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510(k) Data Aggregation
(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: <30 seconds | <30 seconds | Device Description |
| Interfering gas testing: Yes | Yes | Bench Testing |
| Patient interface: Breath Port Mouthpiece | Breath Port Mouthpiece | Device Description |
| Contraindications: None | None | Device Description |
| Performance Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Meets IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Electrical Safety, EMC, EMI Testing, Bench Testing |
| Ingress Protection: IXP0 | IXP0 | Device Description |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for any clinical test set related to the device's accuracy or overall performance with human subjects. The usability/human factors study mentions a "lay user group" but does not give a specific number.
The data provenance is for nonclinical tests. The submission is from Bedfont Scientific Ltd, located in Harrietsham, Maidstone, Kent, ME17 1JA, United Kingdom. Therefore, the nonclinical testing would have been conducted in the UK or a location specified by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies mentioned (Biocompatibility, Electrical Safety, Software, Bench Testing, Usability/Human Factors) are primarily focused on technical specifications and user interaction with the device, not on clinical accuracy requiring expert-established ground truth for breath CO levels.
4. Adjudication method for the test set
This information is not applicable/not provided. The studies described do not involve ambiguous clinical findings that would require an adjudication method among experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) study. The device is a direct measurement tool, not an AI-assisted diagnostic device that would involve human readers interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone sensor that provides a direct measurement of CO. The "iCOquit® App" displays the reading, calculates %COHb, and asks Fagerstrom questions. The bench testing and software verification/validation would represent the "standalone" performance of the hardware and software without human input during the measurement process, beyond providing the breath sample. The document confirms the device performs "as intended" in these tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance aspects (e.g., measurement range, accuracy, cross-sensitivity), the ground truth would typically be established by controlled gas mixtures or calibrated reference instruments during bench testing. For biocompatibility, it's based on recognized standards (ISO 10993-1). For electrical safety and EMC, it's based on compliance with standards (ES60601-1, IEC 60601-1-2, IEC 60601-1-11). For software, it's based on verification and validation against specifications.
8. The sample size for the training set
This information is not provided as the device does not appear to utilize machine learning models that require a separate training set. Its core function relies on an electrochemical sensor.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is mentioned.
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