(115 days)
Not Found
No
The description focuses on data transfer, storage, management, and display for monitoring patient compliance and adjusting device settings, with no mention of AI or ML algorithms for analysis or decision-making.
No.
EasyCare Online is a web application that monitors and manages data from therapy devices, but it does not directly provide therapeutic intervention itself.
No
Explanation: The device is a web application that displays usage and therapeutic information from a remote device to clinicians. It is used to monitor and optimize therapy and patient compliance, as well as to remotely adjust device settings. It does not perform a diagnostic function but rather assists in the management of therapy after a diagnosis has already been made.
Yes
The device is described as a "web application" that transfers, stores, manages, and displays data. While it interacts with hardware (flow generators and communication modules), the device itself is the software application. The description focuses on the software's functionality and data handling, not on any hardware components of the device itself.
Based on the provided information, this device 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 provide information for diagnosis, monitoring, or screening.
- Device Function: EasyCare Online is a web application that transfers, stores, manages, and displays usage and therapy data from a patient's flow generator (a medical device used for treating sleep apnea or respiratory insufficiency). It also allows for remote adjustment of device settings.
- Lack of Biological Sample Analysis: The description clearly states that the data is transferred from the flow generator, either wirelessly or via SD card. There is no mention of analyzing any biological samples from the patient.
- Focus on Device Data: The primary function is to monitor and optimize the therapy provided by the flow generator, based on the device's usage and performance data.
Therefore, EasyCare Online falls under the category of a medical device used for monitoring and managing therapy, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
EasyCare Online transfers and displays to clinicians, 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.
Product codes (comma separated list FDA assigned to the subject device)
73 MNS, 73 BZD
Device Description
EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from ResMed flow generators. The data is transferred from the flow generators either wirelessly through a communications module or with the aid of an SD card, to a central database and then displayed in a clinician computer, through a web application.
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. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance. Clinical users, Home Medical Equipment (HME) providers and other healthcare specialists can access data to monitor patient compliance. Also, clinical users and HMEs are able to address any noncompliance issues in a timely manner and provide the necessary patient support, including the modification of device settings.
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 Medical Equipment (HME) providers and other healthcare specialists.
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)
Design and non-clinical verification activities were performed on EasyCare Online as a result of the risk analysis and design process. Verification testing included end-to-end testing to verify data transfer integrity between the flow generator and EasyCare Online. All tests confirmed the product met the predetermined acceptance criteria.
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.
EasyCare Online (K093684), ResScan (K113815)
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
§ 868.5895 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
K123557
・.
February 2013
· ·
510(k) Summary
| Date Prepared | 16-November-2012 (Amended on 11-Mar-2013) |
|---|---|
| Submitter | Manuel Urena |
| Regulatory Affairs Manager | |
| ResMed Ltd, Australia | |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW 2153, Australia | |
| + 61 2 88842766 | |
| Official Contact | Jim Cassi |
| Vice President Quality Assurance Americas | |
| ResMed Corp | |
| 9001 Spectrum Center Boulevard | |
| San Diego, CA 92123 | |
| +1 858 836 6081 | |
| Jim.Cassi@resmed.com | |
| Device name | EasyCare Online |
| Product code | 73 MNS (Primary) |
| 73 BZD (Secondary) | |
| Classification reference | (Accessory to) Ventilator, Non-Continuous (Respirator) |
| (21 CFR 868.5905, Product Code 73 BZD) | |
| (Accessory to) Ventilator, Continuous, Non-Life- | |
| Supporting (21 CFR 868.5895, Product Code 73 MNS) | |
| Predicate devices | EasyCare Online (K093684) |
| ResScan (K113815) | |
| Reason for submission | Indications for use have been expanded. |
1
5.1 Intended Use
EasyCare Online transfers and displays to clinicians, 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.
5.2 Basis for Determination of Substantial Equivalence
This modified EasyCare Online has the following similarities to the previously cleared predicated devices:
- . Same intended use
- Same operating principle .
- Same technology .
- Same manufacturing (deployment) process .
The modified EasyCare Online implemented changes to provide compatibility with the VPAP ST-A (K113288) flow generator, a device indicated for patients with respiratory insufficiency, with FDA product code 73 MNS. This addition modified the Intended Use Statement, as the condition of respiratory insufficiency was added. This change does not affect the safety and efficacy of the device, as the interface with the VPAP ST-A uses the existing data types and communications mechanisms that are utilised to interface with the flow generators already supported by the predicate devices. The modified device is substantially equivalent to the predicate devices EasyCare Online (K093684) and ResScan (K113815) which includes compatibility with S9 AutoSet, cleared under K091947; VPAP III ST-A, cleared under K033276; and Stellar, cleared under K103167.
Design and non-clinical verification activities were performed on EasyCare Online as a result of the risk analysis and design process. Verification testing included end-to-end testing to verify data transfer integrity between the flow generator and EasyCare Online. 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. The new version of EasyCare Online has not altered safety or effectiveness.
5.3 Device Description
EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from ResMed flow generators. The data is transferred from the flow generators either wirelessly through a communications module or with the aid of an SD card, to a central database and then displayed in a clinician computer, through a web application.
2
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. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance. Clinical users, Home Medical Equipment (HME) providers and other healthcare specialists can access data to monitor patient compliance. Also, clinical users and HMEs are able to address any noncompliance issues in a timely manner and provide the necessary patient support, including the modification of device settings.
5.4 Conclusion
The modified version of EasyCare Online is substantially equivalent to the predicate devices, EasyCare Online (K093684) and ResScan (K113815).
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and country.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2013
Jim Cassi ResMed LTD Vice President Quality Assurance Americas 9001 Spectrum Center Boulevard SAN DIEGO CA 92123
Re: K123557
Trade/Device Name: EasyCare Online Regulation Number: 21 CFR 868.5895 Regulation Name: Ventilator, continuous, non-life-supporting Regulatory Class: Class II Product Code: MNS Dated: February 11, 2013 Received February 11, 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.
4
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 (OS) 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/CDRHQffices/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/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 vours.
Kwame @ اللام السياري | Kwamer for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5
Response -EasyCare Online Traditional 510(k) Premarket Notification ResMed Ltd
Indications for Use Statement
510(k) Number: K123557 EasyCare Online Device Name:
Indications for Use:
EasyCare Online transfers and displays to clinicians, 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.
Prescription Use x (Part 21 CFR 801 Subpart D)
and / or
Over the counter use
(Part 21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Albert E. o=U.S. Government ou=HHS. Moyal -S for LS
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: