MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 5, 2015 Fisher & Paykel Healthcare Ltd Elizabeth Goldstein Regulatory Affairs Specialist 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand Re: K143646 Trade/Device Name: MR810 System Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: December 18, 2014 Received: January 7, 2015 Dear Ms. Goldstein, 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 {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, *Tejashri Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin Keith 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) K143646 Device Name MR810 System ### Indications for Use (Describe) The Fisher & Paykel MR810 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases, when using a continuous or intermittent ventilator system or a continuous gas flow system. The MR810 System is intended for both non-invasive therapies. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through non-invasive or invasive ventilation is beneficial to prevent drying of the patient airways. The MR810 System is for use for adult and pediatric patients requiring a flow range ≥5 L/min. The MR810 System is designed for use in hospitals, long term care facilities and homes under the prescription of a qualified medical professional. | 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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P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com Establishment registration number: 9611451 | Contact person/submitter | Elizabeth Goldstein | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Date prepared | 5 March 2015 | | Contact details | Address: 15 Maurice Paykel Place<br>East Tamaki<br>Auckland 2013, New Zealand<br>Telephone: +64 9 574 0100<br>Fax: +64 9 574 0158 | | Trade name | MR810 System | | Common name | Respiratory gas humidifier | | Classification name | Respiratory gas humidifier<br>II (21 CFR §868.5450), product code BTT | | Predicate device | K131957 MR810 System | | Reason for submission | Expanded indications | {4}------------------------------------------------ #### Device Description 5.1 The Fisher & Paykel MR810 System is intended to heat and humidify breathing gases and therefore meets the definition of a respiratory gas humidifier in accordance with 21 CFR §868.5450 and the FDA guidance document Heated Humidifier Review Guide. The MR810 System consists of the following components: - . MR810 Respiratory Humidifier; - . Accessories: - Breathing circuit (e.g. 900MR810 Adult Single Limb Circuit, 900MR810E o Adult Dual Limb Circuit); and - Humidification chamber (e.g. MR370 reusable humidification chamber). O The MR810 respiratory humidifier is an electrically-powered heat controller which utilizes a microprocessor with embedded software to control the heating elements. Unconditioned (i.e. cold, dry) gases are delivered to the MR810 System from a gas source (e.g. ventilator) via the dryline component of the breathing circuit. The unconditioned gases are transported to the humidification chamber where they are heated and humidified. The heated and humidified gases then travel down the inspiratory limb of the breathing circuit. The inspiratory limb of the 900MR810/900MR810E breathing circuits is electrically heated by means of a heaterwire in order to maintain the temperature of the gases. The heater wire is powered by the MR810 respiratory humidifier via a built-in heaterwire adaptor. When a return flow of expired gases from the patient to the gas source is required, the expired gases are transported via the expiratory limb of the breathing circuit. In other cases, the expired gases from the patient are exhaled into the environment, as per normal, unassisted breathing. #### Intended Use and Indications for Use 5.2 #### Intended Use 5.2.1 The Fisher & Paykel Healthcare MR810 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases to prevent drying of the patient's airways. The intended use of the subject device is identical to the intended use of the predicate device. # 5.2.2 Indications for Use The Fisher & Paykel MR810 System is intended to provide therapeutic levels of heat {5}------------------------------------------------ and humidity to a patient's inspired respiratory gases, when using a continuous or intermittent ventilator system or a continuous gas flow system. The MR810 System is intended for both non-invasive therapies. