EC50 MICRO+ SMOKERLYZER
Device Facts
| Record ID | K082315 |
|---|---|
| Device Name | EC50 MICRO+ SMOKERLYZER |
| Applicant | Bedfont Scientific, Ltd. |
| Product Code | CCJ · Anesthesiology |
| Decision Date | Feb 1, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1430 |
| Device Class | Class 2 |
Intended Use
The Micro+ Smokerlyzer is a Breath Carbon Monoxide Monitor intended for multi-patient use by healthcare professionals in smoking cessation programs and as an indicator of Carbon Monoxide poisoning in healthcare environments.
Device Story
Hand-held, battery-powered electrochemical CO monitor; samples exhaled breath via D-piece with integrated bacterial/viral filter and one-way valve. Patient performs 15-second breath-hold followed by full exhalation into device. Electrochemical sensor generates current proportional to CO concentration; microprocessor converts current to ppm CO and calculates %COHb using formula %COHb = 0.63 + 0.16(ppm). Results displayed on color LCD; device includes audible buzzer. Used in clinical settings by healthcare professionals; data downloadable via USB. Provides objective CO measurement to assist in smoking cessation monitoring and CO poisoning assessment. Benefits include rapid, non-invasive CO level screening.
Clinical Evidence
Bench testing and point-of-care clinical study performed. Accuracy evaluated at 3 clinical sites (N=35, 57, 29) comparing Micro+ to predicate; results showed high correlation (r=0.98-1.15). Precision assessed at 5 temperatures (0-40°C) and 5 CO concentrations (0-251 ppm); CV% ranged from 0.35% to 2.98%. Linearity recovery 94-103%. Cross-reactivity tested for H2S, SO2, NO2, H2, NO, and ethylene; potential interference noted for NO and ethylene.
Technological Characteristics
Electrochemical sensor; battery-powered (4.5V, 3x AA/LR6). Housing: Polycarbonate/ABS blend with elastomeric over-mould. D-piece: Polypropylene. Connectivity: USB for data download. Calibration: User-calibrated, recommended every 6 months. Software: Microprocessor-based signal processing.
Indications for Use
Indicated for use by healthcare professionals in smoking cessation programs and as an indicator of carbon monoxide poisoning in patients within healthcare environments.
Regulatory Classification
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.
Predicate Devices
- Bedfont Scientific Smokerlyzer (k892841)
Related Devices
- K171129 — CO Check Pro, CO Screen · MD Diagnostics Limited · Mar 2, 2018
- K173238 — ToxCO · Bedfont Scientific, Ltd. · Apr 4, 2019
- K080278 — TABATABA COTESTER · Fim Medical · Nov 28, 2008
- K121768 — COSENSE · Capnia, Inc. · Oct 31, 2012
- K151107 — CoSense ETCO Monitor · Capnia, Inc. · Jul 22, 2015
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE
A. 510(k) Number:
k082315
B. Purpose for Submission:
New device
C. Manufacturer and Instrument Name:
Bedfont Scientific Ltd. Micro+ Smokerlyzer and CO data+ application
D. Type of Test or Tests Performed:
Quantitative (electrochemical sensor)
E. System Descriptions:
1. Device Description:
The Micro+ Smokerlyzer is a hand-held, battery powered instrument which uses electrochemical technology to sample the gas and a microprocessor to convert the output from the sensor to a carbon monoxide (CO) concentration. The result and menus are displayed on a color LCD and an accompanying buzzer sounds in response to the CO level. The instrument is controlled using a touch screen operation and has a USB link to a computer to download readings.
The Micro+ uses a breath sampling D-Piece with integrated bacterial and viral filter and a one-way valve designed to maximize infection control. Each patient uses a fresh cardboard mouthpiece for each breath sample. The D-Piece may be reused or replaced as required.
The patient is asked to hold their breath for a 15 second countdown. This is displayed on the screen of the device. At the end of the breath hold, the patient blows gently into the Micro+ expiring as much of the breath in their lungs as possible. The reading on the device shall rise until the peak reading is held on the display.
2. Principles of Operation:
The Micro+ incorporates a sampling method that channels the gas sample directly over the sensor during the test. This ensures that the electrochemical sensor is exposed to the gas sample for the required length of time to give an accurate reading. The
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electrochemical sensor is designed to react to the presence of carbon monoxide and produces an output current proportional to the level of CO. This is then read by the microprocessor and converted to display the equivalent ppm (parts per million) level in the patient's breath. The level of CO in ppm is converted to %COHb and also displayed on the screen. This formula is: %COHb = 0.63 + 0.16(ppm reading)¹.
¹Low cost carbon monoxide monitors in smoking assessment by M j Jarvis, M Belcher, C Vesey, D C S Hutchinson, Thorax 1986; 41: 886-887.
3. Modes of Operation:
This device has only one mode of operation.
4. Specimen Identification:
There is no mechanism to identify the specimen.
5. Specimen Sampling and Handling:
The user provides a breath sample by exhaling into the device.
