F&P Brevida™ Nasal Pillows Mask

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 18, 2017 Fisher & Paykel Healthcare Ltd. Masar Mohammad Regulatory Affairs Specialist 15 Maurice Paykel Place, East Tamaki Auckland 2013 New Zealand Re: K161412 Trade/Device Name: F&P Brevida™ Nasal Pillows Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 19, 2016 Received: December 22, 2016 Dear Masar Mohammad: 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 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 {1}------------------------------------------------ the quality systems (OS) 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 Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K161412 Device Name F&P Brevida Nasal Pillows Mask ### Indications for Use (Describe) The F&P Brevida™ Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Therapy. The F&P Brevida™ Nasal Pillows Mask is intended for single patient adult (> 66 los (30kgs)) use in the home and multiple patient adult use in the clinical setting where proper disinfection of the device can occur between patient uses. | 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. 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, sans-serif font, with the "&" symbol in between. Below this, there is a horizontal line, and below that, the word "HEALTHCARE" is in a smaller, bold, sans-serif font. The entire logo is in a dark blue color. # 5. 510(k) Summary | Contact person/submitter | Masar Mohammad | |--------------------------|-----------------------------------------| | Date prepared | 17 Jan 2017 | | Contact details | Address: 15 Maurice Paykel Place | | | East Tamaki | | | Auckland 2013, New Zealand | | | Telephone: +64 9 574 0100 | | | Fax: +64 9 574 0158 | | Trade name | F&P Brevida™ Nasal Pillows Mask | | Common name | Nasal Pillows Mask | | Classification name | Non Continuous Ventilator (IPPB) | | | Class II (21 CFR §868.5905) | | | Product code BZD (Anaesthesiology) | | Predicate device | K120027 F&P Pilairo™ Nasal Pillows Mask | #### Device Description 5.1. The F&P Brevida™ Nasal Pillows Mask is a non-invasive patient interface with a silicone seal that encloses the nasal airway entrance. The mask is held on the face with a headgear. The mask connects to a single breathing tube by a 22mm swivel adaptor to receive pressurized gases from a continuous airway pressure device (CPAP or Bi-Level). The exhaust holes on the elbow of the mask allow exhaled gases to be flushed out while the system is in operation. The F&P Brevida™ Nasal Pillows Mask is a prescription only device, provided in a nonsterile state. #### 5.2. Intended Use The F&P Brevida™ Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Therapy. The F&P Brevida™ Nasal Pillows Mask is intended for single patient adult (≥ 66lbs (30kgs)) use in the home and multiple patient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses. #### Technological Characteristics Comparison 5.3. The F&P Brevida™ Nasal Pillows Mask has the following similarities to the previously cleared predicate Pilairo™ Nasal Pillows Mask (K120027). - Substantially equivalent intended use with same patient population and operating environment. - . Same mode of operation whereby both masks deliver gases through the nose. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a bold, sans-serif font, with the "&" symbol connecting the two names. A horizontal line runs beneath the company name. Below the line, the word "HEALTHCARE" is written in a similar bold, sans-serif font, but slightly smaller than the company name. - Same breathing tube connection mechanism via a 22mm male connector. ● - . Same silicone seal mechanism where mask seals on the entrance of the nostrils as well as around the nose. - . Both new and predicate device headgear are designed to attach at the same two point on the mask frame. The key differences to the predicate device are that the F&P Brevida™ Nasal Pillows Mask: - . Has colour cues (VisiBlue™) added to swivel, frame, seal, and headgear components to aid the user in the reassembly and orientation of the mask. - . Provide a diffuser system in which the diffuser mat and the cover have been integrated into a single component. This component is washable. - . Has a detachable elbow to aid in mask cleaning and disinfection during multi-patient use. - . Has an adjustable headgear. The below table provides a side-by-side comparison of the