(120 days)
No
The document describes a system for remote monitoring and adjustment of therapy device settings, but there is no mention of AI or ML in the intended use, device description, or performance studies. The system appears to be a data relay and control interface.
No.
The device is a software application and hardware accessory that allows clinicians to monitor and adjust settings of existing therapy devices, but it does not provide therapy itself. It only relays signals and allows for remote control of other therapeutic devices.
No
Explanation: The "Summary of Performance Studies" explicitly states, "Clinical testing was not deemed necessary as identified in the Risk Analysis, as EasyCare Tx only obtains patient and machine information from therapeutic devices and does not provide diagnostic test results." This directly indicates that the device is not intended for diagnostic purposes. While it relays real-time signals to a polysomnograph (PSG), the device itself doesn't perform the diagnosis.
No
The device description explicitly states that the "EasyCare Tx System includes... Tx Link, a hardware accessory that connects to a flow generator and interfaces to a remote PC". This indicates the system is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that EasyCare Tx provides real-time data and treatment settings display, and allows for remote therapy device setting changes. It also relays signals to a polysomnograph (PSG). None of these functions involve examining specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The description reinforces that the system monitors and adjusts flow generator settings and provides analog signals to PSG systems. It does not describe any process of analyzing biological samples.
- Performance Studies: The performance studies section explicitly states that "Clinical testing was not deemed necessary as identified in the Risk Analysis, as EasyCare Tx only obtains patient and machine information from therapeutic devices and does not provide diagnostic test results." This directly indicates that the device is not intended to provide diagnostic information.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to diagnose or monitor medical conditions. The EasyCare Tx system interacts with a therapy device and a PSG, focusing on therapy management and physiological signal relay, not the analysis of biological specimens.
N/A
Intended Use / Indications for Use
EasyCare Tx is intended to be used with ResMed compatible therapy devices via the Tx Link. EasyCare Tx provides real-time data and treatment settings display, and can also provide therapy device setting changes remotely. EasyCare Tx is intended to be used in a clinical environment. The Tx Link is intended to provide connectivity between ResMed EasyCare Tx software and ResMed compatible therapy devices. The Tx Link relays real-time signals measured by the ResMed compatible therapy device to a polysomnograph (PSG). The Tx Link is intended to be used in a clinical environment.
Product codes
BZD
Device Description
ResMed's EasyCare Tx System enables clinicians to monitor real-time patient and flow generator information and adjust flow generator settings as required from the control room within the hospital and sleep lab clinical setting. The EasyCare Tx System includes: EasyCare Tx, a software application that executes on the end-user's PC and interfaces with A the accessory Tx Link to view and set various flow generator parameters and settings; and Tx Link, a hardware accessory that connects to a flow generator and interfaces to a remote A PC via an Ethernet connection. The Tx Link elso provides analog flow generator signals to third party Polysomnograph (PSG) systems, such as Embla (K971813).
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, clinical environment, hospital and sleep lab clinical setting
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)
Non-Clinical Testing: Performance testing of EasyCare Tx has been conducted using End-to-End bench testing methodology to demonstrate that the modified EasyCare Tx performs to design:input specifications. EasyCare Tx met the predetermined pass/fail criteria as defined in the EasyCare Tx System Verification Report!
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
ResMED
APR 2 0 2012
K113780 510(k) Summary - EasyCare Tx System
، ﺗ
[As required by 21 CFR 807.92 (c)]
Date Prepared
Submitter
Official Contact
Classification Reference
Product Code
Common/Usual Name
Proprietary Name
Predicate Device(s)
Reason for submission
02 March 2012
ﺮﻳﺘﻲ
Nicole Gaddi Regulatory Affairs Manager ResMed Ltd, Australia
Mr. David D'Cruz V.P., Clinical & Regulatory Affairs
ResMed Corp 9001 Spectrum Center Boulevard San Diego, CA 92123 USA Tel: (858) 236 2984 Fax: (858) 836 5522
21 CFR 868.5905
73 BZD
Non-continuous ventilator (IPPB)
EasyCare Tx System
EasyCare Tx System (K092026)
New Device
7* March 2012
Page 46
1
Image /page/1/Picture/0 description: The image shows the word "ResMed" in bold, black letters. The letters are slightly slanted to the right, giving the word a dynamic appearance. The font is sans-serif, and the overall impression is one of a clean and modern design.
