(115 days)
No
The description focuses on data transfer, storage, management, and display, with no mention of AI or ML algorithms for analysis or interpretation. The analysis of sleep disordered breathing is described as being assisted by the system, but the mechanism of this assistance is not detailed as AI/ML.
No.
EasyCare Online assists in diagnosis and monitors therapy; it does not directly provide therapeutic intervention to patients.
Yes
The "Intended Use / Indications for Use" section explicitly states that EasyCare Online is 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." This directly indicates a diagnostic purpose.
Yes
The device is described as a "web application" that transfers, stores, manages, and displays data from compatible hardware devices (sleep test devices and therapy devices). While it interacts with hardware, the device itself is the software application running on a computer, not a physical hardware component. The description focuses on the software's functionality in handling and presenting data.
Based on the provided information, EasyCare Online is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- EasyCare Online's Function: EasyCare Online's primary functions are:
- Analysis of data from a home sleep test device: This data is recorded by a device, not a specimen taken from the body.
- Transfer and display of usage and therapeutic information from a therapy device: This is monitoring and management of a treatment device, not analysis of a biological specimen.
- Remote settings capabilities for a therapy device: This is device control, not diagnostic testing of a specimen.
- Lack of Specimen Handling: The description of EasyCare Online does not mention any handling, preparation, or analysis of biological specimens.
Therefore, EasyCare Online falls outside the scope of an In Vitro Diagnostic device. It is a software solution for managing and analyzing data from medical devices used in the diagnosis and treatment of sleep disordered breathing.
N/A
Intended Use / Indications for 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
Product codes
73 MNS, 73 MNR
Device Description
EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from (ResMed compatible flow generators) 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 an SD card and internet technology, to a central database and then displayed on the clinician's/DME's computer, through a web based application such as internet Explorer.
EasyCare Online is used to monitor and optimize the therapy of patients diagnosed with sleep apnea or respiratory insufficiency, who are using a ResMed therapy device or home sleep test study device. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance and home sleep studies. Clinical users. Home Medical Equipment (DME) providers and other healthcare specialists can access data with ResMed approved user accounts. Also, clinical users and DMEs are able to address any clinical issues in a timely manner and provide the necessary patient support, including the modification of device settings. EasyCare Online supports physicians in the diagnosis Sleep Disordered Breathing, by reviewing home sleep test results via their web browser or download the clinical data to their PC for further analysis.
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
clinician's/DME's computer
physician
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
Non Clinical Testing included:
Software verification: Regression and End-to-End system testing was conducted to confirm that changes introduced in the code did not impact on previous ECO functionality (K123557) and verify the addition of ApneaLink Plus (K083575) functionality into ECO. Result: PASS.
Side-by-side testing: Three patient breathing pattern scripts were used for side by side testing of ECO (modified) and ApneaLink Plus PC software ((K083575) to verify that ECO correctly and accurately displayed home sleep test data belonging to ApneaLink Plus devices. Result: PASS.
No clinical testing is required for EasyCare Online.
Key Metrics
Not Found
Predicate Device(s)
EasyCare Online (510(k) number (K123557), ApneaLink Plus (510(k) number (K083575)
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
KJSZ371 NOV 2 2 2013
ResMed
ECO Traditional 510(k) Premarket
Notification
Jul 2013
4A 510(k) Summary
| 510(k) Summary | |||||
|---|---|---|---|---|---|
| Date Prepared | 26 Jul, 2013 | ||||
| Submitter | Greg Dockar | ||||
| Senior Regulatory Affairs Manager | |||||
| ResMed Ltd, Australia | |||||
| 1 Elizabeth Macarthur Drive | |||||
| Bella Vista, NSW 2153, Australia |
- 61 2 8884 2157 (Phone)
- 61 2 8884 2000 (FAX)
GregD@resmed.com.au | | | | |
| Official Contact | Jim Cassi
Vice President Quality Assurance Americas
ResMed Corp
9001 Spectrum Center Boulevard
San Diego, CA 92123
+1 858 836 6081
+1 858 836 5519
Jim. Cassi@resmed.com | | | | |
| Device name | EasyCare Online | | | | |
| Product codes | 73 MNS
73 MNR | | | | |
| Classification reference | Ventilator, Continuous, Non-Life-Supporting (21 CFR 868.5895,
Product Code 73 MNS)
Breathing Frequency Monitor (21CFR 868.2375 product code 73
MNR) | | | | |
| Predicate device(s) | EasyCare Online (510(k) number (K123557)
ApneaLink Plus (510(k) number (K083575) | | | | |
| Reason for submission | Expanded Intended for Use. | | | | |
1
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
Device Description
EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from (ResMed compatible flow generators) 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 an SD card and internet technology, to a central database and then displayed on the clinician's/DME's computer, through a web based application such as internet Explorer.
