AirView
Device Facts
| Record ID | K151901 |
|---|---|
| Device Name | AirView |
| Applicant | Resmed, Ltd. |
| Product Code | CBK · Anesthesiology |
| Decision Date | Nov 5, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for 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 Story
AirView is a web-based software application for healthcare specialists to manage patient therapy data. It receives machine and therapeutic data from ResMed-compatible therapy devices and diagnostic data from home sleep test devices via wireless transmission, data cards, or USB sticks. Data is stored in a central database and displayed via web browser. Clinicians use the platform to monitor patient compliance, review sleep study reports, and remotely adjust settings on non-life support therapy devices. This remote capability facilitates timely clinical intervention and support. The device does not perform primary diagnosis but assists clinicians by aggregating and presenting data, enabling efficient follow-up care and potentially improving patient adherence and therapeutic outcomes.
Clinical Evidence
Bench testing only. No clinical data required as the device functions to transfer and display data from therapeutic devices with established clinical history or predicate comparison.
Technological Characteristics
Web-based application; centralized database architecture. Connectivity via wireless, SD card, or USB/internet. Supports remote settings management for non-life support devices. Compliant with IEC 62304 (software lifecycle), IEC 62366 (usability), and EN ISO 14971 (risk management).
Indications for Use
Indicated for adult patients with sleep disordered breathing requiring diagnosis via home sleep test data analysis, and patients prescribed compatible ResMed therapy devices requiring remote monitoring and follow-up care. Remote settings changes restricted to non-life support devices.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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 Ltd<br>1 Elizabeth Macarthur Drive<br>Bella Vista, NSW 2153, Australia |
| Submitter | Jasjit Baveja<br>Regulatory Affairs Manager<br>ResMed Ltd, Australia<br>1 Elizabeth Macarthur Drive<br>Bella Vista, NSW 2153, Australia<br>+ 61 2 8884 1518 (Phone)<br>+ 61 2 8884 2000 (Fax)<br>Jasjit.baveja@resmed.com.au |
| Official Contact | Larissa D'Andrea<br>Director, Government & Regulatory Affairs<br>ResMed Corp<br>9001 Spectrum Center Boulevard<br>San Diego, CA 92123<br>+1 858 836 6837 (Phone)<br>+1 858 836 5519 (Fax)<br>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 CFR<br>868.5895, Product Code 73 CBK) |
| | (Accessory to) Ventilator, Non-Continuous, (IPPB) (21 CFR<br>868.5905, Product Code 73 BZD) |
| | (Accessory to) Ventilator, Breathing Frequency Monitor (21 CFR<br>868.2375, Product Code 73 MNR) |
| | (Accessory to) Ventilator, Continuous, Non-Life-Supporting (21<br>CFR 868.5895, Product Code 73 MNS) |
| Predicate device(s) | EasyCare Online - 510(k) number (K132371)<br>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
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.
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#### AirView (K151901) Sep 2015
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.
### 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<br>[Primary<br>predicate(K132371] | ResScan<br>predicate(K140054] | AirView (modified) | Comments |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | EasyCare Online is a web<br>based solution for<br>healthcare specialists<br>intended to:<br>assist in the diagnosis<br>of sleep disordered<br>breathing in adult<br>patients through<br>analysis of data<br>recorded by an<br>EasyCare Online<br>compatible home<br>sleep test device. transfer and display,<br>usage and therapeutic<br>information that has<br>been transmitted<br>remotely from the<br>patient's therapy<br>device located in the<br>home. It is intended to<br>support the standard<br>follow-up care of<br>patients that have<br>been prescribed a<br>compatible ResMed<br>therapy device for the<br>treatment of<br>obstructive sleep<br>apnea or respiratory<br>insufficiency.<br>EasyCare Online also<br>provides remote<br>settings capabilities. | ResScan is intended to<br>augment the standard<br>follow-up care of patients<br>by providing transfer of<br>machine and therapeutic<br>information. This includes<br>the ability to remotely<br>change settings in non-life<br>support devices only. It is<br>intended to be used by<br>Clinicians in conjunction<br>with ResMed compatible<br>therapy devices, using<br>ResMed's proprietary<br>communications protocol | AirView is a web based<br>solution for healthcare<br>specialists intended to:<br>assist in the<br>diagnosis of sleep<br>disordered<br>breathing in adult<br>patients through<br>analysis of data<br>recorded by an<br>AirView<br>compatible home<br>sleep test device. transfer and<br>display machine<br>and therapeutic<br>information that<br>has been<br>transmitted<br>remotely from the<br>patient's therapy<br>device. It is<br>intended to<br>support the<br>standard follow-up<br>care of patients<br>that have been<br>prescribed a<br>compatible<br>ResMed therapy<br>device. AirView<br>also provides<br>remote settings<br>capabilities for<br>non-life support<br>devices only. | Equivalent<br>The<br>compatibility of<br>adding the<br>CBK therapy<br>device comes<br>from the<br>secondary<br>predicate,<br>ResScan and<br>further<br>clarification to<br>support that<br>remote<br>changing<br>settings is not<br>applicable to<br>ResMed CBK<br>devices |
| Functionality | Centralised database Reports (Compliance<br>and Therapy) Settings management Patient management Diagnostic Home Sleep<br>Test Reports (HSTR) | Reports (Compliance<br>and Therapy) Settings management<br>(non- life support<br>devices only) Patient management | Centralised database Reports (Compliance<br>and Therapy) Settings<br>management (non-<br>life support devices<br>only) Patient management Diagnostic Home<br>Sleep Test Reports<br>(HSTR) | Equivalent |
| Feature | EasyCare Online<br>[Primary<br>predicate(K132371] | ResScan<br>predicate(K140054] | Airview (modified) | Comments |
| Data<br>transfer<br>Technology | • Wireless<br>• SD Card/Internet<br>• File upload/Internet | • Serial connection<br>(RS232)<br>• SD Card<br>• USB Stick<br>• Smart Media Card<br>• Smart Card | • Wireless<br>• SD Card/Internet<br>• File upload/Internet<br>• USB Stick/Internet | Equivalent<br>Combined<br>features |
| Therapy<br>settings | • Pressure<br>• Mode<br>• Comfort | • Pressure<br>• Mode | • Pressure<br>• Mode<br>• Comfort | Equivalent |
| Patient<br>information | • Mask Leak<br>• AHI<br>• Pressure<br>• Minute Ventilation<br>• Respiratory rate<br>• Mode<br>• EPR Level<br>• Pressure Support Level<br>• Vt<br>• I:E ratio | • Mask Leak<br>• AHI<br>• Pressure<br>• Minute Ventilation<br>• Vt<br>• Respiratory Rate<br>• SpO2 | • Mask Leak<br>• AHI<br>• Pressure<br>• Minute Ventilation<br>• Respiratory rate<br>• Mode<br>• EPR Level<br>• Pressure Support<br>Level<br>• Vt<br>• I:E ratio<br>• SpO2 | Equivalent<br>Combined<br>features |
| Home Sleep<br>Test<br>Information<br>(HSTI) | • Recording times<br>• Event statistics<br>(including AHI)<br>• Oxy statistics<br>• Pulse statistics | — | • Recording times<br>• Event statistics<br>(including AHI)<br>• Oxy statistics<br>• 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. .
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.
# 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).
