HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT

{0}------------------------------------------------ ## HC550 System 510(k) Notification K132017 ### 510(k) Summary 5 # MAR 2 5 2014 5-1 Image /page/0/Picture/5 description: The image shows the logo for Fisher & Paykel. The words "Fisher & Paykel" are on the top line, with an ampersand between the two words. The word "Healthcare" is on the second line, in all caps. 15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com | Contact person/submitter | Elizabeth Goldstein | |--------------------------|-------------------------------------------------------------------------------| | Date prepared | 26 March 2014 | | Contact details | Address: 15 Maurice Paykel Place<br>East Tamaki<br>Auckland 2013, New Zealand | | | Telephone: +64 9 574 0100 | | | Fax: +64 9 574 0148 | | Trade name | HC550 System | | Common name | Respiratory gas humidifier | | Classification name | Respiratory gas humidifier<br>II (21 CFR §868.5450), product code BTT | | Predicate device | K073706 Respiratory Humidifier, Model 850 | {1}------------------------------------------------ ## 5.1 Device Description The Fisher & Paykel Healthcare HC550 System is designed to condition gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases. The HC550 System consists of the following components: - . HC550 Respiratory Humidifier - . Accessories: - a) Breathing circuit (compatible adult breathing circuits as cleared in K983112, K020332, K034026, K103767, K122432) - b) Humidification Chamber (as cleared in K9341401 and K913368) - c) Heaterwire Adaptor (as cleared in K073706) - d) Temperature/Flow Probe (as cleared in K983112) - RT008 Air Entrainer (optional oxygen therapy accessory) (as cleared in K953711) e) The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a humidification chamber. A dryline tube (part of the breathing circuit) transports respiratory gases from a flow source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified. The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube may be electrically heated by means of a heater-wire placed internally to the tube, which is controlled by the HC550 respiratory humidifier. The expiratory limb of the breathing circuit transports expired gas from patient. In the case of a dual-heated breathing circuit, this limb may also be heated in the same manner as the inspiratory limb. If a heated breathing circuit is used, the heaterwire adaptor provides electrical energy from the respiratory humidifier to the heaterwire in the breathing circuit. Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient. Note 1: The MR290 Autofeed Humidification Chamber was originally cleared for market under K934140. Since clearance, there have been two changes to the materials used to construct the device, as currently constructed (i.e. with materials which have been modified since under K934140) has been cleared for market under K131957. #### 5.2 Intended Use HC550 System: The Fisher & Paykel HC550 System is designed for use with artificial ventilation systems. Portable volume ventilation systems, pressure support ventilation and Continuous Positive Airway Pressure (CPAP) systems may incorporate an HC550 to provide therapeutic levels of warm humidified air to adult patients with artificial airways or through mask ventilation. The operating flow range is 5 to 120L/min depending on the patient interface. The HC550 is designed for use in long term care facilities or the home under the prescription of a qualified medical professional. {2}------------------------------------------------ ## 5.2.1 Intended Use Comparison The intended uses of the subject device, HC550 System, and the predicate device, MR850, are identical with the exception of the following: - . The environment for use. Table 1 provides a comparison of the intended use of the HC550 and MR850, where differences are highlighted in gray. | Table 1 HC550 and MR850 intended use comparison summary | | | | |---------------------------------------------------------|--|--|--| |---------------------------------------------------------|--|--|--| | Device feature | HC550 (modified) | MR850 (predicate) | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Purpose and function | Addition of therapeutic levels of<br>heat & humidity to inspired<br>respiratory gases | Addition of therapeutic levels of heat<br>& humidity to inspired respiratory<br>gases | | Patient population | Patients requiring mechanical<br>ventilation or positive pressure<br>breathing assistance, via face non-<br>invasive or invasive | Patients requiring mechanical<br>ventilation or positive pressure<br>breathing assistance, via face non-<br>invasive or invasive | | Environment for use | Long term care facilities or the<br>home<br>Note: The power output of the<br>HC550 has been software limited<br>for home use. Refer to \$5.3. | Hospital | #### Technological Characteristics Comparison 5.3 The electrical hardware of the subject device, HC550 System, and the predicate device, MR850, are identical and therefore the HC550 System is physically and electrically compatible with accessories designed for the MR850 system. However, although the MR850 may be used with adult, infant or neonatal breathing circuits, the HC550 System is being submitted for use with adult breathing circuit accessories. Table 2 provides a comparison of the accessories for the HC550 and MR850, where differences are highlighted in gray. | Device feature | HC550 (modified) | MR850 (predicate) | |---------------------------|-------------------------------------------------------|-------------------------------------------------------| | Humidification chamber | Fisher & Paykel Healthcare<br>humidification chambers | Fisher & Paykel Healthcare<br>humidification chambers | | Breathing circuit - Adult | • Single-heated | • Single-heated | | | • Dual-heated | • Dual-heated | | | • Non-heated | • Non-heated | Table 2 HC550 and MR850 accessories comparison summary {3}------------------------------------------------ | Device feature | HC550 (modified) | MR850 (predicate) | |-------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Breathing circuit - Infant/Neonatal | None | Single-heated Dual-heated Non-heated | | Electrical adaptor | Fisher & Paykel Healthcare Dual<br>Limb Smart Adaptor and Single<br>Limb Smart Adaptor | Fisher & Paykel Healthcare Dual<br>Limb Smart Adaptor and Single<br>Limb Smart Adaptor | | Temperature / flow probe | Fisher & Paykel Healthcare<br>Temperature / Flow Probes | Fisher & Paykel Healthcare<br>Temperature / Flow Probes | | Oxygen therapy | RT008 Air Entrainer | RT008 Air Entrainer | | Mounting accessories | Fisher & Paykel Healthcare<br>ventilator brackets | Fisher & Paykel Healthcare<br>ventilator brackets | The HC550 and MR850 have identical physical characteristics, with minor aesthetic differences. Table 3 provides a comparison of the physical descriptions of the HC550 and MR850, where differences are highlighted in gray. | Device feature | HC550 (modified) | MR850 (predicate) | |-------------------------------|------------------|-------------------| | Height | 140 mm (5.5 in) | 140 mm (5.5 in) | | Weight | 2.8 kg (6.2 lb) | 2.8 kg (6.2 lb) | | Finger guard (color) | White | Blue | | Lens | 2 button design | 3 button design | | (Button location and opacity) | Opaque display | Clear display | Table 3 HC550 and MR850 physical descriptions comparison summary The heating hardware and electrical specifications of the HC550 and MR850 are identical, however the power has been software limited for use in the home. Table 4 provides a comparison of the functional characteristics of the HC550 and MR850, where differences are highlighted in gray. | Table 4 HC550 and MR850 functional characteristics comparison summary | | | |-----------------------------------------------------------------------|------------------|--| | Device feature | HC550 (modified) | | | Device feature | HC550 (modified) | MR850 (predicate) | |----------------|------------------------------|-------------------| | Heater-plate | Aluminum 100 mm Ø | Aluminum 100 mm Ø | | Voltage | 115 Vac | 115 Vac | | Frequency | 50 or 60 Hz | 50 or 60 Hz | | Current | 2.0 A maximum | 2.0 A maximum | | Power | 150 W | 150 W | | | · (Software limited to 105W) | | #### Non-Clinical Tests 5.4 The HC550 is compliant with the same product standards (or equivalent product standards) as the predicate device, MR850. Table 5 provides a comparison of the product standards for the HC550 and MR850. {4}------------------------------------------------ | Standard | HC550 (Modified device) | MR850 (Predicate device) | |-------------------|------------------------------------------------------|------------------------------------------------------| | ISO 8185: 1997 | Compliant with ISO 8185:1997 | Compliant with ISO 8185:1997 | | IEC 60601-1: 1988 | Compliant with IEC 60601-1:1998<br>+A1:1991 +A2:1995 | Compliant with IEC 60601-1:1998<br>+A1:1991 +A2:1995 | | IEC 60601-1-2 | Compliant with IEC 60601-1-2:2007 | Compliant with IEC 60601-1-2:2001 | #### Table 5 HC550 and MR850 functional characteristics comparison summary Compliance of the subject device, HC550 System, and the predicate device, MR850, to the same device standards supports substantial equivalence of these products. In addition, testing to ISO 8185:2007, the particular standard for humidification systems, supports performance of the subject device in accordance with the intended use (i.e. to heat and humidify gases) and substantial equivalence to the predicate device, MR850. As summarized in Table 6 below, the humidity output of both the subject device, HC550 System, and the predicate device, MR850, meets the performance requirements and the enthalpy requirements as specified in ISO 8185:2007 and therefore the performance of the devices is substantially equivalent. | Standard | HC550 (Modified device) | MR850 (Predicate device) | |-------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------| | Humidity performance<br>(for non-invasive mode) | ≥ 10 mg/L over the recommended<br>flow ranges<br>(as required by ISO 8185) | ≥ 10 mg/L over the recommended<br>flow ranges<br>(as required by ISO 8185) | | Humidity performance<br>(for invasive mode) | ≥ 33 mg/L over the recommended<br>flow ranges<br>(as required by ISO 8185) | ≥ 33 mg/L over the recommended<br>flow ranges<br>(as required by ISO 8185) | | Enthalpy | < 194 kJ/kg dry gas<br>(as required by ISO 8185) | < 194 kJ/kg dry gas<br>(as required by ISO 8185) | Table 6 HC550 and MR850 functional characteristics comparison summary ## 5.4.1 Biocompatibility The HC550 System was assessed for biocompatibility in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing and 510(k) Memorandum - #G95-1 Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'. The method of assessing biocompatibility of the subject device, HC550 System, is identical to the method of assessing biocompatibility of the predicate device, MR850. All equivalent components of the HC550 and MR850 Systems have been assessed as having identical patient contact and duration of contact. All patient-contacting accessories which are accessories to the subject device, HC550 System, are also accessories to the predicate device, MR850, i.e. all patient-contacting devices are identical and no new patient-contacting accessories are being presented as part of this 510(k) submission. A summary of the biocompatibility assessments of the HC550 and MR850 is provided in Table 7 below. | System<br>component | Summary of<br>biocompatibility -<br>HC550 (Modified device) | Summary of<br>biocompatibility -<br>MR850 (Predicate<br>device) | Comments | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Respiratory<br>humidifier | Non-patient contact device<br>(no biocompatibility<br>testing required) | Non-patient contact device<br>(no biocompatibility<br>testing required) | Identical | | Breathing<br>circuit<br>accessories | External communicating<br>device<br>(tissue/bone/dentin);<br>permanent contact | External communicating<br>device<br>(tissue/bone/dentin);<br>permanent contact | Identical<br>All breathing circuits<br>recommended for use with<br>the HC550 and/or MR850<br>have been previously<br>cleared. Biocompatibility<br>testing for breathing circuit | | Fisher & Paykel Healthcare | HC550 System | | 510(k) Notification<br>5-6 | | | | | accessories is as per the<br>relevant 510(k) submissions. | | | | | Refer to 510(k) K983112,<br>K020332, K122432. | | Humidification<br>chamber<br>accessories | External communicating<br>device<br>(tissue/bone/dentin);<br>permanent contact | External communicating<br>device<br>(tissue/bone/dentin);<br>permanent contact | Identical<br>All humidification chambers<br>recommended for use with<br>the HC550 and/or MR850<br>have been previously<br>cleared. Biocompatibility<br>testing for humidification<br>chamber accessories is as<br>per the relevant 510(k)<br>submissions. | | | | | Refer to 510(k) K934140',<br>K913368. | | | | | Note 1: The MR290<br>Autofeed Humidification<br>Chamber was originally<br>cleared for market under<br>K934140. Since clearance,<br>there have been two changes<br>to the materials used to<br>construct the device. The<br>device, as currently<br>constructed (i.e. with<br>materials which have been<br>modified since clearance<br>under K934140) has been<br> | | Temperature /<br>flow probe<br>accessories | Primarily non-patient contactFlow probe stem is an external communicating device (tissue/bone/dentin); permanent contact | Primarily non-patient contactFlow probe stem is an external communicating device (tissue/bone/dentin); permanent contact | Identical<br>All temperature/flow probes<br>recommended for use with<br>the HC550 and MR850 have<br>been previously cleared.<br>Biocompatibility testing for<br>temperature/flow probe<br>accessories is as per the<br>relevant 510(k) submissions.<br>Refer to 510(k) K983112. | | Heater wire<br>adaptor | Non-patient contact device<br>(no biocompatibility | Non-patient contact device<br>(no biocompatibility | Identical | {5}------------------------------------------------ #### Clinical Tests ર્ફ્ર ફંડ Not applicable - no clinical testing was performed with respect to the HC550 System. #### Conclusion 5.6 A comparison of the physical and functional characteristics and biocompatibility demonstrates technological equivalence, where only minor differences between the devices exist for aesthetic purposes a revised environment for use. In addition, the subject device is being presented with adult accessories only, whereas the predicate device is presented with adult and infant/neonatal accessories. The aforementioned differences do not affect safety or effectiveness of the subject device. The comparison of the intended purpose/function of the HC550 to the MR850 demonstrates that the systems are substantially equivalent in terms of clinical purpose. Performance of these devices is supported by bench testing, which demonstrates equivalent performance in accordance with the particular standard for humidification systems, ISO 8185. {6}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. #### Public Health Service Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 25, 2014 Fisher & Paykel Healthcare Ltd. Elizabeth Goldstein Regulatory Affairs Specialist 15 Maurice Paykel Place East Tamaki Auckland, New Zealand Re: K132017 Trade/Device Name: HC550 System Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: February 16, 2014 Received: February 18, 2014 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. {7}------------------------------------------------ ## Page 2 - Ms. Elizabeth Goldstein 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Image /page/7/Picture/8 description: The image shows a signature on the left and the text "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR" on the right. The signature is illegible. The text is in a simple, sans-serif font. The word "FOR" is at the bottom right of the image. Erin I. Keith M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infectious Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K132017 ### Device Name HC550 System Indications for Use (Describe) Indications for Use: ### HC550 System: The Fisher & Paykel HC550 System is designed for use with artificial ventilation systems. Portable volume ventilation systems, pressure support ventilation and Continuous Positive Airway Pressure (CPAP) systems may incorporate an HC550 to provide therapeutic levels of warm humidified air to adult patients with artificial airways or through mask ventilation. The operating flow range is 5 to 120L/min depending on the patient interface. The HCS50 is designed for use in long term care facilities or the home under the prescription of a qualified medical professional. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY 1 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 19 .............................................................................................................................................................................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....... Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID 2014.03.25 14:50:11 -04'00' FORM FDA 3881 (9/13) Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. > FF PSC Publicitions: Services (301) 441-6740 {9}------------------------------------------------ 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 mainlain 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."