EMMA Capnograph

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March 29, 2021 Masimo Corporation Katelynn Kirby Regulatory Affairs Specialist III 52 Discovery Irvine, California 92618 Re: K201590 Trade/Device Name: EMMA Capnograph Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: February 26, 2021 Received: March 2, 2021 Dear Katelynn Kirby: We have reviewed vour 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. 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. 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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K201590 Device Name EMMA Capnograph #### Indications for Use (Describe) EMMA® Capnograph measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. Type of Use (Select one or both, as applicable) X 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. 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The logo consists of a red circle with a white checkmark inside, followed by the company name in a stylized font. The checkmark is angled slightly to the right, and the company name is written in all capital letters. ION # 510(k) Summary K201590 | Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: (949) 297-7000<br>FAX: (949) 297-7592 | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------| | Date: | June 11 2020 | | Contact: | Katelynn Kirby<br>Regulatory Affairs Specialist III<br>Masimo Corporation<br>Phone: (949) 297-7408 | | Trade Name: | EMMA Capnograph | | Common Name: | Carbon Dioxide Gas Analyzer | | Classification Regulation: | 21 CFR 868.1400, Class II | | Product Code: | CCK | | Establishment Registration<br>Number: | 3011353843 | | Reason for Premarket<br>Notification: | Addition of Wireless Capabilities | | Predicate Device: | K072813 - EMMA Emergency Capnometer | | Performance Standards | No performance standards for the above device have been<br>promulgated pursuant to Section 514. | #### 5.1. Device Description The subject device, EMMA® Capnograph (EMMA), the same as the predicate, is a portable medical device capable of measuring, displaying, and monitoring carbon dioxide and respiratory rates from exhaled air. The difference between the subject device and the predicate device is the addition of the wireless capability to allow for the wireless transmission of data. The intended use and measurement functions have not changed from the previous clearance. | Feature | EMMA Specification | |--------------------------------|-----------------------------------------------------------------| | General | | | Display type | Integrated Visual Display | | Airway Adapter Adult/Pediatric | Single patient use proprietary airway adapter, 6 cc dead space. | | Airway Adapter Infant | Single patient use proprietary airway adapter, 1 cc dead space. | | Performance Specifications | | | CO2 | 0-40 mmHg: +/- 2 mmHg. | The specifications for EMMA are as follows: {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for Masimo, a medical technology company. The logo features a red circle with a white checkmark inside, followed by the company name "Masimo" in bold, black letters. The checkmark is stylized and appears to be tilted slightly to the left. The overall design is clean and modern. ATION # 510(k) Summary K201590 | Feature | EMMA Specification | |--------------------------------------|---------------------------------------------------------------------------------------------------------------| | Respiration Rate (3-150 breaths/min) | 41-99 mmHg: 6% of reading<br>$\pm$ 1 breaths/min | | Total System Response Time | < 0.7 s | | Displays/ Indicators | | | Data displayed | CO2, Respiration Rate | | Alarm | No Breath Detected, No Adapter, Check Adapter,<br>Low battery, Low / High ETCO2 with adjustable alarm limits. | | Electrical | | | Internal battery power | 2 "AAA" Batteries | | Output Interface | | | Wireless Output | Supports Bluetooth wireless communication | | Mechanical | | | Enclosure Material | Thermoplastic | | Dimensions | 52 x 39 x 39 mm (2.1 x 1.5 x 1.5 inches) | | Weight | 65 g (2.1 oz) with batteries | | Environmental | | | Operating Temperature | -5 to 50 °C (23 to 122 °F) | | Storage/Transport Temperature | -40 to 70 °C (-40 to 158 °F) | | Operating Humidity | 10 - 95%, non-condensing | | Storage/Transport Humidity | 10 - 95%, non-condensing | | Operating Atmospheric Pressure | 60 - 120 kPa | | Compliance | | | Electrical Safety/EMC | IEC 60601 compliant | | Type of Protection | Internally powered | | Degree of Protection | Defibrillation proof, BF-applied part | | Degree of Ingress Protection | IP44 | | Mode of Operation | Continuous operation | | Wireless Specifications | | | Type | Bluetooth GFSK | | Frequency | 2402-2480 MHz | | Max Peak Output Power | -1 dBm | | Antenna Peak Gain | -7 dBi | | Recommended Range | ~10 feet (~3 meters) line-of-sight | #### Intended Use/ Indications for Use 5.2. EMMA® Capnograph measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. ### 5.3. Technological Characteristics Principle of Operation {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the word "Masimo" is the text "MASIMO CORP" followed by the address "52 Discovery, Irvine, CA 