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through non- invasive or invasive ventilation is beneficial to prevent drying of the patient airways. The MR810 System is for use for adult and pediatric patients requiring a flow range ≥ 5 L/min. The MR810 System is designed for use in hospitals, long term care facilities and homes, under the prescription of a qualified medical professional. The indications for use of the subject device and the predicate device are identical with the exception of the applications for use, where: - . The indications for use statement for the subject device. MR810 System, has been revised to specify the intended patient population and operating flow range. - . The predicate device, MR810 System (K131957), is intended for use for non- invasive applications only. - . The subject device, MR810 System, is intended for use for both non-invasive and invasive applications. Performance bench testing has been carried out on the MR810 System which verifies that the system is suitable for use for invasive applications. #### Technological Characteristics Comparison 5.3 The subject device, MR810 System, is a modification of the predicate device, MR810 System (K131957). The subject device is identical to the predicate device with respect to: - Principle device design: The subject device, MR810 System, and the predicate . device, MR810 System (K131957), have identical principle device designs. Both the subject and predicate devices are heated passover humidifiers. - . Patient-contacting components (i.e. material biocompatibility): The subject device, MR810 System, and the predicate device, MR810 System (K131957), have identical patient-contacting components (i.e. breathing circuits, e.g. 900MR810 and 900MR810E, and humidification chambers, e.g. MR370). - . Energy source: The subject device, MR810 System, and the predicate device, MR810 System (K131957), use an identical energy source. Both the subject and predicate respiratory humidifier devices are powered via mains electricity and the heated breathing circuits are powered by the respiratory humidifier devices. - . Operation: The operation of the subject device, MR810 System, and the predicate device, MR810 System (K131957), is identical. Both the subject device and the predicate device have three temperature settings which can be selected by the operator, and two modes of operation which are specific to the type of breathing {6}------------------------------------------------ circuit used (i.e. heater-wire mode, non heater-wire mode). - Safety features: The subject device, MR810 System, and the predicate device, . MR810 System (K131957), have identical safety features. Both the subject device and predicate device have a "see manual" fault indicator, heater wire indicator and shut down mechanisms which render the system inoperable during fault conditions. - Sterility: The subject device, MR810 System, and the predicate device, MR810 . System (K131957), are identical in terms of sterility. No components of the subject device or the predicate device are sold sterile, nor are they intended to be sterilized prior to use. - Reusable accessories: The subject device, MR810 System, and the predicate device, . MR810 System (K131957), can be used with identical reusable accessories. Both the subject device and predicate device can be used with cleared Fisher & Paykel Healthcare reusable breathing circuits (e.g. 900MR810, 900MR810E) and cleared Fisher & Paykel Healthcare reusable humidification chambers (e.g. MR370). Minor revisions have been made to sub-components of the MR810 System assembly since submission of K131957. Performance bench testing has been carried out on the modified MR810 System which verifies that the revisions made to the assembly subcomponents does not raise any new questions of safety or effectiveness when compared with the predicate device. #### Non-Clinical Performance Data 5.4 Bench testing has been carried out on the MR810 System to demonstrate that the differences in indications for use and assembly sub-components does not raise any new questions or safety of effectiveness when compared with the predicate device. MR810 System (K131957). The following bench testing demonstrates subject and predicate devices are substantially equivalent: - System-level performance and safety testing in accordance with ISO 8185 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems. - . Basic safety and essential performance testing in accordance with IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. - . Basic safety and essential performance in accordance with IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. {7}------------------------------------------------ #### 5.5 Clinical Performance Data The subject device, MR810 System, is a modification to the legally marketed predicate device, MR810 System (K131957). Clinical performance data is not required as bench testing was sufficient to demonstrate substantial equivalence to the predicate device. #### Conclusions 5.6 The subject device, MR810 System, is a modification to the legally marketed predicate device, MR810 System. The subject device and the predicate device are identical in terms of the intended use, environment for use, principle device design, patient-contacting components and materials, biocompatibility, energy source, operation, safety features, sterility and reusable accessories. Since submission of K131957, the indications for use of the MR810 System have been expanded to include invasive applications. In addition, minor revisions have been made to MR810 System assembly sub-components. The differences between the subject device and the predicate device do not constitute significant changes in the materials, design, energy source or other features, as demonstrated through bench testing, and therefore the MR810 System is substantially equivalent to the predicate device, MR810 System (K131957).