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The Capnostream®20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is also indicated for continuous non-invasive monitoring of carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). It is intended for use with neonatal, pediatric, and adult patients in hospital-type facilities, intra-hospital transport and home environments. The Capnostream®20p monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

The Capnostream20p bedside monitor is a two parameter monitor consisting of a microMediCO2 capnography module and/or a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed. The device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer with DQA 21 CFR § 870.2700 Pulse Oximeter listed as an additional or alternate classification. This device has two modules that are classified as follows: - 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) . - . 21 CFR 870.2700 Pulse Oximeter (Classification DQA). Each module is controlled by dedicated software that is an integral part of the respective module. Each module provides parameters to the host software (the Capnostream20p device software) which then controls the display of the received parameter values and creates alarms when the values cross the preset thresholds. The microMediCO2 module provides the following inputs to the host monitor: FiCO2, EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI (Integrated Pulmonary Index). The Masimo MX1 SpO2 module, integrated in the Capnostream20 p monitor presented in this submission, provides the following parameters to the host for display: SpO2 (functional oxygen saturation of arterial hemoglobin), pulse rate, SpCO (carboxyhemoglobin saturation in blood), SpMet (methemoglobin saturation in blood) and SpHb (total hemoglobin concentration in blood). The host monitor will display this data to the user in numerics via a screen, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph. The three measurements will be available both real time and in trend summaries. In addition, the MX1 board provides a Perfusion Index (PI) indicating the relative pulsatile strength at the sampling site is provided to the host monitor for display. The host displays the Rainbow SET parameters values on the screen alongside the four IPI (Integrated Pulmonary Index) parameters and the IPI value as presented on the predicate device.

The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital transport and home environments. The Capnostream20 monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

The Capnostream20 bedside monitor is a two parameter monitor consisting of a CO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed. The device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer with DQA 21 CFR § 870.2700 Pulse Oximeter listed as an additional or alternate classification. This device has two modules that are classified as follows: - 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) . - 21 CFR 870.2700 Pulse Oximeter (Classification DQA) . Each module is controlled by dedicated software that is an integral part of the respective module.

The Capnostream 20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital transport and home environments. The Capnostream 20 monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

The Capnostream 20 bedside monitor is a two parameter monitor consisting of a miniMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed. The device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer with DQA 21 CFR § 870.2700 Pulse Oximeter listed as an additional or alternate classification. This device has two modules that are classified as follows: - 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) - 21 CFR 870.2700 Pulse Oximeter (Classification DQA) . Each module is controlled by dedicated software that is an integral part of the respective module. Each module provides parameters to the host software (the Capnostream 20 device software) which then controls the display of the received parameter values and creates alarms when the values cross the preset thresholds. The miniMediCO2 capnography module software presented in this submission includes the ability to receive SpO2 and pulse rate values from a pulse oximetry module and to calculate an integrated pulmonary index (IPI) which provides a simple and clear single parameter representation of the patient's ventilatory status. The IPI, is an integer value ranging from 1-10 based on end tidal CO2, respiration rate, SpO2 (oxygen saturation of arterial hemoglobin) and pulse rate. The calculated IPI is then provided to a host device (the Capnostream 20 device in the case of this submission). The host displays the index value on the screen alongside the four parameters presented on the predicate device. The IPI feature is not intended for use in the monitoring of children aged less than one year or neonates and the feature is disabled when neonatal mode is selected by the user. However, the monitor itself may continue to be used, in a manner that is identical to the predicate device in all respects, for all patient populations. The MiniMediCO2 module software is designed to enable the index to be calculated by accepting SpO2 and heart rate values supplied at the required rate (once a second) by any type of pulse oximetry module implemented in a host device. The miniMediCO2 module with IPI software may be implemented in any other pulse oximetry enabled host monitor after making the required changes to the host software to allow provision of SpO2 and pulse rate values to the module and display of the IPI by the host. The host will continue to display the four reference parameters and any other parameters provided by the monitor with the IPI as an addition.

The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospital type facilities, intra hospital transport and home environments.

The Capnostream20 bedside monitor is a two parameter monitor consisting of a miniMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed. The device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer. This device has two modules that are classified as follows: 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) . 21 CFR870.2700 Pulse Oximeter (Classification DQA) . Each module is controlled by dedicated software that is an integral part of the respective module. Each module provides parameters to the host software (the Capnostream20 device software) which then controls the display of the received parameter values and creates alarms when the values cross the preset thresholds. The miniMediCO2 capnography module software presented in this submission includes an adaptive averaging algorithm defined as the A Algorithm for calculating the respiration rate from the CO2 waveform introduced in software version 2.31 of the miniMediCO2 capnography module software. The calculated respiration rate parameter is then provided to the host (the Capnostream20 device software). The host makes no modification to the values received from the module. The host triggers an alarm when the respiration rate high or respiration rate low thresholds have been crossed. The algorithm employed in the respiration rate calculation reduces false positive alarms by filtering out noise and instantaneous fluctuations without missing true alarms that may indicate a clinically significant change to respiration rate. By employing the adaptive averaging algorithm, the respiration rate accurately reflects the patient's condition and significantly reduces the generation of nuisance alarms by the host.

The Capnostream20 is intended for CO2 and SpO2 indications. The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments. The Capnostream10 is intended for CO2 indications only. The Capnostreamso is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and insoired breath. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.

Capnostream20: The Capnostream20 bedside monitor is a two parameter monitor consisting of an EtCO2 MiniMediCO2 module and a MP100 SpO2 module, displays and alarms. Capnostream10: The Capnostream ( bedside monitor is a one parameter monitor consisting of a MP100 EtCO2 module displays and alarms.