EASYCARE TX, TX LINK

K092026 · Resmed, Ltd. · BZD · Oct 2, 2009 · Anesthesiology

Device Facts

• Record ID: K092026
• Device Name: EASYCARE TX, TX LINK
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2

Intended 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.

Device Story

EasyCare Tx System enables clinicians in sleep labs to monitor and adjust CPAP/Bilevel therapy remotely. System consists of EasyCare Tx software (PC-based) and Tx Link hardware. Tx Link connects to flow generator via proprietary protocol and to PC via Ethernet; it also outputs analog signals to third-party polysomnographs (PSG). Clinicians view real-time patient/flow data on PC and remotely modify device settings. Facilitates titration process within clinical setting; improves workflow efficiency for sleep lab staff.

Clinical Evidence

Bench testing only. No clinical data provided. Design and verification activities were performed based on risk analysis and design requirements, confirming the product met predetermined acceptance criteria.

Technological Characteristics

System includes PC-based software and hardware connection module (Tx Link). Connectivity via Ethernet and proprietary communication protocol. Provides analog signal output to third-party PSG systems. Operates in clinical environment. Complies with FDA guidance for software in medical devices and cybersecurity for networked medical devices.

Indications for Use

Indicated for use in a clinical environment for the remote monitoring and adjustment of ResMed CPAP or Bilevel devices via the Tx Link connection module.

Regulatory Classification

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.

Predicate Devices

• TxControl (K072615)
• ResControl II (K040944)

Reference Devices

• Embla (K971813)

Submission Summary (Full Text)

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K092026

EasyCare Tx System Traditional 510(k) Premarket Notification

### 510(k) Summary - EasyCare Tx System

| Date Prepared | 1 JULY 2009 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Steven Lubke<br>Director Regulatory Affairs<br>ResMed Ltd<br>1 Elizabeth Macarthur Drive<br>Bella Vista, NSW 2153<br>Australia<br>Tel: [phone]<br>Fax: [phone] |
| 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)<br>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.

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#### 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).

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### 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.

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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 [phone] or [phone] 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

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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)

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