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.

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K171129

Device Name

Carbon Monoxide monitors (CO Check Pro & CO Screen)

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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)

{4}------------------------------------------------

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 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.

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

{5}------------------------------------------------

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:

{6}------------------------------------------------

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.

Regulation Number and Section

§ 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).