(239 days)
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.
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.
The Oran Park Mask is a medical device accessory used to deliver airflow and positive air pressure from PAP devices for the treatment of Obstructive Sleep Apnea or ventilator support. The device underwent non-clinical testing to demonstrate its performance and safety, aiming to prove substantial equivalence to the predicate device, AirFit F20 (K153563).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a comparison table between the predicate device (AirFit F20, K153563) and the subject device (Oran Park Mask System) for various design parameters and features. The "Comments" column often indicates the acceptance criteria for the subject device by stating "Equivalent," "Identical," or referencing compliance with specific ISO standards.
| Acceptance Criteria / Design Parameter | Predicate Device Performance (AirFit F20) | Reported Device Performance (Oran Park Mask) | Evaluation / Comment |
|---|---|---|---|
| Indications for Use | Non-invasive CPAP or bi-level PAP therapy for patients > 66lb (30kg). Single-patient reuse home, multi-patient reuse hospital/institutional. | Non-invasive CPAP or bi-level PAP therapy for patients > 66lb (30kg). Home use: single-patient reuse. SLM variant: multi-patient reuse. | Equivalent |
| FDA Product Code | BZD | BZD | Identical |
| Reprocessing | Single patient re-use or multi-patient re-use | Single patient re-use (Oran Park Mask) or multi-patient re-use (Oran Park SLM) | Identical |
| Physical Dead Space (mL) | Small: 199mL, Medium: 219mL, Large: 240mL | Small: 101.1mL, Medium: 107.6mL, Large: 107.0mL | Record-only parameter (implies this value is reported, not directly compared for equivalence acceptance, but still meets a performance standard if it's within expected range for masks) |
| Leakage Flow (L/min) @ Specified Pressure (cmH2O) | 3cmH2O: 19, 4cmH2O: 22, 13cmH2O: 42, 22cmH2O: 57, 31cmH2O: 70, 40cmH2O: 82 | (No N/A for 3cmH2O), 4cmH2O: 20, 13cmH2O: 38, 22cmH2O: 51, 31cmH2O: 62, 40cmH2O: 72 | Equivalent (values are generally similar, within reasonable physiological range, and deemed acceptable) |
| Use Life | AirFit F20 (single patient, multi-use): Visual inspection. AirFit F20 (multi patient, multi-use): 30 validated reprocessing cycles. | Oran Park mask: Visual inspection. Oran Park SLM: 30 validated reprocessing cycles. | Identical |
| Operating and Storage Temperature | Operating: 5°C to 40°C, Storage: -20°C to +60°C | Operating: 5°C to 40°C, Storage: -20°C to +60°C | Identical |
| Sound Power Level & Pressure | Tested and declared in accordance with ISO4871 and ISO3744 | Tested and declared in accordance with ISO4871 and ISO3744 | Equivalent |
| Cushion Assembly Design | Seals above nose and around mouth | Seals under nose and around mouth | Equivalent (due to prior clearance of 'under the nose' design) |
| Elbow Assembly Design | Ball joint, 360-degree rotation | Short tube and swivel cuff | Equivalent (in terms of decoupling and freedom of movement) |
| Vent Design | Multi-hole Vent array in elbow assembly | Two design variants: Multi-hole Vent, QuietAir Vent | Equivalent (both verified to satisfy ISO 17510:2015 mask pressure flow and CO2 rebreathing performance) |
| AAV Design | Two Anti-Asphyxia Valves (AAV) | Single Anti-Asphyxia Valve (AAV) | Equivalent (function is same, verification testing conducted) |
| Patient Connection Port | ISO 5356-1 (22mm) | ISO 5356-1 (22mm) | Identical |
| Flow Generator Setting on ResMed Flow Generators | Full Face Mask | Pillows | Different (but intended to achieve equivalent therapy at patient's airways via appropriate pressure compensation) |
| Pressure Range | 3-40cmH2O | 4-40cmH2O | Subset of predicate device (acceptable) |
| Mask Exhaust Flow (Nominal, ISO 17510:2015 Annex B) | (Values provided at various pressures) | (Values provided at various pressures) | Equivalent (implies the reported values are within an acceptable range compared to the predicate/standard) |
| Resistance to Flow (Pressure drop across mask, ISO 17510:2015 Annex C) | 50L/min: 0.2cmH2O, 100L/min: 0.9cmH2O | 50L/min: 0.3cmH2O, 100L/min: 1.6cmH2O | The pressure drop values have been reported in accordance with ISO17510:2015. (Implies compliance with standard limits, thus acceptable). |
| CO2 Re-breathing Performance (<20%, ISO 17510:2015 Annex F) | Complies with ISO 17510:2015 CO2 requirements (<20%) | Complies with ISO 17510:2015 CO2 requirements (<20%) | Equivalent |
| CO2 Re-breathing Single Fault Use (<60%, ISO 17510:2015 Annex F) | Complies with ISO 17510:2015 CO2 requirements (<60%) | Complies with ISO 17510:2015 CO2 requirements (<60%) | Equivalent |
| Breathing Resistance (single fault) (Inspiratory & Expiratory, <10cmH2O, ISO 17510:2015 Annex E) | <10cmH2O (Inspiratory), <10cmH2O (Expiratory) | <10cmH2O (Inspiratory), <10cmH2O (Expiratory) | Equivalent |
| AAV Operating Pressures (Deactivation & Activation, <4.0cmH2O, ISO 17510:2015 Annex D) | <4.0 cmH2O (Deactivation), <4.0 cmH2O (Activation) | <4.0 cmH2O (Deactivation), <4.0 cmH2O (Activation) | Equivalent |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical verification and validation testing. This type of testing typically involves bench tests on manufactured devices rather than studies on human subjects. Therefore, the concept of "test set" in the context of patient data, sample size of patients, and data provenance (country of origin, retrospective/prospective) is not applicable here. The tests are performed on the device prototypes or production samples in a laboratory setting. No information is provided regarding the number of units tested for each non-clinical test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is also not applicable as the study described is non-clinical, involving engineering and performance testing against established standards and predicate device performance, not clinical interpretation requiring expert ground truth establishment.
