(118 days)
No
The summary describes a web-based data management and analysis system for sleep and therapy data, but does not mention any AI or ML capabilities. The analysis is described as assisting in diagnosis, but the mechanism is not specified as AI/ML.
No
AirView is a web-based solution that assists in diagnosis and facilitates the transfer and display of machine and therapeutic information from other devices, and allows for remote changes to settings of compatible therapy devices, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to "assist in the diagnosis of sleep disordered breathing."
No
The device description explicitly states that AirView transfers data from "ResMed compatible therapy devices" and "ResMed compatible sleep study devices," which are hardware devices. While AirView itself is a web application (software), its function is dependent on and interacts with external hardware.
Based on the provided information, AirView is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AirView's Function: AirView analyzes data recorded by home sleep devices and therapy devices. This data is related to physiological measurements during sleep and the performance of therapy devices, not the analysis of biological specimens from the patient's body.
- Intended Use: The intended use clearly states that AirView assists in the diagnosis of sleep disordered breathing through the analysis of data from a home sleep device. It also manages and displays data from therapy devices. Neither of these activities involves the examination of in vitro specimens.
Therefore, AirView falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
CBK, BZD, MNR, MNS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
healthcare specialists, clinicians
home, facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Study Type: Non Clinical Testing (Verification Testing)
Sample Size: Not explicitly stated
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
- 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.
- 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).
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract design.
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary [As required Section 807.92(c)]
| Date Prepared | 2 July, 2015 |
|---|---|
| Owners Name | ResMed Ltd |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW 2153, Australia | |
| Submitter | Jasjit Baveja |
| Regulatory Affairs Manager | |
| ResMed Ltd, Australia | |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW 2153, Australia |
- 61 2 8884 1518 (Phone)
- 61 2 8884 2000 (Fax)
Jasjit.baveja@resmed.com.au |
| Official Contact | Larissa D'Andrea
Director, Government & Regulatory Affairs
ResMed Corp
9001 Spectrum Center Boulevard
San 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 |
4
73 MNS 73 MNR
| Class | II |
|---|---|
| Classification/s Name/s | (Accessory to) Ventilator, Continuous, Facility use (21 CFR |
| 868.5895, Product Code 73 CBK) | |
| (Accessory to) Ventilator, Non-Continuous, (IPPB) (21 CFR | |
| 868.5905, Product Code 73 BZD) | |
| (Accessory to) Ventilator, Breathing Frequency Monitor (21 CFR | |
| 868.2375, Product Code 73 MNR) | |
| (Accessory to) Ventilator, Continuous, Non-Life-Supporting (21 | |
| CFR 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
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.
5
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.
6
AirView (K151901) Sep 2015
| Feature | EasyCare Online
[Primary
predicate(K132371] | ResScan
predicate(K140054] | AirView (modified) | Comments |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | EasyCare Online 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
EasyCare Online
compatible home
sleep test device. transfer and display,
usage and therapeutic
information that has
been transmitted
remotely from the
patient's therapy
device located in the
home. It is intended to
support the standard
follow-up care of
patients that have
been prescribed a
compatible ResMed
therapy device for the
treatment of
obstructive sleep
apnea or respiratory
insufficiency.
EasyCare Online also
provides remote
settings capabilities. | ResScan is intended to
augment the standard
follow-up care of patients
by providing transfer of
machine and therapeutic
information. This includes
the ability to remotely
change settings in non-life
support devices only. It is
intended to be used by
Clinicians in conjunction
with ResMed compatible
therapy devices, using
ResMed's proprietary
communications protocol | 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. | Equivalent
The
compatibility of
adding the
CBK therapy
device comes
from the
secondary
predicate,
ResScan and
further
clarification to
support that
remote
changing
settings is not
applicable to
ResMed CBK
devices |
| Functionality | Centralised database Reports (Compliance
and Therapy) Settings management Patient management Diagnostic Home Sleep
Test Reports (HSTR) | Reports (Compliance
and Therapy) Settings management
(non- life support
devices only) Patient management | Centralised database Reports (Compliance
and Therapy) Settings
management (non-
life support devices
only) Patient management Diagnostic Home
Sleep Test Reports
(HSTR) | Equivalent |
| Feature | EasyCare Online
[Primary
predicate(K132371] | ResScan
predicate(K140054] | Airview (modified) | Comments |
| Data
transfer
Technology | • 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 | Equivalent
Combined
features |
| Therapy
settings | • Pressure
• Mode
• Comfort | • Pressure
• Mode | • Pressure
• Mode
• Comfort | Equivalent |
| Patient
information | • 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 Support
Level
• Vt
• I:E ratio
• SpO2 | Equivalent
Combined
features |
| Home Sleep
Test
Information
(HSTI) | • Recording times
• Event statistics
(including AHI)
• Oxy statistics
• Pulse statistics | — | • Recording times
• Event statistics
(including AHI)
• Oxy statistics
• Pulse statistics | Equivalent |
7
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)
8
- 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).