92618". The measurement of CO2 in the breathing gas mixture is based on the fact that different gas components absorb infrared light at specific wavelengths. A beam of invisible infrared light is directed through the respiratory gas flow in the EMMA Airway Adapter. As the beam passes through the airway adapter, some of the light is absorbed by the gas mixture. The amount of absorbed light is measured by a miniaturized two channel spectrometer positioned to receive the infrared light beam. The spectrometer incorporates two different optical "color" filters. The wavelength ranges of these filters are chosen such that one filters out wavelengths where carbon dioxide has very strong absorption and the other filters out wavelengths where carbon dioxide has no absorption. The spectrometer also incorporates an infrared detector that converts the light beam to an electrical signal. The electrical signal is converted to a digital value that is fed to a microprocessor. The ratio of the light measured through the two filters is then used by the microprocessor to calculate the carbon dioxide concentration in the breathing gas mixture. ### Mechanism of Action for Achieving the Intended Effect The EMMA works by attaching the EMMA Airway adapter between the endotracheal tube and resuscitation bag. The EMMA Airway Adapter once connected to the EMMA monitor becomes the path in which the breathing gas mixture passes. As the breathing gas mixtures passes, the infrared light passes through the light window provided in the adapter. The light window of the adapter aligns on the side with the infrared source and the other side with infrared detector. Based upon the amount of light absorbed when the different filters are in place, a CO2 and respiration rate is displayed on the EMMA monitor. The EMMA Capnograph snaps in place on top of the EMMA Airway Adapter. The airway adapter may then, for example, be inserted between the endotracheal tube and the resuscitation bag or between the resuscitation bag and the patient mask. Respiratory gas measurements are, as described in the previous section, obtained by continuously measuring the infrared light absorption through the "XTP Windows" that are transparent to light in the wavelength ranges of interest. The Airway Adapters are fully sealed, except for the breathing circuit couplings. The breathing circuit couplings conform to existing standards for this type of couplings. The EMMA Sensor Body (reusable portion) does not come in contact with breathing circuit gases or the patient. ### 5.4. Summary of Technological Characteristics of Subject Device Compared to Predicate Device The subject device incorporates a wireless module and a software modification to enable the radio and support the wireless communication of measurement data from EMMA. There is no change to the intended use as part of this modification. ### 5.4.1 Similarities and Differences between Predicate and Subject Device {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CO" followed by the address "52 Discovery, Irvine, CA 92618". The subject device, EMMA with wireless capabilities, and the predicate device, have the following key similarities: - · Both devices have the same intended use; - · Both devices have the same indicated populations; - · Both devices have the same measurement technology: - · Both devices have the same form factor The subject device, EMMA with wireless capabilities, and the predicate device, have the following key differences: - · Subject device includes the ability to wirelessly communicate - · Subject device has a lower storage/transport specification The purpose of this submission is the addition of the wireless capabilities to the EMMA. As part of the wireless function implementation, a radio module was incorporated into the hardware design and the software was updated to enable the wireless communication. There was no change to the measurement functions or the intended use of the device. To support the wireless capabilities do not raise different questions of safety and effectiveness, the subject device was evaluated for electromagnetic compatibility testing to the latest IEC 60601-1-2 standard, radio co-existence testing, and cybersecurity risk mitigations. The testing conducted supported the subject device to be substantially equivalent to the predicate device. Both devices have the same intended use and that the addition of the wireless capabilities does not raise different questions of safety and effectiveness. