(87 days)
The Nonin® Avant™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care, and subacute environments. It may also be used in patient transport, sleep laboratories, and EMS environments. The Avant™ 9600 is intended for continuous monitoring and / or spot-checking of patients during both no motion and motion conditions, for patients who are well or poorly perfused.
The Avant™ 9600 Digital Pulse Oximeter is a portable tabletop device designed for continuous noninvasive measurement, display, and recording of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using one of a range of compatible oxygen sensors. The Avant™ 9600 is intended for prescription use with adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care, and subacute environments. It may also be used in patient transport, sleep laboratories, and EMS environments.
The Avant™ 9600's display uses light-emitting diodes (LED) components to present patient's SpO2 and pulse rate values, as well as alarm limit and volume settings. The Avant™ 9600 can be powered internally with a 12 VDC 1.5A AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack.
The Avant™ 9600 includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, real-time and print-on-demand data outputs, a patient security mode, and nurse call options.
This document is a 510(k) summary for the Nonin Avant™ 9600 Pulse Oximeter, indicating its substantial equivalence to a predicate device. It does not contain the specific details of a study with acceptance criteria and device performance results. The text describes the device, its intended use, and states that bench and clinical testing were successfully undergone to demonstrate functional characteristics and substantial equivalence, but it does not provide the quantitative results or the specific acceptance criteria used in those tests. The document is primarily a regulatory filing for market clearance.
Therefore, I cannot extract the detailed information requested in the prompt based on the provided text, such as specific acceptance criteria values, reported device performance figures, sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, details of MRMC or standalone studies, or how ground truth was established.
The document states:
- Functional and Safety Testing: "Nonin's Avant™ 9600 Pulse Oximeter has successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional characteristics and is substantially equivalent to the predicate device."
This statement confirms that testing was performed, but it lacks the quantitative details needed to fill out the table and answer the specific questions about acceptance criteria and study methodology.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).