subject and predicate devices. Table 1: Device Comparison Table | | F&P Brevida™ Nasal<br>Pillows Mask | F&P Pilairo™ Nasal<br>Pillows Mask | Comments | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Indications for use and intended use | | | | Intended use | The F&P Brevida™ Nasal<br>Pillows Mask is intended<br>to be used by individuals<br>who have been diagnosed<br>by a physician as<br>requiring CPAP or Bi-<br>Level Therapy. The F&P<br>Brevida™ Nasal Pillows<br>Mask is intended for<br>single patient adult (≥<br>66lbs (30kgs)) use in the<br>home and multiple patient<br>adult use in the hospital or<br>other clinical setting<br>where proper disinfection<br>of the device can occur<br>between patient uses. | The F&P Pilairo™ Nasal<br>Pillows Mask is intended<br>to be used by individuals<br>who have been<br>diagnosed by a physician<br>as requiring CPAP or Bi-<br>Level Ventilator Therapy.<br>The F&P Pilairo™ Nasal<br>Pillows Mask is intended<br>for single-patient adult<br>use in the home and<br>multiple-patient adult use<br>in the hospital or other<br>clinical setting where<br>proper disinfection of the<br>device can occur between<br>patient uses. | Identical intended use and patient<br>population. The Intended Use of the<br>F&P Brevida specifies the minimum<br>weight of an adult patient.<br>Specifying the weight of an adult<br>patient was not found to introduce<br>any new risks to the device and<br>does not alter the intended use of<br>the device. | | Availability | Prescription use<br>(Part 21 CFR 801 Subpart<br>D) | Prescription use<br>(Part 21 CFR 801 Subpart<br>D) | Identical | | Patient<br>Population | Adult | Adult | Identical | | Classification | | | | | Product<br>Code | BZD | BZD | Identical | | Device<br>classification | 868.5905 | 868.5905 | Identical | | | F&P Brevida™ Nasal<br>Pillows Mask | F&P Pilairo™ Nasal<br>Pillows Mask | Comments | | Classification<br>panel | Anaesthesiology | Anaesthesiology | Identical | | | Operation and safety features | | | | Operating<br>Environment | Home, hospital or other<br>clinical setting | Home, hospital or other<br>clinical setting | Identical | | Breathing<br>Circuit | Single Inspiratory Tube | Single Inspiratory Tube | Identical | | Exhalation<br>Vent | Numerous tiny vent holes<br>in Elbow | Numerous tiny vent holes<br>in Elbow | Identical | | Breathing<br>Tube<br>connection to<br>mask | 22mm ISO Taper | 22mm ISO Taper | Identical | | Fixation | Headgear with 2<br>attachment points | Headgear with 2<br>attachment points | Identical | | Headgear<br>Release | One hook connection per<br>side to the mask frame | One hook connection per<br>side to the mask frame | Identical | | Face<br>Coverage | Direct Nasal | Direct Nasal | Identical | | Dead Space | Dynamic<br>29.27cc (XS-S)<br>33.14cc (M-L) | Dynamic<br>32cc (Single size) | The dead space of the small seal is<br>less than that of the predicate,<br>while the larger seal has more dead<br>space. Both seal sizes are in<br>conformance with ISO 17510-2<br>(2007) and this difference does not<br>introduce any additional risk to the<br>user. For additional information<br>please refer to Test Report TR-<br>27521 Attached in Appendix I. | | Patient<br>Consciousness | Responsive and able to<br>remove mask | Responsive and able to<br>remove mask | Identical | | Pressure<br>Range | 4 to 25 cm H20 | 4 to 25 cm H20 | Identical | | | Components and materials | | | | Sterility | Device not provided<br>sterile | Device not provided<br>sterile | Identical | | Reusability | Reusable –<br>Multi Patient Use | Reusable –<br>Multi Patient Use | Identical | | High Level<br>Disinfection<br>Methods | Thermal Disinfection<br>(80°C for 10 mins and<br>75°C for 30 mins) | Sterrad 100S, Cidex OPA,<br>Thermal Disinfection | The parameters used for the<br>thermal disinfection are identical.