Oran Park Mask

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October 19, 2023 ResMed Pty Ltd (Registration Number: 3004604967) % Sheila Bruschi Senior Director, Regulatory Affairs ResMed Corp (Registration Number: 3007573469) 9001 Spectrum Center Boulevard San Diego, California 92123 Re: K230476 Trade/Device Name: Oran Park Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: September 22, 2023 Received: September 22, 2023 Dear Sheila Bruschi: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. ## Rachana Visaria -S Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices {2}------------------------------------------------ Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230476 Device Name Oran Park Mask Indications for Use (Describe) The Oran Park mask is intended for use in the home or hospital/institutional environment on patients weighing more than 661b (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. Only the Sleep Lab Mask (SLM) variant is intended and validated for multi-patient reuse and must be reprocessed if reused between patients. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="font-size: 12px;"> <span style="text-decoration: line-through;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-----------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 12px;">□ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Traditional 510(k) # 510(k) Summary [As required by 21 CFR 807.921(c)] | Date of Submission: | 22 February 2023 | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Name/Owner: | ResMed Pty Ltd<br>1 Elizabeth Macarthur Drive<br>Bella Vista, NSW, 2153 Australia | | Prepared and Submitted by: | Ms Daniellia Chan<br>Regulatory Affairs Specialist<br>Tel: +65 65727166<br>daniellia.chan@resmed.com.sg | | Official Contact: | Ms Sheila Bruschi<br>Senior Director, Regulatory<br>Affairs ResMed Corp<br>9001 Spectrum Center Blvd<br>San Diego CA 92123 USA<br>Tel: +1 858 922 1803<br>sheila.bruschi@resmed.com | | Device Trade Name: | Oran Park Mask | | Device Common Name: | Vented Full Face Mask | | Classification and<br>Classification Name: | 21 CFR 868.5905, 73 BZD (Class II)<br>Accessory to Noncontinuous Ventilator (IPPB) | | Product Code: | BZD | | Legally Marketed Predicate<br>Device: | AirFit F20 (K153563) | | Reference Device: | Moore Park (K183512) | | Submission Reason: | New Device | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the ResMed logo. The logo consists of a curved line of dots that transition in color from blue to red. Below the dots, the word "ResMed" is written in a bold, sans-serif font. #### Device Description The Oran Park Mask is an accessory to deliver air flow and positive air pressure generated by positive airway pressure (PAP) devices such as CPAP or bi-level flow generator systems to the patient's airway, for the treatment of Obstructive Sleep Apnea (OSA) or ventilator support (non-life support). It delivers the treatment pressure from the source device to the patient's upper airway by providing an air seal between the PAP device and under the patient's nose and mouth. There are 2 variants to the Oran Park Mask: - . Oran Park Mask (Home Use) Intended for single patient re-use (SPMU) for home use. It is configured with a diffused venting port located on the elbow, known as the QuietAir elbow. - . Oran Park SLM (Sleep Lab Mask) Intended for multi-patient re-use (MPMU) and must be reprocessed if reused between patients. It is configured with a non-diffused venting port located on the elbow, known as the Multihole elbow. The Oran Park mask comprises of 4 sub-assemblies: headgear, frame, cushion and elbow. The venting ports and anti-asphyxia valve are incorporated into the elbow assembly. There are four magnets incorporated in the Oran Park mask – two magnets in the frame assembly and 2 magnets in the lower headgear clips – with a magnetic field strength up to 400 mT. The mask help facilitate attaching and detaching the headgear to the mask frame when regularly fitting the mask for use. The cushion and headgear are available in various sizes to fit a wide patient population. Soft wraps, which are attached to the Oran Park mask frame, are available as an optional accessory for patient's comfort. The Oran Park mask is a prescription device and is supplied non-sterile. #### Indication For Use The Oran Park full face mask is intended for use in the home or hospital/institutional environment on patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. Only the Sleep Lab Mask (SLM) variant is intended and validated for multi-patient reuse and must be reprocessed if reused between patients. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for ResMed. The logo consists of a curved line of dots that transitions in color from blue to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font. Traditional 510(k) # Comparison table | Design Parameter or | Predicate Device AirFit F20 | Subject Device | Comments | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | feature | K153563 | Oran Park Mask System | | | | | K230476 | | | Indication for Use | The AirFit F20 is to be used by patients<br>weighing more than 66lb (30kg) for<br>whom positive airway pressure therapy<br>(non-invasive CPAP or bi-level positive<br>airway pressure (PAP) therapy) has<br>been prescribed. | The Oran Park mask is intended for use in<br>the home or hospital/institutional<br>environment on patients weighing more<br>than 66lb (30kg), who have been prescribed<br>non-invasive CPAP or bi-level positive airway<br>pressure (PAP) therapy. | Equivalent | | | It is intended for single-patient reuse in<br>the home environment and multi-<br>patient reuse in the<br>hospital/institutional environment. | Only the Sleep Lab Mask (SLM) variant is<br>intended and validated for multi-patient<br>reuse and must be reprocessed if reused<br>between patients. | | | FDA Product Code | BZD | BZD | Identical | | Reprocessing | Single patient re-use or multi-patient<br>re-use | Single patient re-use (Oran Park Mask) or<br>multi-patient re-use (Oran Park SLM) | Identical | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for ResMed. The logo features a series of colored dots arranged in a curved line, transitioning from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font. | Physical Dead space (mL) | Small Cushion: 199mL<br>Medium Cushion:219mL<br>Large Cushion: 240mL | | Small Cushion: 101.1mL<br>Medium Cushion: 107.6mL<br>Large Cushion: 107.0mL | | This is a record-only parameter | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------| | Leakage | Pressure (cmH2O) | Flow (L/min) | Flow (L/min) | | Equivalent | | | 3 | 19 | N/A | | | | | 4 | 22 | 20 | | | | | 13 | 42 | 38 | | | | | 22 | 57 | 51 | | | | | 31 | 70 | 62 | | | | | 40 | 82 | 72 | | | | Use Life | AirFit F20 (single patient, multi-use):<br>Visual inspection per instructions for use<br>AirFit F20 (multi patient, multi-use): 30 validated reprocessing cycles | | | Oran Park mask: Visual inspection per instructions for use<br>Oran Park SLM: 30 validated reprocessing cycles | Identical | | Operating and storage temperature | Operating temperature: 5°C to 40°C<br>Storage temperature: -20°C to +60°C | | | Operating temperature: 5 to 40 °C<br>Storage temperature: -20 to +60°C | Identical | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the ResMed logo. The logo consists of a curved line of dots that transition in color from blue to red. Below the dots is the text "ResMed" in a bold, sans-serif font. | Sound power level and<br>sound pressure | Tested and declared in accordance with<br>ISO4871 and ISO3744 | Tested and declared in accordance with<br>ISO4871 and ISO3744 | Equivalent | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cushion assembly<br>design | Seals above the nose and around the<br>mouth | Seals under the nose and around the mouth | Equivalent | | Elbow assembly<br>design | The body of the elbow includes a ball<br>joint allowing for flex under the load<br>from tube drag. The elbow can be<br>rotated 360 degrees around the frame<br>connection, it connects to a<br>conventional air delivery hose. | A Short tube and swivel cuff form part of<br>mask's elbow assembly, these features<br>allow for the mask to rotate and move<br>independently of the connected<br>conventional air delivery hose. | Both mask systems deliver<br>therapy by providing an air seal<br>at the nose and at the mouth.<br>The 'under the nose' cushion<br>design has been cleared<br>previously in reference device,<br>Moore Park mask (K183512).<br>Equivalent in terms of<br>decoupling and freedom of<br>movement. | | Vent design | Multi-hole Vent array in elbow<br>assembly | Two design variants: | Equivalent | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for ResMed. The logo consists of a series of colored dots arranged in a curved line, transitioning from blue to red. Below the dots, the word "ResMed" is written in a bold, sans-serif font. | Design Parameter or feature | Predicate Device | Subject Device | Comments | |-----------------------------|-----------------------------------|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | AirFit F20<br>K153563 | Oran Park Mask System | | | | | Multi-hole Vent QuietAir Vent | Both vent variants of the subject mask:<br>Serves to exhaust patient expired air into the atmosphere Have been verified to satisfy mask pressure flow and CO2 rebreathing performance requirement of ISO 17510:2015 | | AAV design | Two anti-asphyxia valves<br>(AAV) | Single anti-asphyxia valve<br>(AAV) | Equivalent<br>The function of the AAV is the same as the predicate device. Verification testing has been conducted which demonstrated that the AAV of both masks will activate in the event of a single fault condition at a pressure lower than the minimum rated mask pressure. | | Patient connection port | ISO 5356-1 (22mm) | ISO 5356-1 (22mm) | Identical | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for ResMed. The logo consists of two parts: a curved line made of connected circles that transition in color from blue to red, and the word "ResMed" written in a bold, sans-serif font below the line. The circles are arranged in a wave-like pattern, and the word "ResMed" is written in black. | Design Parameter or feature | Predicate Device | Subject Device | Comments | |-------------------------------------------------------------------|-----------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | AirFit F20<br>K153563 | Oran Park Mask System | | | Flow generator setting on<br>compatible ResMed flow<br>generators | Full Face Mask | Pillows | The ResMed flow generator settings used are<br>different between the subject and predicate<br>device. These are the ResMed flow generator<br>settings indicated when using the respective<br>mask. This sets the appropriate pressure<br>compensation aligned to the mask resistance<br>and exhaust characteristics within the<br>ResMed flow generator to achieve equivalent<br>therapy at the patient's airways. | | Pressure Range | 3-40cmH2O | 4-40cmH2O | Pressure range claim is a subset of the<br>predicate device. | | Mask exhaust<br>flow (Nominal)<br>ISO 17510:2015<br>Annex B | Pressure<br>(cmH2O) | Flow<br>(L/min) | Flow<br>(L/min) | | | 3 | 19 | N/A | | | 4 | 22 | 20 | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the ResMed logo. The logo consists of a curved line of dots that transition in color from blue to red. Below the dots, the text "ResMed" is written in a bold, sans-serif font. | Design Parameter or feature | | Predicate Device | Subject Device | Comments | |--------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------| | | | AirFit F20<br>K153563 | Oran Park Mask System | | | 13 | | 42 | 38 | | | 22 | | 57 | 51 | | | 31 | | 70 | 62 | | | 40 | | 82 | 72 | | | Resistance to<br>flow (Pressure<br>drop across<br>mask) ISO<br>17510:2015<br>Annex C | Nom Flow<br>Rate<br>(L/min) | Pressure (cmH2O) | Pressure (cmH2O) | The pressure drop values have been reported<br>in accordance with ISO17510:2015. | | | 50 | 0.2 | 0.3 | | | | 100 | 0.9 | 1.6 | | | CO2 re-breathing performance<br>(<20%) ISO 17510:2015 Annex<br>F | | Complies with ISO<br>17510:2015 CO2<br>requirements (<20%) | Complies with ISO<br>17510:2015 CO2<br>requirements (<20%) | Equivalent | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image contains the logo for ResMed. The logo consists of two parts: a curved line made of connected circles that transition in color from blue to red, and the word "ResMed" written in a bold, sans-serif font below the line. The circles are arranged in a wave-like pattern, and the word "ResMed" is written in black. | Design Parameter or feature | Predicate Device | Subject Device | Comments | | |-----------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|------------|-----------------------------------------------------------------------------------------------------------------| | | AirFit F20<br>K153563 | Oran Park Mask System | | | | CO₂ re-breathing Single Fault<br>use (<60%) ISO 17510:2015<br>Annex F | Complies with ISO<br>17510:2015 CO₂<br>requirements (<60%) | Complies with ISO<br>17510:2015 CO₂<br>requirements (<60%) | Equivalent | | | Breathing<br>Resistance<br>(single fault)<br>(cmH₂O) ISO<br>17510:2015<br>Annex E | Inspiratory | <10cmH₂O | <10cmH₂O | Equivalent | | | Expiratory | <10cmH₂O | <10cmH₂O | The expiratory and inspiratory breathing<br>resistances are both <10cmH₂O in accordance<br>with ISO 17510:2015. | | AAV Operating<br>Pressures<br>(cmH₂O) ISO<br>17510:2015<br>Annex D | De-<br>activation | <4.0 cmH₂O | <4.0 cmH₂O | Equivalent | | | Activation | <4.0 cmH₂O | <4.0 cmH₂O | | {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the ResMed logo. The logo consists of a series of colored dots arranged in a curved line, transitioning from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font. ### Similarities and differences with the predicate device The subject Oran Park Mask and the previously cleared predicate AirFit F20 (K153563) devices share the same technological characteristics and principle of operation. They act as a patient interface seal to deliver treatment pressure generated from a positive airway pressure (PAP) device to the patient's airway. The subject and predicate device have equivalent intended use and the following similarities: - A silicone elastomer cushion to achieve air seal at the patient's mouth and nose. - The cushion is held in place via the mask frame. - The frame is strapped to the patient's head and sits along the sides of the face, held in place via headgear. - An elbow assembly connects to the PAP device tubing. - . Venting ports/AAV flush out CO2. - The mask can be disassembled for cleaning and reprocessing in accordance with the labelling. - A port compliant to ISO 5356-1 is used to connect to the PAP delivery hose. - . Polymeric