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the text "Page 5 of 8". This indicates that it is a page number within a document. The document has a total of 8 pages, and this image represents the fifth page. Image /page/7/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray. | Feature | EMMA Capnograph with wireless capabilities<br>(Subject Device) | EMMA Emergency Capnometer (Predicate device) | Comparison | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | 510(k) Number | Pending | K072813 | | | General Information | | | | | Classification | 21 CFR 868.1400, Class II | 21 CFR 868.1400, Class II | Same | | Product Code | CCK | CCK | Same | | Indications for Use | EMMA® Capnograph measures, displays and monitors<br>carbon dioxide partial pressure and respiratory rate<br>during anesthesia, recovery and respiratory care. It may<br>be used in the operating suite, intensive care unit, patient<br>room, clinic, emergency medicine and emergency<br>transport settings for adult, pediatric and infant patients. | The EMMA Emergency Capnometer Monitor measures,<br>displays and monitors carbon dioxide concentration and<br>respiratory rate during anesthesia, recovery and<br>intensive care unit, patient room, clinic, emergency<br>medicine and emergency transport settings for adult,<br>pediatric and infant patients. | Similar, carbon dioxide<br>concentration clarified as<br>carbon dioxide partial<br>pressure. | | Principle of<br>Operation | The measurement of CO2 in the breathing gas mixture is<br>based on the fact that different gas components absorb<br>infrared light at specific wavelengths. A beam of<br>invisible infrared light is directed through the respiratory<br>gas flow in the EMMA Airway Adapter. As the beam<br>passes through the airway adapter, some of the light is<br>absorbed by the gas mixture. The amount of absorbed<br>light is measured by a miniaturized two channel<br>spectrometer positioned to receive the infrared light<br>beam.<br>The spectrometer incorporates two different optical<br>"color" filters. The wavelength ranges of these filters are<br>chosen such that one filters out wavelengths where<br>carbon dioxide has very strong absorption and the other<br>filters out wavelengths where carbon dioxide has no<br>absorption.<br>The spectrometer also incorporates an infrared detector | The measurement of CO2 in the breathing gas mixture is<br>based on the fact that different gas components absorb<br>infrared light at specific wavelengths. A beam of<br>invisible infrared light is directed through the respiratory<br>gas flow in the EMMA Airway Adapter. As the beam<br>passes through the airway adapter, some of the light is<br>absorbed by the gas mixture. The amount of absorbed<br>light is measured by a miniaturized two channel<br>spectrometer positioned to receive the infrared light<br>beam.<br>The spectrometer incorporates two different optical<br>"color" filters. The wavelength ranges of these filters are<br>chosen such that one filters out wavelengths where<br>carbon dioxide has very strong absorption and the other<br>filters out wavelengths where carbon dioxide has no<br>absorption.<br>The spectrometer also incorporates an infrared detector | Same | | | that converts the light beam to an electrical signal. The<br>electrical signal is converted to a digital value that is fed<br>to a microprocessor. The ratio of the light measured | that converts the light beam to an electrical signal. The<br>electrical signal is converted to a digital value that is fed<br>to a microprocessor. The ratio of the light measured | | | | through the two filters is then used by the<br>microprocessor to calculate the carbon dioxide<br>concentration in the breathing gas mixture. | through the two filters is then used by the<br>microprocessor to calculate the carbon dioxide<br>concentration in the breathing gas mixture. | | | Display | | | | | Display type | Integrated visual display | Integrated visual display | Same | | Airway Adapter<br>Adult/Pediatric | Single patient use proprietary airway adapter, 6 cc dead space. | Single patient use proprietary airway adapter, 6 cc dead space. | Same | | Airway Adapter<br>Infant | Single patient use proprietary airway adapter, 1 cc dead space. | Single patient use proprietary airway adapter, 1 cc dead space. | Same | | Technological Characteristics EMMA | | | | | Display/Indicators | | | | | Data displayed | CO2, Respiration Rate | CO2, Respiration Rate | Same | | Alarm | No Breath Detected, No Adapter, Check Adapter,<br>Low battery, Low / High ETCO2 with adjustable<br>alarm limits. | No Breath Detected, No Adapter, Check Adapter,<br>Low battery, Low / High ETCO2 with adjustable<br>alarm limits. | Same | | Accuracy | | | | | CO2 | 0-40 mmHg: +/- 2 mmHg,<br>41-99 mmHg: 6% of reading | 0-40 mmHg: +/- 2 mmHg,<br>41-99 mmHg: 6% of reading | Same | | Respiration rate | 3-150 breaths/min $\pm$ 1 breaths/min | 3-150 breaths/min $\pm$ 1 breaths/min | Same | | Environmental | | | | | Operating Temperature | -5 to 50 °C (23 to 122 °F) | -5 to 50 °C (23 to 122 °F) | Same | | Storage/Transport Temperature | -40 to 70 °C (-40 to 158 °F) | -30 to 70 °C (-22 to 158 °F) | Subject Device<br>Storage/Transport<br>Temperature Extended to<br>-40 to 70 °C | | Operating Humidity | 10 - 95%, non-condensing | 10 - 95%, non-condensing | Same | | Storage/Transport Humidity | 10 - 95%, non-condensing | 5 - 100%, non-condensing | Subject Device<br>Storage/Transport<br>narrowed to 10 - 95% | | Operating Atmospheric Pressure | 60 - 120 kPa | 70 - 120 kPa | Subject Device<br>Operating Atmospheric<br>Pressure extended to 60 - | | | | | 120 kPa | | Mechanical | | | | | Enclosure Material | Thermoplastic | Thermoplastic | Same | | Dimensions | 52 x 39 x 39 mm (2.1 x 1.5 x 1.5 inches) | 52 x 39 x 39 mm (2.1 x 1.5 x 1.5 inches)…