(43 days)
No
The summary describes software for downloading, viewing, storing, and reporting therapy data from flow generators, with no mention of AI or ML capabilities.
No
ResScan™ is a software intended for clinicians to download, view, store, and report therapy data from ResMed flow generators, and to set flow generator parameters. It does not directly provide therapy to a patient.
No
Explanation: The document states that ResScan™ software is used to download, view, store, and report therapy data, as well as set flow generator parameters. It does not mention any function related to diagnosing medical conditions. Its purpose is to manage and present data from a ResMed flow generator, not to identify or determine the nature of a disease or condition.
Yes
The device is described as "ResScan™ software" and its functions are entirely software-based (downloading, viewing, storing, reporting, transferring parameters). While it interacts with a hardware device (ResMed flow generator), the 510(k) summary focuses solely on the software's functionality and verification.
Based on the provided information, the ResScan™ software is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ResScan™ is used to download, view, store, and report on therapy data from ResMed flow generators. It also allows for setting flow generator parameters. This is related to managing and monitoring a patient's therapy, not performing diagnostic tests on biological samples.
- Device Description: The description reinforces the intended use, focusing on data management and parameter transfer for flow generators.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions based on such analysis, or providing diagnostic information derived from in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The ResScan™ software's function is entirely focused on managing data and settings related to a medical device used for therapy (flow generators for conditions like sleep apnea).
N/A
Intended Use / Indications for Use
The ResScan™ software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan™ is used to download and view therapy data, as well as store therapy information and print reports. ResScan™ also provides functionality for setting flow generator parameters.
Product codes
73 BZD
Device Description
The performance and functional characteristics of ResScan includes all the user friendly features of the predicate device. ResScan allows the clinician to, - download and view data from a ResMed Flow Generator r - store patient details and downloaded treatment data ﺮ - create reports on patient details and downloaded treatment data , L - transfer treatment parameters to a ResMed Flow Generator ﺮ
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 new version of ResScan as a result of the risk Design and vehilodion activities we All tests confirmed the product met the acceptance criteria. andiysis and product requirement wevice is substantially equivalent to the predicate device. Resided has not alternation not the now deffectiveness when used for patient compliance management as resocurriod hot aller a the salery that have software incorporating proprietary communication an adjance with Normount in I gollies with the applicable standards and requirements referenced in the FDA guidance documents: - FDA Reviewer Guidance for Premarket Notifications, November 1993. r - FDA reviewer's and industry, Guidance for the content of premarket submissions for software ﺮ contained in medical devices, May 1998.
Key Metrics
Not Found
Predicate Device(s)
ResScan™ (K034033), S8 Pioneer CPAP System (K041209)
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
MAY 10 2005
RESMED
| Date Prepared | 23 March 2005 |
|---|---|
| Official Contact | Dr Lionel King |
| V.P., 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 868.5895 |
| Product Code | 73 BZD |
| Common/Usual Name | CPAP System / Non continuous Ventilator (with accessory) |
| Proprietary Name | ResScan™ |
| Predicate Device(s) | ResScan™ (K034033) |
| S8 Pioneer CPAP System (K041209) | |
| Reason for submission | Expanded indication; change in design |
| Indications for Use | The ResScan™ software is intended to be used by clinicians |
| ResMed flow generators that have software incorporating |
510(k) Summary -- ResScan™
vith ResMed's proprietary communication protocol. ResScan™ ાંક used to download and view therapy data, as well as store therapy information and print reports. ResScan™ also provides functionality for setting flow generator parameters.
1
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device.
- ﺮ Similar intended use
- Same operating principle , ﻟ
- Same technologies r
- Same manufacturing process ﺮ
Design and Verification activities were performed on the new version of ResScan as a result of the risk Design and vehilodion activities we All tests confirmed the product met the acceptance criteria. andiysis and product requirement wevice is substantially equivalent to the predicate device. Resided has not alternation not the now deffectiveness when used for patient compliance management as resocurriod hot aller a the salery that have software incorporating proprietary communication an adjance with Normount in I gollies with the applicable standards and requirements referenced in the FDA guidance documents:
- FDA Reviewer Guidance for Premarket Notifications, November 1993. r
- FDA reviewer's and industry, Guidance for the content of premarket submissions for software ﺮ contained in medical devices, May 1998.
Intended Use
The ResScan™ software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan™ is used to download and view therapy data, as well as store therapy information and print reports. ResScan™ also provides functionality for setting flow generator parameters.
Device Description
The performance and functional characteristics of ResScan includes all the user friendly features of the predicate device.
ResScan allows the clinician to,
- download and view data from a ResMed Flow Generator r
- store patient details and downloaded treatment data ﺮ
- create reports on patient details and downloaded treatment data , L
- transfer treatment parameters to a ResMed Flow Generator ﺮ
Sumathy Ramesh Manager. Regulatory Affairs ResMed.
March 23, 2005
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle symbol, with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle symbol.
MAY 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ResMed Limited C/O Mr. David D' Cruz Vice President US Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K050775
Trade/Device Name: ResScan™ Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 24, 2005 Received: March 28, 2005
Dear Mr. D' Cruz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your because as ne he device is substantially equivalent (for the relications 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 Interstate conmiseed procession in accordance with the provisions with the provisions of Amendinents, or to act 1,000 and Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 00d, Drag, and Commay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
ﻴﺮ ﺍﻟﻤﺮﺍﺟﻊ
If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (oos as olditional controls. Existing major regulations affecting (FMA), it may be subject to back address.
your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the estas nouncements concerning your device in the Federal Register.
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 mean that i DA mas made a actes and regulations administered by other Federal agencies.
3
Page 2 - Mr. D' Cruz
You must comply with all the Act's requirements, including, but not limited to: registration r ou intist compry with and 807); labeling (21 CFR Part 801); good manufacturing practice and home (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as between as 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) rins letter will and if you be began finding of substantial equivalence of your device to a premarket nothroation. - In 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), 11 you donto the Office of Compliance at (240) 276-0115. 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 maj overni 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,
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
RESMED
Indication for Use
510(k) Number (if known):
Device Name:
ResScan™
Indications for Use:
The ResScan™ software is intended to be used by clinicians with ResMed flow generators that The Resocal " soltware is linendouts broprietary communication protocol. ResScan™ is used have soltware incorporating Noundal o propristary of therapy information and print reports.
to download and view therapy data, as well as store therapy information and print ResScan™ also provides functionality for setting flow generator parameters.
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 | |
|---|---|
| Division Sign-Off | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(K) Number: | K050775 |
Cum Diom