ToxCO

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Bedfont Scientific Ltd Louise Bateman OA & RA Manager Station Road, Harrietsham Maidstone, ME17 1JA UNITED KINGDOM Re: K173238 Trade/Device Name: ToxCO Regulation Number: 21 CFR 868.1430 Regulation Name: Carbon Monoxide Gas Analyzer Regulatory Class: Class II Product Code: CCJ Dated: March 5, 2019 Received: March 8, 2019 Dear Louise Bateman: 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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, Todd D. Courtney -5 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) K173238 Device Name ToxCO® Indications for Use (Describe) The ToxCO® breath Carbon Monoxide monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | <span style="font-size:10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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ToxCO® # 510K Number _K173238 ### 510(k) Summary This summary of 510(k) information is being submitted in accordance with the requirement of 21 CFR 807.92. - l. SUBMITTER Identification: Bedfont Scientific Ltd Station Road, Harrietsham Maidstone, Kent. ME17 1JA United Kingdom - Telephone: +44 1622 851122 Fax: +44 1622 854860 Contact Person: Louise Bateman Email louise@bedfont.com Date of Summary: 04 April 2019 ### II. DEVICE | Device Name: | ToxCO® | |-----------------------------|-----------------------------------------------| | Classification Name: | Analyzer, Gas, Carbon Monoxide, Gaseous-Phase | | Product Regulatory Class: | | | Product Regulatory Code: | CCJ | | Panel: | Anesthesiology | | Code of Federal Regulation: | 21 CFR 868.1430 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features the word "bedfont" in a bold, lowercase font, with the registered trademark symbol next to it. Above the word, there are five colorful circles in yellow, pink, orange, purple, and blue. Below the word "bedfont" is the text "est. 1976". #### III. PREDIČATE AND REFERENCE DEVIČE Predicate Device Manufacturer: Device Trade Name: Device 510(k): Bedfont Scientific Ltd Micro*™ Smokerlyzer K082315 Reference only Predicate Device Manufacturer: Bedfont Scientific Ltd Device Trade Name: EC ToxCO® + Device 510(k): K070259 EC ToxCO® + K070259 #### IV. DEVICE DESCRIPTION The ToxCO® is a hand held exhaled breath monitor for the detection of Carbon Monoxide on the breath. The battery powered monitor uses an electrochemical sensor, designed to react specifically to carbon monoxide producing an electrical output. The output is then amplified and a microcontroller processes the signal and converts it to a meaningful displayed result on an LCD touch screen. The sample system for the ToxCO® mimics the predicate device channeling the breath sample directly over the sensor during test ensuring the sensor is exposed to the gas sample for the required length of time to give an accurate reading. The ToxCO® Monitor uses a non-patient contacting D-piece™ sampling system, with integrated bacterial and viral filter and a one-way valve, attached directly to the monitor. A patient contacting, single patient use SteriBreath™ mouthpiece is connected to the D-piece™ sampling system to perform a breath sample. The D-piece™ is designed to have minimal dead space and therefore initial dilution of the sample is reduced. The patient is required to hold their breath for a 15 second countdown. This is displayed on the LCD screen of the device. At the end of the breath hold, the patient shall blow gently but fully into the ToxCO®, exhaling as much of the breath in their lungs as possible. The reading on the display shall rise until the peak reading is held on the display. Use of the breath sampling D-piece™ and disposable SteriBreath™ mouthpiece may be impossible if the patient is unconscious or injured. In this event, a modified sampling technique can be used, which consists of a specially constructed face mask sampling system, which allows exhaled breath to be directed to the instrument's sensor for analysis. The Face mask sampling system is a single-use, pre-assembled adapter to enable a breath sample to be taken with a single use face mask, connected to the ToxCO® breath Carbon Monoxide monitor by means of a breath sampling D-piece™. