The Scone 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 Scone Mask is an externally placed vented respiratory mask. Positive air pressure (PAP) source is directed to the patient's airway non-invasively, via the nose. 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 head straps.

The Scone Mask comprises 4 subassemblies: headgear, frame, cushion and elbow. The exhaust ports are incorporated into the elbow and cushion assemblies. The cushion and frame are available in various sizes to fit a wide patient population.

The Scone Mask is a prescription device supplied non-sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Scone Mask, based on the provided document. It's important to note that this is a medical device (mask), not an AI/algorithm-based device, so many of the typical AI/ML study questions (like MRMC, standalone algorithm performance, training set details) are not applicable to this submission. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Acceptance Criteria and Device Performance for Scone Mask

The provided document describes the FDA 510(k) submission for the Scone Mask, a non-invasive positive airway pressure (PAP) therapy mask. The "acceptance criteria" and "device performance" in this context refer to the mask's ability to meet established safety and performance standards for such devices, primarily by demonstrating substantial equivalence to a legally marketed predicate device (AirFit N20, K171212).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Requirements)	Reported Device Performance (Demonstrated by Testing)
Applicable Performance and Safety Tests (ISO 17510:2015):	Met all intended performance requirements.
- CO2 rebreathing	Verified to be within acceptable limits.
- Total mask flow	Verified to be within acceptable limits.
- Flow resistance	Verified to be within acceptable limits.
Other Bench Tests:	Met all intended performance requirements.
- Physical dead space	Verified to be within acceptable limits.
- Functional tests	Passed.
- Mechanical integrity performance following relevant environmental exposure (Home cleaning, Transportation, Operation environment, Relevant abuse use case tests)	Maintained mechanical integrity and performance.
Biocompatibility Evaluation (ISO 10993 series):	Components shown to be biocompatible.
Validation of Reprocessing Claims:	Successfully validated.
- Cleaning efficacy	Demonstrated effective cleaning.
- Disinfection efficacy	Demonstrated effective disinfection.
- Residual toxicity	Confirmed acceptable levels.
- Mechanical integrity testing	Maintained integrity after reprocessing.
Substantial Equivalence to Predicate (AirFit N20):	Concluded to be substantially equivalent.
- Same intended use	Confirmed.
- Similar technological characteristics	Confirmed.
- Similar performance characteristics	Confirmed.
- Differences do not raise new safety/effectiveness questions	Confirmed by non-clinical testing.
- At least as safe and effective as predicate	Confirmed by non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "sample size" in terms of subject counts for a clinical trial, as this was a non-clinical verification and validation study. The "samples" referred to are the actual Scone Mask prototypes and their components used for the various bench and laboratory tests. The number of masks/components tested for each specific test (e.g., CO2 rebreathing, flow resistance, mechanical integrity) is not detailed.
Data Provenance: This was an internal validation study conducted by ResMed Ltd. The location of the test facility is not explicitly stated beyond ResMed Ltd's address being in Bella Vista, NSW, Australia. The data is non-clinical (bench testing), not collected from human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This submission is for a medical device (mask) based on non-clinical engineering and performance testing, not an AI/ML device requiring clinical expert review to establish ground truth from medical images/data. The "ground truth" here is objective physical and chemical measurements (e.g., CO2 levels, flow rates, material composition, mechanical properties) against established industry standards (ISO).

4. Adjudication Method for the Test Set

Not Applicable. As this is a non-clinical device performance study, there's no need for an adjudication method by medical experts. The results are derived from objective measurements and laboratory analyses, compared against predetermined acceptance limits derived from international standards (e.g., ISO 17510, ISO 10993 series).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for diagnostic AI devices where human reader performance is being evaluated with and without AI assistance. This document describes the testing for a PAP mask, which is a physical medical device, not a diagnostic AI.

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

Not Applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, industry standards (ISO 17510 for masks, ISO 10993 for biocompatibility), and established scientific principles for device safety and performance. This includes:
- Objective measurements: CO2 levels, airflow, pressure, mechanical strength, chemical composition.
- Compliance with published standards: Meeting the specified requirements of ISO standards.
- Performance equivalence: Demonstrating that the device performs similarly to a legally marketed predicate device under tested conditions.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

Not Applicable. Given that this is not an AI/ML device, there is no "training set" or "ground truth" in that context.

