CO Check Pro, CO Screen

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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) 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) | #### 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 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 {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)<br>0 to 375ppm (CO Screen) | 0 to 500 ppm | 0 to 100ppm | | Accuracy | +/- 2ppm or 5%, whichever is greater (CO Check Pro)<br>+/- 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.