, standard deviation) are applied directly to these comparative measurements, rather than requiring expert adjudication of "results" in the typical sense of image interpretation. The standard outlines specific procedures for simultaneous measurements by multiple observers to minimize bias in reference readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/CAD systems that assist human readers in interpreting medical images (e.g., detecting lesions). For a blood pressure monitor, the study evaluates the device's direct measurement accuracy against a gold standard, not its comparative effectiveness with or without human assistance in interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the clinical validation described in the document is a standalone performance study. The device, a blood pressure monitor, measures blood pressure and pulse rate directly and automatically. The reported performance metrics (mean difference, standard deviation) are of the device itself, without human intervention in the measurement process (beyond proper cuff placement and initiation of the measurement).
7. The Type of Ground Truth Used
The ground truth used was reference blood pressure measurements obtained through a validated clinical method (implied to be auscultatory or an equivalent gold standard method, as per ISO 81060-2) against which the automated device's readings were compared. This is a form of "outcomes data" in the sense of comparing the device's output to a clinically accepted reference measurement for the physiological parameter it is designed to measure.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. For a blood pressure monitor that uses an oscillometric method, the device's algorithm for determining BP values from oscillation waveforms is pre-programmed/calibrated. It's not typically a machine learning model that undergoes a 'training phase' on a distinct dataset in the way an AI image analysis algorithm would. The clinical studies described are for validation (test set performance) of the final device, not for training internal algorithms.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no mention of a traditional "training set" in the context of an AI/ML algorithm that would require a separate ground truth establishment for training. The ground truth for the device's internal calibration/oscillometric algorithm (if applicable) would have been established during its development and calibration phases, likely using established physiological models and comparisons to known accurate pressure measurements, but these details are not part of this 510(k) submission. The clinical studies establish the accuracy of the final, already "trained" or calibrated, 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).