The myAir app is indicated for patients:
• prescribed with a compatible ResMed Air11 platform device to simulate therapy prior to using their device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to their therapy device.
• prescribed a NightOwl wearable device to provide the user interface to operate the connected device and aid in the home sleep testing process.
The device is intended for home and hospital use for:
• new and existing patients of ResMed Air11 PAP therapy devices and
• new users who are prescribed a compatible NightOwl home sleep test (HST).

Device Description

myAir is a companion mobile medical application ("app") for self-monitoring use of the compatible devices that serve as a patient Home Sleep Test (HST), pre-therapy, and engagement platform for positive airway pressure (PAP) therapy. The app allows the patient to connect via Bluetooth to a compatible hardware device for temporary control of their prescribed HST or PAP device and to allow self-tracking of device usage data. myAir can also be used as a communication pathway using the Bluetooth connection with the compatible device in order to send or receive data. Analysis of patient diagnostic data or display of diagnostic results are not in scope of myAir features.
The subject device modifies the predicate device by adding interoperability with the NightOwl HST (Stella functions) in addition to sustaining previously cleared medical device function of connecting to the Air 1 platform.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. The document is primarily a 510(k) summary for the myAir app, outlining its substantial equivalence to a predicate device and a reference device. It mentions "non-clinical verification and validation testing" but does not elaborate on the specific tests, acceptance criteria, or results.

Therefore, I cannot provide the requested table or detailed information regarding the study.

However, I can extract the available relevant information:

Acceptance Criteria and Device Performance:

The document states: "Non-clinical verification and validation testing completed for NightOwl HST interoperable (Stella) functions introduced with the modifications to the myAir app demonstrated that the device met all intended performance requirements."

This is a general statement that the device met its intended performance requirements, but no specific acceptance criteria (e.g., accuracy metrics, thresholds for errors) or reported device performance data (e.g., a measured accuracy of X%) are provided in the text.

Regarding the study (based on limited information):

Sample size used for the test set and data provenance: Not specified. The document only mentions "non-clinical verification and validation testing," implying a test set was used, but details on its size or provenance (country of origin, retrospective/prospective) are absent.
Number of experts used to establish the ground truth for the test set and their qualifications: Not specified. The information provided is about software testing, not clinical performance evaluation that would typically involve expert ground truth.
Adjudication method: Not applicable/specified. This type of method is typically used in clinical studies with human assessors, which is not described here.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The document focuses on software interoperability and functional testing, not comparative clinical effectiveness with human readers.
Standalone (i.e., algorithm only without human-in-the-loop performance) study: The "non-clinical verification and validation testing" likely includes standalone software testing, but specific details or results are not provided. The myAir app acts as a user interface and data transfer mechanism, not an algorithm for diagnostic analysis or interpretation.
Type of ground truth used: Not specified. For software functional testing, ground truth would typically be defined by expected system behavior and output under various conditions.
Sample size for the training set: Not applicable and not specified. The myAir app described here is a companion mobile medical application for control and data transfer, not one that employs machine learning models requiring a training set for diagnostic purposes.
How the ground truth for the training set was established: Not applicable and not specified.

Summary of what is available from the text:

The document concerns the ResMed myAir app (K241216). It states that non-clinical verification and validation testing was performed for the NightOwl HST interoperable (Stella) functions. This testing "demonstrated that the device met all intended performance requirements." The testing followed FDA guidance documents: "Content of Premarket Submissions for Device Software Functions: June 2023" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: September 2023."

The core of the submission is to establish Substantial Equivalence because:

The subject device (myAir) and predicate device (Galapagos, K200565) have the same intended use.
They have similar technological characteristics and operating principles.
The subject device adds interoperability with the NightOwl HST (Stella functions) to its existing cleared function of connecting to the Air11 platform.
The differences do not raise any new questions of safety or effectiveness.
It is as safe and effective as the predicate devices.

