(55 days)
The Microlife Upper Arm Blood Pressure Monitor, Model BP 3BT0-AP, 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.
The Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-AP 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".
Here's an analysis of the provided text regarding the Microlife Blood Pressure Monitor, Model BP3BT0-AP:
Acceptance Criteria and Study Details for Microlife Blood Pressure Monitor, Model BP3BT0-AP
The provided 510(k) summary focuses primarily on establishing substantial equivalence to predicate devices based on the blood pressure measurement algorithm and a separate simulator study for the irregular heartbeat detection function.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Blood Pressure Measurement Accuracy | ||
| General Functions Test | Alignment with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements. | "Since the blood pressure measuring algorithm in this device is exactly the same as in the predicate device, BP3BT0-1, no clinical validation for blood pressure measurement is required." Implies performance is equivalent to the predicate, which is presumed to meet accuracy standards by virtue of its predicate status and compliance with ANSI/AAMI SP10-1992. |
| Reliability Test Operation Conditions | Adherence to requirements outlined in FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions". | "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Microlife Automatic Blood Pressure Monitor, Model BP-3BT0-AP tested met all relevant requirements of the aforementioned tests." |
| Reliability Test Drop Testing | Adherence to requirements outlined in FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions". | "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Microlife Automatic Blood Pressure Monitor, Model BP-3BT0-AP tested met all relevant requirements of the aforementioned tests." |
| Reliability Test Storage | Adherence to requirements outlined in FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions". | "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Microlife Automatic Blood Pressure Monitor, Model BP-3BT0-AP tested met all relevant requirements of the aforementioned tests." |
| Reliability Test Vibrating Testing | Adherence to requirements outlined in FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions". | "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Microlife Automatic Blood Pressure Monitor, Model BP-3BT0-AP tested met all relevant requirements of the aforementioned tests." |
| EMC Test | Adherence to requirements outlined in FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions". | "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Microlife Automatic Blood Pressure Monitor, Model BP-3BT0-AP tested met all relevant requirements of the aforementioned tests." |
| IEC 60601-1 Safety Test | Compliance with IEC 60601-1 safety standards. | "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Microlife Automatic Blood Pressure Monitor, Model BP-3BT0-AP tested met all relevant requirements of the aforementioned tests." |
| Irregular Heartbeat Detection | ||
| Simulator Comparison Study | The study demonstrated appropriate functionality and accuracy of the irregular heartbeat detection function when compared to a predicate device's (A&D Medical Lifesource, Model UA-787V) irregular heartbeat detection, as evaluated through simulator testing. The specific metric for "appropriate functionality and accuracy" is not detailed, but the intent is to show equivalence in this feature. | A "simulator comparison study for the function of irregular heartbeat detection" was conducted. The conclusion states that the device is "as safe and effective as the predicate...based on electrical, mechanical and environmental testing results as well as the FDA DCRND November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions', and, the ANSI/AAMI Voluntary Standard, SP10-1992 testing results." This implies the simulator study found acceptable performance for this feature. |
2. Sample Size Used for the Test Set and Data Provenance
- Blood Pressure Measurement: No specific test set or data provenance for blood pressure measurement is described. The submission states that "no clinical validation for blood pressure measurement is required" because the algorithm is identical to that of the predicate device (BP3BT0-1).
- Irregular Heartbeat Detection: The submission mentions a "simulator comparison study."
- Sample Size: Not specified for this simulator study.
- Data Provenance: The nature of a "simulator" implies artificially generated or controlled data, not human patient data from a specific country. It's a prospective study in the sense that the simulator tests were performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Blood Pressure Measurement: Not applicable, as no new clinical validation was performed for the blood pressure algorithm. Ground truth for the predicate device would have been established according to relevant standards (e.g., ANSI/AAMI SP10-1992), likely requiring a panel of experts often including physicians or trained clinical staff.
- Irregular Heartbeat Detection: Not specified. Since it was a simulator study, the "ground truth" would be determined by the simulator's programmed conditions for irregular heartbeats and standard definitions of such events. Experts (e.g., biomedical engineers, cardiologists) might have designed or validated the simulator's output, but this is not explicitly stated.
4. Adjudication Method for the Test Set
- Both are not applicable directly from this summary. For the simulator study, adjudication methods are less typical than for human reader studies, as the truth is defined by the simulator itself.
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 MRMC comparative effectiveness study was done or mentioned. This submission does not describe an AI system designed to assist human readers; it's a standalone device that provides measurements.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the device operates in a standalone manner. The blood pressure measurement algorithm is described as "oscillometric method" which is inherent to the device's function. The irregular heartbeat detection is also an algorithmic function within the device. The "simulator comparison study" for irregular heartbeat detection would evaluate this standalone algorithmic performance.
7. The Type of Ground Truth Used
- Blood Pressure Measurement: Implicitly, the ground truth for blood pressure measurement would be the auscultatory method (mercury manometer with stethoscope) as defined by the standards (e.g., ANSI/AAMI SP10-1992) that the predicate device would have followed.
- Irregular Heartbeat Detection: The ground truth for the simulator study would be the pre-defined, programmed irregular heartbeat patterns generated by the simulator.
8. The Sample Size for the Training Set
- Blood Pressure Measurement: Not explicitly stated. The algorithm is "exactly the same as in the predicate device, BP3BT0-1." The training data for the original predicate device's algorithm is not provided here.
- Irregular Heartbeat Detection: Not explicitly stated. The irregular heartbeat detection function is new to this specific model compared to the BP3BT0-1 predicate but is present in the A&D Medical Lifesource predicate. It's possible the algorithm was developed (trained, if applicable) using internal data or known irregular heartbeat signal patterns, but no details are given.
9. How the Ground Truth for the Training Set Was Established
- Blood Pressure Measurement: Not explicitly stated. For the predicate device's algorithm, the ground truth would have been established through clinical trials comparing oscillometric readings against a gold standard like the auscultatory method, following established protocols (e.g., those in ANSI/AAMI SP10).
- Irregular Heartbeat Detection: Not explicitly stated. If the irregular heartbeat detection algorithm involved machine learning (unlikely given the 2004 submission date, but possible for rule-based systems), its ground truth would have been based on expert-labeled physiological signals or known irregular heartbeat patterns. However, the submission doesn't provide this level of detail.
§ 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).