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The Capnostream™35 monitor is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused. The Capnostream™35 monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up . The OxiMax SPD™ alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs. The Nellcor™ respiration rate parameter is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities. Other than the OxiMax SPD™ alert and Nellcor™ respiration rate features, the device is intended for use in hospitals, hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 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 microMediCO2 module provides the following inputs to the host monitor: EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI). The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2, Pulse Rate, Respiratory Rate, and saturation pattern detection (SPD) parameters to the host for display. The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI. The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph. The device is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.

- Microstream™ Advance Neonatal-Infant Nasal Filter Line with O2 Tubing . - Microstream™ Advance Pediatric Oral-Nasal Filter Line with O2 Tubing ● - Microstream™ Advance Adult Oral-Nasal Filter Line with O2 Tubing 0 Used to conduct a sample of the subject's breathing to a gas measurement device (capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The device is to be used with monitors using Microstream™ technology. o Microstream™ Luer Adult Oral-Nasal Sampling Line Used whenever the physician needs to collect a sample of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.

Similar to their predicates, the Microstream non-intubated sampling line/Filter Line family is intended to conduct CO2 from the patient's breath to a gas measurement device (Capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation (when connected to an O2 source). The proposed devices are a modification of their predicates' material compounds (not made with DEHP or PHT materials), a change of dryer location to off the patient's face, and the integration of softer face-contacting tubes, mainly to enhance patient comfort, increase flexibility and reduce smell. The proposed devices are sampling lines which are intended to be used with Capnograph monitors using Microstream technology. These sampling lines incorporate a luer connector with a recognition system: - Microstream™ Advance Neonatal-Infant Nasal Filter Line with O2 Tubing . - . Microstream™ Advance Pediatric Oral-Nasal Filter Line with O2 Tubing - Microstream™ Advance Adult Oral-Nasal Filter Line with O2 Tubing . In addition, this sampling line which is intended to be used with any Capnograph monitor is proposed: - Microstream™ Luer Adult Oral-Nasal Sampling Line .

Intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a gas measurement device for measuring the percentage of CO2 in the patient's exhaled breath. The set is intended for single patient use only. Intended population: Intubated Adult- Pediatric patients.

Similar to their predicates the devices are non-sterile, disposable, single patient use, intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a device for measuring the percentage of CO2 in the patient's exhalation when connected to a capnograph. The device's main components are PVC tubing, airway adapter and a luer connector. Microstream™ Advance Adult-Pediatric Intubated Filter Line can be used only with Microstream™ capnography technology. Microstream™ Luer Adult-Pediatric Intubated Sampling Line can be used with any capnograph with a luer connection. An Accessory (extension line) to the proposed devices: Microstream™ Advance Filter Line, MRI is composed of PVC tubing and a luer connector. It is Intended to be used when longer tubing is required to allow CO2 sampling for environments such as an MRI suite. The straight tubing is then connected to the FilterLine/ Sampling Line end from one side and from the other side to the monitor, which is placed outside of MRI suite. The main reason for this submission is the modification of the CO2 tubing to material not made with phthalates.

The Capnostream™35 is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused. The Capnostream™35 also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up. The device is intended for use in hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 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 microMediCO2 module provides the following inputs to the host monitor: EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI). The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2 and Pulse Rate parameters to the host for display. The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI. The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph. The device is intended for use in hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.

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 non-invasive monitoring of functional oxygen saturation of arterial hemoqlobin (SpO2) and pulse rate. It is also indicated for continuous noninvasive 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. Capnostream®20p is to be operated by qualified healthcare personnel only. 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 HiFi mode provides a measurement of expired carbon dioxide and detects spontaneous breaths for infant/neonatal patients ventilated using high frequency oscillatory ventilation (HFOV).

The Capnostream20p bedside monitor is a two parameter monitor consisting of a microMediCO2 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 HiFi capnography software feature, presented in this submission, is intended to enable measurement of airway CO2 for infant/neonatal patients during high frequency oscillatory ventilation (HFOV) and detects spontaneous breaths for infant/neonatal patients ventilated using high frequency oscillatory ventilation (HFOV).

The Carinal VitaLine™ Set sampling line is intended to provide for CO2 measurement of intubated neonates and infants with a Microstream monitor. It enables either standard sampling via the airway adapter and main lumen of an endotracheal tube or sampling from the carina via the monitoring lumen of the same tube. The set is intended for single patient use only.

The Carinal VitaLine Set comprises Microstream FilterLine ICU that is modified to enable the clinician to select between central monitoring from the trachea above the carina via the monitoring lumen of the ETT and traditional monitoring with a CO2 sampling airway adapter. The following components are included in the Carinal VitaLine Set: - sampling line . - airway adapter with tube and luer connected. . The Carinal VitaLine Set is designed for use with an infant neonatal size uncuffed endotracheal tube equipped with a monitoring lumen. The endotracheal tube must be supplied by the end user and is not provided by Oridion as part of the Carinal VitaLine. The tubing leading to the CO2 monitor includes two dryer sections to support use in high humidity environments and prevent rapid occlusion of the tubing.

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 non-invasive 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 hospitals, hospitals, 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 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 microMediCO2 module provides the following inputs to the host monitor: FiCO2. EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI (Integrated Pulmonary Index), Continuous CO2 numeric and waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI). The SpO2 module, integrated in the Capnostream20p 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 (%SpCO), SpMet: methemoglobin saturation in blood (%SpMet), SpHb: total hemoglobin concentration in blood (g/dl SpHb). The SpO2 measurements are also provided to the microMediCO2 module enabling the calculation of the IPI and the ODI. 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 Apnea per Hour (A/hr) is defined as the number of cessations of breathing of 10 seconds or more that have occurred per hour. The Oxygen Desaturation Index (ODI) is the number of desaturation events of 4% or more with a return to baseline within 240 seconds or less identified with pulse oximetry (following the AASM definitions)1. The values are updated once a minute. The Smart A/hr & ODI™ feature presented in this submission is intended only for adult patients (age 22 and up) in hospital ICU and general floor environments. whilst the patient is being monitored using capnography and pulse oximetry as part of his medical care. The feature is not available for pediatric, infant and neonatal patients.

The Smart CapnoLine Guardian™ is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 60 fr. bite block, during upper endoscopy type procedures. The set is intended for single patient use only.

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The proposed device, Smart BiteBloc™, will be used during endoscopy procedures that require a bite block that enables and supports the convenient use of, and will not interfere with, an oral nasal cannula (K011536) for collecting samples of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose for inhalation. It can be used for non intubated patients who weigh more than 55 lbs (25 kg).

Bite blocks indicated for use as an endoscopy accessory are usually classified, according to 21CFR876.1500, as exempt from pre market notification. The submitted endoscopy accessory, Smart BiteBloc™, has been modified to allow the convenient use of an oral nasal cannula (K011536) for sampling of EtCO2 and administration of O2 during endoscopic procedures. Oridion considers this device to be a capnography accessory.

The MicroCap Plus /NPB-75 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 of arterial oxygen saturation (SpO2) and pulse rate.

The Oridion MicroCap Plus/NPB-75 (the device being modified) (K964239) is an integrated instrument that measures end tidal CO2 (EtCO2) and saturated arterial oxygen (SpO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR) and as a derivative of the saturated arterial oxygen measurement the devices measure and display the pulse rate (PR). The capnograph section of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status. The pulse oximeter module in both devices measures the oxygenated hemoglobin (HbO>) and displays the results as a percent of oxygen and as a plethysmographic waveform.