(88 days)
Not Found
No
The description focuses on data transfer, storage, retrieval, and display, along with remote settings capabilities. There is no mention of AI, ML, or any features that would suggest algorithmic learning or decision-making beyond simple data presentation and transmission. The performance studies are limited to bench testing confirming data flow and settings changes.
No
The device primarily displays usage and therapeutic information, and allows for remote settings adjustments for a flow generator. It augments care but does not directly apply therapy to the patient. Its function is to facilitate the management of information and settings for a therapeutic device (the flow generator), rather than being a therapeutic device itself.
No
This device is designed to display usage and therapeutic information and provide remote settings capabilities for already diagnosed patients. It does not perform diagnostic functions such as identifying or characterizing a disease.
No
The device description explicitly states that EasyCare Online comprises two distinct components: the wireless transmitter/receiver located on the flow generator and the Server System. The wireless transmitter/receiver is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to augment the standard follow-up care of patients with obstructive sleep apnea by displaying usage and therapeutic information from a flow generator and providing remote settings capabilities. This is related to monitoring and managing a patient's treatment, not performing tests on biological samples to diagnose or monitor a disease state.
- Device Description: The device description focuses on the transfer, storage, retrieval, and display of data from a flow generator (a medical device used for treatment). It also mentions remote settings changes. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic or prognostic information based on sample analysis
- Mentioning specific analytes or biomarkers
- Describing any laboratory procedures
The device functions as a data management and remote control system for a therapeutic device (the flow generator), which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
EasyCare Online is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been transmitted from the patient's flow generator located in the home to the care giver. EasyCare Online also provides remote settings capabilities.
It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators.
Product codes (comma separated list FDA assigned to the subject device)
73 BZD
Device Description
The performance and functional characteristics of EasyCare Online includes all the user features of the predicate device, ResTraxx Online (K083816).
EasyCare Online is designed to function with ResMed OSA treatment systems for the transfer, storage, retrieval and display of stored information from the flow generator to a centralized server. This information can then be accessed by the clinician where the information can be displayed on the clinician's PC using a web browser application. Flow Generator settings changes, via wireless transmission can also be made from the clinicians PC. Access to the data is limited to subscribers of the system. Patients cannot access the system.
EasyCare Online comprises two distinct components, the wireless transmitter/receiver located on the flow generator and the Server System. Data taken from the flow generator is transmitted wa a wireless network and stored on the EasyCare Online database.
Wireless Module: The Wireless Module is similar in size to a mobile phone, it contains a GSM device and some interface hardware and firmware that functions in a similar manner as a mobile phone by transferring data to and from the server and the flow generator. It is designed to attach to a compatible ResMed flow generator using a docking mechanism and is powered via the electrical connection from the flow generator. This mechanism allows the device to be electrically connected via the existing expansion port located at the rear of the flow generator. When attached, the wireless modules can automatically collect patient and machine information stored within the flow generator's memory. The wireless module sends information utilizing existing wireless networks providing coverage to large portions of the US population.
All flow generators capable of being connected to the GSM wireless module and therefore able to transfer patient and machine data to the server are classified as 73 BZD devices.
Server System: The Server System consists of several functional software modules that are designed to retrieve information from ResMed flow generators through the wireless network, store the information in a database and provide a secure interface into the system. The system allows users to schedule information retrieval and view patient and treatment information, including the ability to retrieve existing settings from and apply new settings to the flow generator remotely from the Clinical reviewer's PC.
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
Not Found
Intended User / Care Setting
Clinicians, Home
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, sample size, AUC, MRMC, standalone performance, key results)
End-to-End bench testing was performed. All tests confirmed that EasCare Online met the predetermined acceptance criteria. No clinical trials were needed to demonstrate Safety and Efficacy. Based upon the Risk Analysis, Endto-End bench testing alone is sufficient as no new features were added that could raise concerns regarding Safety or Efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ResTraxx Online (K083816), ResScan Pro (K082983)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
KC093684
RESMED
EasyCare Online Traditional 510(k) Premarket Notification
510(k) Summary - EasyCare Online
| Date Prepared | 1st Feb, 2010 | FEB 2 6 2010 |
|---|---|---|
| Official Contact | Dr Lionel King | |
| V.P., Quality Assurance & Regulatory Affairs | ||
| ResMed Ltd | ||
| 1 Elizabeth Macarthur Drive | ||
| Bella Vista, NSW 2153 | ||
| Australia | ||
| Tel: +61 (2) 8884 1000 | ||
| Fax: +61 (2) 8884 2021 | ||
| Classification Reference | 21 CFR 868.5905 | |
| Product Code | 73 BZD | |
| Common/Usual Name | Noncontinuous ventilator (IPPB). | |
| Proprietary Name | EasyCare Online | |
| Predicate Device(s) | ResTraxx Online (K083816) | |
| ResScan Pro (K082983) | ||
| Reason for submission | New Device |
1গ February, 2010
1
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
- Similar intended use >
- Same operating principle A
- Similar technologies 入
-
Same manufacturing process
EasyCare Online remains largely the same as the predicate devices ResTraxx Online (K083816) for web based browser and patient data management and ResScan Pro (K082983) for Graphics User Interface (GUI) functionality, including the use of ResMed's proprietary communications protocol. Areas : of difference relate to new operating platform and software operating system (Windows 2000 NT to Windows 2008) which provides improved performance in the connectivity and transfer of data from the flow generator to the clinician along with improved (GUI) which provides better usability.
