Medical Gas Analyzer (AG200)

The Medical Gas Analyzer (AG200) is a mainstream respiratory gas analyzer based on infrared spectrometry that connects to other medical devices (such as the C50 Multi-parameter Patient Monitor) to monitor breathing gases CO2 and N2O and anesthetic agents (Halothane, Enflurane, Isoflurane, Sevoflurane, Desflurane) during anesthesia, recovery, and respiratory care. It is intended for use in operating suites, intensive care units, patient rooms, and emergency medical services for adult, pediatric, and infant patients.

The subject device uses infrared gas spectrometry with no moving parts, operates on 4.5–5.5 VDC at maximum 1.5W, measures CO2 (0–15 vol%, ±0.2 vol% + 2% of reading) and multiple anesthetic agents with specified accuracy ranges. Key differences from the predicate include: no breath rate monitoring capability (predicate includes this), manual anesthetic agent selection via clinician key operation (predicate uses automatic identification), heater-based water vapor prevention without optional HME (predicate offers optional HME), and warm-up time of 10–180 seconds depending on ambient temperature (predicate <20 seconds).

ANSI AAMI ES60601-1:2005/(R)2012 with amendments; IEC 60601-1-2:2020-09; ISO 80601-2-55:2018-02 (respiratory gas monitors); ISO 10993-1, -5, -10, -23 (biocompatibility); ISO 18562-1, -2, -3, -4 (breathing gas pathway biocompatibility); ISO 14971:2019-12 (risk management).

The device is substantially equivalent to the IRMA AX+ predicate (K123043) because it uses the same infrared absorption measurement principle, has the same regulatory classification and product code, applies to the same patient populations and clinical settings, and achieves equivalent performance for CO2 and anesthetic gas measurement. Although the subject device omits breath rate monitoring, uses manual instead of automatic anesthetic agent identification, lacks optional HME, and has a longer warm-up time, the submission argues these differences do not raise safety or effectiveness concerns: breath rate omission is a reduced feature; manual selection by clinicians demonstrated higher reliability than automatic identification; the heater method is validated by the predicate's CO2-focused reference device (K042601) with over 15 years of commercial history; and warm-up times were verified by bench testing and the surface heating temperature (38°C nominal, 43.6°C maximum) is safe. All differences were tested and shown compliant with ISO 80601-2-55.