assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an AirView compatible home sleep device.
transfer and display machine and therapeutic information that has been transmitted remotely from the patient's therapy device. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device. AirView also provides remote settings capabilities for non-life support devices only.

Device Description

AirView is a web application that can transfer, store, analyse, manage, and display machine and therapy data (from ResMed compatible therapy devices) and diagnostic data (from ResMed compatible sleep study devices). The data is transferred from the device either wirelessly through a communications module or with the aid of a data card/USB stick and internet technology to a central database and then displayed on the healthcare professional's computer through a web browser such as Internet Explorer.

The software application enables patient machine and therapy data to be shared across several different user groups for the primary purpose of monitoring patient compliance and home sleep studies. Clinical users and other healthcare specialists can access data with ResMed approved user accounts.

AirView can also be used by the healthcare specialist to remotely change the machine settings of compatible therapy devices. This assists in addressing any clinical issues in a timely manner and providing the necessary patient support. This is restricted to non-life support therapy devices only.

AI/ML Overview

The provided document describes the AirView device, a web-based solution for healthcare specialists. It aims to assist in the diagnosis of sleep-disordered breathing and manage patient therapy data. The submission highlights that the modified AirView device underwent non-clinical testing to demonstrate substantial equivalence to its predicate devices (EasyCare Online (K132371) and ResScan (K140054)). No clinical testing was deemed necessary.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states that "All tests confirmed the product met the predetermined acceptance criteria". However, the specific quantitative acceptance criteria themselves are not explicitly listed in the provided text. The performance is reported in a descriptive manner, focusing on verification activities.

Acceptance Criteria (Implicit)	Reported Device Performance
Data transfer integrity between CBK therapy devices and AirView.	End-to-End testing verified data transfer integrity between the CBK therapy devices and AirView.
No existing functionality impacted by modifications.	Regression Testing ensured no existing functionality was impacted.
Data output comparability with predicate device ResScan (K140054).	Side-by-Side testing compared data output between the modified AirView and the predicate ResScan (K140054), confirming comparability.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "End-to-End testing," "Regression Testing," and "Side-by-Side testing," but it does not specify the sample size for any of these test sets, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective nature of the data used in these tests).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish ground truth for the test set. The testing appears to be focused on technical validation (data transfer, functionality, output comparison) rather than clinical interpretation by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method as it does not involve expert consensus or human interpretation for the ground truth.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in the provided text. The AirView device's primary function is data management, transfer, and display, and to "assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an AirView compatible home sleep device," not necessarily to directly improve human reader performance in interpreting images or complex diagnostic output requiring "readers." The "analysis" of data for diagnosis is performed by the system itself based on recorded sleep data.

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

The testing conducted ("End-to-End testing," "Regression Testing," "Side-by-Side testing") assessed the standalone performance of the algorithm/software in terms of data transfer, functionality, and output comparability. The device "assists in the diagnosis" through this analysis, implying it has a standalone analytical component without a human "in the loop" for that specific analytical function.

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

Given the nature of the testing (data transfer, functional verification, output comparison), the "ground truth" implicitly refers to:

Correct data transmission: Ensuring the data sent matches the data received.
Expected software behavior: Verifying that existing functionalities remain unchanged and new functionalities operate as designed.
Concordance with predicate device output: Comparing the output of the modified AirView with a known, cleared predicate device (ResScan) to ensure they produce comparable results.

There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in these non-clinical tests.

8. The sample size for the training set

The document does not mention a training set or any machine learning model training. The described activities are verification testing, not model development or validation.

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

As no training set is mentioned, this information is not applicable or provided.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 5, 2015

ResMed Ltd. C/O Ms. Larissa D'andrea Director, Government and Regulatory Affairs ResMed Corp 9001 Spectrum Center Boulevard San Diego, CA 92123

Re: K151901

Trade/Device Name: AirView Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK. BZD. MNR. MNS Dated: September 28, 2015 Received: October 5, 2015

Dear Ms. Larissa D'andrea:

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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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Indications for Use

510(k) Number (if known) K151901

Device Name AirView

Indications for Use (Describe)

AirView is a web based solution for healthcare specialists intended to:

assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an AirView compatible home sleep device.
transfer and display machine and therapeutic information that has been transmitted remotely from the patient's therapy device. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device. AirView also provides remote settings capabilities for non-life support devices only.

