(319 days)
Not Found
No
The device description explicitly states that a microprocessor converts the sensor output into a displayed result, and there is no mention of AI or ML in the device description, performance studies, or other sections.
No
The device is used for monitoring carbon monoxide levels, which is a diagnostic function, not a therapeutic intervention. It helps healthcare professionals assess a patient's condition but does not treat it.
Yes
The device monitors carbon monoxide in exhaled breath to screen for CO poisoning and smoke inhalation, and it provides a "meaningful displayed result" of carbon monoxide or carboxyhaemoglobin levels, which are diagnostic indicators.
No
The device description clearly outlines hardware components including a handheld, battery-powered analyzer, a keypad, an LCD display, colored lights, a buzzer, an electrochemical sensor, a microprocessor, and a breath sampling system with a mouthpiece adapter and mouthpiece. Performance studies also include testing of the device housing robustness (drop tests).
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For monitoring of carbon monoxide in adult exhaled breath." Exhaled breath is a biological specimen.
- Device Description: The device description details how it analyzes "carbon monoxide in adult exhaled breath."
- Mechanism: It uses an electrochemical sensor to sample the gas and a microprocessor to convert the output into a result related to carbon monoxide in the breath or carboxyhaemoglobin in the blood. This is a diagnostic measurement performed on a biological sample.
- Predicate Devices: The listed predicate devices (K080278 TABATABA CO TESTER and K950197 MicroCO meter) are also devices used for measuring carbon monoxide in exhaled breath, which are typically classified as IVDs.
While the device can also be used for ambient air monitoring, its primary intended use and the way it interacts with a biological sample (exhaled breath) firmly place it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
CCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
adult exhaled breath
Indicated Patient Age Range
Adult
Intended User / Care Setting
healthcare professionals only in professional healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
a) Gas performance testing - using known calibrated gases, to demonstrate the linearity and repeatability of CO ppm readings recorded across the device measurement ranges (20pm, 50pm, 100ppm & 375ppm – CO Screen only), with an acceptance criteria of +/- 2ppm or 5% (CO Check Pro) and +/-3% (CO Screen). The test results obtained were within +/- 2ppm for each measurement point.
b) Temperature testing - to demonstrate that the device operates successfully across the environment operating temperature range for the device.
c) Packaging testing - to demonstrate the robustness of the device housing via a series of drop tests and the ability to function as intended thereafter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 2, 2018
MD Diagnostics Limited Glen Hillsley Regulatory Affairs 15 Hollingworth Court, Turkey Mill Maidstone, Kent, ME14 5PP UNITED KINGDOM
Re: K171129
Trade/Device Name: Carbon Monoxide Monitors (CO Check Pro & CO Screen) Regulation Number: 21 CFR 868.1430 Regulation Name: Carbon Monoxide Gas Analyzer Regulatory Class: Class II Product Code: CCJ Dated: January 29, 2018 Received: February 1, 2018
Dear Glen Hillsley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171129
Device Name
Carbon Monoxide monitors (CO Check Pro & CO Screen)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
MD Diagnostics Ltd. - Carbon monoxide monitors
Submitter's Name. Address. Telephone Number. Contact Person and Date Prepared
MD Diagnostics Ltd. 15 Hollingworth Court, Turkey Mill, Maidstone, Kent. ME14 5PP GB
| Phone: | +44(0) 1622 682686 |
|---|---|
| Facsimile: | +44(0) 1622 681693 |
- Contact Person: Glen Hillsley Date Prepared: March 1, 2017
Candidate Device details
| Proprietary/Trade name: | Carbon monoxide monitors (CO Check Pro & CO Screen) |
|---|---|
| ------------------------- | ----------------------------------------------------- |
Common or Usual Name: Carbon Monoxide Gas Analyzer.
Classification Name: Carbon Monoxide Gas Analyzer, 21 C.F.R. § 868.1430.
Device classification: Il
Product code: CCJ
Classification Panel: Anesthesiology
Predicate Device details
Predicate 1: Device name / 510k: TABATABA CO TESTER (K080278) Manufacturer: FIM Medical, France.
Predicate 2: Device name / 510k: MicroCO meter (K950197)
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Manufacturer: Carefusion, USA
Further to a review of the MAUDE database, from 1970 to the present day – There is no record of any product problems or safety issues relating to the use carbon monoxide gas analyzers.
Device Description
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.
Intended Use / Indications for Use
The Carbon monoxide monitors are used to measure the concentration of carbon monoxide in exhaled breath
The devices are indicated for:
For monitoring of carbon monoxide in adult exhaled breath. They are for use 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.