Summary

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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 26, 2024

ResMed Corp Rose Malonzo Senior Specialist, Regulatory Affairs 9001 Spectrum Center Blvd. San Diego, California 92123

Re: K241216

Trade/Device Name: myAir Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: August 28, 2024 Received: August 28, 2024

Dear Rose Malonzo:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

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Sincerely,

Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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) K241216

Device Name myAir

Indications for Use (Describe)

The myAir app is indicated for patients:

• prescribed with a compatible ResMed Air11 platform device to simulate therapy prior to using their device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to their therapy device. · prescribed a NightOwl wearable device to provide the user interface to operate the connected device and aid in the home sleep testing process.

The device is intended for home and hospital use for:

• new and existing patients of ResMed Air11 PAP therapy devices and

· new users who are prescribed a compatible NightOwl home sleep test (HST).

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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510(k) SUMMARY

[As required by 21 CFR 807.92(c)]

Date of Submission:	25 September 2024
Company Name/Owner:	ResMed Corp9001 Spectrum Center BlvdSan Diego, CA 92123USA
Official Contact:	Mrs. Rose MalonzoSenior Specialist, Global Product Regulatory AffairsResMed Corp9001 Spectrum Center BlvdSan Diego, CA 92123 USATel: 858-285-5670rose.malonzo@resmed.com
Device Trade Name:	myAir
Device Common Name:	Ventilator, Non-Continuous (Respirator) [primary]
Classification andClassification Name:	IINoncontinuous ventilator (IPPB) [primary]
Product Code:	BZD
Primary Predicate Device:	GalapagosK200565
Reference Device:	NightOwl Companion App (patient mobile application in theNightOwl System)K220028
Submission Reason:	Modified device

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Image /page/5/Picture/0 description: The image shows the ResMed logo. The logo features 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. The logo is set against a white background.

Device Description

The subject device modifies the predicate device by adding interoperability with the NightOwl HST (Stella functions) in addition to sustaining previously cleared medical device function of connecting to the Air 1 platform.

Indications for Use

The myAir app is indicated for patients:

prescribed with a compatible ResMed Air11 platform device to simulate therapy prior to using their ● device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to their therapy device.
. prescribed a NightOwl wearable device to provide the user interface to operate the connected device and aid in the home sleep testing process.

The device is intended for home and hospital use for:

new and existing patients of ResMed Air10 and Air11 PAP therapy devices and ●
new users who are prescribed a compatible NightOwl home sleep test (HST). ●

Non-clinical testing

Non-clinical verification and validation testing completed for NightOwl HST interoperable (Stella) functions introduced with the modifications to the myAir app demonstrated that the device met all intended performance requirements. Testing included:

Software verification and validation, including non-functional requirements and end-to-end ● functional testing.
The following FDA guidance were conformed to:

Public

Content of Premarket Submissions for Device Software Functions: June 2023 ●
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket . Submissions: September 2023

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Substantial Equivalence

The subject device and predicate device have the same intended use, and similar technological characteristics and operating principle.

The technological differences between the predicate device and subject device are:

The subject device adds interoperability with the NightOwl HST, allowing myAir to control the . hardware HST (on/off) and facilitate data transfer during the home sleep testing process (i.e., non-device MDDS function) to the EctoSense NightOwl backend server for analysis.
. The subject device sustains the previously cleared medical device function of connecting to the Air11 platform device to allow the subject device app to control (on/off the hardware and to facilitate transfer of data (i.e., non-device MDDS function) between the hardware and cloud backend server.