materials are used for the construction of the pneumatic and structural components. - . Foam padded fabric materials are used for the construction of the head straps. - . Multiple cushion sizes are available to allow for adequate mask fit over the intended patient population. - . Similar performance i.e., both masks have similar operating pressure range and pressure flow characteristics. - Same operating environments i.e., re-use in the home and hospital/institution environment. The main difference between the subject Oran Park Mask and the predicate AirFit F20 device (K153563) ાંડ: - Mask component design and geometry - Different operating ResMed flow generator settings i.e., "Full Face Mask" vs "Pillows" - Incorporation of new materials for Headgear laminate and elbow assembly vent ring - Reprocessing claims These differences do not affect the substantial equivalence claim to the predicate device because nonclinical testing demonstrated that the new device has equivalent performance to and is as safe as the predicate device. {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for ResMed. The logo consists of a curved line of dots that transition in color from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font. #### Non-clinical data submitted Non-clinical verification and validation testing completed for the new device demonstrated that the Oran Park Mask met all intended performance requirements. These included: Applicable performance and safety tests in accordance with ISO 17510:2015 Medical devices – Sleep apnoea breathing therapy – Masks and application accessories: - CO2 rebreathing - Pressure-Flow characteristics - Resistance to flow - Anti-Asphyxia valve operating pressures - Breathing resistance (single fault) - Through impedance - . Inadvertent anti-asphyxia valve operation Other Bench tests: - . Mechanical Integrity of the mask system before and after the following environmental tests: - Home cleaning . - Transportation and storage - Operation environment - l Free fall Biocompatibility evaluation was conducted in accordance with ISO 10993-1, ISO 10993-10, ISO 10993-12, ISO 10993-17, ISO 10993-18 and ISO 18562 on components that had patient exposure classifications of permanent external communicating device (tissue) and /or permanent skin contact. Validation of reprocessing claims included a combination of cleaning efficacy, disinfection efficacy, residual toxicity, and mechanical integrity testing. Verification confirmed that the new device met the predetermined acceptance criteria, and the performance is substantially equivalent to the previously cleared predicate AirFit F20 (K153563). Oran Park Mask System was designed and tested in accordance with the applicable requirements in relevant FDA consensus standards including: | Standards | Title | |----------------|-------------------------------------------------------------------------------------------| | ISO 17510:2015 | Medical devices -- Sleep apnoea breathing therapy -- Masks and application<br>accessories | {15}------------------------------------------------ Image /page/15/Picture/0 description: The image contains the logo for ResMed. The logo features a curved line made up of a series of circles that transition in color from blue to red. Below the line of circles is the text "ResMed" in a bold, sans-serif font. | Standards | Title | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 18562-<br>1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications --<br>Part 1: Evaluation and testing within a risk management process | | ISO 10993-<br>1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk<br>management process | | ISO 17664-<br>1:2021 | Processing of health care products - Information to be provided by the medical<br>device manufacturer for the processing of medical devices - Part 1: Critical and semi-<br>critical medical devices | | ISO 17664-<br>2:2021 | Processing of health care products - Information to be provided by the medical<br>device manufacturer for the processing of medical devices - Part 2: Non-critical<br>medical devices. | | ISO 5356-1:<br>2015 | Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and<br>sockets | | ISO 15223-<br>1:2021 | Medical devices - Symbols to be used with information to be supplied by the<br>manufacturer - Part 1: General requirements | | ISO20417:2021 | Medical devices - Information to be supplied by the manufacturer | {16}------------------------------------------------ Image /page/16/Picture/0 description: The image contains the ResMed logo. The logo features a curved line made of small circles that transition in color from blue to red. Below the line is the word "ResMed" in a bold, sans-serif font. Oran Park Traditional 510(k) ### Substantial Equivalence Conclusion The Oran Park Masks are substantially equivalent to the AirFit F20 (K153563). The differences described above do not raise new questions of safety and effectiveness.