(100 days)
The MicroCap Plus /NPB-75 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and of arterial oxygen saturation (SpO2) and pulse rate.
The Oridion MicroCap Plus/NPB-75 (the device being modified) (K964239) is an integrated instrument that measures end tidal CO2 (EtCO2) and saturated arterial oxygen (SpO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR) and as a derivative of the saturated arterial oxygen measurement the devices measure and display the pulse rate (PR). The capnograph section of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status. The pulse oximeter module in both devices measures the oxygenated hemoglobin (HbO>) and displays the results as a percent of oxygen and as a plethysmographic waveform.
The provided text describes the MicroCap Plus/NPB-75 device, a combination oximeter/carbon dioxide gas analyzer. The document is primarily a 510(k) summary for a modification to an existing device, specifically changing the pulse oximeter module. However, it does not contain specific acceptance criteria, study details, or performance data for demonstrating the device meets any acceptance criteria. It mainly focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as these details are not present in the provided document.
The document only states:
- Device Description: The MicroCap Plus/NPB-75 measures end tidal CO2 (EtCO2), saturated arterial oxygen (SpO2), breath rate (BR), and pulse rate (PR).
- Substantial Equivalence: The modified device (using the NPB MP507 SpO2 module) is substantially equivalent to the predicate device (using the MP204 module) in terms of indications for use and technological characteristics. The MP507 is described as an "improved version" of the MP204.
- Intended Use: For continuous, non-invasive measurement and monitoring of CO2 concentration, respiration rate, arterial oxygen saturation (SpO2), and pulse rate by trained healthcare providers in various critical care settings.
Without a performance study section or specific testing results, it's impossible to derive the requested information.
§ 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).