The EasyCare Tx System comprises of the titration software, EasyCare Tx, and the connection module accessory, Tx Link.
Indication for Use
EasyCare Tx is intended to be used with ResMed compatible therapy devices via the Tx Link. EasyCare Tx provides real-time data and treatment settings display, and can also provide therapy device setting changes remotely.
EasyCare Tx is intended to be used in a clinical environment.
The Tx Link is intended to provide connectivity between ResMed EasyCare Tx software and ResMed compatible therapy devices. The Tx Link relays real-time signals measured by the ResMed compatible therapy device to a polysomnograph (PSG).
The Tx Link is intended to be used in a clinical environment.
Device Description
ResMed's EasyCare Tx System enables clinicians to monitor real-time patient and flow generator information and adjust flow generator settings as required from the control room within the hospital and sleep lab clinical setting.
The EasyCare Tx System includes:
- EasyCare Tx, a software application that executes on the end-user's PC and interfaces with A the accessory Tx Link to view and set various flow generator parameters and settings; and
- Tx Link, a hardware accessory that connects to a flow generator and interfaces to a remote A PC via an Ethernet connection. The Tx Link elso provides analog flow generator signals to third party Polysomnograph (PSG) systems, such as Embla (K971813).
Substantial Equivalence
The modified EasyCare Tx System has the following similarities to the previously cleared predicate device.
- A Similar intended use
- Similar operating principle A
- A Same technologies
- Same manufacturing process A
Design and Verification activities were performed on the EasyCare Tx System as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the modified device is Substantially Equivalent to the predicate device (K092026). The new device complies with the applicable standards and requirements referenced in the FDA guidance documents:
- FDA Draft Reviewer Guidance for Ventilators (July 1995) A
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical A 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-A the-Shelf (OTS) Software (January 14, 2005)
Non-Clinical Testing:
Performance testing of EasyCare Tx has been conducted using End-to-End bench testing methodology to demonstrate that the modified EasyCare Tx performs to design:input specifications.
2
RESMED
EasyCare Tx met the predetermined pass/fail criteria as defined in the EasyCare Tx System
Verification Report!
Clinical Testing:
Clinical testing was not deemed necessary as indentified in the Risk Analysis, as EasyCare Tx only Offical read not decined necessary as indentified in the Rincel Inc.alincal trials have already
obtains patient and machine information from therapeutic aest results. Accordi testing is required!
Conclusion
The modified EasyCare Tx System is Substantially Equivalent to the previously cleared predicate device, EasyCare Tx System (K092026).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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
APR 2 0 2012
Re: K113780
Trade/Device Name: EasyCare Tx System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 7, 2012 Received: March 14, 2012
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. 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
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
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 Tx System
The EasyCare Tx System comprises of the Titration Software, EasyCare Tx, and the Connection Module accessory, Tx Link.
Indication for Use
EasyCare Tx is intended to be used with ResMed compatible therapy devices via the Tx Link. EasyCare Tx EasyCare TX is littended to be used with Resired Occhpanist therapy device setting changes remotely.
EasyCare Tx is intended to be used in a clinical environment.
The Tx Link is intended to provide connectivity between ResMed EasyCare Tx software and ResMed THE TX Link is mended to provide connectives between Norther Resured by the ResMed compatible therapy device to a polysomnograph (PSG).
The Tx Link is intended to be used in a clinical environment.
Prescription Use _
AND/OR .
Over-The-Counter. Use_
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 807 Subpart C)
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| Concurrence of CDRH; Office of Device Evaluation (ODE) | Page 1 of 1 | |
|---|---|---|
| (Division Sign-Off) | ||
| Division of Anesthesiology, General Hospital | ||
| Infection Control, Dental Devices | ||
| 15-Dec-11 | 510(k) Number: | Page 13 |