The Moore Park mask is intended to be used by patients weighing more than 66 lb (30 kg) who have been prescribed noninvasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The mask is intended for single patient re-use in the home and multi-patient re-use in the hospital/institutional environment.

Device Description

The Moore Park mask is an externally placed vented respiratory mask. Positive air pressure (PAP) is directed to the patient's airway non-invasively, via the nose and/or mouth. The mask connects to the positive pressure flow source through conventional air tubing via an industry standard conical connector. The mask is held in place with adjustable headgear straps.

The Moore Park mask comprises 4 assemblies: headgear, frame, cushion and elbow. The exhaust ports are incorporated into the elbow and cushion assemblies. The anti-asphyxia valve is incorporated in the frame assembly. The cushion is available in various sizes to fit a wide patient population. The Moore Park mask is a prescription device supplied non-sterile.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Moore Park Mask

Based on the provided FDA 510(k) summary, here's a description of the acceptance criteria and the study conducted to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on non-clinical verification and validation testing, confirming compliance with relevant standards rather than stating specific quantitative performance metrics as acceptance criteria. However, the types of tests performed indicate the implicit acceptance criteria for safety and performance.

Acceptance Criteria Category	Implicit Acceptance Criteria / Standard Compliance	Reported Device Performance
Performance (per ISO 17510:2015)	- CO2 rebreathing: (Compliance with ISO 17510:2015 limits)	Met all intended performance requirements. (Detailed rebreathing values not provided, but compliance with standard is asserted).
	- Pressure-Flow characteristics: (Compliance with ISO 17510:2015, similar to predicate)	Met all intended performance requirements. (Detailed characteristics not provided, but compliance with standard and similarity to predicate acknowledged).
	- Resistance to flow: (Compliance with ISO 17510:2015 limits)	Met all intended performance requirements.
	- Anti-Asphyxia valve operating pressures: (Compliance with ISO 17510:2015 specifications)	Met all intended performance requirements.
	- Breathing resistance: (Compliance with ISO 17510:2015 limits)	Met all intended performance requirements.
Other Bench Tests	- Pressure performance testing: (Met predetermined acceptance criteria)	Met all intended performance requirements.
	- Mechanical Integrity (before/after environmental tests: Home cleaning, Transportation & Storage, Operation environment): (Maintained integrity and functionality)	Met all intended performance requirements.
Biocompatibility	- Compliance with ISO 18562 series (Parts 1, 2, 3) and ISO 10993 series (Parts 1, 3, 5, 10, 11, 17, 18) for materials with patient exposure (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, VOCs, particulate matter, leachables).	Biocompatibility evaluation conducted and concluded to meet all intended performance requirements. (Specific test results not provided, but compliance with listed standards is asserted).
Validation of Reprocessing Claims	- Cleaning efficacy: (Demonstrated effective cleaning)	Validation confirmed that the new device met the predetermined acceptance criteria.
	- Disinfection efficacy: (Demonstrated effective disinfection)	Validation confirmed that the new device met the predetermined acceptance criteria.
	- Residual toxicity: (No unacceptable residual toxicity post-reprocessing)	Validation confirmed that the new device met the predetermined acceptance criteria.
	- Mechanical integrity post-reprocessing: (Maintained mechanical integrity after reprocessing)	Validation confirmed that the new device met the predetermined acceptance criteria.
Overall Substantial Equivalence	- Performance is substantially equivalent to the predicate Mirage Liberty Full Face Mask (K063011).	Verification confirmed that the new device met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate Mirage Liberty Full Face Mask (K063011).

2. Sample Size for the Test Set and Data Provenance

The provided document describes non-clinical verification and validation testing (bench testing). Therefore, the concept of "test set" in the context of patient data (as might be applicable for an AI/diagnostic device) does not directly apply.

Sample Size: Not applicable in the context of patient data for this device. The testing involved physical units of the mask and its components. The document does not specify the number of mask units or components used for each bench test.
Data Provenance: Not applicable in the context of patient data. The data is generated from laboratory (bench) testing of the physical device components and assembled products. The company (ResMed Ltd) is based in Australia, suggesting the testing activities likely took place there or at affiliated test facilities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the described studies are non-clinical, bench-top engineering and biocompatibility tests for a medical device (mask), not a diagnostic algorithm that requires expert-established ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

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 information is not applicable. The device is a PAP mask, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a PAP mask, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable in the sense of clinical "ground truth" for a diagnostic device. For the non-clinical tests described:

Performance Tests: "Ground truth" is established by the specifications in the referenced ISO standards (e.g., ISO 17510:2015 for CO2 rebreathing limits, pressure-flow characteristics) or internal design specifications that ensure equivalence to the predicate device.
Biocompatibility Tests: "Ground truth" is defined by the acceptance criteria within the referenced ISO 18562 and ISO 10993 series standards, which specify acceptable levels of biological response, emissions, or leachable substances.
Reprocessing Validation: "Ground truth" is established by predetermined efficacy criteria for cleaning, disinfection, and maintenance of material properties.

