(335 days)
The Scian Automatic Digital Blood Pressure Monitor LD-576, LD-579 are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Scian Automatic Digital Blood Pressure Monitor, Model LD-575, LD-576 and LD-579
This FDA 510(k) clearance letter for the Scian Automatic Digital Blood Pressure Monitor (Models LD-575, LD-576, and LD-579) indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, the provided documents do not contain a detailed study report or specific acceptance criteria and performance data for the device itself.
The letter confirms the device's regulatory classification, product code, and indications for use, but it does not include the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
To answer your prompt, a separate study report or detailed validation document would be required, which is not present in the provided text. The FDA 510(k) process primarily assesses substantial equivalence, and while performance data is part of that assessment, the specific details you're asking for are usually in separate submissions that aren't typically summarized directly in this type of 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).