ResTraxx System is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been wirelessly transmitted from the patient's home to the care giver.

It is intended to be used in the home only and with compatible S7 Elite, AutoSet Spirit, AutoSet Respond, S8 Series CPAP Systems, VPAP III, VPAP III ST and VPAP Malibu positive airway pressure flow generators.

Device Description

The performance and functional characteristics of the ResTraxx System includes all the user features of the predicate device, ResTraxx Data Center System (K053205).

ResTraxx System is designed to function with ResMed OSA treatment devices for the transfer, storage, retrieval and display of stored information from the flow generator to the clinician's PC, via wireless transmission and web-based access. Access to the data is limited to subscribers of the system. Patients cannot access the system.

The ResTraxx System comprises two distinct components, the wireless transmitter/receiver located on the flow generator (referred to as, ResTraxx or S8 ResTraxx) and the web-based application, referred to as ResTraxx Online. Data taken from the flow generator is transmitted via a wireless network, stored in the ResTraxx Online database, transmitted via the Internet and displayed on the Clinical reviewer's PC.

ResTraxx™ and S8 ResTraxx™ - are wireless modules designed to attach to a compatible ResMed flow generator using a docking mechanism. This mechanism allows the device to be electrically connected via the existing expansion port located at the rear of the flow generator. When attached, the ResTraxx or S8 ResTraxx can automatically collect patient and machine information stored within the flow generator's memory. The ResTraxx and S8 ResTraxx sends information utilizing existing messaging networks providing wireless coverage to large portions of the USA population (The VPA) Museus uses the ResTraxx model).

ResTraxx Online – consists of several functional software modules that are designed to retrieve information from ResMed flow generators through ResTraxx via a wireless messaging network, store the information in a database and provide a secure interface into the system, allowing users to schedule information retrieval and view patient and machine information.

AI/ML Overview

The provided document, K070746, does not contain the detailed information necessary to fully address all aspects of the request. The document is primarily a 510(k) summary for a substantial equivalence determination, focusing on the similarities between the ResTraxx System and its predicate device, and confirming that the device meets predetermined acceptance criteria through design and verification activities. It does not describe a clinical study with detailed performance metrics, ground truth establishment, or reader studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All tests confirmed the product met the predetermined acceptance criteria." However, it does not provide a table outlining specific acceptance criteria or the reported performance metrics of the device. The device in question (ResTraxx System) is a data transfer and display system for CPAP usage, not a diagnostic or treatment delivery device with typical performance metrics like sensitivity, specificity, or image quality. Its "performance" would relate to data transmission reliability, accuracy of display, data security, etc., but these details are not provided.

Acceptance Criteria	Reported Device Performance
(Not specified in document)	(Not specified in document)
System design and verification activities confirmed product met predetermined criteria.	(Detailed performance metrics not provided)

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

The document does not mention a specific "test set" in the context of a clinical study involving patients or patient data. The "Design and Verification activities" refer to engineering and functional testing of the device itself (ResTraxx System with the inclusion of the VPAP Malibu). No information is provided regarding data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not available in the document. The ResTraxx System is a data management system, not a device requiring expert interpretation for establishing ground truth of a medical condition.

4. Adjudication Method for the Test Set

This information is not applicable and not available in the document. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this document. The device is for data display, not for aiding human readers in interpretation or diagnosis in a way that would warrant an MRMC study to measure improved effectiveness.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The ResTraxx System's primary function is to collect, transmit, store, and display data. While it performs these functions "stand-alone" from direct human intervention in the data transfer process (e.g., wireless transmission, database storage), it is inherently designed to deliver information to a human caregiver. Therefore, the concept of "standalone performance" in the context of an algorithm interpreting data is not directly applicable or described here. The document focuses on the system's functional integrity.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) as it applies to diagnostic or prognostic performance is not relevant to this device. The ResTraxx System handles existing usage and therapeutic information from a flow generator. The "truth" would be the accurate transmission and display of this factual usage data. The document implies that the device accurately conveys the data generated by the CPAP devices, which would be the "ground truth" for its function.

8. The Sample Size for the Training Set

No information regarding a "training set" is provided. The device is not based on machine learning or AI that would require a distinct training set for model development.

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

This information is not applicable as no training set is mentioned or implied for this device.

Summary

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K070746 Page 1 of 3

JUL 1 8 2007

RESMED

ResTraxx Sytem Traditional 510(k) Premarket Notification

510(k) Summary – ResTraxx System

Date Prepared

12" March, 2007

Official Contact	Dr Lionel King
	V.P., Quality Assurance & Regulatory Affair
	ResMed Ltd
	1 Elizabeth Macarthur Drive
	Bella Vista, NSW 2153
	Australia
	Tel: +61 (2) 8884 1000
	Fax: +61 (2) 8884 2021
Classification Reference	21 CFR 868.5905
Product Code	73 BZD
Common/Usual Name	Noncontinuous ventilator (IPPB).
Proprietary Name	ResTraxx System
Predicate Device(s)	ResTraxx Data Center (K053205)
Reason for submission	Change to Indications for Use

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KC70746 Page 2083

RESMED

ResTraxx Sytem Traditional 510(k) Premarket Notification

Substantial Equivalence

The new device has the following similarities to the previously cleared predicate device.

ﻨﺰ Similar intended use
ﺎ ﺗﺴﺮ Same operating principle
ﻧﺮ Same technologies
ﻨﺰ Same manufacturing process

Design and Verification activities were performed on the ResTraxx System with the inclusion of the VPAP Malibu (K062291) as a result of the risk analysis and product requirements. All tests ronfirmed the product met the predetermined acceptance criteria. ResMed has determined that the nevide is Substantially Equivalent to the predicate device. The inclusion of the VPAP Malibu as another CPAP (73 BZD) device with the ResTraxx System has not altered the safety and effectiveness when used in the management of Obstructive Sleep Apnea (OSA) in patients. The new device complies with the applicable standards and requirements referenced in the FDA guidance documents:

ﻨﺰ FDA Draft Reviewer Guidance for Ventilators (July 1995)
ﺳﺘﺮ FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999) ﻨﺰ
FDA Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off-the-ﺮ ﺍ Shelf (OTS) Software (January 14, 2005)

Intended Use

It is intended to be used in the home only and with compatible S7 Elite, AutoSet Respond, S8 Series CPAP Systems, VPAP III, VPAP III ST and VPAP Malibu positive airway pressure flow generators.

Device Description

The performance and functional characteristics of the ResTraxx System includes all the user features of the predicate device, ResTraxx Data Center System (K053205).

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KC40746, Page 3 of 3

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ResTraxx Sytem Traditional 510(k) Premarket Notification

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2007

ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K070746

Trade/Device Name: ResTraxx System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 2, 2007 Received: July 2, 2007

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sajitte H. Michie Dmd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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RESMED

Indication for Use

510(k) Number (if known): KO70741

Device Name:

ResTraxx System

Indication for Use

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

l A Del

(Division Siyi, " Division of Anesto-Stology, General Hospital Infection Control, Jental Devices

510(k) Number: K070746

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).