(88 days)
Embla (K971813)
No
The summary describes software and hardware for remote monitoring and control of CPAP/Bilevel devices, focusing on data display and setting adjustments. There is no mention of AI or ML algorithms for analysis, prediction, or automated decision-making based on the data.
No
This device monitors and adjusts settings of therapeutic devices (CPAP/Bilevel devices) but does not directly provide therapy itself. It is a system for managing other therapeutic devices.
No
The text describes the "EasyCare Tx System" as a tool for monitoring real-time data from CPAP/Bilevel devices, displaying treatment settings, and remotely changing device settings. It also relays signals to a polysomnograph (PSG). While it observes device data, its primary purpose is device management and signal relay, not diagnosing medical conditions. The PSG (polysomnograph) is the diagnostic device that would interpret the relayed signals.
No
The device description explicitly states that the EasyCare Tx System includes both the EasyCare Tx software application and the Tx Link, which is described as a "hardware accessory."
Based on the provided information, the EasyCare Tx System 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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- EasyCare Tx System Function: The EasyCare Tx System is designed to interface with and control CPAP/Bilevel devices used for treating sleep apnea. It monitors real-time data from these devices and allows for remote adjustment of settings. It also relays signals from the CPAP/Bilevel device to a polysomnograph (PSG).
- Lack of Specimen Analysis: The description clearly states that the system works with and monitors data from the CPAP/Bilevel device and relays signals to a PSG. There is no mention of collecting, preparing, or analyzing any specimens from the human body.
Therefore, the EasyCare Tx System falls outside the scope of an In Vitro Diagnostic device. It is a system used in a clinical setting to manage and monitor respiratory therapy devices.
N/A
Intended Use / Indications for Use
The EasyCare Tx System comprises of the titration software, EasyCare Tx, and the connection module accessory, Tx Link.
The EasyCare Tx is intended to be used with ResMed continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol via the Tx Link. EasyCare Tx provides real time data and treatment settings display, and can also provide CPAP or Bilevel 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 continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol. The Tx Link relays real-time signals measured by the CPAP or Bilevel device to a polysomnograph (PSG).
The Tx Link is intended to be used in a clinical environment.
Product codes
73 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 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 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 incorporating ResMed's proprietary D communication protocol, and interfaces to a remote PC via an Ethernet connection. The Tx Link also 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
EasyCare Tx is intended to be used in a clinical environment.
The Tx Link is intended to be used in a clinical environment.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TxControl (K072615), ResControl II (K040944)
Reference Device(s)
Not Found
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).
0
EasyCare Tx System Traditional 510(k) Premarket Notification
510(k) Summary - EasyCare Tx System
| Date Prepared | 1 JULY 2009 |
|---|---|
| Official Contact | Steven Lubke |
| Director Regulatory Affairs | |
| ResMed Ltd | |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW 2153 | |
| Australia | |
| Tel: +61 (2) 8884 1000 | |
| Fax: +61 (2) 8884 2000 | |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | 73 BZD |
| Common/Usual Name | Non-continuous ventilator (IPPB) |
| Proprietary Name | EasyCare Tx System |
| Predicate Device(s) | TxControl (K072615) |
| ResControl II (K040944) | |
| Reason for submission | New Device |
OCT - 2 2009#### Intended Use
RESMED
The EasyCare Tx System comprises of the titration software, EasyCare Tx, and the connection module accessory, Tx Link.
The EasyCare Tx is intended to be used with ResMed continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol via the Tx Link. EasyCare Tx provides real time data and treatment settings display, and can also provide CPAP or Bilevel 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 continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol. The Tx Link relays real-time signals measured by the CPAP or Bilevel device to a polysomnograph (PSG).
The Tx Link is intended to be used in a clinical environment.
1
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 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 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 incorporating ResMed's proprietary D communication protocol, and interfaces to a remote PC via an Ethernet connection. The Tx Link also provides analog flow generator signals to third party Polysomnograph (PSG) systems, such as Embla (K971813).
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
- ﺧﺰ Similar intended use
- 沙 Similar operating principle
- ど Similar technologies
-
Similar manufacturing process
Desion 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 new device is Substantially Equivalent to the predicate devices. 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
- 公 FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- FDA Guidance for 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) 以 Software (January 14, 2005)
Conclusion
The EasyCare Tx System is Substantially Equivalent to the previously cleared predicate devices, TxControl (K072615) and ResControl II (K040944).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring. MD 20993-0002
Mr. Steven Lubke Director Regulatory Affairs ResMed, Limited 1 Elizabeth Macarthur Drive Bella Vista, NSW 2153 AUSTRALIA
OCT - 2 2009
Re: K092026
Trade/Device Name: EasyCare Tx System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 1, 2009 Received: July 6, 2009
Dear Mr. Lubke:
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.
3
Page 2 - Mr. Lubke
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
h for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
RESMED
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 continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol via the Tx Link. EasyCare Tx provides real time data and treatment settings display, and can also provide CPAP or Bilevel 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 continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol. The Tx Link relays real-time signals measured by the CPAP or Bilevel device to a polysomnograph (PSG).
The Tx Link is intended to be used in a clinical environment.
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K 092026 510(k) Number:
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × AND/OR
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Page 1 of 1