Capnostream™35 Portable Respiratory Monitor (PM35MN)

The Capnostream™ 35 is a portable, 4-inch color screen monitor for non-invasive monitoring of carbon dioxide (EtCO2), respiration rate, oxygen saturation (SpO2), and pulse rate in neonatal, pediatric, and adult patients. It integrates a microMediCO2 capnography module and a Nellcor™ Nell-EQ™ Intelligent Processor for pulse oximetry, intended for use in hospitals, hospital-type facilities, intra-hospital transport, and mobile emergency medical applications including ground and air transport.

The primary technological difference is the integration of the Nell-EQ™ Intelligent Processor (PCBA) as the updated pulse oximetry engine, replacing the legacy PMB05N processor in the predicate. The Nell-EQ adds heart rate variability (HRV) and perfusion index (PI) as supplemental displayed parameters, and introduces TrueSpectrum™ Calibration using additional patient-specific optical inputs. All connectivity options (LAN, Wi-Fi, Bluetooth, RS232, SD card, USB) present in the predicate were irreversibly removed from the subject device. The capnography module, specifications, and fundamental NDIR/plethysmography technology remain unchanged.

ISO 80601-2-55 (capnography), ISO 80601-2-61 (pulse oximetry), ISO 80601-2-49 (multifunction patient monitors), IEC 62133-2 (battery safety), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), EN 62366-1 and IEC 62366-1 (human factors). The device was verified and validated through bench testing, software testing, human factors evaluation, and clinical testing across diverse skin tones using Monk Skin Tone (MST) scale and Individual Typology Angle (ITA) measurements.

The subject device is substantially equivalent to predicate K200594 because both share the same intended use, patient populations, indications for use, and core capnography technology. The integration of the Nell-EQ PCBA represents an improved oximetry engine that maintains SpO2 and pulse rate accuracy specifications while adding supplemental parameters (HRV, PI). Verification and validation testing confirmed that SpO2 accuracy met or exceeded specifications (within 2.0% ARMS) across monitoring conditions including motion, low perfusion, and diverse skin tones. The removal of connectivity does not impact the device's intended use, and comprehensive risk management confirmed no new safety or effectiveness questions are raised.