TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)

The TG-980P and TG-980P1 are CO2 sensor kits that measure carbon dioxide concentration in exhaled patient breath using mainstream infrared absorption. They are intended for use by qualified medical personnel in hospitals, ambulatory care, transport, and other clinical environments to aid in determining a patient's ventilatory status.

Both the subject device and predicate use mainstream infrared absorption with non-dispersive infrared (NDIR) single-wave spectroscopic measurement. The subject device has a faster response time (60 msec vs. 120 msec for EtCO2), can support both intubated and non-intubated patients (versus intubated only for the predicate), weighs less (65g vs. 120g), and has a simplified configuration without a separate CO2 adapter. The TG-980P1 variant includes a higher data sampling rate (62.5 Hz vs. 40 Hz) and shorter warm-up time (5 seconds vs. 10 seconds).

IEC 60601-1 (general medical electrical equipment safety), ISO 80601-2-55 (respiratory gas monitors), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-12 (emergency medical services environment), ISO 10993-1 (biocompatibility), ISO 14971 (risk management), IEC 62366-1 (usability engineering), IEC 60601-1-6 (usability), IEC 62304 (software lifecycle), and ISO 17664-2 (reprocessing information).

The subject device shares identical regulatory classification (Class II, 21 CFR 868.1400), intended use, and indications for use with the predicate TG-970P. Both employ the same measurement principle (mainstream NDIR spectroscopy) and achieve the same CO2 measurement specifications and accuracy. The dimensional and design changes (removal of CO2 adapter, lighter weight, faster response, extended patient population) represent improvements that do not compromise safety or effectiveness. Performance testing using identical test methods and specifications to the predicate establishes that these modifications do not raise concerns regarding safety and effectiveness.