(319 days)
For monitoring of carbon monoxide in adult exhaled breath. They are in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. Also can be used for ambient air monitoring. For use by healthcare professionals only in professional healthcare facilities.
The Carbon monoxide monitors (CO Check Pro & CO Screen) are hand held, battery powered, carbon monoxide analyzers, used for monitoring the concentration of carbon monoxide in adult exhaled breath, typically for use in smoking cessation programs and for the screening of CO poisoning.
The devices are controlled via a two button kevpad with the measured parameters displayed on a simple LCD with coloured lights and an accompanying buzzer sound in response to the CO level.
Electrochemical sensor technology is utilized to sample the gas and a microprocessor converts the output from the sensor into a meaningful displayed result, either as carbon monoxide in parts per million (CO) or the percentage of carboxyhaemoglobin in the blood (%COHb).
The breath sampling system that attaches directly to the carbon monoxide monitors, comprises of a non-patient contacting mouthpiece adapter incorporating a one way valve to prevent cross contamination and a single use, patient contacting cardboard mouthpiece. The mouthpiece adapter maybe replaced or reused as required.
The Carbon monoxide monitors are supplied non sterile for use by healthcare professionals only and can also be used for ambient air monitoring.
Here's a breakdown of the acceptance criteria and study information for the Carbon Monoxide monitors (CO Check Pro & CO Screen) as described in the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Device | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| CO Measurement Range | CO Check Pro | 0 to 99 ppm | 0 to 99 ppm |
| CO Measurement Range | CO Screen | 0 to 375 ppm | 0 to 375 ppm |
| Accuracy (Gas Performance Testing) | CO Check Pro | +/- 2ppm or 5%, whichever is greater | Within +/- 2ppm for each measurement point (20ppm, 50ppm, 100ppm, 375ppm – CO Screen only) |
| Accuracy (Gas Performance Testing) | CO Screen | +/- 3% | Within +/- 2ppm for each measurement point (20ppm, 50ppm, 100ppm, 375ppm – CO Screen only) |
| Operating Temperature Range | Both devices | Device operates successfully across the environment operating temperature range | Device operates successfully across the environment operating temperature range |
| Robustness (Packaging Testing) | Both devices | Device housing demonstrates robustness via drop tests and functions as intended thereafter | Device housing demonstrates robustness via drop tests and functions as intended thereafter |
Note: The reported device performance for accuracy is stated as "within +/- 2ppm for each measurement point" for both devices, even though the CO Screen has an acceptance criterion of +/-3%. This implies that the CO Screen also met the stricter +/-2ppm criteria during testing.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the test set used in the performance testing.
The data provenance is retrospective, as it refers to performance testing conducted by the manufacturer to support the 510(k) submission. The country of origin for the data is not explicitly stated for the performance testing itself, but the manufacturer is based in the United Kingdom.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in this context. The "ground truth" for the performance testing was established using known calibrated gases rather than expert interpretation of patient data.
4. Adjudication Method for the Test Set:
This information is not applicable. The ground truth was based on objective measurements from calibrated gases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data. This device is a direct measurement instrument, not an AI interpretation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance evaluation was done. The performance testing described (gas performance testing, temperature testing, packaging testing) assesses the device's accuracy and functionality independently of human interaction for interpretation purposes. The device directly measures CO levels.
7. The Type of Ground Truth Used:
The type of ground truth used was objective measurements from known calibrated gases for assessing accuracy. For temperature and packaging testing, the ground truth was the expected functional performance under specific environmental and physical stress conditions.
8. The Sample Size for the Training Set:
This information is not applicable. This device is a hardware-based carbon monoxide monitor using electrochemical sensor technology and a microprocessor for conversion. It is not an AI/machine learning algorithm that requires a "training set" in the traditional sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" for this type of device. The device's operation is based on its sensor and programmed algorithms, not on learning from a dataset.
§ 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).