(88 days)
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.
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
The ResScan-Pro 510(k) summary does not contain sufficient information to answer your request.
Here's why and what information is missing:
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Acceptance Criteria and Reported Device Performance: The document states, "All tests confirmed the product met the predetermined acceptance criteria," but it does not list what those acceptance criteria were or what the specific performance metrics were that met them. Without these criteria and corresponding performance data, the table cannot be created.
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Sample Size for Test Set and Data Provenance: The document mentions "Design and Verification activities were performed," but it does not specify the sample size of any test set used for these activities, nor does it provide details about the data's origin (country, retrospective/prospective). This information is crucial for understanding the rigor of the testing.
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Number of Experts and Qualifications: There is no mention of experts being used to establish ground truth for a test set. The device appears to be data management software, not a diagnostic AI device requiring expert consensus for ground truth.
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Adjudication Method: Since there's no indication of experts or complex diagnostic interpretations, an adjudication method is not applicable or mentioned.
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MRMC Comparative Effectiveness Study: The document does not describe any Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device's function is to transfer and manage data/settings, not to assist human readers in interpretation.
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Standalone Performance: The 510(k) summary focuses on the device's functionality in transferring and managing data/settings. While "performance" is mentioned in a general sense, there's no specific "standalone" performance study detailed in the way one would expect for an AI diagnostic algorithm (e.g., sensitivity, specificity for a particular condition). The device's performance is tied to its ability to correctly transfer information, which is a functional test, not a diagnostic one.
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Type of Ground Truth: Given the device's nature (data transfer and settings management), the concept of "ground truth" as typically applied to diagnostic algorithms (expert consensus, pathology, outcomes data) is not directly relevant or discussed. The performance would likely be validated against successful data transfer and accurate setting changes.
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Sample Size for Training Set and Ground Truth Establishment for Training Set: The document does not refer to a "training set" because this device is not an AI/ML algorithm that learns from data in that manner. It's software for managing and transferring existing machine and therapeutic information.
In summary, the provided 510(k) summary for ResScan-Pro describes a device for data transfer and settings management for non-continuous ventilators, not a diagnostic AI/ML device. Therefore, many of the typical questions regarding acceptance criteria, study design, and ground truth for AI algorithms are not applicable or the information is not present in this type of submission.
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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
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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).
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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.
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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 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
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:
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 |
§ 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).