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Characteristic	Primary PredicateDevice:GalapagosManufacturer:ResMed Corp510(k) Number:K200565	Reference Device:NightOwl CompanionApp (patient mobileapplication in theNightOwl System)Manufacturer:EctoSense510(k) Number:K220028	Subject Device:myAir with Stella functionsManufacturer:ResMed Corp510(k) Number:K241216	Substantial Equivalence
Indications forUse	The Galapagos app isintended for patients whoare prescribed acompatible ResMed S10platform device tosimulate therapy prior tousing their device withtheir prescribed settings. Itis an optional softwareaccessory to allowpatients to acclimate totheir therapy device.	The NightOwl is awearable deviceintended for use in therecording, analysis,displaying, exporting,and storage ofbiophysical parametersto aid in the evaluationof sleep-relatedbreathing disorders ofadult patientssuspected of sleepapnea. The device isintended for the clinicaland home setting useunder the direction of aHealthcareProfessional (HCP).	The myAir app is indicated forpatients:• prescribed with acompatible ResMedAir11 platform device tosimulate therapy prior tousing their device withtheir prescribed settings.It is an optional softwareaccessory to allowpatients to acclimate totheir therapy device.prescribed a NightOwlwearable device toprovide the user interfaceto operate the connecteddevice and aid in thehome sleep testingprocess.The device is intended forhome and hospital use for:• new and existing patientsof ResMed Air10 and Air11PAP therapy devices and	The proposed myAir indications for use adding Stellafunctions (i.e., compatibility with NightOwl HSTsensor) with this premarket submission is similar tothe predicate device in that the subject device mobileapp has software device functions which areconsidered medical functions associated withBluetooth connection intended for limited devicecontrol and non-device-MDDS data transfer.The difference in the indications for use does not raisenew questions of safety or efficacy for the subjectdevice as the devices have the same intended use.
Characteristic	Primary PredicateDevice:GalapagosManufacturer:ResMed Corp510(k) Number:K200565	Reference Device:NightOwl CompanionApp (patient mobileapplication in theNightOwl System)Manufacturer:EctoSense510(k) Number:K220028	Subject Device:myAir with Stella functionsManufacturer:ResMed Corp510(k) Number:K241216	Substantial Equivalence
			• new users who areprescribed a compatibleNightOwl home sleep test(HST).
RegulationNumber	21 CFR §868.5905	21 CFR §868.2375	Primary: 21 CFR §868.5905	Similar. The modification to add device compatibilitydoes not raise new questions of safety or efficacy forthe subject device as the deviceshave the same intended use.
ClassificationName	Noncontinuous ventilator(IPPB)	Ventilatory effortrecorder	Primary: Noncontinuousventilator (IPPB)	Similar. The subject device adds device compatibilitywith the cleared NightOwl device (K220028). Dataanalysis, processing, and results are out of scope fromthe subject device functions.
FDA ProductCode	BZD	MNR	BZD	Similar. The subject device adds compatibility withcleared NightOwl device (K220028).
PrescriptionUse	Yes	Yes	Yes	Identical
Characteristic	Primary PredicateDevice:GalapagosManufacturer:ResMed Corp510(k) Number:K200565	Reference Device:NightOwl CompanionApp (patient mobileapplication in theNightOwl System)Manufacturer:EctoSense510(k) Number:K220028	Subject Device:myAir with Stella functionsManufacturer:ResMed Corp510(k) Number:K241216	Substantial Equivalence
PatientPopulation	Patients weighing morethan 66 lb (30kg)	22 years old and older	Patients weighing morethan 66 lb (30kg)	Identical. The difference in patient population for thereference device does not raise new questions of safetyor effectiveness for the subject device. Patients areunable to use myAir as intended without connecting tothe intended compatible device. Due to the intendedcompatibility of myAir with the Air11 or NightOwldevices, the same patient population and userenvironment for the respective compatible hardwaredevices inherently applies to the subject myAir device.
IntendedEnvironment ofUse	Home	Clinical and home	Home	Identical
PatientContacting	No, Galapagos issoftware.	No, NightOwlCompanion App issoftware.	No, myAir is software.	Identical
Display Type	Smartphone display	Smartphone display	Smartphone display	Identical
DeviceInteroperabilityand V&V	ResMed Air11 platformdevices	NightOwl HST	ResMed Air11 platformdevices and EctoSenseNightOwl HST	The modification for additional compatibility with thecleared NightOwl Companion App (patient mobile appwithin the NightOwl System, K220028) does not raisenew questions of safety or effectiveness.Furthermore, all non-clinical performance benchtesting required for the subject device myAir with Stellafunctions support the intended design of the product,and device safety and effectiveness.