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Bedfont Scientific. The logo features five colorful circles in yellow, pink, orange, purple, and blue. Below the circles is the word "bedfont" in a sans-serif font, with the registered trademark symbol next to it. The face mask sampling procedure does not require a 15 second breath hold to be performed before the test can begin. Sampling will last 60 seconds as the %COHb/ppm levels rise and then hold at the peak level. The result will be shown on the LCD monitor screen. The ToxCO® breath Carbon Monoxide monitor and accessories are used by healthcare professionals in medical institutions and healthcare environments where Carbon Monoxide exposure is suspected. #### V. INTENDED USE / INDICATIONS FOR USE The ToxCO® Breath Carbon Monoxide Monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The ToxCO® Breath Carbon Monoxide Monitor and its accessories are used as indication of Carbon Monoxide (CO) poisoning and Carboxyhaemoglobin (COHb) when blood testing is not available. The predicate Micro+® Smokerlyzer and the ToxCO® monitor are substantially equivalent as they are both breath carbon monoxide monitors that can be used to provide a reading to determine levels of Carbon Monoxide (CO) poisoning and calculation of the carboxyhaemoglobin (COHb) level. The predicate Micro+® Smokerlyzer and ToxCO® monitor are both for multi-patient use by health professionals; both used in health environments and used to determine levels of carbon monoxide (CO) poisoning. The predicate and the ToxCO® monitor are manufactured using the same processes. They are both hand held, battery operated breath Carbon Monoxide Monitors manufactured with identical materials, components, technology and use the same electrochemical sensor. The Reference Device EC ToxCO® + (K070259) has been included to determine substantial equivalence as the EC ToxCO+ and the subject ToxCO® monitor both utilize a facemask sampling system, using commercially available facemasks. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features the word "bedfont" in a lowercase, sans-serif font, with the "o" in "bedfont" colored in a bright blue that matches the color of a large circle above the word. Above the word "bedfont" are five smaller circles in a variety of colors: yellow, pink, orange, purple, and blue. The ToxCO® Breath Carbon Monoxide Monitor is substantially equivalent to the predicate Micro+ Smokerlyzer Device (K082315) in the following areas: Equivalence, Similarities and Differences: ToxCO® and Predicate Micro+™ Smokerlyzer® | Substantial<br>Equivalent<br>comparison<br>Criteria | ToxCO® Monitor | Predicate Device<br>Micro+™ Smokerlyzer® | Equivalence, Similarities &<br>Differences | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Bedfont Scientific Ltd | Bedfont Scientific Ltd | EQUIVALENT | | Trade name | ToxCO® | Micro+™ Smokerlyzer® | n/a | | Product code | CCJ | CCJ | EQUIVALENT | | Regulation<br>number | 868.1430 | 868.1430 | EQUIVALENT | | Intended use /<br>Indications for<br>use | The ToxCO® Breath<br>Carbon Monoxide<br>Monitor and accessories<br>are used by healthcare<br>professionals to<br>determine levels of<br>Carbon Monoxide (CO)<br>poisoning. | The Micro+™ Smokerlyzer®<br>is a Breath Carbon<br>Monoxide Monitor<br>intended for multi-<br>patient use by healthcare<br>professionals in smoking<br>cessation programs and<br>as an indicator of Carbon<br>Monoxide poisoning in<br>healthcare environments. | EQUIVALENT<br>Both devices are breath<br>carbon monoxide monitors<br>that can be used to provide<br>a reading to<br>determine/indicate levels of<br>Carbon Monoxide (CO)<br>poisoning. | | Design | The ToxCO® was designed<br>to be hand held, easy to<br>use with different<br>sampling techniques. | The Micro+™ Smokerlyzer®<br>was designed to be hand<br>held, easy to use and has<br>one sampling technique. | EQUIVALENT<br>Both devices are handheld,<br>easy to use Breath Carbon<br>Monoxide (CO) Monitors.