(179 days)
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 provided text describes a 510(k) summary for the Capnostream 20 with Integrated Pulmonary Index (IPI) software. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report as would be found in a comprehensive clinical trial publication.
Based on the provided document, here's an attempt to extract the requested information. It's important to note that many specific details about how the acceptance criteria were met (like sample sizes for specific tests, expert qualifications, or detailed ground truth establishment methods) are not explicitly stated in this type of summary document. The document primarily focuses on asserting that these studies were performed and that the device met the requirements.
Acceptance Criteria and Device Performance for Capnostream 20 with Integrated Pulmonary Index (IPI)
The Capnostream 20 with IPI is primarily compared to its predicate device, the Capnostream 20 (miniMediCO2 software version 2.31), to demonstrate substantial equivalence. The acceptance criteria are implicitly those of safety and performance equivalent to the predicate device, with specific attention to the new IPI functionality.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Equivalent to the predicate device, raising no new potential safety risks. | "Capnostream 20 with the IPI functionality does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed device. Therefore, the device is substantially equivalent to the predicate device with respect to safety, effectiveness, and intended use." "A hazard analysis was carried out... concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the system." |
| Software Validation | New software performs as intended and is substantially equivalent to the predicate device's software. | "Software testing was performed to validate the performance of the new software and its substantial equivalence to the predicate device." |
| Clinical Performance (IPI) | IPI meets user requirements; identifies all instances requiring clinical intervention and alerts practitioners to changes in pulmonary status, and is an effective adjunct to vital sign monitoring (not a replacement). Not for use in children |
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).