(15 days)
The UB-322 is designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. UB-322 is using oscillometric method to conduct the measurement. It is not designed for ambulatory use. The wrist circumference range shall be within 5.3 inches to 7.7 inches.
UB-322 Watch Style Wrist Digital Blood Pressure Monitor
This document is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report detailing acceptance criteria and performance data. Therefore, the requested information cannot be fully extracted from the provided text.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance.
- Details about the study design, sample sizes (for test or training sets), data provenance, number or qualifications of experts, or adjudication methods.
- Information about MRMC studies, standalone algorithm performance, or how ground truth was established.
The document primarily states that the A&D UB-322 Watch Style Wrist Digital Blood Pressure Monitor has been found "substantially equivalent" to predicate devices marketed prior to May 28, 1976. It specifies the "Indications for Use" as:
- For end-users 18 years and older at home.
- To monitor blood pressure (systolic and diastolic) and pulse rate.
- Not for users with common arrhythmias (atrial or ventricular premature beats or atrial fibrillation).
- Uses the oscillometric method.
- Not designed for ambulatory use.
- Wrist circumference range: 5.3 inches to 7.7 inches.
The FDA clearance process for a 510(k) relies on demonstrating substantial equivalence, which often involves comparing the new device's performance to an existing legally marketed predicate device. The detailed performance criteria and the study results demonstrating how the device met those criteria would typically be found in the 510(k) submission itself or a separate validation report, not in the FDA's clearance letter.
§ 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).