6. Calibration:
The sponsor recommends a recalibration interval of every six months. These intervals are based on calibration stability data collected internally. The unit can be calibrated by the user and instructions are given in the labeling on how to calibrate the device.
7. Quality Control:
An external quality control canister at 20 ppm CO, which serves as the high level control, is included with the device. A low level control can be tested by sampling breath from a non-smoker. The expected non-smoker range is within the 0 to 3 ppm. The sponsor recommends that the controls be tested prior to each patient measurement and provides acceptable ranges in the labeling.
8. Software:
FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:
Yes ☐ X ☐ or No ☐
F. Regulatory Information:
1. Regulation section:
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21 CFR 868.1430, Carbon monoxide gas analyzer
21 CFR 862.3200, Clinical toxicology calibrator
21 CFR 862.3280, Clinical toxicology control material
2. Classification:
Class II
Class II
Class I
3. Product code:
CCJ, analyzer, gas, carbon-monoxide, gaseous-phase
DLJ, calibrators, drug specific
LAS, drug specific control materials
4. Panel:
Anesthesiology (73) and clinical chemistry (75)
G. Intended Use:
1. Indication(s) for Use:
The Micro+ Smokerlyzer is a Breath Carbon Monoxide Monitor intended for multi-patient use by healthcare professionals in smoking cessation programs and as an indicator of Carbon Monoxide poisoning in healthcare environments.
2. Special Conditions for Use Statement(s):
For prescription use.
H. Substantial Equivalence Information:
1. Predicate Device Name(s) and 510(k) numbers:
Bedfont Scientific Smokerlyzer
k892841
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2. Comparison with Predicate Device:
| Similarities | | |
| --- | --- | --- |
| Item | EC50 Micro+ Smokerlyzer (new device) | EC50 Smokerlyzer (predicate) |
| Intended Use | The Micro+ Smokerlyzer is a breath carbon monoxide monitor intended for multi-patient use by healthcare professionals in smoking cessation programs and as an indicator of carbon monoxide poisoning, within a healthcare environment. | The Micro 4 Smokerlyzer is a breath carbon monoxide monitor intended for multi-patient use by healthcare professionals in smoking cessation programs and as an indicator of carbon monoxide poisoning, within a healthcare environment. |
| Indications for Use | Carbon monoxide in parts per million (ppm) and % Carboxyhemoglobin (%COHb) Breath-hold countdown | Carbon monoxide in parts per million (ppm) and % Carboxyhemoglobin (%COHb). Breath-hold countdown |
| Where used | Healthcare environments | Healthcare environments |
| Energy used | Battery powered 4.5V, 3 x AA/LR6 type | Battery powered 9V, PP3 type |
| Design | • Hand-held battery powered
• Visual and audible alarms
• Single use cardboard mouthpiece | • Hand-held battery powered
• Visual and audible alarms
• Single use cardboard mouthpiece |
| Human Factors | Hand-held with instructions on the LCD
Patient interface through a cardboard mouthpiece and sample system | Hand-held with instructions on the LCD
Patient interface through a cardboard mouthpiece and sample system |
| Differences | | |
| --- | --- | --- |
| Item | EC50 Micro+ Smokerlyzer (new device) | EC50 Smokerlyzer (predicate) |
| Energy used | Battery powered 4.5V, 3 x AA/LR6 type | Battery powered 9V, PP3 type |
| Design | • Colour graphic LCD
• Touch-screen interface
• Side-stream breath sample using D-piece | • Alphanumeric LCD
• Mechanical buttons and switches
• Side-stream breath sample using T-piece |
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| Differences | | |
| --- | --- | --- |
| Item | EC50 Micro+ Smokerlyzer (new device) | EC50 Smokerlyzer (predicate) |
| Materials | Product: Polycarbonate/ABS blend with elastomeric over-mould D-piece sample system: Polypropylene | Product: ABS T-piece sample system: Polypropylene |
I. Special Control/Guidance Document Referenced (if applicable):
1. BS EN ISO 60601-1:1990 Electrical Safety for General Electrical Safety Standard
2. BS EN ISO 60601-1-2:2007 Electromagnetic Compatibility (requirements and testing)
3. ISO 10993-1:2003 Biological Evaluation of Medical Devices
J. Performance Characteristics:
1. Analytical Performance:
a. Accuracy:
The sponsor performed a point of care study to test the Micro+ in its intended use settings. The device was evaluated in 3 locations where the device is intended to be used against the predicate device, the EC50 Micro Smokerlyzer (k892841) and was completed by a healthcare professional trained in smoking cessation. Results are summarized in the table below.
| Site | 1 | 2 | 3 |
| --- | --- | --- | --- |
| Slope | 0.9068 | 0.9692 | 0.9050 |
| y-intercept | 1.0111 | 0.0645 | 0.1948 |
| Corr Coeff | 1.1577 | 0.9837 | 0.9842 |
| N | 35 | 57 | 29 |
| Range of samples tested | 0 – 24 ppm | 0 – 34 ppm | 0 – 26 ppm |
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For all measurements, the maximum deviation between the new device and the predicate is $\pm 3$ ppm.