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 Section 807.92(c)]

Date Prepared	2 July, 2015
Owners Name	ResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW 2153, Australia
Submitter	Jasjit BavejaRegulatory Affairs ManagerResMed Ltd, Australia1 Elizabeth Macarthur DriveBella Vista, NSW 2153, Australia+ 61 2 8884 1518 (Phone)+ 61 2 8884 2000 (Fax)Jasjit.baveja@resmed.com.au
Official Contact	Larissa D'AndreaDirector, Government & Regulatory AffairsResMed Corp9001 Spectrum Center BoulevardSan Diego, CA 92123+1 858 836 6837 (Phone)+1 858 836 5519 (Fax)Larissa.D'Andrea@resmed.com
Device Trade name	AirView
Device Common name	(Accessory to) Continuous Ventilator
Product codes	73 CBK

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73 MNS 73 MNR

Class	II
Classification/s Name/s	(Accessory to) Ventilator, Continuous, Facility use (21 CFR868.5895, Product Code 73 CBK)
	(Accessory to) Ventilator, Non-Continuous, (IPPB) (21 CFR868.5905, Product Code 73 BZD)
	(Accessory to) Ventilator, Breathing Frequency Monitor (21 CFR868.2375, Product Code 73 MNR)
	(Accessory to) Ventilator, Continuous, Non-Life-Supporting (21CFR 868.5895, Product Code 73 MNS)
Predicate device(s)	EasyCare Online - 510(k) number (K132371)ResScan - 510(k) number (K140054)
Reason for submission	Expanded Indications for Use

Intended Use

AirView is a web based solution for healthcare specialists intended to:

. assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an AirView compatible home sleep test device.
. transfer and display machine and therapeutic information that has been transmitted remotely from the patient's therapy device. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device. AirView also provides remote settings capabilities for non-life support devices only.

Device Description

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AirView (K151901) Sep 2015

Basis for Determination of Substantial Equivalence

The modified AirView has the following similarities to the previously cleared predicated devices:

. Similar intended use
Same operating principle
Same technology ●
o Same manufacturing (deployment) process

The modified AirView has the additional compatibility with ResMed CBK therapy devices. This compatibility is limited to the transfer and display of machine and therapeutic information. AirView provides remote setting capabilities for non-life support devices only.

Design and verification activities were performed on the modified AirView as a result of the updated design inputs changes for the inclusion of CBK compatibility into AirView. Verification testing included End-to-End testing to verify data transfer integrity between the CBK therapy devices and AirView, Regression Testing to ensure no existing functionality was impacted, and Side-by-Side testing to compare data output between the modified AirView and the predicate ResScan (K140054). All tests confirmed the product met the predetermined acceptance criteria and demonstrated that the modified AirView is substantially equivalent to the predicate devices, EasyCare Online (K132371) and ResScan (K140054).

The modified version of AirView does not raise new safety or effectiveness concerns.