<br>Both devices offer a Breath<br>Sampling technique that<br>uses the same disposable<br>single use SteriBreath<br>mouthpiece and D-Piece<br>mouthpiece filter.<br>DIFFERENCES<br>The ToxCO® device offers a<br>modified sampling<br>technique if the patient is<br>unconscious or injured,<br>using a disposable single<br>use Facemask sampling<br>system and single use<br>Facemask. | | CO measurement<br>range - Breath<br>Test | 0-500 ppm | 0-500 ppm | EQUIVALENT | | CO measurement<br>range - modified<br>Breath Test | 0-200 ppm | n/a | DIFFERENT<br>The predicate Micro+ does<br>not include the option to<br>perform a breath test with a<br>modified sampling<br>technique, consisting of a<br>specially constructed face<br>mask sampling system. This<br>was available on the EC<br>ToxCO+ reference device.<br>This method for use has<br>been validated as an<br>effective method to indicate<br>levels of CO poisoning up to<br>up to 200ppm. | | Detection<br>principle | Electrochemical sensor | Electrochemical sensor | EQUIVALENT | | Sensor sensitivity | 1 ppm | 1 ppm | EQUIVALENT | | Accuracy | ≤ ±3ppm/10% -<br>whichever is greater | ≤±2ppm/5% whichever is<br>greater | SIMILAR<br>The operating range on the<br>ToxCO, is the same as the<br>Micro+ & the reference<br>ToxCO+, which is 0-500ppm<br>(0 – 50%COHb -<br>carboxyhaemoglobin).<br>The accuracy of the ToxCO<br>is ≤±3ppm or 10%<br>(whichever is greater),<br>which is due to the extend<br>temperature range being 0<br>to 45°C. | | Power | 3 x AA batteries | 3 x AA batteries | EQUIVALENT | | Monitor outer<br>enclosure<br>material | Polycarbonate/ABS blend<br>with SteriTouch® Anti-<br>microbial Additive | Polycarbonate/ABS blend<br>with SteriTouch® Anti-<br>microbial Additive | EQUIVALENT | | Mouthpiece<br>Sample System | Single Use SteriBreath<br>Mouthpiece -<br>Polypropylene | Single Use SteriBreath<br>Mouthpiece -<br>Polypropylene | EQUIVALENT | | Modified Sample<br>System | Single Use Facemask -<br>PVC/Polyethylene<br>Facemask sampling<br>system -<br>Styrene Butadiene<br>Polypropylene<br>Silicone | Not Applicable | DIFFERENT<br>Use of the breath sampling<br>D-piece™ and disposable<br>SteriBreath™ mouthpiece<br>may be impossible if the<br>patient is unconscious or<br>injured. In this event, a<br>modified sampling<br>technique can be used,<br>which consists of a specially<br>constructed face mask<br>sampling system, which<br>allows exhaled breath to be<br>directed to the instrument's<br>sensor for analysis. Refer to<br>reference EC ToxCO+ below<br>for equivalence. | | Medical class | II | II | EQUIVALENT | | Electrical Safety<br>Testing<br>IEC 60601-1 | Yes | Yes | EQUIVALENT | | EMC Testing<br>IEC 60601-1-2 | Yes | Yes | EQUIVALENT | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Bedfont logo. The logo consists of five colored circles in yellow, pink, orange, purple, and blue. Below the circles is the word "bedfont" in blue, and below that is the text "est. 1976". {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features the word "bedfont" in a bold, dark blue font. Above the word, there are five colorful circles in yellow, pink, orange, purple, and blue. The text "est. 1976" is located below the word "bedfont". ### Equivalence, Similarities and Differences: ToxCO® and Predicate Reference Device EC ToxCO+ | Substantial<br>Equivalent<br>comparison<br>Criteria | ToxCO® Monitor | Reference Device<br>EC ToxCO+ | Equivalence & Differences | |-----------------------------------------------------|------------------------|-------------------------------|---------------------------| | Manufacturer | Bedfont Scientific Ltd | Bedfont Scientific Ltd | EQUIVALENT | | Trade name | ToxCO® | EC ToxCO+ | n/a | | Product code | CC1 | CCJ | EQUIVALENT | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features five colorful circles in yellow, pink, orange, purple, and blue. Below the circles is the word "bedfont" in a bold, sans-serif font, with the registered trademark symbol next to it. Underneath "bedfont" is the text "est. 1976". | Regulation<br>number | 868.1430 | 868.1430 | EQUIVALENT | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CO