AirLife DuoTherm™ Humidification System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 10, 2023 Vyaire Medical, Inc. Megan Walsh Manager, Regulatory Affairs 26125 N. Riverwoods Blvd. Mettawa, Illinois 60045 Re: K231380 Trade/Device Name: AirLife DuoTherm™ Humidification System Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT, BZE Dated: May 12, 2023 Received: May 12, 2023 Dear Megan Walsh: 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. 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. {1}------------------------------------------------ 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) 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. # Ethan L. Nyberg -S Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K231380 Device Name AirLife DuoTherm™ Humidification System ### Indications for Use (Describe) The AirLife DuoTherm™ Heated Humidifier is intended to add moisture to, and warm, the breathing gases for administration to a patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. This product is non-sterile, reusable, and intended to be used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients ranging from neonates to adults using a heated humidifier. The product is a single use device, nonsterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Neonate Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Neonate Heated-Wire Circuits are used with a pediatric population, specifically the neonate (birth to 28 days) and infant (29 days to 2 years) pediatric subgroups with an ideal body weight of 0.5 to 8kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Neonate Heated-Wire Circuits are used for flow rates greater than 1 LPM. The product is single patient use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Pediatric Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Pediatric Heated-Wire Circuits are used with the pediation, specifically infant (29 days to 2 years) and children (2 years) with an ideal body weight of 6 to 42kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Pediatric Heated-Wire Circuits are used for flow rates greater than 2 LPM. The product is single use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Adult Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire Circuits are used with the adult population and pediation, specifically those with an ideal body weight of 30kg or above, that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Adult Heated-Wire Circuits are used for flow rates greater than 3 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Adult Heated-Wire NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire NV Circuit is used with the spontaneously breathing adult population (>21 years), specifically those with an ideal body weight of 30kg or above, that benefit from high flow therapy. The Adult Heated-Wire NIV Circuits are used for flow rates greater than 5 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. 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. {3}------------------------------------------------ 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the "Vyaire Medical" logo. The logo consists of a circular graphic on the left, with red and blue overlapping circles. To the right of the graphic is the word "Vyaire" in a stylized font, with the word "MEDICAL" in smaller letters below it. K231380 # 510(k) Summary AirLife DuoTherm™ Humidification System Date Prepared: August 8, 2023 This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR §807.92. - Submitter (21 CFR §807.92(a)(1)) l. Vyaire Medical, Inc. 26125 N. Riverwoods Blvd. Mettawa, IL 60045 USA Applicant: Aaron Lynch Title: Senior Regulatory Affairs Specialist aaron.lynch@vyaire.com Email: Official Correspondent: Megan Walsh Title: Manager, Regulatory Affairs Email: megan.walsh@vyaire.com II. Device Information (21 CFR §807.92(a)(2)) Device Name: AirLife DuoTherm™ Humidification System Proprietary Name: AirLife DuoTherm™ Device Classification: Class II Primary Product Code: BTT Regulation: Regulation Name: 21 CFR §868.5450 Respiratory gas humidifier 73 – Anesthesiology Humidifier Secondary Product Code: Common Name: Review Panel: Common Name: BZE Heated Breathing Circuits {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the VyAire Medical logo. The logo consists of three overlapping circles in red and blue, followed by the word "vyaire" in a dark blue sans-serif font. Below "vyaire" is the word "MEDICAL" in a smaller, red sans-serif font. #### III. Primary Predicate Device and Reference Device Information (21 