Design and Verification activities such as software development life cycle according to FDA guidance documents were followed as a result of the risk analysis and design requirements. Demonstrating Substantial Equivalence between the predicate device ResTraxx Online (K083816) and the new device (EasyCare Online) involved End to-End testing that shows patient and treatment data can be successfully transferred from the flow generator to the EasyCare Online system.
System testing includes a PC (GU1) with a Web Browser which is used to access the EasyCare Online server. Based upon the user's instructions, the PC sends a request via the internet to the server (EasyCare Online) to retrieve patient and machine data from the flow generator located in the patient's home via a secure telemetry network (GSM network).
If the user decides to update treatment parameters in the flow generator, this can be done by sending appropriate commands from the PC to the flow generator via the server and GSM network. The flow generator, via the GSM network, will send confirmation back to the user once these new settings have been implemented.
All tests confirmed that EasCare Online met the predetermined acceptance criteria. ResMed has determined that the new device is Substantially Equivalent to the predicate devices – ResTraxx Online (K083816) for web based wireless transfer and functionality of patient and machine information and ResScan Pro (K082983) for (GUI). The new device complies with the applicable requirements referenced in the FDA quidance documents:
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices > (May 11, 2005)
- FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999) A
-
FDA Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software (January 14, 2005)
No clinical trials were needed to demonstrate Safety and Efficacy. Based upon the Risk Analysis, Endto-End bench testing alone is sufficient as no new features were added that could raise concerns regarding Safety or Efficacy.
Intended Use
EasyCare Online is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been transmitted from the patient's flow generator located in the home to the care giver. EasyCare Online also provides remote settings capabilities.
It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators.
1st February, 2010
2
Device Description
General
The performance and functional characteristics of EasyCare Online includes all the user features of the predicate device, ResTraxx Online (K083816).
EasyCare Online is designed to function with ResMed OSA treatment systems for the transfer, storage, retrieval and display of stored information from the flow generator to a centralized server. This information can then be accessed by the clinician where the information can be displayed on the clinician's PC using a web browser application. Flow Generator settings changes, via wireless transmission can also be made from the clinicians PC. Access to the data is limited to subscribers of the system. Patients cannot access the system.
EasyCare Online comprises two distinct components, the wireless transmitter/receiver located on the flow generator and the Server System. Data taken from the flow generator is transmitted wa a wireless network and stored on the EasyCare Online database.
Wireless Module
The Wireless Module is similar in size to a mobile phone, it contains a GSM device and some interface hardware and firmware that functions in a similar manner as a mobile phone by transferring data to and from the server and the flow generator. It is designed to attach to a compatible ResMed flow generator using a docking mechanism and is powered via the electrical connection from the flow generator. This mechanism allows the device to be electrically connected via the existing expansion port located at the rear of the flow generator. When attached, the wireless modules can automatically collect patient and machine information stored within the flow generator's memory. The wireless module sends information utilizing existing wireless networks providing coverage to large portions of the US population.
All flow generators capable of being connected to the GSM wireless module and therefore able to transfer patient and machine data to the server are classified as 73 BZD devices.
Server System
The Server System consists of several functional software modules that are designed to retrieve information from ResMed flow generators through the wireless network, store the information in a database and provide a secure interface into the system. The system allows users to schedule information retrieval and view patient and treatment information, including the ability to retrieve existing settings from and apply new settings to the flow generator remotely from the Clinical reviewer's PC.
Conclusion
Based upon the Risk Analysis and results obtained from End-to-End bench testing as detailed in this submission, EasyCare Online is as safe, as effective, and performs as well as the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 9001 Spectrum Center Boulevard San Diego, California 92123
FEB 2 6 2010
Re: K093684 Trade/Device Name: EasyCare Online Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 20, 2009 Received: November 30, 2009
Dear Mr. D'Cruz:
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.
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.
4
Page 2 - Mr. D'Cruz
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 (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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ for the CDRI4'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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
for
Arthur D. Watson, B.S., M.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known):
Device Name:
EasyCare Online
Indication for Use
EasyCare Online is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been transmitted remotely from the patient's flow generator located in the home to the care giver. EasyCare Online also provides remote settings capabilities.
It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-T he-Counter Use_
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONT NUE ON ANOT HER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
L. Schult
Page 1 of _ 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093684
20吨 Nov, 2009