(183 days)
The iCOquit® Smokelyzer® breath carbon monoxide (CO) monitor is intended for single patient use by cigarette smoking individuals, notifying the individual user of the amount of CO on their breath produced as a consequence of smoking activity. The device can be used in smoking cessation programmes.
The iCOquit® Smokerlyzer® device is a hand-held breath monitor for the detection of Carbon Monoxide (CO) on the breath, using a non-invasive method of breath analysis to detect levels of Carbon Monoxide (CO). The iCOquit® Smokerlyzer® device works in conjunction with the iCOquit® App developed for smartphone or tablet, which the user pairs to the device via Bluetooth. The iCOquit® App works in conjunction with the iCOquit® Smokerlyzer® personal stop-smoking tool to provide visual motivation to help the user quit as track their quitting progress in real-time. The iCOquit® Smokerlyzer® is an over-the-counter, hand-held breath monitor. It is not for use with other inhaled products. Using an electrochemical sensor designed to react specifically to carbon monoxide producing an electrical output, the sensor measures the level of carbon monoxide (CO) on the breath. The output is then amplified into a meaningful result by the device. The result is sent to the iCOquit® App wirelessly, allowing the meaningful result to be displayed on the user's smartphone or tablet. The App displays the reading received from the iCOquit® Smokerlyzer® on the smartphone or tablet paired with the device and based on the questions the user answers within the App relating to their smoking habits and the CO reading, they will then receive a result from the Fagerstrom Test of Nicotine Dependence. The sample method for the iCOquit® Smokerlyzer® channels the breath sample exhaled by the user into an integrated breath port on the device. This passes directly over the sensor during the test, ensuring the sensor is exposed to the gas sample for the required length of time to give an accurate reading. The user is required to hold their breath for a 15 second countdown. This is displayed via the iCOquit® App and guides the user through the process of providing a breath sample for measurement. At the end of the breath hold, the patient shall blow gently but fully into the iCOquit, exhaling as much of the breath in their lungs as possible. The reading shown on the App is the peak reading. Once a breath test has been completed the user will be navigated to a screen where they will see their CO result in PPM (parts per million) and %COHb (Carboxyhemoglobin). The reading shown on the App is the peak reading. Users are then asked Fagerstrom questions to determine their smoking status of either low, moderate or high and the result is then saved in a graph. The level of CO measured in PPM is also calculated as %COHB and displayed in the App.
The provided text describes the iCOquit® Smokerlyzer® device and its comparison to a predicate device. Here's a breakdown of the acceptance criteria and the study details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from Subject Device) | Reported Device Performance (iCOquit® Smokerlyzer®) | Related Study/Assessment |
|---|---|---|
| Measurement Range: 0 – 100 PPM | 0 – 100 PPM (parts per million) | Bench Testing |
| Accuracy: ±≤3PPM / ±≤10% of reading* | ±≤3PPM / ±≤10% of reading* (whichever is greater) | Bench Testing |
| H2 Cross Sensitivity: ≤6% | ≤6% | Bench Testing |
| Power Source: Lithium battery | Lithium battery (Lithium-ion coin cell) | Device Description |
| Battery Life: 12 months | 12 months | Device Description |
| Operating Temperature: 15°-35° Celsius | 15°-35° Celsius (59°-95° Fahrenheit) | Device Description |
| Operating Humidity range: 10-90% RH non-condensing | 10-90% RH non-condensing | Device Description |
| Type of Use: Over the counter | Over the counter | Indication for Use |
| Sensor Technology: Electrochemical Sensor | Electrochemical Sensor | Device Description |
| Sensor Life: 500 breath tests/12 months | 500 breath tests/12 months (Whichever occurs first) | Device Description |
| Connectivity: Bluetooth | Bluetooth | Device Description |
| Breath Hold: 15 seconds | 15 seconds | Device Description |
| Analysis Time: |
§ 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).