RESTRAXX DATA CENTRE, MODEL R10

K070746 · Resmed, Ltd. · BZD · Jul 13, 2007 · Anesthesiology

Device Facts

• Record ID: K070746
• Device Name: RESTRAXX DATA CENTRE, MODEL R10
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2

Intended Use

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 Respond, S8 Series CPAP Systems, VPAP III, VPAP III ST and VPAP Malibu positive airway pressure flow generators.

Device Story

ResTraxx System facilitates remote monitoring of obstructive sleep apnea (OSA) patients. System consists of a wireless transmitter/receiver module (ResTraxx/S8 ResTraxx) that docks into compatible ResMed flow generators (S7 Elite, AutoSet Respond, S8 Series, VPAP III, VPAP III ST, VPAP Malibu) and a web-based application (ResTraxx Online). Module automatically collects patient/machine data from flow generator memory; transmits data via wireless network to ResTraxx Online database. Clinicians access stored data via secure web interface on PC to view usage/therapeutic information. System intended for home use; operated by patients (passive data collection) and clinicians (data review). Enables clinicians to monitor therapy adherence and efficacy, potentially improving patient management and outcomes. Access restricted to authorized subscribers.

Clinical Evidence

Bench testing only. Design and verification activities were performed to confirm the system met predetermined acceptance criteria, including integration with the VPAP Malibu flow generator.

Technological Characteristics

System comprises a wireless hardware module (transmitter/receiver) and a web-based software application. Hardware connects to flow generator expansion port. Connectivity via wireless messaging network and Internet. Software is web-based, requiring secure subscriber access. Complies with FDA guidance for software in medical devices and cybersecurity for networked medical devices.

Indications for Use

Indicated for patients diagnosed with obstructive sleep apnea (OSA) to facilitate follow-up care via remote transmission of usage and therapeutic data from home-based CPAP/VPAP flow generators to clinicians.

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

• ResTraxx Data Center (K053205)

Reference Devices

• VPAP Malibu (K062291)

Submission Summary (Full Text)

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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: [phone] |
| | Fax: [phone] |
| 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

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 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.

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KC40746, Page 3 of 3

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ResTraxx Sytem Traditional 510(k) Premarket Notification

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.

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Public Health Service

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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 [phone]. 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 [phone] or [phone] 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

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.

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