(163 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home N (BP3MX1-4) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm.
The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.
The device can be used in connection with your personal computer (PC) running the WatchBP Analyzer Home N software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home N (BP3MX1-4) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive 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".
The device has >, > and > measurement modes and has atrial fibrillation detection function, medication record function. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP Analyzer Home N software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable.
Here's a breakdown of the acceptance criteria and study information for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home N (BP3MX1-4), based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards rather than presenting specific quantitative acceptance criteria and device performance values for blood pressure accuracy.
However, based on the clinical evaluations section (8.a and 8.b), we can infer the following:
| Feature | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Blood Pressure Measurement Accuracy | Compliance with ANSI/AAMI SP10 (requiring specific accuracy thresholds for systolic and diastolic measurements). | "The modified device... is from the technical point of view identical to the blood pressure monitor model WatchBP Home (BP3MX1-1)... Therefore the clinical accuracy in terms of blood pressure detection will not be affected." This implies that the device is expected to meet ANSI/AAMI SP10 given its technical identity with a previously validated device. |
| Atrial Fibrillation (AF) Detection | Demonstrated equivalence in AF detection performance to predicate device model BP3MQ1-2D (K080337). | "The Atrial Fibrillation Detection technique utilized in the modified device... is from the technical point of view identical to what is utilized in the predicate device model BP3MQ1-2D. The clinical test report of BP3MQ1-2D is applicable to WatchBP Home N (BP3MX1-4)." |
| Electrical, Mechanical, Environmental Performance | Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions," DCRND. | "None of the testing demonstrated any design characteristics that violated the requirements... It was our conclusion that Microlife Upper Arm Automatic Digital Blood Pressure Monitor... met all relevant requirements..." This includes Storage, Operating, Vibration, Drop, Life, and EMC tests. |
| Software Validation | Compliance with FDA November 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (moderate level of concern) and FDA September 1999 "Guidance for Off-The-Shelf Software Use in Medical Devices" (for PC-link function). | "Software validation was conducted in accordance with a moderate level of concern designation..." and "we adhered to the FDA September 1999 document..." |
2. Sample Size Used for the Test Set and Data Provenance
- Blood Pressure Measurement Accuracy: The document states that "repeated clinical testing in accordance with ANSI/AAMI SP10 is therefore not required" for the new device because it is technically identical to a previously validated model (WatchBP Home, K073198). This implies the sample size and data provenance for the original validation of the predicate device would be relevant, but this information is not provided in the current document.
- Atrial Fibrillation Detection: Similarly, for AF detection, the document refers to the "clinical test report of BP3MQ1-2D" (K080337) being applicable. The sample size and data provenance for the AF detection test are therefore not in the provided document but would be found in the K080337 submission.
- Other tests (Reliability, EMC, etc.): The document does not specify sample sizes for these non-clinical tests. These tests are typically conducted on a representative sample of devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. Since the device relies on substantial equivalence to predicate devices and existing clinical test reports for accuracy claims, the details regarding experts used for ground truth establishment would be found in the original clinical validation studies of the predicate devices (K073198 for BP accuracy and K080337 for AF detection).
4. Adjudication Method for the Test Set
This information is not provided in the document. As with ground truth experts, details of adjudication methods would be found in the original clinical validation studies of the predicate devices.
5. 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, an MRMC comparative effectiveness study involving human readers and AI assistance was not discussed or conducted for this device. This device is an automated blood pressure monitor with an AF detection function, not an imaging or diagnostic AI tool designed to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, implicitly.
- The blood pressure measurement is described as an "automatic digital blood pressure monitor" using an "oscillometric method," which is a standalone algorithm within the device. The claim of technical identity to a predicate device (K073198) implies that the standalone accuracy of this device's blood pressure algorithm was previously validated.
- The atrial fibrillation detection function is also described as a built-in feature ("detects the appearance of atrial fibrillation during measurement and gives a warning signal"). Its performance relies on the standalone algorithm, with its validation referencing the predicate device K080337.
7. The Type of Ground Truth Used
- Blood Pressure Measurement Accuracy: For blood pressure measurement, the standard ground truth in ANSI/AAMI SP10 validation studies is typically simultaneous or near-simultaneous measurements by trained observers using a mercury sphygmomanometer (auscultatory method), often overseen by a qualified medical professional (e.g., physician or trained nurse).
- Atrial Fibrillation (AF) Detection: For AF detection, the ground truth would typically be established by a cardiologist or electrophysiologist analyzing concurrent ECG recordings.
8. The Sample Size for the Training Set
This information is not provided in the document. As an established oscillometric blood pressure monitor and AF detection algorithm (referencing predicate devices), the "training set" concept in the context of deep learning AI might not be directly applicable in the same way. If any machine learning was used in the development of the oscillometric or AF detection algorithms, the details of their training sets are not present in this submission. The document emphasizes technical identity and adherence to established methods.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. Similar to point 8, if ground truth was established for "training" an algorithm, those details would be found in the development records or prior submissions of the predicate devices, not in this submission confirming substantial equivalence. The document primarily relies on the "well-known technique" of the oscillometric method and proven AF detection algorithms from predicate devices.
§ 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).