<br>Please see Section 14 for testing of<br>both sets of parameters. | | Facial Seal | Soft pliable seal between<br>mask base and nares | Soft pliable seal between<br>mask base and nares | Identical | | Seal sizes | Available in two different<br>sizes (XS-S, and M-L) | 1 size | The subject device has two seal | | | F&P Brevida™ Nasal<br>Pillows Mask | F&P Pilairo™ Nasal<br>Pillows Mask | Comments | | | | | not been found to introduce any<br>additional risk to the patient. Both<br>seal sizes have undergone product<br>verification and meet all productrequirements. Please see Section<br>18 for details on performance<br>testing. | | Mask Frame | Two piece coloured/clear<br>polycarbonate with<br>connection for elbow,<br>silicone seal, and<br>headgear | Two piece coloured / clear<br>polycarbonate with<br>connection for silicone<br>seal, and headgear | The components and structure of<br>the mask frame is identical,<br>however, there have been some<br>changes in the materials used. The<br>new materials have been assessed<br>for biocompatibility and no<br>additional risk to the patient was<br>found to have been introduced due<br>to the new materials. Please refer<br>to Section 15 for Biocompatibility<br>assessment. | | Mask Elbow<br>Design | Removable | Non-removable | The F&P Brevida™ Nasal Pillows<br>Mask has a removable elbow to aid<br>the user in the cleaning and<br>disinfection of the mask during<br>multi-patient reuse. | | Headgear | Adjustable headgear<br>made up of one strap,<br>elastic. | Non-adjustable headgear.<br>Headgear is elastic. | The design of the subject device<br>headgear consists of two parts. At<br>the back of the headgear, two<br>straps form a halo which is then<br>connected to a single strap on<br>either side. This is different to the<br>single strap of the predicate device.<br>Additionally, the headgear used in<br>the predicate would stretch to fit the<br>patient, while the subject device's<br>headgear is adjustable. These<br>differences are intended to better fit<br>a larger percentage of the patient<br>population and have not been<br>found to introduce any new risk to<br>the patient. | | Accessories | | | | | Oxygen/Pres<br>sure Port<br>(900HC452) | Available as a separate<br>part, not provided with<br>device. | Available as a separate<br>part, not provided with<br>device. | Identical - The Oxygen/Pressure<br>port is the same accessory used<br>with the predicate device. This<br>accessory was cleared under<br>K023559 and has not been<br>modified. | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, blue font on the top line. Underneath that, there is a blue line, and then the word "HEALTHCARE" is in a smaller, bold, blue font. {6}------------------------------------------------ ## F&P Brevida™ Nasal Pillows Mask – Traditional 510(k) Image /page/6/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, blue font. Below that, the word "HEALTHCARE" is in a smaller, bold, blue font. There is a blue line above the word "HEALTHCARE". {7}------------------------------------------------ #### 5.4. Non-Clinical Performance Data Testing of the Brevida™ Nasal Pillows Mask was compared to the predicate K120027 F&P Pilairo™ Nasal Pillows Mask for performance. These tests demonstrate substantial equivalence of the Brevida™ Nasal Pillows Mask to the predicate device. The results of the comparative bench testing do not raise any new questions of safety or effectiveness for the F&P Brevida™ Nasal Pillows Mask. The Brevida™ Nasal Pillows Mask has been tested to the following standards: - ISO 17510-2:2007, Sleep Apnoea Breathing Therapy- Part 2: Masks and Application . Accessories - ISO 5356-1:2004, Anaesthetic and respiratory equipment- Conical connectors: Part ● 1: Cones and sockets. - ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. - . ISO 10993-2:2006, Biological evaluation of medical devices – Part 2: Animal Welfare requirements. - . ISO 10993-3:2014, Biological evaluation of medical devices - Part 3: Tests for Genotoxicity Carcinogenicity and reproductive toxicity. - . ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - . ISO 10993-6:2007, Biological evaluation of medical devices – Part 6: Tests for local effects after implantation. - . ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. - ISO 10993-11:2006, Biological evaluation of medical devices – Part 11: Tests for systemic Toxicity. - . ISO 10993-12:2012, Biological evaluation of medical devices - Part 12: Sample preparation and reference material. - . ISO 10993-17:2002, Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances. - ISO 10993-18:2005, Biological evaluation of medical devices – Part 18: chemical characterization of materials. #### 5.5. Clinical Performance Data Substantial equivalence was not based on an assessment of clinical performance data #### 5.6. Conclusions The comparison of features, performance, and intended use demonstrate that the Brevida™ Nasal Pillows Mask is substantially equivalent to the predicate K120027 F&P Pilairo™ Nasal Pillows Mask.