CFR §807.92(a)(3)) | Primary Predicate Device | | | |-------------------------------------------------------|---------------|--------------------| | Device Name | 510(k) Number | Decision Date | | MR850 Respiratory Humidifier, Model MR850JHU | K033710 | April 13, 2004 | | Reference Devices | | | | Device Name | 510(k) Number | Decision Date | | MODELS MR700/MR720/MR730 DUAL SERVO<br>RESP HUMID ACC | K913368 | January 13, 1992 | | AirLife™ Autofill Humidification Chamber | K160764 | August 25, 2016 | | AirLife™ Adult Heated Wire Circuit | K153234 | July 7, 2016 | | AirLife™ Adult Heated Wire BiPAP/NIV Circuit | K170378 | September 14, 2017 | | AirLife™ Infant Heated Wire Circuit | K151303 | January 21, 2016 | #### IV. Device Description (21 CFR §807.92(a)(4)) The AirLife DuoTherm™ Humidification System is used to deliver heated, humidified breathing gases to a patient's airway when he/she is mechanically ventilated, receiving continuous noninvasive (NIV) positive airway pressure or high-flow oxygen therapy. The system is intended for use in a standard hospital or professional health care environment. The AirLife DuoTherm™ Humidification System consists of: - A heated humidifier, which includes reusable temperature probes, heated wire adapters, and a power cord, - A humidification chamber, and - . Heated wire circuits, which include neonate, pediatric, and adult single and dual limb circuits, as well as an adult heated wire NIV circuit. #### V. Intended Use (21 CFR §807.92(a)(5)) The AirLife DuoTherm™ Humidification System is intended to add moisture and warmth to breathing gases administered to patients that require assistance breathing or mucosal humidification. Gases that are available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract. ## Indications for Use: The AirLife DuoTherm™ Heated Humidifier is intended to add moisture to, and to warm, the breathing gases for administration to a patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for Vyaire Medical. The logo features a red and blue overlapping circle design on the left, followed by the word "Vyaire" in a stylized, sans-serif font. Below "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font. K231380 patients whose supraglottic airways have been bypassed. This product is non-sterile, reusable, and intended to be used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients ranging from neonates to adults using a heated humidifier. The product is a single-use device, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Neonate Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Neonate Heated-Wire Circuits are used with a pediatric population, specifically the neonate (birth to 28 days) and infant (29 days to 2 years) pediatric subgroups with an ideal body weight of 0.5 to 8kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Neonate Heated-Wire Circuits are used for flow rates greater than 1 LPM. The product is single patient use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Pediatric Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Pediatric Heated-Wire Circuits are used with the pediatric patient population, specifically infant (29 days to 2 years) and children (2 years to 12 years) with an ideal body weight of 6 to 42kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Pediatric Heated-Wire Circuits are used for flow rates greater than 2 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Adult Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire Circuits are used with the adult population and pediatric population, specifically those with an ideal body weight of 30kg or above, that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Adult Heated-Wire Circuits are used for flow rates greater than 3 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Adult Heated-Wire NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire NIV Circuit is used with the spontaneously breathing adult population (>21 years), specifically those with an ideal body weight of 30kg or above, that benefit from high flow therapy. The Adult Heated-Wire NIV Circuits are used for flow rates greater than 5 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. #### VI. Summary of Substantial Equivalence (21 CFR §807.92(a)(6)) {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the VyAire Medical logo. The logo consists of a stylized letter "V" in dark blue, followed by the rest of the company name in the same color. To the left of the name is a graphic of overlapping red and blue circles. The word "MEDICAL" is