Characteristic	Primary PredicateDevice:GalapagosManufacturer:ResMed Corp510(k) Number:K200565	Reference Device:NightOwl CompanionApp (patient mobileapplication in theNightOwl System)Manufacturer:EctoSense510(k) Number:K220028	Subject Device:myAir with Stella functionsManufacturer:ResMed Corp510(k) Number:K241216	Substantial Equivalence
DeviceConnectionRequirement	Yes. Galapagos app mustbe connected to acompatible therapy devicefor usage.	Yes. NightOwlCompanion App mustbe connected to acompatible HST devicefor usage.	Yes. myAir app must beconnected to acompatible HST tooperate Stella functionsas intended.	Difference in functionality does not raise newquestions of safety or effectiveness.
Device Control	Yes. Galapagos cancontrol the connectedtherapy device.	No. NightOwlCompanion App doesnot allow control of theconnected therapydevice.	Yes. myAir can controlthe connected therapyor HST device.	Difference in functionality from the NightOwlcompanion app does not raise new questions of safetyor effectiveness.
CommunicationPathwaysAvailable	Bluetooth and HTTPS(cellular or wirelessinternet connection)	Bluetooth and HTTPS(cellular or wirelessinternet connection)	Bluetooth and HTTPS(cellular or wireless internetconnection)	Identical
Device data toappcommunicationpathway	Pathways:1) Device data transfers toMachine Cloud Service(MCS) then to Galapagos.Therapy device datatransferred from device toapp to MCS.	Pathways:HST device datatransfers from sensorthrough the NightOwlCompanion App to theEctoSense backendserver for analysis.	Pathways:1) Device data transfers toMachine Cloud Service(MCS) then to Galapagos.Therapy device datatransferred from device toapp to MCS.	Differences in types of data transferred andcommunication pathways available does not raise newquestions of safety or effectiveness. Software functionsrelated to data analysis and display ofdiagnostic results are out of scope of the subjectdevice myAir app as these medical device softwarefunctions are within the NightOwl Backend Server and
Characteristic	Primary PredicateDevice:GalapagosManufacturer:ResMed Corp510(k) Number:K200565	Reference Device:NightOwl CompanionApp (patient mobileapplication in theNightOwl System)Manufacturer:EctoSense510(k) Number:K220028	Subject Device:myAir with Stella functionsManufacturer:ResMed Corp510(k) Number:K241216	Substantial Equivalence
			3) HST device data transfersfrom sensor through themyAir app to EctoSensebackend server for analysis.	HCP Dashboard components of the NightOwl System(K220028).
App StoreAvailability	Google Play Store	Google Play Store andApple App Store	Apple App Store	Difference in mobile app store availability does notraise new questions of safety or efficacy for the subjectdevice.
Therapy SettingsChanges	None. The Galapagos appdoes not have capabilitiesof altering therapy settings.	Not applicable	None	Identical
Adjust ComfortSettings	None. The Galapagos appdoes not have capabilitiesof adjusting comfortsettings.	Not applicable	None	Identical
Software Level ofDocumentation	Moderate	Moderate	Basic	Similar. The differences in level of softwaredocumentation are determined in accordance with theFDA guidance "Content of Premarket Submissions forDevice Software Functions". The subject devicefollows FDA's risk-based approach for basic vs.enhanced (2023), while the predicate devices followedFDA's Guidance for the Content of PremarketSubmissions for Software Contained in MedicalDevices issued on May 11, 2005.

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Image /page/10/Figure/0 description: The image shows the logo for ResMed. The logo consists of the company name "ResMed" in a bold, italicized font. Above the name is a curved line made up of a series of circles that transition in color from blue to red.

Public

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Image /page/11/Figure/0 description: The image shows the ResMed logo. 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.

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Image /page/12/Picture/0 description: The image shows the ResMed logo. The logo consists of the word "ResMed" in a bold, sans-serif font, with the "R" slightly larger than the other letters. Above the wordmark is a curved line made up of a series of colored dots, transitioning from blue to red. The dots are arranged in a wave-like pattern, creating a visual representation of airflow or breathing.

Substantial Equivalence Conclusion

The subject device is substantially equivalent to the predicate K200656 because:

They have the same intended use; ●
They have similar technological characteristics;
. They have similar performance characteristics;
The differences do not raise any new questions of safety or effectiveness; and
. It is as safe and effective as the predicate devices.

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).