Summary

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Image /page/0/Picture/0 description: The image shows 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, and then the word "ADMINISTRATION" in a smaller font size below that.

June 15, 2018

ResMed Ltd Ms. Kim Kuan Lee Senior Regulatory Affairs Manager 1 Elizabeth Macarthur Drive Bella Vista, 2153 Au

Re: K180497

Trade/Device Name: Scone Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: May 16, 2018 Received: May 18, 2018

Dear Ms. Lee:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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.

James J. Lee -S

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

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K180497

Device Name Scone 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY
[As required by 21 CFFR 807.92(c)]

Date Prepared	February 23, 2018
Company Name /Owner	ResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW, 2153 Australia
Prepared & submittedby	Mr. Kim Kuan LEESenior Regulatory Affairs ManagerTel: +61 2 8884 1000Fax: + 61 2 8884 2004kim.lee@resmed.com.au
Official Contact	Ms Cecilia SilvaAssociate Manager, Regulatory AffairsResMed Corp.9001 Spectrum Center BlvdSan Diego CA 92123 USATel: +1 858 836 6256Fax: +1 858 836 5519Cecilia.Silva@resmed.com
Device Trade Name	Scone Mask
Device Common Name	Vented Nasal Mask
Classification &Classification Name	21 CFR 868.5905, 73 BZD (Class II)Accessory to Noncontinuous Ventilator (IPPB)
Legally MarketedPredicate Device	AirFit N20 (K171212)
Device Description	The Scone Mask is an externally placed vented respiratory mask.Positive air pressure (PAP) source is directed to the patient's airwaynon-invasively, via the nose. The mask connects to the positivepressure flow source through conventional air tubing via an industrystandard conical connector. The mask is held in place with adjustablehead straps.The Scone Mask comprises 4 subassemblies: headgear, frame,cushion and elbow. The exhaust ports are incorporated into the elbowand cushion assemblies. The cushion and frame are available invarious sizes to fit a wide patient population.The Scone Mask is a prescription device supplied non-sterile.
Intended Use	The Scone mask is intended to be used by patients weighing morethan 66 lb (30 kg) who have been prescribed non-invasive positiveairway pressure (PAP) therapy such as CPAP or bi-level therapy. Themask is intended for single patient re-use in the home and multi-patient re-use in the hospital/institutional environment.
Submission reason	New Device

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Similarities and differences with the predicate AirFit N20 device

Delivering treatment pressure generated from a positive airway pressure (PAP) device to the patient's airway is the technological principle of both the subject Scone Mask and the previously cleared predicate AirFitN20 (K171212) device.

The subject and predicate device have an identical intended use and the following similarities:

. A silicone elastomer cushion to achieve an air seal at the patient's 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 head straps.
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 head strap.
A port compliant to ISO 5356-1 is used to connect to the PAP delivery hose.
. Multiple cushion and frame 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 and operate on the same "Pillows" ResMed flow generator settings.
. Same operating environments i.e. re-use in the home and hospital / institution environments

The main differences between the subject Scone Mask and the previously cleared predicate device AirFit N20 (K171212) are:

. The PAP device tubing is connected to the Scone device at the top of the patient's head, whereas the predicate device is connected near the nose.
The new device is labelled for a smaller operating pressure . range compared to the predicate AirFit N20 device.

These differences do not affect the substantial equivalence claim to the predicate device because non-clinical testing demonstrated that the new device has equivalent performance to and is as safe as the predicate device.

Non-clinical data Non-clinical verification and validation testing completed for the new device demonstrated that the Scone device 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
Total mask flow ●
. Flow resistance

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Other bench tests:

Physical dead space
Functional tests .
Mechanical integrity performance following relevant . environmental exposure
- o Home cleaning
- O Transportation
- Operation environment O
- Relevant abuse use case tests O

Biocompatibility evaluation was conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12, ISO 10993-17 and ISO 10993-18 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 AirFit N20 (K171212).

The Scone Mask is substantially equivalent to the predicate AirFit

Substantial Equivalence Conclusion

it has the same intended use -
N20 device (K171212):
it has similar technological characteristics
it has similar performance characteristics
the differences do not raise any new questions of safety or effectiveness
it is at least as safe and as effective as the predicate device -

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).