measurement<br>range - Breath<br>Test | 0-500 ppm | 0-500 ppm | EQUIVALENT | | CO measurement<br>range - modified<br>Breath Test | 0-200 ppm | 0-500 ppm | SIMILAR<br>The ToxCO and reference<br>predicate EC ToxCO+<br>includes the option to<br>perform a breath test with a<br>modified sampling<br>technique, consisting of a<br>specially constructed face<br>mask sampling system. This<br>method for use has been<br>validated as an effective<br>method to indicate levels of<br>CO poisoning up to up to<br>200ppm. | | Modified Sample<br>System | Single Use Facemask -<br>PVC/Polyethylene<br>Facemask sampling<br>system –<br>Styrene Butadiene<br>Polypropylene<br>Silicone | Single Use Facemask -<br>PVC/Polyethylene<br>Facemask sampling<br>system –<br>Styrene Butadiene<br>Polypropylene<br>Silicone | EQUIVALENT | ### Differences & Similarities discussion The ToxCO® and its predicate Micro+™ Smokerlyzer® are breath carbon monoxide monitors that can be used to provide a reading to determine levels of Carbon Monoxide (CO) poisoning. Both Devices are for Multi-patient use by Health Professionals and both can be used in Healthcare environments. Both the ToxCO® and its predicate Micro+™ Smokerlyzer® calculate the carboxyhaemoglobin (COHb) level and can display the % carboxyhaemoglobin (COHb) level on their LCD touch screen, using the same sensor to enable calculation via the same internal processor. Although the ToxCO® is not specifically indicated for smoking cessation programs as the predicate Micro+™ Smokerlyzer®, this does not raise different questions of safety and effectiveness of the ToxCO® monitor as both devices determine levels of Carbon Monoxide (CO) poisoning, which is monitored regularly during smoking cessation programs. Both devices use the same sensor and internal processor to determine levels of Carbon Monoxide (CO) poisoning. The ToxCO® breath Carbon Monoxide monitor's predicate device, the Micro+™ Smokerlyzer® is not for use on unconscious patients, the ToxCO® breath Carbon Monoxide Monitor has been developed with an alternative sampling system via a Facemask and sampling adapter for use in these circumstances. The Facemask sampling system was previously used in the Bedfont Scientific Ltd EC50 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "ToxCO" in bold, black font. A circled capital R symbol is to the right of the word. The text is simple and clear, with a focus on the company name. Image /page/10/Picture/1 description: The image shows the logo for Bedfont Scientific Ltd. The logo features five colorful circles in yellow, pink, orange, purple, and blue. Below the circles is the word "bedfont" in a bold, sans-serif font, with the registered trademark symbol. Underneath "bedfont" is the text "est. 1976". ToxCO® + breath Carbon Monoxide Monitor cleared for market under K070259. This device also used a Facemask sampling system, utilizing commercially available facemasks. Use of the breath sampling Dpiece™ and disposable SteriBreath™ mouthpiece may be impossible if the patient is unconscious or injured. In this event, the modified sampling technique can be used, which consists of a specially constructed face mask sampling system, which allows exhaled breath to the instrument's sensor for analysis. The performance of the ToxCO® using the alternative sampling system has been comprehensively tested to confirm its effectiveness. These minor differences in the intended use and breath sampling method do not raise different questions of safety and effectiveness of the ToxCO® breath Carbon Monoxide monitor, therefore it can be considered substantially equivalent to its predicate device. #### VII. PERFORMANCE DATA The following performance data was provided in support of the substantial equivalence determination: ### Biocompatibility Evaluation The evaluation of biocompatibility requirements for the ToxCO® breath Carbon Monoxide monitor and accessories was performed in accordance with FDA recognized Consensus Standard ISO 10993-1, Part 1: Evaluation and testing within a risk management process. ### Electrical Safety and Electromagnetic