(30 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office Target (BP3MD1-4) is a device intended to measure the systolic and diastolic blood pressure, pulse rate and pulse pressure (PP) of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office Tarqet (BP3MD1-4) is designed to measure systolic and diastolic blood pressure, pulse rate and pulse pressure (PP) of an individual by using a noninvasive 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 a resistive 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 a breakdown of the acceptance criteria and study information for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office Target (BP3MD1-4), based on the provided 510(k) summary:
This device did not undergo a clinical accuracy study for its blood pressure measurement technology as part of this 510(k) submission. The manufacturer claimed substantial equivalence to a predicate device (Model BP3BT0-1) on the basis that the differences between the new device and the predicate did not affect the blood pressure measurement technology. Therefore, they concluded that repeated clinical testing in accordance with ANSI/AAMI SP10 was not required.
However, the submission does detail non-clinical tests that were performed.
1. Table of Acceptance Criteria and Reported Device Performance
Since no new clinical accuracy study for blood pressure measurement was performed for this specific device model, the table below refers to the non-clinical tests mentioned. The acceptance criteria for these would generally be adherence to the relevant standards and guidance documents.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Reliability Test Requirements: | Met all relevant requirements. |
| a. Storage test | Passed |
| b. Operating test | Passed |
| c. Vibration test | Passed |
| d. Drop test | Passed |
| e. Life test | Passed |
| EMC Test Requirements | Met all relevant requirements. |
| f. EMC Test | Passed |
| Software Validation Requirements (Moderate level of concern) | Met all relevant requirements. |
| Validation conducted in accordance with FDA November 2005 guidance document. | |
| Overall Safety and Effectiveness | Demonstrated substantial equivalence with predicate devices. |
| No significant differences in terms of safety and effectiveness (electrical, mechanical, environmental) per FDA DCRND November 1993 Draft "Reviewer Guidance" and ANSI/AAMI SP10:2008. |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical Tests: The documentation does not specify the sample sizes (e.g., number of devices tested) for the reliability, EMC, or software validation tests.
- Clinical Accuracy (for blood pressure measurement): No new clinical test set was used for this 510(k) submission. The manufacturer relied on the clinical accuracy of its predicate device, Model BP3BT0-1, which presumably underwent clinical testing prior to its own clearance.
- Data Provenance: Not applicable for new clinical data for this submission. The non-clinical tests would have been performed by the manufacturer (Microlife Intellectual Property GmbH, Switzerland).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable for this 510(k) submission. Since no new clinical accuracy testing was performed, there was no need to establish ground truth for a new clinical test set. The manufacturer's argument for substantial equivalence was based on engineering analysis and non-clinical testing, plus the prior clearance of a clinically-tested predicate device.
4. Adjudication Method for the Test Set
- Not applicable for this 510(k) submission. No clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
- No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating devices where human interpretation of medical images or data is involved, often with AI assistance. This device is a standalone blood pressure monitor.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No standalone clinical performance study was performed for this specific device model as part of this 510(k) submission. The device (Microlife Upper Arm Automatic Digital Blood Pressure Monitor) inherently operates in a "standalone" manner (algorithm-only for blood pressure measurement, without human intervention in the interpretive phase), but the clinical accuracy validation was based on substantial equivalence to a predicate device, rather than a de novo clinical trial for this specific model.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For the non-clinical tests, the ground truth was derived from adherence to engineering standards and regulatory guidance documents.
- For the blood pressure measurement accuracy (which was deemed unchanged from the predicate), the ground truth for the predicate device's clinical testing would have been reference measurements from trained clinicians using a validated gold-standard method (e.g., auscultation by multiple observers, or intra-arterial measurement, as per ANSI/AAMI SP10). However, this was not directly assessed again for the subject device.
8. The Sample Size for the Training Set
- Not applicable. This device uses a well-known "oscillometric method" algorithm, not a machine learning model that requires a "training set" in the typical sense. The algorithm is based on established physical principles.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device uses an established oscillometric algorithm, there isn't a "training set" with associated ground truth in the context of AI/ML development. The algorithm's principles and parameters would have been developed and refined through engineering and physiological understanding, and validated against clinical data during the development of earlier 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).