(22 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS) is a device intended to measure the systolic and diastolic blood pressure, pulse rate, pulse pressure (PP) and mean arterial pressure (MAP) of an adult individual by using a non-invasive oscillometric technique in one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s).
The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS) is designed to measure systolic and diastolic blood pressure, pulse rate, pulse pressure (PP) and mean arterial pressure (MAP) of an individual by using a non-invasive technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, pulse pressure (PP) and mean arterial pressure (MAP), 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, inflation pressure setting function, measurement intervals setting function etc.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study data:
This submission (K101275) is for a modified device, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS). The manufacturer largely relies on previous clearances for its predicate devices (K082357 and K080337) to demonstrate substantial equivalence, particularly by asserting that the relevant clinical accuracy and AF detection functionalities are identical. This means detailed new clinical study data for this specific device is not provided in this summary, but rather referenced from previous submissions.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (from referenced predicate devices) | Reported Device Performance (from referenced predicate devices) |
|---|---|---|
| Blood Pressure Detection Accuracy | Compliance with ANSI/AAMI SP10 (standard for BP monitors) | "Identical to our predicate device Model WatchBP Office (Twin200) [K082357]." The previous device met ANSI/AAMI SP10. |
| Atrial Fibrillation (AF) Detection | Not explicitly stated, but implied to be sufficient for a warning signal | "Identical to what is utilized in our predicate device Model BP3MQ1-2D [K080337]." The previous device achieved intended AF detection. |
| Electrical, Mechanical, Environmental Performance | Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND | All relevant requirements met; no design characteristics violated the guidance or resulted in safety hazards. |
| Software Validation | Moderate level of concern designation in accordance with FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Validation conducted in accordance with the guidance. |
2. Sample Size Used for the Test Set and Data Provenance
- Blood Pressure Accuracy: The original clinical test report for the predicate device Model WatchBP Office (Twin200), K082357, would contain this information. This current submission does not provide new sample size data for blood pressure accuracy validation as it claims identity to the predicate. The provenance of that original data is not stated in this summary.
- Atrial Fibrillation (AF) Detection: The original clinical test report for the predicate device Model BP3MQ1-2D, K080337, would contain this information. This current submission does not provide new sample size data for AF detection validation as it claims identity to the predicate. The provenance of that original data is not stated in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information would be found in the original clinical test reports for the predicate devices (K082357 for BP accuracy and K080337 for AF detection), which are not provided in this summary. The summary simply states that these reports are "applicable" to the subject device.
4. Adjudication Method for the Test Set
- Again, this information would be detailed in the original clinical test reports for the predicate devices (K082357 and K080337), which are not included in this summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done or reported in this summary. For a blood pressure monitor and AF detection, the primary clinical validation typically involves comparing the device's readings against a gold standard (e.g., auscultation by trained observers) rather than assessing human reader improvement with AI assistance. The device functions as a standalone diagnostic aid.
6. Standalone (Algorithm Only) Performance Study
- Yes, implicitly. The clinical validation for blood pressure accuracy (referenced to K082357) and AF detection (referenced to K080337) represents standalone performance. These devices provide readings and AF warnings without requiring a human-in-the-loop to interpret the raw signals. The device itself is the "algorithm only" in this context, providing a direct output.
7. Type of Ground Truth Used
- For Blood Pressure: The ground truth for oscillometric blood pressure monitors, when validated against standards like ANSI/AAMI SP10, typically involves simultaneous auscultatory measurements performed by trained human observers using a mercury sphygmomanometer, often in a double-blinded fashion.
- For Atrial Fibrillation Detection: The ground truth for AF detection (referenced to K080337) would typically involve simultaneous Electrocardiogram (ECG) recordings interpreted by electrophysiologists or cardiologists.
8. Sample Size for the Training Set
- The summary does not provide information on the training set sample size. This submission is for a device based on an established oscillometric method and AF detection algorithm (from predicate devices). Such algorithms are typically developed and refined using substantial datasets, but the details of those development datasets (including sizes) are not part of this 510(k) summary, which focuses on validation.
9. How the Ground Truth for the Training Set Was Established
- Similar to point 8, the summary does not provide details on how the ground truth for the training set was established. This information would pertain to the development of the underlying algorithms, not their validation for substantial equivalence. The validation ground truth (as per point 7) is what's relevant to this submission.
§ 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).