(372 days)
The CoSense ETCO Monitor is indicated for the monitoring of carbon monoxide from endogenous sources (including hemolysis) and exogenous sources (including CO poisoning and smoke inhalation) in exhaled breath. The end tidal carbon monoxide level can be used for the monitoring of carbon monoxide in medical conditions in which the rate of hemolysis may be relevant. It is also for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation.
The CoSense ETCO Monitor is a battery-operated carbon monoxide (CO) monitor. It uses an infrared capnometer to detect the end-tidal portion of the breath and an electrochemical carbon monoxide sensor to measure the end-tidal breath CO concentration. The device consists of a portable unit with software controlled menu (date, time, patient identification, measurement time of monitoring), single-use nasal cannula, replaceable CO Sensor, and a battery charger/power supply.
The CoSense ETCO Monitor is a carbon monoxide (CO) monitor that uses an infrared capnometer to detect the end-tidal portion of the breath and an electrochemical carbon monoxide sensor to measure the end-tidal breath CO concentration.
Here's an analysis of its acceptance criteria and the study that proves it:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device K121768) | Reported Device Performance (Subject Device K130036) | Reference Predicate (K974805) |
|---|---|---|---|
| Accuracy | +/- 10% or +/-0.5ppm, whichever is greater | +/- 10% or +/-0.5ppm, whichever is greater | +/- 10% or +/-0.3ppm (whichever is greater) at 8-60 bpm |
| CO Measurement Range | 1.0 - 25.0ppm | 1.0 - 25.0ppm | 0-25 ppm |
| Resolution | 0.1 ppm | 0.1 ppm | 0.1 ppm |
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly reported as a human test set. The submission relies on the identical performance specifications of its predicate device, K121768, and a clinical data analysis of published studies on other FDA-cleared CO monitoring devices.
- Data Provenance: The study performed an "analysis of published clinical data" on "uses of other FDA-cleared CO monitoring devices." This suggests the data is retrospective and collected from existing literature and studies, likely covering various clinical sites and geographical locations if the published data is diverse. No specific country of origin is mentioned for this retrospective analysis.
3. Number of Experts and Qualifications:
- Not applicable for establishing ground truth for a test set, as the study relied on an analysis of published clinical data on other devices and the identical performance specifications to a predicate device. The performance specifications themselves would have been established through engineering and laboratory testing, rather than expert interpretation of a specific test set.
4. Adjudication Method:
- Not applicable as the study did not involve a human-in-the-loop test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The submission does not describe an MRMC comparative effectiveness study for the subject device. It focuses on demonstrating equivalence to predicate devices and analyzing existing published clinical data.
6. Standalone Performance:
- Yes. The device's performance specifications (accuracy, range, resolution) are presented as "identical" to its predicate (Capnia CoSense CO Monitor K121768) and "similar" to a reference predicate (Natus CO-STAT End Tidal Breath Analyzer K974805), indicating a standalone assessment of the device's technical specifications. The submission states, "The CoSense ETCO Monitor uses the identical performance specifications (accuracy, range, and resolution), software algorithms, sensors, and accessories as our predicate device, the CoSense CO Monitor."
7. Type of Ground Truth Used:
- The ground truth for the performance specifications (accuracy, range, resolution) are established through objective measurements against known standards, typical for medical device engineering and testing.
- For the "analysis of published clinical data," the "ground truth" would be the clinical outcomes and CO measurements reported in those studies, which are assumed to be established by the methodologies used in the respective published research. The submission states this analysis provides "objective evidence that the functional and performance specifications of CoSense device are similar to the devices in the published studies."
8. Sample Size for the Training Set:
- Not applicable. This device is primarily hardware with established performance specifications. The "software algorithms" are stated to be "identical" to the predicate, implying they were developed and "trained" (if machine learning was involved, which is unlikely for this type of device based on the description) during the development of the predicate device. No details are provided on a specific training set for the subject device.
9. How Ground Truth for the Training Set Was Established:
- Not applicable, as no training set for the subject device is described. The ground truth for the underlying performance of the electrochemical sensor and capnometer would have been established through precise laboratory calibration and gas measurement standards.
§ 868.1430 Carbon monoxide gas analyzer.
(a)
Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.(b)
Classification. Class II (performance standards).