4. Adjudication Method (2+1, 3+1, none) for the Test Set:
This information is not applicable for the same reasons as points 2 and 3. Non-clinical bench testing does not involve adjudication methods used in clinical studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device, an Oran Park Mask, is a physical patient interface for respiratory therapy. It is not an AI-powered diagnostic or assistive tool, so an MRMC study comparing human reader performance with and without AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The device is a physical mask, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" or reference for acceptance was primarily:
- International Standards: Specifically ISO 17510:2015 (Medical devices – Sleep apnoea breathing therapy – Masks and application accessories), ISO 10993 series (Biocompatibility), ISO 18562 series (Biocompatibility of breathing gas pathways), ISO 5356-1 (Conical connectors), etc.
- Performance of the Predicate Device: The AirFit F20 (K153563) served as a direct comparison for various parameters to establish substantial equivalence.
- Predetermined Acceptance Criteria: These are likely internal specifications derived from the standards and predicate device performance, ensuring safety and effectiveness.
8. The Sample Size for the Training Set:
This is not applicable as there is no "training set" in the context of non-clinical device testing for a physical mask. Device design and validation follow engineering and regulatory processes, not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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"
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(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
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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) |
|---|
| ------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the logo for ResMed. The logo consists of the word "ResMed" in a bold, sans-serif font. Above the word is a curved line made up of a series of dots that transition in color from blue to red. The dots are arranged in a wave-like pattern.
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 Ltd1 Elizabeth Macarthur DriveBella Vista, NSW, 2153 Australia |
| Prepared and Submitted by: | Ms Daniellia ChanRegulatory Affairs SpecialistTel: +65 65727166daniellia.chan@resmed.com.sg |
| Official Contact: | Ms Sheila BruschiSenior Director, RegulatoryAffairs ResMed Corp9001 Spectrum Center BlvdSan Diego CA 92123 USATel: +1 858 922 1803sheila.bruschi@resmed.com |
| Device Trade Name: | Oran Park Mask |
| Device Common Name: | Vented Full Face Mask |
| Classification andClassification Name: | 21 CFR 868.5905, 73 BZD (Class II)Accessory to Noncontinuous Ventilator (IPPB) |
| Product Code: | BZD |
| Legally Marketed PredicateDevice: | AirFit F20 (K153563) |
| Reference Device: | Moore Park (K183512) |
| Submission Reason: | New Device |
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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.