8. The sample size for the training set

This information is not applicable. The device is a PAP mask, not an AI-powered device, and therefore does not have a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable, as there is no "training set" for this type of medical device.

Summary

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May 7, 2019

ResMed Ltd % Sheila Bruschi Director, Regulatory Affairs ResMed Corp 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K183512

Trade/Device Name: Moore Park Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: April 4, 2019 Received: April 5, 2019

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices 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) K183512

Device Name Moore Park Mask

Indications for Use (Describe)

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)

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1 510(k) Summary

[As required by 21 CFR 807.92(c)]

Date of Submission:	7 May 2019
Company Name/Owner:	ResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW, 2153 Australia
Prepared and Submitted by:	Ms Nerida HuntSenior Regulatory Affairs ManagerTel: +612 8884 1000Fax: +612 8884 2004nerida.hunt@resmed.com
Official Contact:	Ms Sheila BruschiDirector, Regulatory AffairsResMed Corp9001 Spectrum Center BlvdSan Diego CA 92123 USATel: +1 858 836 5934Fax: +1 858 836 5519sheila.bruschi@resmed.com
Device Trade Name:	Moore Park Mask
Device Common Name:	Vented Full Face Mask
Classification andClassification Name:	Class IINoncontinuous Ventilator (IPPB) (21 CFR 868.5905)
Product Code:	BZD
Predicate Device:	Mirage Liberty Full Face Mask (K063011)
Reference Device:	Scone Mask (K180497)
Device Description:	The Moore Park mask is an externally placed vented respiratorymask. Positive air pressure (PAP) is directed to the patient's airwaynon-invasively, via the nose and/or mouth. The mask connects tothe positive pressure flow source through conventional air tubingvia an industry standard conical connector. The mask is held inplace with adjustable headgear straps.The Moore Park mask comprises 4 assemblies: headgear, frame,cushion and elbow. The exhaust ports are incorporated into theelbow and cushion assemblies. The anti-asphyxia valve isincorporated in the frame assembly. The cushion is available invarious sizes to fit a wide patient population. The Moore Park maskis a prescription device supplied non-sterile.
Indications For Use:	The Moore Park mask is intended to be used by patients weighingmore than 66 lb (30 kg) who have been prescribed non-invasivepositive airway pressure (PAP) therapy such as CPAP or bi-leveltherapy. The mask is intended for single patient re-use in the homeand multi-patient re-use in the hospital/institutional environment.
Submission Reason:	New device
Similarities and differenceswith the predicate device:	The subject and predicate device have an identical intended useand the following similarities:A silicone elastomer cushion to achieve an 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 Exhaust ports flush out CO₂ The mask can be disassembled for cleaning and reprocessing in accordance with the labelling Polymeric materials are used for the construction of the pneumatic and structural components. Foam padded fabric materials are used for the construction of the headgear.
	• A port compliant to ISO 5356-1 is used to connect to the PAPdelivery hose
	• Similar performance i.e. both masks have similar operatingpressure range and pressure flow characteristics
	• Same operating environments i.e. re-use in the home andhospital/institution environments
	The main difference between the subject Moore Park device andthe previously cleared predicate Mirage Liberty Full Face Mask(K063011) is:
	• The PAP device tubing is connected to the Moore Parkdevice at the top of the patient's head, whereas thepredicate device is connected near the mouth.
Non-clinical data submitted:	Non-clinical verification and validation testing completed for thenew device demonstrated that the Moore Park mask met allintended performance requirements. These included:
	Applicable performance and safety tests in accordance with ISO17510:2015 Medical devices -- Sleep apnoea breathing therapy --Masks and application accessories:
	• CO2 rebreathing• Pressure-Flow characteristics

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Resistance to flow ●
Anti-Asphyxia valve operating pressures .
. Breathing resistance

Other bench tests:

Pressure performance testing
. Mechanical Integrity of the mask system before and after the following environmental tests:
- o Home cleaning
- O Transportation and Storage
- Operation environment O

Biocompatibility evaluation was conducted in accordance with the following standards:

. ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process

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ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter
. ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 3: Tests for emissions of volatile organic compounds (VOCs)
. ISO 10993-1:2009 Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process
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 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
. 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

This evaluation was conducted on components that were manufactured using new materials with 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 Mirage Liberty Full Face Mask (K063011).

Substantial Equivalence
                                The Moore Park mask is substantially equivalent to the predicate
Conclusion:
                                Mirage Liberty Full Face Mask ([K063011](https://510k.innolitics.com/search/K063011)).

Regulation Number and Section

§ 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).