(17 days)
The Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) is a device 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 upper arm.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) is 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 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 detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol " irreqular heart beat signal has been detected.
This document describes the 510(k) submission for the Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50). The primary claim of substantial equivalence is based on its similarity to a previously cleared device, Model BP2BI0, with the addition of an irregular heartbeat detection function inherited from another cleared device, Model BP3BT0-AP.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in a table format for accuracy. Instead, it refers to compliance with a recognized standard, ANSI/AAMI SP10: 2002 "National Standard for Noninvasive Sphygmomanometers".
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Blood Pressure Measurement) | "Relevant tests in accordance with ANSI/AAMI SP10: 2002 'National Standard for Noninvasive Sphygmomanometers' had been performed in the Manufacturer, Electric, Automatic, Sphygmomanometers and were addressed and tested." |
| Safety and Effectiveness (General) | "Electrical, mechanical and environmental test results, the FDA DCRND November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions', and the ANSI/AAMI Voluntary Standard, SP10: 2002 test results." |
| Irregular Heartbeat Detection | Functionality described as "same as what is used in Microlife Upper Arm Automatic Blood Pressure Monitor, model BP3BT0-AP, with 510(K) cleared number K#041411." |
2. Sample Size for Test Set and Data Provenance
The document states:
"Since the cleared device, BP2BI0, and the program codes of the BP3MR1-H(BP A50) remain unchanged and the fundamental scientific technology of the modified device is the same as the 510(k) cleared device, BP2BI0. Clinical performance of the modified device will remain unchanged; therefore another clinical test for the modified device, BP3MR1-H(BP A50) is not required."
This indicates that no new clinical test set was used for the BP3MR1-H(BP A50) to demonstrate its blood pressure measurement accuracy. The clinical performance is inferred from the predicate device (BP2BI0). Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a new test set for the BP3MR1-H(BP A50) device is not provided.
For the irregular heartbeat detection feature, it is stated that the technology is the "same as what is used in Microlife Upper Arm Automatic Blood Pressure Monitor, model BP3BT0-AP, with 510(K) cleared number K#041411." To understand the sample size and data provenance for the irregular heartbeat detection, one would need to refer to Exhibit#3, which contains the 510(k) summary for BP3BT0-AP. This information is not available in the provided text.
3. Number of Experts and Qualifications for Ground Truth of Test Set
As no new clinical test was conducted for the blood pressure measurement accuracy of the BP3MR1-H(BP A50), this information is not provided. If an ANSI/AAMI SP10 study was performed for the predicate device (BP2BI0), it would typically involve trained observers (likely clinicians or medical professionals) taking reference measurements, but the specifics are not detailed here. For the irregular heartbeat detection, the information might be in the 510(k) for BP3BT0-AP, but is not provided in the given text.
4. Adjudication Method for Test Set
Since no new clinical test was conducted for the blood pressure measurement accuracy of the BP3MR1-H(BP A50), this information is not applicable/provided. For studies adhering to ANSI/AAMI SP10, there are specific requirements for agreement between observers, which implicitly involves a form of "adjudication" if discrepancies arise, but the details are not given here. For the irregular heartbeat detection, the information might be in the 510(k) for BP3BT0-AP, but is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or conducted, as the device is a standalone blood pressure monitor and does not involve human readers interpreting its output in a comparative AI-assisted vs. non-AI-assisted scenario. Therefore, not applicable, and no effect size for human readers with/without AI assistance is provided.
6. Standalone Performance Study
A standalone performance evaluation (algorithm only without human-in-the-loop) for blood pressure measurement accuracy was implied to have been conducted for the predicate device (BP2BI0) in accordance with ANSI/AAMI SP10: 2002. The current device's performance is asserted to be unchanged due to identical programming and fundamental technology.
A standalone performance evaluation for the irregular heartbeat detection feature was likely conducted for the predicate device BP3BT0-AP, as the technology is stated to be derived from it. The specifics are not provided in the given text but would be in the 510(k) for BP3BT0-AP.
7. Type of Ground Truth Used
For blood pressure measurement accuracy, the ground truth for studies adhering to ANSI/AAMI SP10 typically involves simultaneous auscultatory measurements performed by trained observers using a mercury manometer or a validated reference device. This is a form of expert consensus/reference measurement.
For irregular heartbeat detection, the ground truth for the BP3BT0-AP (from which this device's technology is derived) would typically involve a gold standard like electrocardiogram (ECG) recordings. This implies outcomes data/reference standard.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning, as this is a traditional medical device (oscillometric blood pressure monitor) and not explicitly an AI/ML-driven device in the modern sense. The "program codes" for the BP3MR1-H(BP A50) are stated to be "unchanged" from the predicate BP2BI0, implying that any underlying algorithms were developed and "trained" (or validated) as part of the predicate device's clearance. Therefore, a specific training set size for this device is not provided or explicitly applicable in the context of its submission strategy.
9. How the Ground Truth for the Training Set was Established
Similar to point 8, the concept of a "training set" with distinct ground truth establishment for this device is not directly applicable given the submission strategy of substantial equivalence to a predicate. The underlying algorithms for the core oscillometric measurement and irregular heartbeat detection would have been developed and validated using relevant physiological data (e.g., simultaneous auscultatory readings or ECGs) in accordance with recognized standards for the predicate devices. The specifics of how this ground truth was established for the predicate devices are not detailed in the provided text.
§ 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).