(337 days)
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 provided text is a 510(k) Summary for a medical device (Capnostream20p with Smart A/hr & ODI™). It states that the device is substantially equivalent to a predicate device (Capnostream20p). However, it does not contain the specific details of a study that proves the device meets acceptance criteria.
The document states:
- "Software testing was performed to validate the performance of the new monitor and its substantial equivalence to the predicate device."
- "A hazard analysis was carried out on the Capnostream host monitor displaying the A/hr and ODI values. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the system."
These statements imply that testing was done, but the summary does not provide any quantitative acceptance criteria, reported performance values, sample sizes, data provenance, ground truth details, expert qualifications, adjudication methods, or effects of AI assistance.
Therefore, I cannot fulfill your request for the tables and detailed study information as the necessary data is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing a de novo study with specific performance metrics against pre-defined acceptance criteria.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).