(28 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GT1-6X 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 irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.
The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) 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 BP3GT1-6X is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive MAM (Microlife Average Mode) 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 capacitor 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".
And the device has Irregular Heartbeat Detection (IHD) function. It detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol "is displayed on the LCD screen if any irregular heart beat signal has been detected. In addition, the device has a traffic light function. And the device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.
· The device features an interactive touch screen which operates similarly to traditional buttons, but requires only a light touch of the finger to operate.
Here's a breakdown of the acceptance criteria and study information for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GT1-6X, based on the provided text:
Key Finding: The submission does not contain a standalone clinical study for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GT1-6X. Instead, it relies on a declaration of clinical identity and substantial equivalence to a previously cleared predicate device, Model BP3AP1-3E.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Blood Pressure Accuracy | The device is considered clinically accurate in terms of blood pressure detection based on its technical identity to the predicate device (Model BP3AP1-3E), which was presumably tested against ANSI/AAMI SP10. |
| Reliability | Met requirements for: |
- Storage test
- Operating test
- Vibration test
- Drop test
- Life test |
| EMC (Electromagnetic Compatibility) | Met requirements. |
| Electrical, Mechanical, Environmental Performance | Met all relevant requirements as per FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND. |
| Software Validation | Conducted in accordance with: - FDA November 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (moderate level of concern)
- FDA September 1999 "Guidance for Off-The-Shelf Software Use in Medical Devices" (for PC-link function) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No dedicated clinical test set for blood pressure accuracy was performed for this specific device model.
- Data Provenance: Not applicable for a new clinical study. The device's clinical accuracy is inferred from a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No new clinical study was conducted for this device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No new clinical study was conducted for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Study: No, a standalone clinical accuracy study for blood pressure measurement was not done for this specific device. The clinical accuracy is based on the technical identity to a predicate device, which itself would have undergone such validation against a standard like ANSI/AAMI SP10.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the claim of blood pressure accuracy, the ground truth would have been established through a clinical validation study of the predicate device (Model BP3AP1-3E) in accordance with a recognized standard like ANSI/AAMI SP10. This standard typically involves comparison against mercury sphygmomanometry (auscultatory method performed by trained observers).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device uses an oscillometric method, not a machine learning algorithm that typically requires a 'training set' in the conventional sense. The "training" for such devices is inherent in their design and calibration based on established physiological principles and prior validation data from similar devices.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable in the context of an AI/ML training set. The calibration and underlying principles of the oscillometric method are based on established medical science and validated against clinical standards.
§ 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).