RES TRAXX DATA CENTER

K053205 · Resmed, Ltd. · BZD · Feb 3, 2006 · Anesthesiology

Device Facts

• Record ID: K053205
• Device Name: RES TRAXX DATA CENTER
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ResTraxx Data Center system is intended to augment the standard follow-up care of adult patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. It is intended to be used in the home only and with compatible S7 Elite, AutoSet Spirit, AutoSet Respond, VPAP III & S8 Series CPAP Systems, positive airway pressure flow generators.

Device Story

ResTraxx Data Center system facilitates remote monitoring for obstructive sleep apnea patients. Device receives usage and therapeutic data wirelessly from compatible ResMed CPAP/positive airway pressure flow generators (S7 Elite, AutoSet Spirit, AutoSet Respond, VPAP III, S8 Series). System transmits data to a central location for display. Intended for home use by patients; healthcare providers access displayed information to augment standard follow-up care. Output allows clinicians to review patient compliance and therapy efficacy, potentially improving clinical decision-making and patient management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Wireless data transmission system for CPAP/positive airway pressure flow generators. Compatible with S7 Elite, AutoSet Spirit, AutoSet Respond, VPAP III, and S8 Series. Functions as a data relay/display system for usage and therapeutic information.

Indications for Use

Indicated for adult patients diagnosed with obstructive sleep apnea. Intended for home use in conjunction with compatible ResMed CPAP/positive airway pressure flow generators.

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 System (K051314)

Submission Summary (Full Text)

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K053205

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ResTraxx Data Center Traditional 510(k) Premarket Notification

| Date Prepared | 1st November, 2005 | FEB 3<br>2006 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Official Contact | Dr Lionel King<br>V.P., Quality Assurance & Regulatory Affairs<br>ResMed Ltd<br>97 Waterloo Road<br>North Ryde, NSW 2113<br>Australia<br>Tel: [phone]<br>Fax: [phone] | |
| Classification Reference | 21 CFR 868.5905 | |
| Product Code | 73 BZD | |
| Common/Usual Name | Noncontinuous ventilator (IPPB). | |
| Proprietary Name | ResTraxx Data Center System | |
| Predicate Device(s) | ResTraxx Data Center System (K051314) | |
| Reason for submission | Additional Indications | |

## 510(k) Summary - ResTraxx Data Center

The ResTraxx Data Center system is intended to augment the standard follow-up care of adult patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information.

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

Indications for Use

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2006

ResMed Limited C/O Mr. David D'Cruz ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K053205

Trade/Device Name: ResTraxx Data Center Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 1, 2005 Received: November 16, 2005

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 yours,

Sutie y. Michie Cms.

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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## Indication for Use

**510(k) Number (if known):**

053205

Device Name:

ResTraxx Data Center

Indication for Use

The ResTraxx Data Center system is intended to augment the standard follow-up care of adult patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information.

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

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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K053 205

151 November, 2005