(90 days)
The BPM-100:
- Measures systolic and diastolic blood pressure and pulse rate in adults greater than 18 years of age.
- Is intended for use in physicians' offices, nursing units, and patient care areas of hospitals.
Automated Non-Invasive Blood Pressure Monitor, Model BPM-100
The provided text is an FDA 510(k) clearance letter for an "Automated Non-Invasive Blood Pressure Monitor, Model BPM-100". It merely states that the device is substantially equivalent to legally marketed predicate devices and is approved for market.
Crucially, the document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes (for test or training sets), expert qualifications, ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot provide the requested information. To answer your questions, I would need access to the actual 510(k) submission summary or detailed study reports for the BPM-100 device.
§ 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).