RES TRAXX DATA CENTER by RESMED LTD.

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 Description

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification for the ResTraxx Data Center, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.

The information provided includes:

Device Name: ResTraxx Data Center
Intended Use: To augment standard follow-up care of adult obstructive sleep apnea patients by providing wireless transmission and display of usage and therapeutic information.
Operating Environment: Home use only, with compatible CPAP systems.
Predicate Device: ResTraxx Data Center System (K051314)
Regulation Number: 21 CFR 868.5905 (Noncontinuous Ventilator (IPPB))

To answer your request, a performance study (including acceptance criteria, sample size, ground truth establishment, etc.) would typically be detailed in a separate section of the 510(k) submission, often under "Performance Data" or "Clinical Data," which is not present in the provided excerpts. The FDA's letter indicates that the device has been found substantially equivalent, but it does not elaborate on specific performance metrics or studies beyond the intended use and predicate comparison.

Summary

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K053205

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ResTraxx Data Center Traditional 510(k) Premarket Notification

Date Prepared	1st November, 2005	FEB 32006
Official Contact	Dr Lionel KingV.P., Quality Assurance & Regulatory AffairsResMed Ltd97 Waterloo RoadNorth Ryde, NSW 2113AustraliaTel: +61 (2) 9886 5000Fax: +61 (2) 9878 5517
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

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 (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 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

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

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).