(315 days)
The Nonin® Model Avant™ 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for spot-checking and / or continuous monitoring of patients during both no motion and motion conditions, for patients who are well or poorly perfused. Its functions may be used separately or simultaneously.
The Model Avant™ 2120 combines Pulse Oximetry and NIBP, utilizing the same fundamental scientific technology and intended use as the predicate devices.
Pulse Oximetry: The NONIN® Model Avant™ 2120 Finger Pulse Oximeter passes red and infrared light through perfused tissue and detects the fluctuating signals caused by arterial blood pressure pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is dark red. The pulse oximeter determines functional oxygen saturation of arterial hemoglobin from this color difference by measuring the ratio of absorbed red and infrared light as the blood volume fluctuates with each heart beat.
Blood Pressure Measurement: The NONIN® Model Avant™ 2120 NIBP uses an oscillometric step deflate technique to determine blood pressure. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. During cuff deflation, small cuff pressure changes (resulting from arterial blood pressure pulses) are analyzed by the microprocessor, in order to determine the blood pressure. The Model Avant™ 2120 has the ability to make blood pressure measurements at predetermined intervals or on demand. The Model 2120 has a Memory playback feature, allowing stored data to be transferred to a computer through data acquisition software for analysis.
The provided text is a 510(k) summary for a medical device (Nonin Model 2120 Avant Pulse Oximeter and NIBP Monitor). It details the device's description, intended use, and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria for performance, a study proving device performance against such criteria, data provenance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for training and testing.
The document is purely a regulatory submission demonstrating substantial equivalence to existing legally marketed devices, not a clinical study report. Therefore, I cannot extract the requested information 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).