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AirView (K151901) Sep 2015

Feature	EasyCare Online[Primarypredicate(K132371]	ResScanpredicate(K140054]	AirView (modified)	Comments
IntendedUse	EasyCare Online is a webbased solution forhealthcare specialistsintended to:assist in the diagnosisof sleep disorderedbreathing in adultpatients throughanalysis of datarecorded by anEasyCare Onlinecompatible homesleep test device. transfer and display,usage and therapeuticinformation that hasbeen transmittedremotely from thepatient's therapydevice located in thehome. It is intended tosupport the standardfollow-up care ofpatients that havebeen prescribed acompatible ResMedtherapy device for thetreatment ofobstructive sleepapnea or respiratoryinsufficiency.EasyCare Online alsoprovides remotesettings capabilities.	ResScan is intended toaugment the standardfollow-up care of patientsby providing transfer ofmachine and therapeuticinformation. This includesthe ability to remotelychange settings in non-lifesupport devices only. It isintended to be used byClinicians in conjunctionwith ResMed compatibletherapy devices, usingResMed's proprietarycommunications protocol	AirView is a web basedsolution for healthcarespecialists intended to:assist in thediagnosis of sleepdisorderedbreathing in adultpatients throughanalysis of datarecorded by anAirViewcompatible homesleep test device. transfer anddisplay machineand therapeuticinformation thathas beentransmittedremotely from thepatient's therapydevice. It isintended tosupport thestandard follow-upcare of patientsthat have beenprescribed acompatibleResMed therapydevice. AirViewalso providesremote settingscapabilities fornon-life supportdevices only.	EquivalentThecompatibility ofadding theCBK therapydevice comesfrom thesecondarypredicate,ResScan andfurtherclarification tosupport thatremotechangingsettings is notapplicable toResMed CBKdevices
Functionality	Centralised database Reports (Complianceand Therapy) Settings management Patient management Diagnostic Home SleepTest Reports (HSTR)	Reports (Complianceand Therapy) Settings management(non- life supportdevices only) Patient management	Centralised database Reports (Complianceand Therapy) Settingsmanagement (non-life support devicesonly) Patient management Diagnostic HomeSleep Test Reports(HSTR)	Equivalent
Feature	EasyCare Online[Primarypredicate(K132371]	ResScanpredicate(K140054]	Airview (modified)	Comments
DatatransferTechnology	• Wireless• SD Card/Internet• File upload/Internet	• Serial connection(RS232)• SD Card• USB Stick• Smart Media Card• Smart Card	• Wireless• SD Card/Internet• File upload/Internet• USB Stick/Internet	EquivalentCombinedfeatures
Therapysettings	• Pressure• Mode• Comfort	• Pressure• Mode	• Pressure• Mode• Comfort	Equivalent
Patientinformation	• Mask Leak• AHI• Pressure• Minute Ventilation• Respiratory rate• Mode• EPR Level• Pressure Support Level• Vt• I:E ratio	• Mask Leak• AHI• Pressure• Minute Ventilation• Vt• Respiratory Rate• SpO2	• Mask Leak• AHI• Pressure• Minute Ventilation• Respiratory rate• Mode• EPR Level• Pressure SupportLevel• Vt• I:E ratio• SpO2	EquivalentCombinedfeatures
Home SleepTestInformation(HSTI)	• Recording times• Event statistics(including AHI)• Oxy statistics• Pulse statistics	—	• Recording times• Event statistics(including AHI)• Oxy statistics• Pulse statistics	Equivalent

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AirView (K151901) Sep 2015

Non Clinical Testing

The modified AirView device was designed in accordance with the applicable requirements in relevant FDA guidance documents and international standards including:

FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices (May 11, 2005)
FDA Guidance Off-the-Shelf Software Use in Medical Devices (September 9, 1999) .
. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2, 2014)

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IEC 62304:2006 Medical device software Software life cycle processes .
IEC 62366: 2007 Medical devices Application of usability engineering to medical devices .
EN ISO 14971: 2012 Medical devices Application of risk manaqement to medical devices. .

The modified version of AirView does not raise new safety or effectiveness concerns.

Clinical Testing

Clinical testing was not deemed necessary. AirView only obtains machine and therapy data from therapeutic devices for which clinical trials have already been conducted, or compared with previous predicate comparison test results.

Conclusion

The indications for use, technological characteristics and principles of operation are similar or the same as the predicate devices. Performance data demonstrated that the modified device is as safe and effective as the predicate devices. Thus the modified AirView is substantially equivalent to the predicate devices, EasyCare Online (K132371) and ResScan (K140054).

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).