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The intended use of the Apieron INSIGHT™ eNO System is to quantitatively measure exhaled nitric oxide (eNO) in expired human breath as a marker of inflammation in persons with asthma. Measurement of eNO in expired human breath by the Apieron INSIGHT eNO System is a non-invasive, simple and safe method to measure a decrease in eNO in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of the therapeutic effects in patients with elevated eNO levels. The Apieron INSIGHT eNO System is suitable for use in children ages 8 to 17 years of age, and in adults 18 years of age and older. eNO measurements, as an adjunct to established clinical assessments, provide the physician an objective marker to evaluate the patient's response to anti-inflammatory therapy. The Apieron INSIGHT eNO System can be used by trained operators in a physician's office laboratory setting. The Apieron INSIGHT eNO System should not be used in critical care, emergency care or in anesthesiology.

The proposed Apieron INSIGHT™ eNO System consists of a Monitor, a multi-use disposable Sensor Cartridge and the same disposable test supplies as the cleared device. The only difference between the proposed devices and the cleared device is that the single-use disposable eNO Sensor Cartridge of the INSIGHT System has been tested and proven to support up to 10 patient uses and 5 QC tests. A modification has been made to the software which will allow for counting the uses of the Sensor Cartridge and prevention of uses beyond the specified limits. Two sensors are being proposed for clearance one for 10 patient uses and 5 QC tests and one for 5 patient uses and 5 QC tests. The Monitor functions the same and contains the same measurement and breath sampling hardware to provide for a user-friendly interface guiding the operator through the test sequence and the patient through the breath sampling maneuver. The 10-use and the 5-use disposable Sensor Cartridges contain the same Biosensor as in the cleared device which changes its optical transmission properties when it reacts with the nitric oxide in the breath sample. Apart for some software changes to deal with the number of sensor uses, and the addition of more air purges between tests to clear the sensor of nitric oxide from the previous test, the proposed Apieron INSIGHT eNO System is unchanged. It is transportable, operated by an AC outlet and designed for use with the Sensor Cartridge. The proposed Apieron INSIGHT eNO System has the same indication for use as the predicate device, the Apieron INSIGHT eNO System (K073265).

The intended use of the Apieron INSIGHT™ eNO System is to quantitatively measure exhaled nitric oxide (eNO) in expired human breath as a marker of inflammation in persons with asthma. Measurement of eNO in expired human breath by the Apieron INSIGHT eNO System is a non-invasive, simple and safe method to measure a decrease in eNO in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of the therapeutic effects in patients with elevated eNO levels. The Apieron INSIGHT eNO System is suitable for use in children ages 8 to 17 years of age, and in adults 18 years of age and older. eNO measurements, as an adjunct to established clinical assessments, provide the physician an objective marker to evaluate the patient's response to anti-inflammatory therapy. The Apieron INSIGHT eNO System can be used by trained operators in a physician's office laboratory setting. The Apieron INSIGHT eNO System should not be used in critical care, emergency care or in anesthesiology.

The Apieron INSIGHT™ eNO System consists of a Monitor, a single-use disposable Sensor Cartridge and other disposable test supplies. The Monitor contains the measurement and breath sampling hardware and provides a user-friendly interface to guide the operator through the test sequence and guide the patient through the breath sampling maneuver. The disposable Sensor Cartridge contains a Biosensor that changes its optical transmission properties when it reacts with the nitric oxide in the breath sample. The Apieron INSIGHT eNO System is transportable, operated by an AC outlet and designed for use with the disposable Sensor Cartridge.