(98 days)
nordiclCE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians-The software-runs on a standard "off-the-shelf" PC -workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
nordic!CE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRJ, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.
DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain.
Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data of the brain, showing properties of changes in contrast over time where such techniques are useful or necessary.
nordiclCE – Nordic Image Control and Evaluation software – is a medical viewing, analysis, and processing package developed with a view to ease of use and high performance on a standard Windows platform. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive functionality for dynamic image analysis and processing/display of functional MRI (fMRI) data. The main user of the program will be imaging professionals who need to visualize and analyze images taken primarily from a MRI system.
The provided 510(k) summary (K090546) for the nordicICE Software does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
This document is a 510(k) premarket notification for a modification to an existing device (nordicICE). The modification involves adding new software modules for dynamic contrast-enhanced imaging data analysis (Perfusion and DCE Modules).
Here's what can be extracted and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Missing. The document states, "The nordicICE software has been tested for function and safety and fulfills all requirement specifications." However, it does not provide any specific acceptance criteria (e.g., performance metrics, thresholds) or report any quantitative device performance data from a validation study.
2. Sample Size Used for the Test Set and Data Provenance
- Missing. The document does not mention any test set, sample size, or the provenance (country of origin, retrospective/prospective) of any data used for testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Missing. There is no mention of experts, ground truth establishment, or their qualifications.
4. Adjudication Method
- Missing. No information on adjudication methods is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Missing. There is no indication that an MRMC study was performed, nor any data on human reader improvement with or without AI assistance. The device is primarily a viewing, processing, and analysis tool, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for interpretation.
6. Standalone (Algorithm Only) Performance Study
- Missing. While the device offers analysis capabilities, the document does not describe a standalone performance study where the algorithm's output is compared against a ground truth without human intervention. The nature of the device as a "viewing, analysis, and processing package" suggests it's primarily a tool for professionals, rather than a fully autonomous diagnostic algorithm.
7. Type of Ground Truth Used
- Missing. The document does not describe any specific ground truth used for testing or validation of the expanded functionality.
8. Sample Size for the Training Set
- Missing. There is no mention of a training set, as the document focuses on modifications to an existing software package and its functional testing rather than a new machine learning algorithm that requires extensive training data.
9. How the Ground Truth for the Training Set Was Established
- Missing. As no training set is mentioned, information on how its ground truth was established is also absent.
Summary of available information related to testing:
The document states:
"The nordicICE software has been tested for function and safety and fulfills all requirement specifications."
This statement confirms that testing was conducted to ensure the device met its functional and safety requirements, but it does not provide any details about the methodologies, data, or results of these tests, especially concerning clinical performance or diagnostic accuracy. The 510(k) process for this type of modification often relies on functional verification and validation that the new modules perform as intended and do not introduce new safety concerns, rather than extensive clinical comparative studies, particularly when the device is an image processing tool rather than a diagnostic algorithm.
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K090546
Page 1 of 3
JUN - 8 2009
510(k) Summary
Traditional 510(k) Type: Submission Date: 05.05.2009
Submitter:
and the country of the county
NordicImagingLab AS Møllendalsveien 65C N-5009 Bergen Norway ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Phone: +47 55 70 70 95 Fax: +47 55 70 70 96 Email: chandana@nordicimaginglab.com
Contact:
.
Chandana Gurung Bhandari Møllendalsveien 65C N-5009 Bergen Norway
Direct: +47 92 86 31 60 Phone: +47 55 70 70 95 Fax: +47 55 70 70 96 Email: chandana@nordicimaginglab.com
Predicate device name and 510(k) number: Nordic Image Control and Evaluation (nordiclCE) Software, K082441
| Modified Device Name: | nordicICE Software |
|---|---|
| Device Common Name: | PACS |
| Basis for Submission: | Device modification with new software |
| Classification Regulation: | 892.2050 |
| Class: | II |
| Panel: | Radiology |
| Product Code: | LLZ |
| Trade/Proprietary Name: | nordicICE Software |
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Device Description
nordiclCE – Nordic Image Control and Evaluation software – is a medical viewing, analysis, and processing package developed with a view to ease of use and high performance on a standard Windows platform. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive functionality for dynamic image analysis and processing/display of functional MRI (fMRI) data. The main user of the program will be imaging professionals who need to visualize and analyze images taken primarily from a MRI system.
Intended Use
nordiclCE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" PCworkstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.
DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain.
Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data of the brain, showing properties of changes in contrast over time where such techniques are useful or necessary.
Identification of Change to Unmodified Device
The nordicICE software offers comprehensive functionality for dynamic image analysis and visualization, where signal changes over time are analyzed to determine various modality dependent functional parameters. Now this functionality has been extended to include dedicated analysis methods and visualization tools for dynamic contrast enhanced imaging data (from MRI or CT) where a bolus injection of a contrast agent material results in a temporal change in the signal intensity. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow (perfusion) and tissue blood volume as well as leakage (due to capillary permeability) of the injected contrast material from the intravascular- to the extracellular space. The functionality has been implemented as additional software modules to the existing device, and is referred to as:
NordicImagingLab AS nordicICE Software
510(k) Summary Attachment 1
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K090546
Page 3 of 3
- nordicICE Perfusion Module Calculation of parameters related to tissue flow (perfusion) and . tissue blood volume.
- nordicICE DCE Module – Calculation of parameters related to leakage of injected contrast material from intravascular- to extracellular space.
The changes summarized above are the only modification made to the nordicICE software.
Statement of Substantial Equivalence
To summarize, the modified nordic!CE software is found substantial equivalent to the previously cleared device. The modified software only includes additional modules which-extend the current functionality used for dynamic image analysis and the indications for the modified nordic!CE software have remained unchanged.
Summary of Testing
The nordicICE software has been tested for function and safety and fulfills all requirement specifications.
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Image /page/3/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized image of three birds in flight, arranged in a stacked formation.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2009
Mr. Chandana G. Bhandari Quality Manager NordicImagingLab AS Møllendalsveien 65C N-5009 Bergen NORWAY
Re: K090546
Trade/Device Name: Nordic Image Control and Evaluation (nordicICE) Software Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: LLZ Dated: May 5, 2009 Received: May 14, 2009
Dear Mr. Bhandari:
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.
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.
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Page 2
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 one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Ko 905 46
Device Name: Nordic Image Control and Evaluation (nordicICE) Software
Indications for Use:
nordiclCE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians-The software-runs on a standard "off-the-shelf" PC -workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
nordic!CE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRJ, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.
DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain.
Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data of the brain, showing properties of changes in contrast over time where such techniques are useful or necessary.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| Hulbert |
NordicImagingLab AS nordicICE Software
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Indications for Use Attachment 2
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).