(88 days)
No
The document describes a system for remote monitoring and data transfer of sleep apnea device usage, with no mention of AI or ML capabilities for analysis or decision-making.
No
ResTraxx Online is a system for tracking and displaying usage and therapeutic information from obstructive sleep apnea treatment systems (flow generators) to a caregiver, and allows for remote settings. It does not directly provide therapy.
No
The device is intended to augment the standard follow-up care of patients with obstructive sleep apnea by displaying usage and therapeutic information, and providing remote settings capabilities. It does not diagnose.
No
The device description explicitly states that ResTraxx Online comprises two distinct components: "the wireless transmitter/receiver located on the flow generator and the Server System." This indicates the presence of hardware components (the transmitter/receiver) in addition to the software (Server System and web-based applications).
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 patients with obstructive sleep apnea by displaying usage and therapeutic information from a flow generator and providing remote settings capabilities. This is related to monitoring and managing a diagnosed condition, not performing a diagnostic test on a biological sample.
- Device Description: The device description focuses on the transfer, storage, retrieval, and display of data from a medical device (flow generator) and remote control capabilities. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or prognosis of a disease based on analysis of biological samples.
The device functions as a data management and remote control system for a therapeutic device (the flow generator), not as a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
ResTraxx Online 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 flow generator located in the home to the care giver. ResTraxx Online also provides remote settings capabilities.
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, VPAP Malibu, VPAP Auto 25, VPAP S and VPAP ST variants positive airway pressure flow generators.
Product codes
73 BZD
Device Description
The performance and functional characteristics of ResTraxx Online includes all the user features of the predicate device, ResTraxx System (K070746).
ResTraxx Online is designed to function with ResMed OSA treatment systems for the transfer, storage, retrieval and display of stored information from the flow generator to the clinician's PC, including remote settings functionality, via wireless transmission and web-based applications. Access to the data is limited to subscribers of the system. Patients cannot access the system.
ResTraxx Online comprises two distinct components, the wireless transmitter/receiver located on the flow generator and the Server System. 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.
Wireless Module
Wireless modules are designed 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 wireless modules can automatically collect patient and machine information stored within the flow generator's memory. The wireless modules send information utilizing existing wireless networks providing coverage to large portions of the US population.
Server System
The Server System consists of several functional software modules that are designed to retrieve information from ResMed flow generators through the wireless network, store the information in a database and provide a secure interface into the system. The system allows users to schedule information retrieval and treatment information, including the ability to retrieve existings from and apply new settings to the flow generator remotely from the Clinical reviewer's PC.
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
Not Found
Intended User / Care Setting
"care giver"
"In the home"
"clinician's PC"
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)
Design and Verification activities were performed on ResTraxx Online as a result of the risk analysis and product requirements. All tests confirmed the predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ResTraxx System (K070746)
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).
0
510(k) Summary - ResTraxx Online
Date Prepared
5th Dec, 2008
K08 38'4
MAR 2 0 2009
| Official Contact | Dr Lionel King |
|---|---|
| V.P., Quality Assurance & Regulatory Affairs | |
| 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 Online |
| Predicate Device(s) | ResTraxx System (K070746) |
| Reason for submission | Change to Indications for Use |
1
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device.
- Similar intended use ్రామ
- 产 Same operating principle
- Same technologies #
- Same manufacturing process ్లో స్ట
Design and Verification activities were performed on ResTraxx Online as a result of the risk analysis and product requirements. All tests confirmed the predetermined acceptance criteria. ResMed has determined that the new device is Substantially Equivalent to the predicate device (K070746). The new device complies with the applicable standards and requirements referenced in the FDA guidance documents:
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) 产
- FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999) :
- FDA Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software - 2014 (January 14, 2005)
Intended Use
ResTraxx Online 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 palient's flow generator located in the home to the care giver. ResTraxx Online also provides remote settings capabilities.
It is intended to be used in the home only and with compatible $7 Elite, AutoSet Respond, S8 Series CPAP Systems, VPAP III, VPAP III ST, VPAP Malibu, VPAP Auto 25, VPAP S and VPAP ST variants positive airway pressure flow generators.
Device Description
General
The performance and functional characteristics of ResTraxx Online includes all the user features of the predicate device, ResTraxx System (K070746).
ResTraxx Online is designed to function with ResMed OSA treatment systems for the transfer, storage, retrieval and display of stored information from the flow generator to the clinician's PC, including remote settings functionality, via wireless transmission and web-based applications. Access to the data is limited to subscribers of the system. Patients cannot access the system.
ResTraxx Online comprises two distinct components, the wireless transmitter/receiver located on the flow generator and the Server System. 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.
Wireless Module
Wireless modules are designed 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 wireless modules can automatically collect patient and machine information stored within the flow generator's memory. The wireless modules send information utilizing existing wireless networks providing coverage to large portions of the US population.
Server System
The Server System consists of several functional software modules that are designed to retrieve information from ResMed flow generators through the wireless network, store the information in a database and provide a secure interface into the system. The system allows users to schedule information retrieval and treatment information, including the ability to retrieve existings from and apply new settings to the flow generator remotely from the Clinical reviewer's PC.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. Encircling the eagle are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2009
ResMed Limited C/o·Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064
Re: K083816
Trade/Device Name: ResTraxx Online Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 5, 2008 Received: December 22, 2008
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.
3
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 clectronic 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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suiste Y. Michael Duns
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known):
Device Name:
ResTraxx Online
Indication for Use
ResTraxx Online 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 flow generator located in the home to the care giver. ResTraxx Online also provides remote settings capabilities.
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, VPAP Malibu, VPAP Auto 25, VPAP S and VPAP ST variants 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)
Susan Fraser
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K053816
5th Dec, 2008