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 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).

AI/ML Overview

The EasyCare Tx System is a software and hardware system designed for clinicians to monitor and adjust settings of ResMed CPAP or Bilevel devices in a sleep lab clinical setting. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding specific studies, sample sizes, and expert adjudication to prove performance against acceptance criteria is not typically found in this type of submission.

Here's a breakdown of the available information and what cannot be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary explicitly states: "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." However, it does not provide a table detailing those specific acceptance criteria nor the quantitative performance metrics achieved for each criterion. The submission focuses on substantial equivalence based on similar intended use, operating principle, technology, and manufacturing process to the predicate devices (TxControl K072615 and ResControl II K040944).

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. The submission does not detail specific studies with test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for proving device performance against acceptance criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the 510(k) summary. As no explicit studies for establishing clinical performance against ground truth are detailed, there is no mention of experts or their qualifications for establishing such ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the absence of detailed performance studies, there is no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or, at least, not reported in this 510(k) summary. The device's primary function is to facilitate clinicians' interaction with a CPAP/Bilevel device, rather than to make interpretations or diagnoses from data that would typically require MRMC studies.

6. Standalone Performance Study

A standalone performance study (algorithm only without human-in-the-loop performance) was not detailed as a separate clinical study in this 510(k) summary. The system integrates software and hardware to enable human clinicians to monitor and adjust device settings. While components would undergo verification (e.g., software functionality, hardware connectivity), a "standalone" clinical performance study in the sense of an AI algorithm making independent decisions is not applicable here given the device's intended use.

7. Type of Ground Truth Used

The 510(k) summary does not specify a type of ground truth used, as it doesn't describe clinical studies with endpoints requiring a "ground truth" (e.g., expert consensus, pathology, or outcomes data). The "verification activities" mentioned are likely related to engineering and system functionality, ensuring the device accurately displays data and transmits setting changes as intended, rather than clinical diagnostic accuracy.

8. Sample Size for the Training Set

This information is not provided in the 510(k) summary. The EasyCare Tx System is a control and monitoring system, not a device that employs machine learning or AI models requiring a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the 510(k) summary, as it's not applicable to this type of device and submission.

Summary based on the provided document:

The 510(k) summary for the EasyCare Tx System indicates that "Design and Verification activities were performed... All tests confirmed the product met the predetermined acceptance criteria." However, it does not elaborate on these criteria, the specific studies performed, sample sizes, expert involvement, or adjudication methods beyond that statement. The submission primarily relies on demonstrating substantial equivalence to its predicate devices based on similar intended use, operating principle, technologies, and manufacturing processes, rather than presenting de novo clinical performance data against new acceptance criteria.

Summary

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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 LubkeDirector Regulatory AffairsResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW 2153AustraliaTel: +61 (2) 8884 1000Fax: +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 be used in a clinical environment.

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Device Description

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 (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

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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 in a clinical environment.

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

Regulation Number and Section

§ 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).