Compatibility (EMC) The ToxCO® breath carbon monoxide monitor was subject to Electrical Safety Testing and EMC testing. The monitor complies with IEC 60601-1 Electrical Safety Standard and IEC 60601-1-2 EMC standards. ### Software (Firmware) Verification and Validation Testing The ToxCO® breath carbon monoxide monitor includes Firmware that was subject to Verification and Validation testing performed as recommended by FDA's Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software was determined to be a Moderate level of concern. ### Performance testing Bench testing was performed during the Validation and Verification cycle to confirm the device performs as intended across its operational range. Validation tests were carried out with calibrated CO gases (0, 20, 50, 158, 605 ppm) to confirm Accuracy of readings and repeatability within specification .Further testing was executed to confirm the device performs across the specified Operating (0-45°c) and Storage (0-50°c) temperatures, carried out with calibrated CO gases (0, 20, 50, 158, 500, 605 ppm) and to also to ensure the Device responds to CO gas, calculating and displaying the correct PPM and %COHB, carried out with calibrated CO gases (0, 20, 50, 158, 605 ppm). Comprehensive testing was carried out to verify the performance of the ToxCO® device when used in facemask mode. A calibrated Volume/Flow simulator was used to adjust the relevant respiratory rates and tidal volume parameters enabling simulation of human lungs. A Facemask sampling adapter was connected to the ToxCO® device and the simulator, with a CO Monitor to measure the sampled air and to measure the CO concentration when the calibrated test CO gas was applied (0 (clean air), 50, 158, 605 ppm). It was concluded the ToxCO® is able to provide readings within the operating tolerances specified when tested across the detection range. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features five colorful circles in yellow, pink, orange, purple, and blue. Below the circles is the word "bedfont" in a lowercase, sans-serif font, with the registered trademark symbol. Underneath "bedfont" is the text "est. 1976". #### CONCLUSION VIII. After analyzing Performance data, bench and non-clinical data it is the conclusion of Bedfont Scientific Ltd that the ToxCO® breath Carbon Monoxide monitor is as safe and effective as the predicate device, with equivalence in design, materials, technology, classification and Intended Use as a breath Carbon Monoxide monitor. The subject and predicate device both use identical moldings made from the same material, size and weight. The same mouthpiece is used for the ToxCO® and predicate device again using the same material, classification of applied part, touch times and internal breath sampling system. Equivalence is also established between the predicate and subject Device as the ToxCO® is a Multipatient use device, used by health professionals in healthcare environments, providing a reading to determine levels of Carbon Monoxide (CO) poisoning. These are all identical characteristics to the Predicate device. The few minor differences present when compared to the Micro+™ Smokerlyzer® predicate device include the alternative breath sampling method and the face mask breath test concentration range. These do not raise different questions of safety and effectiveness of the ToxCO® breath Carbon Monoxide monitor as comprehensive testing of the Facemask sampling method was performed to declare the device is able to provide readings within the operating tolerances specified. The face mask testing protocol has been developed for use on patients with a respiration rate of between 12-20 breaths per minute. The manual advises if face mask testing is used outside of these specifications, this may result in decreased accuracy of readings. Both devices are Product Regulatory Class II and Product Regulatory Code CCJ and no additional risks are generated to achieve the desired intended use, therefore the ToxCO® breath carbon monoxide monitor can be considered substantially equivalent to its predicate device.