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The AeroNOx is intended to provide a constant controlled concentration of nitric oxide in breathing gas by delivering a constant controlled flow of nitric oxide into the inspiratory limb of a mechanical ventilator that operates using a continuous constant flow of fresh gas into the inspiratory limb of the ventilator. The AeroNOx is also intended to be used with a flow inflating manual ventilator (an AeroNOx accessory), by introducing controlled flows of nitric oxide into the fresh gas flow to the manual ventilator. It is also intended to monitor nitric oxide, nitrogen dioxide, and oxygen concentrations in the breathing gas. The AeroNOx is intended to be used within a hospital or during air or ground transport outside the hospital.

The AeroNOx nitric oxide delivery system is specifically designed for the transmission . and control of gaseous nitric oxide (NO) in parts per million (ppm) concentrations. It is divided into two main components: the titration delivery system and the NO/NO2/O2 . analyzer. These two components are mounted into a single enclosure. The construction materials are compatible with NO and will not contaminate the gas stream. A stainless steel, two stage regulator with CGA 626 gas fittings is coupled to a calibrated, high accuracy NO mass flow meter and precision metering valve. The NO is titrated continuously via tubing nearest to the ventilator outlet circuit where it is diluted by the ventilator gas flow. Initial NO flow required to approximate a desired NO concentration is estimated by calculation and verified by the monitoring component of the system. We have also included a look-up table for specific ventilator settings, AeroNOx NO flow setting and expected NO2 production based on 100% Oxygen source, in the operating manual. The AeroNOx analyzer continuously draws a sample from the ventilator circuit on the distal point of the inspiratory circuit nearest the patient wye connection. The sensors then measure NO and NO2 concentration in parts per million and Oxygen in %. The sensors operate by electrochemical means. NO, O2 and NO2 molecules diffuse across a membrane and react in the electrolyte solution augmenting an electrical current between the anode and cathode. The augmented current is proportional to the NO, O2 and NO2 concentration. The AeroNOx analyzer has been designed so that the user can set alarm limits to ensure that deviations in NO and NO2 can be monitored. These alarms are visual and audible. An oxygen analyzer is also incorporated into the system to act as a secondary monitor to display the fractional inspired oxygen concentration.

The provided document is a Special 510(k) submission for a device modification to the AeroNOx Nitric Oxide Titration & Monitoring System. Based on the document, no studies related to device performance or clinical claims were conducted or are presented.

The modification described is solely an update to the User Manual to include three additional ventilators in the list of validated ventilators that can be connected to the AeroNOx system. The submission explicitly states: "No device modifications have been made from the predicate device. The only modification made is to the list of ventilators that may connect to the AeroNOx in the Operator's Manual (page 22)."

Therefore, there is no information available in this document to populate the requested table or answer questions regarding acceptance criteria, device performance, sample size, ground truth, expert involvement, or study methodologies. The substantial equivalence argument is based on the device's continued use of the same intended use, operating principle, design, electronic circuitry, and materials as the predicate device.

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