# b. Precision/Reproducibility:
The sponsor assessed device precision by analyzing CO gas at five concentrations and five temperatures. There were 15 measurements at each combination of temperature and CO concentration. Results are summarized in the table below.
| Temperature | Reference Concentration | Standard deviation | Mean | CV (%) |
| --- | --- | --- | --- | --- |
| 0 | 0 | 0.0000 | 0.0000 | 0.0000 |
| | 20 | 0.5606 | 18.8000 | 2.9820 |
| | 50 | 0.6399 | 48.4667 | 1.3204 |
| | 102 | 1.1212 | 100.6000 | 1.1145 |
| | 251 | 1.3345 | 248.9333 | 0.5361 |
| 40 | 0 | 0.0000 | 0.0000 | 0.0000 |
| | 20 | 0.4577 | 20.0667 | 2.2811 |
| | 50 | 0.6325 | 51.6000 | 1.2257 |
| | 102 | 1.2799 | 102.7333 | 1.2458 |
| | 251 | 0.0000 | 250.0000 | 0.0000 |
| 10 | 0 | 0.0000 | 0.0000 | 0.0000 |
| | 20 | 0.2582 | 19.0667 | 1.3542 |
| | 50 | 0.9155 | 50.1333 | 1.8261 |
| | 102 | 0.7237 | 100.6667 | 0.7190 |
| | 251 | 0.8837 | 249.0667 | 0.3548 |
| 30 | 0 | 0.0000 | 0.0000 | 0.0000 |
| | 20 | 0.3519 | 20.1333 | 1.7477 |
| | 50 | 0.5071 | 51.4000 | 0.9866 |
| | 102 | 0.7746 | 103.2000 | 0.7506 |
| | 251 | 0.0000 | 250.0000 | 0.0000 |
| 20 | 0 | 0.0000 | 0.0000 | 0.0000 |
| | 20 | 0.4577 | 20.0667 | 2.2811 |
| | 50 | 1.2799 | 50.0667 | 2.5564 |
| | 102 | 0.9612 | 100.9333 | 0.9523 |
| | 251 | 1.0328 | 249.2667 | 0.4143 |
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c. Linearity:
This device will report concentrations from 0 to 250 ppm. The measuring range was evaluated in section J.1.a and J.1.b above. Recovery ranged from 94% to 103% across the range.
d. Carryover:
Carryover was not specifically evaluated for this device; however, users are instructed to use a different mouthpiece for each measurement so that fresh air can purge the sensor between measurements.
e. Interfering Substances:
The design of the sensor causes a cross-sensitivity to several gases. The table below shows the response of the sensor when exposed to a given test gas concentration.
| Gas | Concentration | Reading Variation |
| --- | --- | --- |
| Hydrogen Sulfide | 15 ppm | ±0.5 ppm |
| Sulphur Dioxide | 5 ppm | 0 ppm |
| Nitrogen Dioxide | 5 ppm | <0.5 ppm |
| Hydrogen | 100 ppm | ±5 ppm |
| Nitric Oxide | 35 ppm | 12 ppm |
| Ethylene | 100 ppm | 60 ppm |
These gases have the potential to affect the CO result. The sponsor notes in the labeling that gastrointestinal conditions could cause the presence of hydrogen and cross-react with the sensor. The sponsor also notes nitric oxide and ethylene as cross-reactants in the labeling.
2. Other Supportive Instrument Performance Data Not Covered Above:
a. Limit of Detection:
In I. b. above a value of 0 was obtained for each of 5 different temperatures when no CO was present in the sample.
b. Temperature:
Precision data was collected and analyzed at five different temperatures. Please see section J.1.b above. The user manual states that temperature may have an effect on the results and it is recommended that the unit is calibrated at the temperature at
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which it is to be used. The device is calibrated at $21^{\mathrm{o}} \pm 4^{\mathrm{o}}$ C when supplied to customers.
c. Cutoff:
The device is intended use in healthcare environments for smoking cessation programs and as an indicator of Carbon Monoxide. As there is no agreed upon cutoff for what constitutes a smoker nor a claim of what level of $\% \mathrm{COHb}$ is an indicator of CO poisoning, the sponsor provides the following in the labeling as a guide to the levels of Carboxyhemoglobin and what the level may indicate in a patient.
| COHb² | Symptom |
| --- | --- |
| 0.5-1% | Normal |
| Up to 5% | May be found in cigarette smokers |
| Up to 10% | May cause worsening of angina or respiratory symptoms |
| Up to 20% | May cause mild symptoms |
| 20 – 30% | Usually causes marked symptoms |
| Over 30% | May cause severe symptoms |
| Over 40 – 50% | May be fatal |
²From Practice Nursing 1994, Vol5, No 18 Carbon Monoxide Poisoning by John Henry.
³The labeling also recommends a cutoff of 6 ppm as a cutoff to distinguish smokers from non-smokers.
³E.Middleton, A.Morice; Breath carbon monoxide as an indication of smoking habit; Chest (2000) 117, 758-763
K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