EasyCare Online is used to monitor and optimize the therapy of patients diagnosed with sleep apnea or respiratory insufficiency, who are using a ResMed therapy device or home sleep test study device. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance and home sleep studies. Clinical users. Home Medical Equipment (DME) providers and other healthcare specialists can access data with ResMed approved user accounts. Also, clinical users and DMEs are able to address any clinical issues in a timely manner and provide the necessary patient support, including the modification of device settings. EasyCare Online supports physicians in the diagnosis Sleep Disordered Breathing, by reviewing home sleep test results via their web browser or download the clinical data to their PC for further analysis.
Basis for Determination of Substantial Equivalence
The modified EasyCare Online has the following similarities to the previously cleared predicated device:
- Similar intended use .
- Same operating principle .
- 0 Same technology
- Same manufacturing (deployment) process 0
EasyCare Online modifications provide additional features for collection, storage and reporting of respiratory nasal airflow, respiratory effort, pulse rate and oxygen saturation during sleep studies which is used to assist the physician in diagnosis sleep disordered breathing. The physician prescribed device will help to recognize sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy.
2
With the ApneaLink Plus (also referred to as ApneaLink to Cloud - ALC) Software integration with EasyCare Online, a regression analysis showed that minimal affect on the existing system would occur. Confidence system level testing was conducted to ensure integration of ALC was conducted and found not to change the performance of EasyCare Online. Accordingly, 73 MNS and 73 MNR ResMed compatible devices function correctly with EasyCare Online. These changes do not affect the safety and efficacy of the device, as the EasyCare Online uses the existing data types and communications mechanisms between therapy devices as supported by the predicate device (K123557).
| Feature | EasyCare Online [Primary predicate(K123557)] | ApneaLink Plus [Secondary predicate(K083575)] | EasyCare Online (modified) | Comments |
|---|---|---|---|---|
| Intended | ||||
| Use | EasyCare Online | |||
| transfers and displays | ||||
| to physicians, usage | ||||
| and therapeutic | ||||
| information that has | ||||
| been transmitted | ||||
| remotely from the | ||||
| patient's flow generator | ||||
| located in the home. | ||||
| EasyCare Online also | ||||
| provides remote | ||||
| settings capabilities. |
EasyCare Online is
intended to support the
standard follow-up care
of patients that have
been prescribed a
compatible ResMed
flow generator for the
treatment of obstructive
sleep apnea or
respiratory insufficiency | The ApneaLink Plus
device is indicated for
use by Health Care
Professionals(HCP),
where it may aid in the
diagnosis of sleep
disordered breathing for
adult patients.
ApneaLink Plus records
the following data:
patient respiratory nasal
airflow, snoring, blood
oxygen saturation,
pulse and respiratory
effort during sleep. The
device uses these
recordings to produce a
report for the HCP that
may aid in the diagnosis
of sleep disordered
breathing or for further
clinical investigation. | 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 | Equivalent
Combined and
simplified-
same intent. |
| Functionality | • Centralised
database
• Compliance reports
• Therapy reports.
• Settings
management
• Patient management | • Diagnostic Home
Sleep Test Reports
(HSTR) | • Centralised database
• Compliance reports
• Therapy reports.
