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510(k) Data Aggregation
(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 < 1 year. | "A clinical evaluation was performed to ensure that the modified device meets user requirements. A safety and effectiveness evaluation was performed to demonstrate that the IPI identified all instances in which clinical intervention was required and alerted the practitioner to these changes." "The IPI is an adjunct to, and is not intended to replace, vital sign monitoring." "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." |
| Intended Use | Meets the same intended use as the predicate device, with the addition of the IPI functionality as a single index of ventilatory status for adults and pediatric patients. | "The functional features and the intended use of Capnostream 20 with IPI are substantially equivalent to the predicate device." (Indications for use explicitly state the added IPI functionality and target population). |
| Hazard Analysis | Residual risks are acceptable when weighed against benefits. | "A hazard analysis was carried out on the module with the IPI functionality and on the Capnostream 20 host monitor displaying the IPI values. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the system." |
| Design | Identical to predicate device except for specified software changes. | "Identical to the Capnostream 20 described in K072295 with the exception of the software changes in both the EtCO2 module and host monitor described in this submission." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided document. The document mentions "software testing" and "clinical evaluation" but does not give specific numbers for test cases, patients, or data points.
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. "Clinical evaluation" implies human subject data, but details are missing.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The document refers to the IPI being intended for "professionally trained health care providers" and that the clinical evaluation was performed "to ensure that the modified device meets user requirements" and identified "instances in which clinical intervention was required." This implies clinical experts were involved, but their specific roles, number, or qualifications are not detailed.
4. Adjudication Method
- Adjudication Method: Not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not explicitly stated. The document mentions a "clinical evaluation" and a "safety and effectiveness evaluation" that demonstrated the IPI's ability to alert clinicians and identify intervention needs. However, it does not describe a comparative study measuring human reader improvement with or without AI assistance. The IPI is presented as an adjunct to vital sign monitoring.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: The description of the clinical evaluation implies that the IPI (an algorithmically derived value) was evaluated for its ability to identify intervention needs and alert practitioners. While not explicitly called "standalone performance," the IPI itself is an algorithm-generated index displayed on the monitor. The evaluation of this index's clinical utility could be considered a form of standalone performance assessment in the context of its intended use as an alert system.
7. Type of Ground Truth Used
- Type of Ground Truth: The "safety and effectiveness evaluation" aimed "to demonstrate that the IPI identified all instances in which clinical intervention was required and alerted the practitioner to these changes." This suggests that the ground truth was based on clinical assessment and the need for intervention as determined by medical observation (likely expert consensus or established clinical protocols, though not specified).
8. Sample Size for the Training Set
- Training Set Sample Size: Not explicitly stated. (This document is a 510(k) summary for a device iteration, not a detailed algorithm development paper. Information on training data for the IPI algorithm would likely be in internal development documents, not typically disclosed in this summary.)
9. How Ground Truth for Training Set was Established
- Ground Truth Establishment for Training Set: Not explicitly stated. Given the IPI is an "Integrated Pulmonary Index" based on four physiological parameters (end tidal CO2, respiration rate, SpO2, and pulse rate) to represent "ventilatory status" and trigger alerts for "changes in the patient's pulmonary status," its development likely involved expert knowledge and potentially retrospective data analysis to correlate these parameters with specific clinical states or interventions. However, the document does not provide these details.
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