(88 days)
No
The summary describes a data transfer and remote setting adjustment tool, with no mention of AI/ML terms or capabilities.
No.
The device's intended use is to transfer machine and therapeutic information and remotely change settings, not to directly provide therapy. It is a tool for clinicians to manage treatment parameters for a flow generator, which would be the therapeutic device.
No
The device is described as providing transfer of machine and therapeutic information and remotely changing settings, focusing on data management and adjustment of treatment parameters rather than diagnosing conditions.
Unknown
The summary describes software functionalities (downloading, viewing, storing, creating reports, transferring parameters) and mentions interaction with a "ResMed Flow Generator," which is a hardware device. While the summary focuses on the software's capabilities, it doesn't explicitly state that ResScan-Pro is only software and does not include any hardware components or require hardware verification/validation beyond the interaction with the flow generator. The description of "Design and Verification activities" could potentially include aspects related to the software's interaction with hardware, making it unclear if it's purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ResScan-Pro is for augmenting the standard follow-up care of patients by providing transfer of machine and therapeutic information and allowing remote setting changes. This is related to managing a patient's therapy device (a flow generator), not performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The description focuses on downloading, viewing, storing, reporting on, and transferring parameters to a flow generator. These are functions related to device management and patient therapy data, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on biological sample analysis.
- Focus on Therapy Management: The core function is managing a therapeutic device (ResMed Flow Generator) and the data generated by it.
Therefore, ResScan-Pro falls under the category of a device used for managing patient therapy and device settings, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
ResScan-Pro is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information, including the ability to remotely change settings.
It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators.
Product codes
73 BZD
Device Description
The performance and functional characteristics of ResScan-Pro includes all the user friendly features of the predicate device.
ResScan-Pro allows the clinician to:
- Download, view and store patient and machine details from a ResMed Flow Generator
- Create and print reports on patient and machine details
- Transfer treatment parameters to a ResMed Flow Generator
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
Clinicians
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
Design and Verification activities were performed on the ResScan-Pro system as a result of the risk and design requirements. All tests confirmed the product met the predetermined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
ResScan (K050775)
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
K0f2983
510(k) Summary - ResScan-Pro
Date Prepared
30th Sept, 2008
JAN - 2 2009
Official Contact
Dr Lionel King V.P., Quality Assurance & Regulatory Affairs ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
| Classification Reference | 21 CFR 868.5905 |
|---|---|
| Product Code | 73 BZD |
| Common/Usual Name | Non continuous ventilator (IPPB). |
| Proprietary Name | ResScan-Pro |
| Predicate Device(s) | ResScan (K050775) |
Reason for submission
New Device
30th Sept, 2008
Tel: +61 (2) 8884 2243 Fax: +61 (2) 8884 2000
1
Indication for Use
ResScan-Pro is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information, including the ability to remotely change settings.
It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device.
- _六海 Similar intended use
- Same operating principle 15
- Similar technologies ﻌﺔ ﺍﻟﻤﺘﺤﺪﺓ
- Same manufacturing process ్లో ప్రాథమ
Design and Verification activities were performed on the ResScan-Pro system as a result of the risk and design requirements. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new device is substantially equivalent to the predicate device. ResScan-Pro has not altered the safety and effectiveness when used for patient compliance management as an adjunct with ResMed flow generators that have software incorporating proprietary communication protocol. The new device complies with the applicable requirements referenced in the FDA guidance documents:
- 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)
Device Description
The performance and functional characteristics of ResScan-Pro includes all the user friendly features of the predicate device.
ResScan-Pro allows the clinician to:
- Download, view and store patient and machine details from a ResMed Flow Generator ﺮ ﺍﻟﻤﺮﺍﺟﻊ
- Create and print reports on patient and machine details
- Transfer treatment parameters to a ResMed Flow Generator
Conclusion
The ResScan-Pro System is substantially equivalent to the predicate device, ResScan (K050775).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 2 2009
ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K082983
Trade/Device Name: ResScan-Pro Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 30, 2008 Received: October 6, 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 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 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 vours.
Audite H. Mchan Davis.
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
4
:
Indication for Use
. . . .
.
510(k) Number (if known):
Device Name: ResScan-Pro
. .
Indication for Use
ResScan-Pro is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information, including the ability to remotely change settings. It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators.
:
| Prescription Use | X | 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 | (Division Sign-Off) |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 0(k) Number: | K082983 |
| 30th Sept, 2008 | Page 13 |