(148 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data tracking and device control, not analytical capabilities.
No.
The myAir app is a companion mobile medical application for self-monitoring and temporary control of compatible devices, but it does not directly treat or mitigate a disease or condition; it supports the use of therapeutic devices like PAP therapy devices.
No
The "Device Description" explicitly states, "Analysis of patient diagnostic data or display of diagnostic results are not in scope of myAir features." While it can connect to a Home Sleep Test (HST) device and track usage data, it does not perform the diagnostic analysis itself.
No
The device description explicitly states it is a "companion mobile medical application" that connects via Bluetooth to "compatible hardware devices" (ResMed Air11 platform device and NightOwl wearable device) for control and data transfer. While the app itself is software, its function is intrinsically linked to and dependent on these external hardware devices, making it a software component of a larger system, not a standalone software-only medical device.
Based on the provided information, the myAir app is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- myAir App Functionality: The myAir app's intended use and device description clearly state its purpose is to:
- Simulate therapy for PAP devices.
- Provide a user interface for a home sleep testing device (NightOwl).
- Allow self-tracking of device usage data.
- Facilitate communication with compatible devices.
- Lack of Biological Sample Analysis: The description explicitly states that "Analysis of patient diagnostic data or display of diagnostic results are not in scope of myAir features." This confirms that the app does not perform any analysis on biological samples.
- Focus on Device Interaction and Data Tracking: The app's primary functions revolve around interacting with and tracking data from medical devices used for sleep therapy and home sleep testing, not analyzing biological samples for diagnostic purposes.
Therefore, the myAir app falls under the category of a medical device accessory or companion app that supports the use of other medical devices, rather than an in vitro diagnostic device.
N/A
Intended Use / 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 Air11 PAP therapy devices and
• new users who are prescribed a compatible NightOwl home sleep test (HST).
Product codes
BZD
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.
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
Patients weighing more than 66 lb (30kg)
Intended User / Care Setting
Home and hospital use
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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"
1
(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).
2
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
3
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 Corp |
| 9001 Spectrum Center Blvd | |
| San Diego, CA 92123 | |
| USA | |
| Official Contact: | Mrs. Rose Malonzo |
| Senior Specialist, Global Product Regulatory Affairs | |
| ResMed Corp | |
| 9001 Spectrum Center Blvd | |
| San Diego, CA 92123 USA | |
| Tel: 858-285-5670 | |
| rose.malonzo@resmed.com | |
| Device Trade Name: | myAir |
| Device Common Name: | Ventilator, Non-Continuous (Respirator) [primary] |
| Classification and | |
| Classification Name: | II |
| Noncontinuous ventilator (IPPB) [primary] | |
| Product Code: | BZD |
| Primary Predicate Device: | Galapagos |
| K200565 | |
| Reference Device: | NightOwl Companion App (patient mobile application in the |
| NightOwl System) | |
| K220028 | |
| Submission Reason: | Modified device |
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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.
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 Predicate
Device:
Galapagos
Manufacturer:
ResMed Corp
510(k) Number:
K200565 | Reference Device:
NightOwl Companion
App (patient mobile
application in the
NightOwl System)
Manufacturer:
EctoSense
510(k) Number:
K220028 | Subject Device:
myAir with Stella functions
Manufacturer:
ResMed Corp
510(k) Number:
K241216 | Substantial Equivalence |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Galapagos app is
intended for patients who
are prescribed a
compatible ResMed S10
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. | The NightOwl is a
wearable device
intended for use in the
recording, analysis,
displaying, exporting,
and storage of
biophysical parameters
to aid in the evaluation
of sleep-related
breathing disorders of
adult patients
suspected of sleep
apnea. The device is
intended for the clinical
and home setting use
under the direction of a
Healthcare
Professional (HCP). | 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 | The proposed myAir indications for use adding Stella
functions (i.e., compatibility with NightOwl HST
sensor) with this premarket submission is similar to
the predicate device in that the subject device mobile
app has software device functions which are
considered medical functions associated with
Bluetooth connection intended for limited device
control and non-device-MDDS data transfer.