written in smaller, red letters below the company name. See below for a device comparison table for the AirLife DuoTherm™ Humidification System, which compares the system (subject device) to its primary predicate device (MR850 Heated Humidifier, K033710) and reference device (MR730 Heated Humidifier, K913368) with respect to intended use, technological characteristics, and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. ## Device Comparison Table – AirLife DuoTherm™ Humidification System | | Subject Device | Primary Predicate<br>Device | Reference Device | Comparison | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | AirLife<br>DuoTherm™<br>Humidification<br>System | MR850 Heated<br>Humidifier | MR730 Heated<br>Humidifier | | | | Manufacturer:<br>Vyaire Medical, Inc. | Manufacturer:<br>Fisher & Paykel<br>Healthcare, Ltd.<br>(K033710) | Manufacturer:<br>Fisher & Paykel<br>Electronics, Ltd.<br>(K913368) | | | | AirLife DuoTherm™ Humidification System | | | | | Intended Use | The AirLife<br>DuoTherm™<br>Humidification<br>System is intended<br>to add moisture<br>and warmth to<br>breathing gases<br>administered to<br>patients that<br>require assistance<br>breathing or<br>mucosal<br>humidification.<br>Gases that are<br>available for<br>medical use do not<br>contain sufficient<br>moisture and may<br>damage or irritate<br>the respiratory<br>tract. | The MR850<br>humidifier is<br>intended to add<br>moisture to, and<br>to warm, the<br>breathing gases<br>for administration<br>to a patient. Gases<br>available for<br>medical use do not<br>contain sufficient<br>moisture and may<br>damage or irritate<br>the respiratory<br>tract, or desiccate<br>secretions of<br>patients whose<br>supraglottic<br>airways have been<br>bypassed. | Not published on<br>the FDA website | The subject device<br>is similar to the<br>primary predicate<br>device cleared<br>under K033710.<br>Both are intended<br>to add moisture<br>and warmth to<br>breathing gases<br>administered to<br>patients.<br><br>Verbiage<br>differences<br>between the<br>intended use of<br>the subject device<br>and the primary<br>predicate device<br>are only cosmetic<br>in nature.<br><br>These differences<br>have no impact to | | | | | | K231380 | | | Subject Device | Primary Predicate Device | Reference Device | Comparison | | | AirLife<br>DuoTherm™<br>Humidification<br>System | MR850 Heated<br>Humidifier | MR730 Heated<br>Humidifier | | | | Manufacturer:<br>Vyaire Medical, Inc. | Manufacturer:<br>Fisher & Paykel<br>Healthcare, Ltd.<br>(K033710) | Manufacturer:<br>Fisher & Paykel<br>Electronics, Ltd.<br>(K913368) | | | | AirLife DuoTherm™ Humidification System | | | safety and<br>effectiveness. | | Principle of<br>Operation | The AirLife<br>DuoTherm™<br>Heated Humidifier<br>heats and<br>humidifies<br>respiratory gases<br>that are delivered<br>to patients via<br>mechanical<br>ventilation, the<br>trachea with<br>assisted, positive<br>air pressure, or a<br>nose and/or face<br>mask. | Heat is used to<br>provide<br>evaporated water<br>content to dry<br>breathing gases.<br>Heated or<br>unheated<br>breathing tubes<br>can be used to<br>deliver the<br>humidified gas to<br>the patient.<br>Heated breathing<br>tubes increase<br>operating<br>efficiency and<br>reduce excessive<br>water and heat<br>loss. | Not available | The subject device<br>is similar to the<br>primary predicate<br>device cleared<br>under K033710.<br>Both heat and<br>humidify<br>respiratory gases<br>that are delivered<br>to patients. | | | The AirLife<br>DuoTherm™<br>Humidification<br>Chamber fits to<br>the heated<br>humidifier and<br>holds the water<br>required to<br>humidify the<br>breathing gases<br>that are delivered<br>to patients. | The chamber<br>slides onto the<br>heater plate and<br>contains the water<br>supply for adding<br>humidity to<br>breathing gases. | | Verbiage<br>differences<br>between principle<br>of operation of the<br>subject device and<br>the primary<br>predicate device<br>are only cosmetic<br>in nature. | | | Resistance wires<br>within the tubing | Resistance wires<br>within the tubing<br>generate heat to | | These differences<br>have no impact to<br>safety and<br>effectiveness. | | | | | | | | K2313 | | 380 | | | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the VyAire Medical logo. The logo consists of a circular graphic on the left, with red and blue overlapping circles. To the right of the graphic is the company name, "VyAire" in a stylized, sans-serif font, with the word "MEDICAL" in smaller, red letters below it. The logo is clean and modern, with a focus on the company name. