(216 days)
The Bosch Blood Pressure Monitor (BP5000 BT) is intended for use by adults to measure systolic and diastolic pressures, as well as pulse rate, by the oscillometric method, with a telehealth system or for home use.
The Bosch Blood Pressure Monitor (BP5000 BT) is an upper arm, non-invasive, blood pressure device, designed for home use. It is a simple device designed to measure a patient's systolic and diastolic pressures, as well as pulse rate using the oscillometric measuring method. The Bosch Blood Pressure Monitor (BP5000 BT) has a voice prompt function and a memory function. There are five available languages to choose from (US English, UK English. Spanish. French and German). The BP5000 BT can store up to 42 measurements, including their date and time stamp, in its memory. By pressing the memory button on the device, the last blood pressure measurement and pulse rate is displayed on the LCD screen and announced by the voice prompt. The volume can be adjusted by pressing the volume button. The Bosch Blood Pressure Monitor (BP5000 BT) is also designed to connect wirelessly, via Bluetooth, to a Bosch or Continua compliant telehealth patient interface. The connection is made automatically when the telehealth device prompts the patient to take their blood pressure measurement. Once the measurement is complete, the Bluetooth symbol on the blood pressure monitor will flash, indicating that the measurement is being transferred to the telehealth device. If Bluetooth is disabled, the BP5000 BT will store the measurements in its merhorv and will transmit all the stored data to the telehealth device once Bluetooth has been enabled.
The provided text describes a 510(k) submission for the Bosch Blood Pressure Monitor (BP5000 BT). While it mentions that "verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of the BP5000 BT," and that "The Bosch Blood Pressure Monitor (BP5000 BT) performed as intended," it does not provide any specific acceptance criteria or detailed results from a study proving these criteria were met.
Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth derivation based on the provided document. The document only broadly states that the device performed as intended and was found substantially equivalent to a predicate 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).