The difference in the indications for use does not raise
new questions of safety or efficacy for the subject
device as the devices have the same intended use. |
| Characteristic | Primary Predicate
Device:
Galapagos
Manufacturer:
ResMed Corp
510(k) Number:
K200565 | Reference Device:
NightOwl Companion
App (patient mobile
application in the
NightOwl System)
Manufacturer:
EctoSense
510(k) Number:
K220028 | Subject Device:
myAir with Stella functions
Manufacturer:
ResMed Corp
510(k) Number:
K241216 | Substantial Equivalence |
| | | | • new users who are
prescribed a compatible
NightOwl home sleep test
(HST). | |
| Regulation
Number | 21 CFR §868.5905 | 21 CFR §868.2375 | Primary: 21 CFR §868.5905 | Similar. The modification to add device compatibility
does not raise new questions of safety or efficacy for
the subject device as the devices
have the same intended use. |
| Classification
Name | Noncontinuous ventilator
(IPPB) | Ventilatory effort
recorder | Primary: Noncontinuous
ventilator (IPPB) | Similar. The subject device adds device compatibility
with the cleared NightOwl device (K220028). Data
analysis, processing, and results are out of scope from
the subject device functions. |
| FDA Product
Code | BZD | MNR | BZD | Similar. The subject device adds compatibility with
cleared NightOwl device (K220028). |
| Prescription
Use | Yes | Yes | Yes | Identical |
| Characteristic | Primary Predicate
Device:
Galapagos
Manufacturer:
ResMed Corp
510(k) Number:
K200565 | Reference Device:
NightOwl Companion
App (patient mobile
application in the
NightOwl System)
Manufacturer:
EctoSense
510(k) Number:
K220028 | Subject Device:
myAir with Stella functions
Manufacturer:
ResMed Corp
510(k) Number:
K241216 | Substantial Equivalence |
| Patient
Population | Patients weighing more
than 66 lb (30kg) | 22 years old and older | Patients weighing more
than 66 lb (30kg) | Identical. The difference in patient population for the
reference device does not raise new questions of safety
or effectiveness for the subject device. Patients are
unable to use myAir as intended without connecting to
the intended compatible device. Due to the intended
compatibility of myAir with the Air11 or NightOwl
devices, the same patient population and user
environment for the respective compatible hardware
devices inherently applies to the subject myAir device. |
| Intended
Environment of
Use | Home | Clinical and home | Home | Identical |
| Patient
Contacting | No, Galapagos is
software. | No, NightOwl
Companion App is
software. | No, myAir is software. | Identical |
| Display Type | Smartphone display | Smartphone display | Smartphone display | Identical |
| Device
Interoperability
and V&V | ResMed Air11 platform
devices | NightOwl HST | ResMed Air11 platform
devices and EctoSense
NightOwl HST | The modification for additional compatibility with the
cleared NightOwl Companion App (patient mobile app
within the NightOwl System, K220028) does not raise
new questions of safety or effectiveness.
Furthermore, all non-clinical performance bench
testing required for the subject device myAir with Stella
functions support the intended design of the product,
and device safety and effectiveness. |
| Characteristic | Primary Predicate
Device:
Galapagos
Manufacturer:
ResMed Corp
510(k) Number:
K200565 | Reference Device:
NightOwl Companion
App (patient mobile
application in the
NightOwl System)
Manufacturer:
EctoSense
510(k) Number:
K220028 | Subject Device:
myAir with Stella functions
Manufacturer:
ResMed Corp
510(k) Number:
K241216 | Substantial Equivalence |
| Device
Connection
Requirement | Yes. Galapagos app must
be connected to a
compatible therapy device
for usage. | Yes. NightOwl
Companion App must
be connected to a
compatible HST device
for usage. | Yes. myAir app must be
connected to a
compatible HST to
operate Stella functions
as intended. | Difference in functionality does not raise new
questions of safety or effectiveness. |
| Device Control | Yes. Galapagos can
control the connected
therapy device. | No. NightOwl
Companion App does
not allow control of the
connected therapy
device. | Yes. myAir can control
the connected therapy
or HST device. | Difference in functionality from the NightOwl
companion app does not raise new questions of safety
or effectiveness. |
| Communication
Pathways
Available | Bluetooth and HTTPS
(cellular or wireless
internet connection) | Bluetooth and HTTPS
(cellular or wireless
internet connection) | Bluetooth and HTTPS
(cellular or wireless internet
connection) | Identical |
| Device data to
app
communication
pathway | Pathways:
- Device data transfers to
Machine Cloud Service
(MCS) then to Galapagos.
Therapy device data
transferred from device to
app to MCS. | Pathways:
HST device data
transfers from sensor
through the NightOwl
Companion App to the
EctoSense backend
server for analysis. | Pathways: - Device data transfers to
Machine Cloud Service
(MCS) then to Galapagos.
Therapy device data
transferred from device to
app to MCS. | Differences in types of data transferred and
communication pathways available does not raise new
questions of safety or effectiveness. Software functions
related to data analysis and display of
diagnostic results are out of scope of the subject
device myAir app as these medical device software
functions are within the NightOwl Backend Server and |
| Characteristic | Primary Predicate
Device:
Galapagos
Manufacturer:
ResMed Corp
510(k) Number:
K200565 | Reference Device:
NightOwl Companion
App (patient mobile
application in the
NightOwl System)
Manufacturer:
EctoSense
510(k) Number:
K220028 | Subject Device:
myAir with Stella functions
Manufacturer:
ResMed Corp
510(k) Number:
K241216 | Substantial Equivalence |
| | | | 3) HST device data transfers
from sensor through the
myAir app to EctoSense
backend server for analysis. | HCP Dashboard components of the NightOwl System
(K220028). |
| App Store
Availability | Google Play Store | Google Play Store and
Apple App Store | Apple App Store | Difference in mobile app store availability does not
raise new questions of safety or efficacy for the subject
device. |
| Therapy Settings
Changes | None. The Galapagos app
does not have capabilities
of altering therapy settings. | Not applicable | None | Identical |
| Adjust Comfort
Settings | None. The Galapagos app
does not have capabilities
of adjusting comfort
settings. | Not applicable | None | Identical |
| Software Level of
Documentation | Moderate | Moderate | Basic | Similar. The differences in level of software
documentation are determined in accordance with the
FDA guidance "Content of Premarket Submissions for
Device Software Functions". The subject device
follows FDA's risk-based approach for basic vs.
enhanced (2023), while the predicate devices followed
FDA's Guidance for the Content of Premarket
Submissions for Software Contained in Medical
Devices issued on May 11, 2005. |
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Image /page/9/Figure/0 description: The image shows the logo for ResMed. The logo features a curved line of dots that transition in color from blue to red. Below the dots, the word "ResMed" is written in a bold, italicized font.
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Public
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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.