(219 days)
The Electronic Sphygmomanometer and Automatic Blood Pressure Monitor are intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
The proposed devices, ABPM50 Automaitc Blood Pressure Monitor, CONTEC08A and CONTEC08C Electronic Sphygmomanometers are battery driven automatic non-invasive Blood Pressure Monitor. They can automatically complete the inflation and BP measurement, which can measure systolic, and diastolic blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. ABPM50 and CONTEC08A and CONTEC08C can be only used on adult individuals.
The devices have the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure and pulse rate.
ABPM50 and CONTEC08A have physiological over-limit prompt function which can be turned on or off by users. When the measurement results exceed the over-limit prompt limit, the physiological over-limit prompt function will be triggered. The over-limit can be set by users, and the low limit must be lower than the corresponding high limit.
In addition, all of the three proposed devices have technical over-limit prompt function, which will be triggered when the battery voltage is low, and this technical over-limit prompt function can not be cancelled unless being closed or the power replaced.
The provided FDA 510(k) summary (K202757) for the Electronic Sphygmomanometer, Automatic Blood Pressure Monitor CONTEC08A/CONTEC08C/ABPM50 details the non-clinical and clinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's an breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device, being a non-invasive blood pressure measurement system, are primarily based on established international standards for accuracy and safety. The reported device performance is presented as compliance with these standards and specific measurement ranges.
| Category | Acceptance Criteria (Standard/Range) | Reported Device Performance/Compliance |
|---|---|---|
| Accuracy | ISO 81060-2 (Clinical Investigation of Intermittent Automated Measurement Type) | "Total 85 subjects are included in each clinical study, the results of proposed device meet the performance parameters claimed in user manual, and the proposed device complies with ISO 81060-2." (Page 6) |
| "The clinical trial results verify that the clinical accuracy of the proposed device is not inferior to that of predicate device." (Page 6) | ||
| Static Pressure | ±3 mmHg | ±3 mmHg (Page 8, Table 7-1) |
| Pulse Accuracy | ±5% | ±5% (Page 8, Table 7-1) |
| Electrical Safety | IEC 60601-1, IEC 60601-1-11 | Complies with IEC 60601-1, IEC 60601-1-11 (Page 7, Table 7-1) |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 | Complies with IEC 60601-1-2:2014 (Page 6, Table 7-1) |
| Performance Test | IEC 80601-2-30 Edition 1.1 2013-07 (Particular Requirements for Basic Safety and Essential Performance of Automated Non-Invasive Sphygmomanometers) | Complies with IEC 80601-2-30 Edition 1.1 2013-07 (Page 7, Table 7-1) |
| "the proposed device has passed the IEC8601-2-30 and ISO81069-2 test, the performance of the proposed device can be guaranted..." (Page 9, Analysis 2) | ||
| Biocompatibility | ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization) | Complies with ISO 10993-5 and ISO 10993-10. (Page 7, Table 7-1) |
| "has passed the Biocompatibility test (including Cytotoxicity, Skin Sensitization, Skin Irritation)..." (Page 9, Analysis 3) | ||
| Measurement Range (BP) | Varies (Predicate: 30-255 mmHg) | 10-270 mmHg (Proposed device, Page 8, Table 7-1) |
| Measurement Range (Pulse) | Varies (Predicate: 40-199 bpm) | 40-240 BPM (Proposed device, Page 8, Table 7-1) |
| Operating Environment | +5 °C | "has passed the IEC 60601-1-1 test, the safety and performance of the proposed device can be guaranteed." (Page 9, Analysis 1) |
| Storage Environment | -20 °C~+55 °C, ≤95% RH, 700 hPa~1060 hPa (No corrosive gas and drafty) | "has passed the IEC 60601-1-1 test, the safety and performance of the proposed device can be guaranteed." (Page 9, Analysis 1) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Total 85 subjects are included in each clinical study." (Page 6)
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that the manufacturer and correspondent are based in China, it is highly probable the clinical study was conducted in China. The study appears to be prospective as it describes a clinical investigation for the purpose of regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document states that the clinical study was conducted "in accordance with ISO 81060-2". ISO 81060-2 (Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type) outlines specific requirements for the observers and the comparison method to establish ground truth.
While the exact number and qualifications of experts (e.g., clinicians, trained observers) are not explicitly stated in this FDA submission summary, ISO 81060-2 typically requires:
- At least two trained observers to measure blood pressure using a reference sphygmomanometer simultaneously with the device under test.
- These observers must be trained and certified to perform auscultatory blood pressure measurements (e.g., using a mercury column or validated alternative) with high accuracy and reproducibility. The standard often specifies requirements for their training and regular performance validation to ensure inter-observer agreement.
4. Adjudication Method for the Test Set
The document does not explicitly describe an "adjudication" method in the context of expert consensus, as this is typically seen in studies where multiple readers interpret images or data and discrepancies need resolving. For blood pressure measurement, ISO 81060-2 mandates a specific comparison method where the device's measurements are compared against simultaneous auscultatory measurements obtained by trained observers. The standard defines how these measurements are to be collected and statistically analyzed (e.g., mean difference and standard deviation between the device and the reference measurements) to determine accuracy, rather than an "adjudication" of differing expert opinions on a specific diagnosis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance
This device (Electronic Sphygmomanometer/Automatic Blood Pressure Monitor) is a medical measurement device, not an AI-based diagnostic tool that assists human readers in interpreting complex data like medical images. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which is common for AI tools in radiology or pathology, was not performed or applicable here. The study focused on demonstrating the device's accuracy and safety against established standards and a predicate device through direct measurement comparison.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the primary evaluation of this device is a standalone performance assessment. The device is designed to automatically measure and display blood pressure and pulse rate without continuous human intervention during the measurement process. The clinical study evaluated the device's direct measurement performance against a gold standard (auscultatory measurements) as per ISO 81060-2.
7. The Type of Ground Truth Used
The ground truth used for the clinical study was expert consensus/reference measurement through a standardized protocol. Specifically, it involved:
- Simultaneous blood pressure measurements taken by trained observers using a reference method (typically auscultation with a mercury sphygmomanometer or validated equivalent) alongside the device under test.
- This is the standard approach defined in ISO 81060-2 for validating automated non-invasive sphygmomanometers.
8. The Sample Size for the Training Set
The document does not mention a training set because this medical device approval is for a physical measurement device, not a machine learning or AI algorithm that requires a separate training set. The "study" described is a clinical validation study to confirm the accuracy and safety of already developed hardware and software, rather than a development and training phase for a learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of an AI/ML algorithm for this type of device, this question is not applicable. The device's underlying measurement algorithms are based on established oscillometric principles and do not "learn" from a dataset in the way a deep learning model would.
§ 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).