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Vyaire Medical. The logo consists of a circular graphic on the left, composed of overlapping red and blue shapes. To the right of the graphic is the word "Vyaire" in a stylized, sans-serif font, with the letters in a dark blue color. Below "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font, with the letters in a red color. | | | | | K23138 | |-----------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device<br>AirLife<br>DuoTherm™<br>Humidification<br>System | Primary Predicate<br>Device<br>MR850 Heated<br>Humidifier | Reference Device<br>MR730 Heated<br>Humidifier | Comparison | | | Manufacturer:<br>Vyaire Medical,<br>Inc. | Manufacturer:<br>Fisher & Paykel<br>Healthcare, Ltd.<br>(K033710) | Manufacturer:<br>Fisher & Paykel<br>Electronics, Ltd.<br>(K913368) | | | | | AirLife DuoTherm™ Humidification System | | | | | maintain<br>temperature and<br>humidity. | temperature and<br>humidity. | | | | Patient<br>Population | IDENTICAL TO<br>K033710 | Neonates to<br>Adults | Not available | The subject device<br>is identical to the<br>primary predicate<br>device cleared<br>under K033710. | | Use<br>Environment | Hospital, subacute<br>care facilities and<br>intra-hospital<br>transfer by trained<br>personnel | Hospital intensive<br>care units by<br>trained personnel | Hospital use by<br>trained personnel | The subject device<br>is similar to the<br>primary predicate<br>device and<br>reference device<br>cleared under<br>K033710 and<br>K913368,<br>respectively. All<br>are intended to be<br>used in a<br>professional<br>healthcare facility.<br>Verbiage<br>differences in use<br>environment<br>between the<br>subject device and<br>the primary<br>predicate and<br>reference devices<br>have no impact to<br>safety and<br>effectiveness. | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Vyaire Medical. The logo consists of a circular graphic on the left, with two overlapping circles in red and blue. To the right of the graphic is the word "Vyaire" in a stylized, sans-serif font, with the letters in dark blue. Below "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font, with the letters in red. | | Subject Device | Primary Predicate | Reference Device | Comparison | |----------------------------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | AirLife | Device | MR730 Heated | | | | DuoTherm™ | MR850 Heated | Humidifier | | | | Humidification | Humidifier | | | | | System | | Manufacturer: | | | | | Manufacturer: | Fisher & Paykel | | | | Manufacturer: | Fisher & Paykel | Electronics, Ltd. | | | | Vyaire Medical, | Healthcare, Ltd. | (K913368) | | | | Inc. | (K033710) | | | | | AirLife DuoTherm™ Humidification System | | | | | System<br>Components<br>(Comparison<br>on Subsequent<br>Pages) | IDENTICAL to<br>K033710 &<br>K913368 | Heated humidifier<br>(electrical<br>adapters and<br>temperature/flow<br>probes),<br>humidification<br>chamber, and<br>breathing circuits<br>(multiple<br>configurations) | Heated humidifier<br>(electrical<br>adapters and<br>temperature/flow<br>probes),<br>humidification<br>chamber, and<br>breathing circuits<br>(multiple<br>configurations) | The subject device<br>is identical to the<br>primary predicate<br>device and the<br>reference device<br>cleared under<br>K033710 and<br>K913368,<br>respectively. | #### VII. Performance Testing (21 CFR §807.92(b)(1)) The subject device was designed and tested in accordance with the consensus standards listed below: #### . Non-clinical Performance Testing | Standard | Description | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 80601-2-74:2017 | Medical electrical equipment – Part 2-74: Particular requirements for basic<br>safety and essential performance of respiratory humidifying equipment | | IEC 60601-1:2012 | Medical electrical equipment – Part 1: General requirements for basic<br>safety and essential performance | | IEC 60601-1-2:2014 | Medical electrical equipment – Part 1-2: General requirements for basic<br>safety and essential performance – Collateral standard: Electromagnetic<br>disturbances – Requirements and tests | | IEC TR 60601-4-2 | Medical electrical equipment – Part 4-2: Guidance and interpretation –<br>Electromagnetic immunity: Performance of medical electrical equipment<br>and medical electrical systems | | IEC 60601-1-6:2013-10 | Medical electrical equipment – Part 1-6: General requirements for basic<br>safety and essential performance – Collateral standard: Usability | | IEC 60601-1-8:2012 | Medical electrical