(101 days)
MD200A Blood Pressure Monitor is an automatic electronic blood pressure monitor intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.
MD200A Blood Pressure Monitor is a handheld device, which can connected to the blood pressure cuff with various specifications, intended for measuring the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique.
The provided text details the 510(k) summary for the MD200A Blood Pressure Monitor (K093013). However, it does not contain the specific information requested in the prompt regarding acceptance criteria, reported device performance, details of a study with sample sizes, expert involvement, adjudication methods, or ground truth establishment.
The document states: "Performance testing including clinical and bench testing was conducted to validate and verify that the proposed device, MD200A Blood Pressure Monitor met all design specifications and was substantially equivalent to the predicate device." While a clinical study is alluded to, its specifics are not provided in this summary.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or delve into the details of the study, as this information is absent from the provided text.
§ 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).