• Settings management
• Patient management
• Diagnostic Home Sleep
Test Reports (HSTR) | Equivalent
Combined
features |
| Data
transfer
Technology | • Wireless
• SD Card/Internet | USB connection from
ApneaLink Plus to the
Personal Computer | • Wireless
• SD Card/Internet
• File upload/Internet | Equivalent |
3
ResMed
| Feature | EasyCare Online
[Primary
predicate(K123557)] | ApneaLink Plus
[Secondary
predicate(K083575)] | EasyCare Online (modified) | Comments |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Therapy
settings | • Pressure
• Mode
• Comfort | — | • Pressure
• Mode
• Comfort | Equivalent |
| Patient
information | • Mask Leak
• AHI
• Prescription
Pressure
• Start Pressure
• Minute Ventilation
• Respiratory rate
• Mode
• EPR Level
• Pressure Support
Level | — | • Mask Leak
• AHI
• Prescription Pressure
• Start Pressure
• Minute Ventilation
• Respiratory rate
• Mode
• EPR Level
• Pressure Support Level | Equivalent |
| Home Sleep
Test
Information
(HSTI) | — | • Recording times
• Event statistics
(including AHI, apnea
index, hypopnea
index, apnea
classification)
• Oxy statistics (ODI,
oxygen saturation)
• Pulse statistics
• Breath statistics | • Recording times
• Event statistics (including
AHI, apnea index,
hypopnea index, apnea
classification)
• Oxy statistics (ODI, oxygen
saturation)
• Pulse statistics
• Breath statistics | Equivalent
Side by side
testing of ECO
(modified) and
ApneaLink
Plus PC
software
demonstrated
that ECO
correctly and
accurately
displayed
home sleep
test data
belonging to
ApneaLink
Plus devices. |
Non Clinical Testing
Design and non-clinical verification activities were performed on EasyCare Online as a result of the updated risk analysis and design requirements. Verification testing included end-to-end testing to verify data transfer integrity between end user browser PC and EasyCare Online was successfully implemented. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that new version of EasyCare Online is substantially equivalent to the predicate device, EasyCare Online (K123557).
Side-by-Side testing using the same data showed that both the predicate device ApneaLink Plus (K083575) and EasyCare Online produced the same home sleep test data. EasyCare Online met the predetermined pass/fail criteria.
4
| Testing | Scope of testing | Result |
|---|---|---|
| Software | ||
| verification | Regression and End-to-End system testing was conducted to confirm that | |
| changes introduced in the code did not impact on previous ECO functionality | ||
| (K123557) and verify the addition of ApneaLink Plus (K083575) functionality into | ||
| ECO. | PASS | |
| Side-by-side | ||
| testing | Three patient breathing pattern scripts were used for side by side testing of ECO | |
| (modified) and ApneaLink Plus PC software ((K083575) to verify that ECO | ||
| correctly and accurately displayed home sleep test data belonging to ApneaLink | ||
| Plus devices. | PASS |
Clinical Testing
No clinical testing is required for EasyCare Online.
Conclusion
The modified version of EasyCare Online is substantially equivalent to the predicate device, EasyCare Online (K123557)
The modified version of EasyCare Online is as safe and as effective, and performs substantially equivalent to the predicate devices, EasyCare Online (K123557) and ApneaLink Plus (K083575).
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2013
Resmed Corporation Jim Cassi Vice President, Quality Assurance Americas 9001 Spectrum Center Blvd. SAN DIEGO, CA 92123
Re: K132371 Trade Name: EasyCare Online Regulatory Class: III Product Code: MNS Dated: October 16, 2013 Received: October 21, 2013
Dear Mr. Cassi:
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 with all the Act's requirements, including, but not limited to: registration and listing (21
6
Page 2 - Mr. Jim Cassi
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
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Erin Keith Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
510(k) Number (if known) K132371
Device Name EasyCare Online
Indications for Use (Describe)
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
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
・・・・・・・ FOR FOR FDA USE ONLY . . . . 1-2-2-2 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/7/Picture/13 description: The image shows a digital signature of Anya C. Harry, along with the FDA logo. The signature includes a DN (Distinguished Name) that specifies the U.S. Government, HHS (Health and Human Services), and People. The date and time of the signature are also included, which is November 20, 2013, at 15:25:31 with a time zone offset of -05'00'.