equipment – Part 1-8: General requirements for basic<br>safety and essential performance – Collateral standard: General | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the VyAire Medical logo. The logo consists of a red and blue overlapping circle on the left, followed by the word "VyAire" in a stylized font. Below "VyAire" is the word "MEDICAL" in smaller, sans-serif font. The logo is clean and modern, with a focus on the company name. | | requirements, tests and guidance for alarm systems in medical electrical<br>equipment and medical electrical systems | |------------------|----------------------------------------------------------------------------------------------------------------------| | IEC 62366-1:2015 | Medical devices ">– Part 1: Application of usability engineering to medical | | | devices | | IEC 62304:2015 | Medical device software – Software life cycle processes | | ISO 5356-1:2015 | Anaesthetic and respiratory equipment – Conical connectors – Part 1: | | | Cones and sockets | | ISO 5367:2014 | Anaesthetic and respiratory equipment – Breathing sets and connectors | #### Biocompatibility ● | Standard | Description | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare<br>applications – Part 1: Evaluation and testing within a risk management<br>process | | ISO 18562-2:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare<br>applications - Part 2: Tests for emissions of particulate matter | | ISO 18562-3:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare<br>applications – Part 3: Tests for emissions of volatile organic compounds | | ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare<br>applications – Part 4: Tests for leachables in condensate | | ISO 10993-1:2018 | Biological evaluation of medical devices – Part 1: Evaluation and testing<br>within a risk management process | | ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity,<br>carcinogenicity and reproductive toxicity | | ISO 10993-5:2009 | Biological evaluation of medical devices – Part 5: Tests for in vitro<br>cytotoxicity | | ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for skin<br>sensitization | | ISO 10993-11:2017 | Biological evaluation of medical devices - Part 11: Tests for systemic<br>toxicity | | ISO 10993-12:2021 | Biological evaluation of medical devices – Part 12: Sample preparation and<br>reference materials | | ISO 10993-17:2002 | Biological evaluation of medical devices – Part 17: Establishment of<br>allowable limits for leachable substances | | ISO 10993-17:2022<br>(draft) | Biological evaluation of medical devices – Part 17: Establishment of<br>allowable limits for leachable substances (draft) | | ISO 10993-18:2020 | Biological evaluation of medical devices – Part 18: Chemical<br>characterization of medical device materials within a risk management<br>process | | ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the "Vyaire Medical" logo. The logo features a stylized graphic to the left of the text. The graphic consists of overlapping red and blue semi-circles. The text "Vyaire" is in a bold, sans-serif font, with the word "MEDICAL" in smaller, red, sans-serif letters below. | ISO 21726:2019 | Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents | |----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K23138 | | - Clinical Performance Data (21 CFR §807.92(b)(2)): There was no clinical testing required to . support the AirLife DuoTherm™ Humidification System, as the intended use and indications for use are equivalent to the primary predicate and reference devices. These types of devices, including the primary predicate device, have been on the market with a proven safety and efficacy record for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the AirLife DuoTherm™ Humidification System, and its safety and effectiveness. #### VIII. Substantial Equivalence Conclusion (21 CFR §807.92(b)(2)) The AirLife DuoTherm™ Humidification System is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: MR850 Heated Humidifier (K033710). The AirLife DuoTherm™ Humidification System met all specified criteria and did not raise new safety and/or effectiveness questions. The substantial equivalence of the subject device is based on similar indications for use, fundamental technology, including design, and operational principles. Based on the similarities to the primary predicate device, reference devices, and performance data, the AirLife DuoTherm™ Humidification System is substantially equivalent to its primary predicate device (K033710) and reference devices.