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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 patientsweighing more than 66lb (30kg) forwhom positive airway pressure therapy(non-invasive CPAP or bi-level positiveairway pressure (PAP) therapy) hasbeen prescribed. | The Oran Park mask is intended for use inthe home or hospital/institutionalenvironment on patients weighing morethan 66lb (30kg), who have been prescribednon-invasive CPAP or bi-level positive airwaypressure (PAP) therapy. | Equivalent |
| It is intended for single-patient reuse inthe home environment and multi-patient reuse in thehospital/institutional environment. | Only the Sleep Lab Mask (SLM) variant isintended and validated for multi-patientreuse and must be reprocessed if reusedbetween patients. | ||
| FDA Product Code | BZD | BZD | Identical |
| Reprocessing | Single patient re-use or multi-patientre-use | Single patient re-use (Oran Park Mask) ormulti-patient re-use (Oran Park SLM) | Identical |
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| Physical Dead space (mL) | Small Cushion: 199mLMedium Cushion:219mLLarge Cushion: 240mL | Small Cushion: 101.1mLMedium Cushion: 107.6mLLarge 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):Visual inspection per instructions for useAirFit F20 (multi patient, multi-use): 30 validated reprocessing cycles | Oran Park mask: Visual inspection per instructions for useOran Park SLM: 30 validated reprocessing cycles | Identical | ||
| Operating and storage temperature | Operating temperature: 5°C to 40°CStorage temperature: -20°C to +60°C | Operating temperature: 5 to 40 °CStorage temperature: -20 to +60°C | Identical |
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| Sound power level andsound pressure | Tested and declared in accordance withISO4871 and ISO3744 | Tested and declared in accordance withISO4871 and ISO3744 | Equivalent |
|---|---|---|---|
| Cushion assemblydesign | Seals above the nose and around themouth | Seals under the nose and around the mouth | Equivalent |
| Elbow assemblydesign | The body of the elbow includes a balljoint allowing for flex under the loadfrom tube drag. The elbow can berotated 360 degrees around the frameconnection, it connects to aconventional air delivery hose. | A Short tube and swivel cuff form part ofmask's elbow assembly, these featuresallow for the mask to rotate and moveindependently of the connectedconventional air delivery hose. | Both mask systems delivertherapy by providing an air sealat the nose and at the mouth.The 'under the nose' cushiondesign has been clearedpreviously in reference device,Moore Park mask (K183512).Equivalent in terms ofdecoupling and freedom ofmovement. |
| Vent design | Multi-hole Vent array in elbowassembly | Two design variants: | Equivalent |
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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 F20K153563 | Oran Park Mask System | ||
| Multi-hole Vent QuietAir Vent | Both vent variants of the subject mask: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(AAV) | Single anti-asphyxia valve(AAV) | EquivalentThe 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 |
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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 F20K153563 | Oran Park Mask System | ||
| Flow generator setting oncompatible ResMed flowgenerators | Full Face Mask | Pillows | The ResMed flow generator settings used aredifferent between the subject and predicatedevice. These are the ResMed flow generatorsettings indicated when using the respectivemask. This sets the appropriate pressurecompensation aligned to the mask resistanceand exhaust characteristics within theResMed flow generator to achieve equivalenttherapy at the patient's airways. |
| Pressure Range | 3-40cmH2O | 4-40cmH2O | Pressure range claim is a subset of thepredicate device. |
| Mask exhaustflow (Nominal)ISO 17510:2015Annex B | Pressure(cmH2O) | Flow(L/min) | Flow(L/min) |
| 3 | 19 | N/A | |
| 4 | 22 | 20 |
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| Design Parameter or feature | Predicate Device | Subject Device | Comments | |
|---|---|---|---|---|
| AirFit F20K153563 | Oran Park Mask System | |||
| 13 | 42 | 38 | ||
| 22 | 57 | 51 | ||
| 31 | 70 | 62 | ||
| 40 | 82 | 72 | ||
| Resistance toflow (Pressuredrop acrossmask) ISO17510:2015Annex C | Nom FlowRate(L/min) | Pressure (cmH2O) | Pressure (cmH2O) | The pressure drop values have been reportedin accordance with ISO17510:2015. |
| 50 | 0.2 | 0.3 | ||
| 100 | 0.9 | 1.6 | ||
| CO2 re-breathing performance(<20%) ISO 17510:2015 AnnexF | Complies with ISO17510:2015 CO2requirements (<20%) | Complies with ISO17510:2015 CO2requirements (<20%) | Equivalent |
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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 F20K153563 | Oran Park Mask System | |||
| CO₂ re-breathing Single Faultuse (<60%) ISO 17510:2015Annex F | Complies with ISO17510:2015 CO₂requirements (<60%) | Complies with ISO17510:2015 CO₂requirements (<60%) | Equivalent | |
| BreathingResistance(single fault)(cmH₂O) ISO17510:2015Annex E | Inspiratory | <10cmH₂O | <10cmH₂O | Equivalent |
| Expiratory | <10cmH₂O | <10cmH₂O | The expiratory and inspiratory breathingresistances are both <10cmH₂O in accordancewith ISO 17510:2015. | |
| AAV OperatingPressures(cmH₂O) ISO17510:2015Annex D | De-activation | <4.0 cmH₂O | <4.0 cmH₂O | Equivalent |
| Activation | <4.0 cmH₂O | <4.0 cmH₂O |
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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.
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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 applicationaccessories |
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| Standards | Title |
|---|---|
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications --Part 1: Evaluation and testing within a risk management process |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process |
| ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medicaldevice manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices |
| ISO 17664-2:2021 | Processing of health care products - Information to be provided by the medicaldevice manufacturer for the processing of medical devices - Part 2: Non-criticalmedical devices. |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones andsockets |
| ISO 15223-1:2021 | Medical devices - Symbols to be used with information to be supplied by themanufacturer - Part 1: General requirements |
| ISO20417:2021 | Medical devices - Information to be supplied by the manufacturer |
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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.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).