(79 days)
Not Found
No
The summary describes a system for wireless transmission and display of usage and therapeutic information, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as augmenting follow-up care and providing usage/therapeutic information, not directly providing therapy itself.
No
The device provides wireless transmission and display of usage and therapeutic information to augment follow-up care for diagnosed patients, but it does not diagnose obstructive sleep apnea.
No
The description explicitly states the system provides "wireless transmission and display of usage and therapeutic information" from compatible CPAP systems, implying hardware components for data transmission and display are part of the system, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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." This describes a system for monitoring and managing a patient's therapy, not for performing diagnostic tests on biological samples.
- Device Description: The description reiterates the intended use, focusing on data transmission and display related to CPAP therapy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing diagnostic tests, or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications 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.
Product codes
73 BZD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
home only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ResTraxx Data Center System (K051314)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image contains the word "RESMED" in bold, black font. The letters are capitalized and evenly spaced. The word appears to be a logo or brand name.
ResTraxx Data Center Traditional 510(k) Premarket Notification
| Date Prepared | 1st November, 2005 | FEB 3
2006 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Official Contact | Dr Lionel King
V.P., Quality Assurance & Regulatory Affairs
ResMed Ltd
97 Waterloo Road
North Ryde, NSW 2113
Australia
Tel: +61 (2) 9886 5000
Fax: +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
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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three human profiles facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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
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)
Page 1 of 1
K053 205
151 November, 2005