Comparison of Technological Characteristics with the Predicate Device Substantial Equivalence Determination
Measurement of carbon monoxide in exhaled breath for use in smoking cessation programs and for screening for CO poisoning is the technological principle for both the candidate and predicate devices.
The MD Diaqnostics Carbon monoxide monitors are substantially equivalent to the predicate devices, in terms of intended use, indications for use, technological characteristics, principle of operation, materials and performance characteristics to the cleared TABATABA CO tester covered
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under K080278 and the MicroCO covered under K950197. Any minor differences in this section do not raise any different questions of safety and effectiveness.
| Item | Candidate device - MD Diagnostics - Carbon monoxide monitors (CO Check Pro & CO Screen) | Predicate device - FIM Medical - TABATABA CO tester | Predicate device – Carefusion – MicroCO meter |
|---|---|---|---|
| Intended use | Measurement of Carbon monoxide in parts per million (PPM) and Carboxyhaemoglobin (%COHb) in exhaled breath. | SAME | SAME |
| Indications for Use | For monitoring of carbon monoxide in adult exhaled breath. They are for use 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 | SIMILAR, The CO Screen indications statement is the same as the predicate with the exception of explicitly stating the device is for use in adults and in professional healthcare facilities. These minor additions do not change the intended use compared to the predicate. | The predicate indications are not stated. However, the CO Check Pro has the same intended use as the predicate and similar indications as the predicate TABATABA. |
| Environments used | Professional healthcare facilities | SAME | SAME |
| Sensor | Electrochemical fuel cell | SAME | SAME |
| Human Factor | Hand held, two button operated with screen instructions via LCD. | SAME | Slide switch operation |
| Patient breath sampling system | Disposable Cardboard mouthpiece and plastic mouthpiece adapter | Disposable Plastic mouthpiece | SAME |
| Enclosure material | ABS | SAME | SAME |
| CO measurement range | 0 to 99 ppm (CO Check Pro) | ||
| 0 to 375ppm (CO Screen) | 0 to 500 ppm | 0 to 100ppm | |
| Accuracy | +/- 2ppm or 5%, whichever is greater (CO Check Pro) | ||
| +/- 3% (CO Screen) | +/- 5ppm | +/- 1ppm or 5%, whichever is greater | |
| Power source | 1 x Battery 9V, PP3 | 2 x Battery AA | SAME |
Performance Data
The following performance data was provided in support of the substantial equivalence determination:
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Biocompatibility Evaluation
The biocompatibility assessment for the Carbon monoxide monitors and its operational accessories was conducted in accordance with International Standard ISO 10993-1 - Biological Evaluation of the Medical Devices. Part 1 – Evaluation and testing in the risk management process as recognized by FDA. The Evaluation criteria considered the Cytotoxicity, Sensitization and Irritation aspects only.
Electrical Safety and ElectroMagnetic Compatibility Testing
Electrical Safety testing, to establish the basic safety and essential performance of the device and also EMC testing, to establish the emissions and immunity characteristics, was conducted on the CO Check Pro in accordance with IEC60601-1 and IEC60601-1-2 standards respectively.
Performance testing
Performance testing on the Carbon monoxide monitors was conducted to verify the devices' functionality across their operational ranges. This comprises of:
a) Gas performance testing - using known calibrated gases, to demonstrate the linearity and repeatability of CO ppm readings recorded across the device measurement ranges (20pm, 50pm, 100ppm & 375ppm – CO Screen only), with an acceptance criteria of +/- 2ppm or 5% (CO Check Pro) and +/-3% (CO Screen). The test results obtained were within +/- 2ppm for each measurement point.
b) Temperature testing - to demonstrate that the device operates successfully across the environment operating temperature range for the device. c) Packaging testing - to demonstrate the robustness of the device housing via a series of drop tests and the ability to function as intended thereafter.
Conclusion
The Carbon monoxide monitors are considered as safe and as effective as the predicate devices and are manufactured to a similar basic specification as the predicate devices. The Performance data demonstrates that the devices are fit for purpose and the results observed were as expected and in accordance with recognized standards.
The Carbon monoxide monitors have the same intended use, indications for use, principles of operation and virtually identical technological characteristics as the predicate devices. Due to the similarities, it's considered that the minor technical differences between the Carbon monoxide monitors and its predicate devices' do not raise any different questions of safety or effectiveness.
Thus, the Carbon monoxide monitors are considered substantially equivalent to the predicate devices.