(88 days)
nordicICE 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.
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, showing properties of changes in contrast over time where such techniques are useful or necessary.
nordicICE (nlCE) - 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.
This 510(k) summary for the Nordic Image Control and Evaluation (nordicICE) Software primarily focuses on demonstrating substantial equivalence to a predicate device (Nordic Image Control and Evaluation (nordicICE) Software, K063539) and detailing its intended use and features rather than providing extensive details about specific acceptance criteria and a structured study to prove those criteria.
Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as many of the requested study details, cannot be fully extracted because the document does not contain this specific information in the format requested for a detailed AI/CAD device study. This document is a regulatory submission for a PACS-like software, which historically did not require the same rigorous, quantitative performance studies as modern AI/CAD algorithms. Instead, the focus is on verification and validation (V&V) of software functionality and substantial equivalence.
However, I can extract what is implied and stated regarding validation and equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Ability to perform image viewing, processing, and analysis of medical images (DICOM compliant), including BOLD fMRI, DWI/Fiber Tracking, and Dynamic Analysis. | "nordicICE has been verified and validated according to NIL's procedures for product design and development. The validation proves the safety and effectiveness of the system.""The information provided by nordicICE was found to be substantially equivalent with the predicate device Nordic Image Control and Evaluation (nordicICE) Software (K063539)." |
| Safety and Effectiveness: Ensuring the software functions without introducing new risks or compromising diagnostic accuracy compared to the predicate. | Demonstrated through verification and validation procedures, and determination of substantial equivalence. |
| Adherence to Design Specifications: Software performs as intended per internal design documents. | "nordicICE has been verified and validated according to NIL's procedures for product design and development." |
2. Sample Size Used for the Test Set and Data Provenance
- Not specified. The document mentions "verification and validation" but does not detail a specific "test set" in terms of patient cases or images, sample size, or data provenance (e.g., country of origin, retrospective/prospective). This is typical for software validation focused on functional correctness rather than diagnostic performance against ground truth.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable/Not specified. The document does not describe a study involving human experts establishing ground truth for a test set to measure diagnostic performance. The validation appears to be against internal specifications and comparison to a predicate device's functionality.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. No mention of adjudication, as there is no described study comparing the software's output against an expert-adjudicated ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study was not done. This device is a general image viewing, processing, and analysis software, not an AI/CAD diagnostic aid for which MRMC studies are typically performed. The document focuses on the software's functionality and its equivalence to a predicate, not its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable in the typical sense of AI algorithms. While the software itself performs analysis (e.g., BOLD fMRI analysis, DWI processing), the validation described is for the software's computational correctness and functional equivalence to a predicate, not for its standalone diagnostic performance. There is no "algorithm only" performance reported against a clinical outcome or expert ground truth in the document.
7. The Type of Ground Truth Used
- Internal specifications and predicate device functionality. The "ground truth" for the validation appears to be the expected behavior as defined in the product design and development procedures, and the established functionality of the predicate device. It is not clinical ground truth like pathology, expert consensus, or outcomes data, which would be expected for a diagnostic AI device.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This software is described as an image processing, viewing, and analysis package. It is not an AI/Machine Learning algorithm that typically requires a large 'training set' for model development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified. As there is no mention of a training set for an AI/ML algorithm, the method for establishing ground truth for such a set is not discussed.
Summary of the Study (Implied):
The "study" described is a verification and validation (V&V) process and a substantial equivalence comparison to a predicate device. This type of submission, especially from 2008 for a PACS-like viewing/processing software, focuses on:
- Confirming the software meets its design specifications (internal V&V).
- Demonstrating that the new device has the same intended use and technological characteristics as a previously cleared device (the predicate K063539), and any differences do not raise new questions of safety or effectiveness.
The document explicitly states: "nordicICE has been verified and validated according to NIL's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by nordicICE was found to be substantially equivalent with the predicate device Nordic Image Control and Evaluation (nordicICE) Software (K063539)." This is the core "study" proving the device met its implied acceptance criteria (functional correctness, safety, effectiveness, and substantial equivalence).
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KOr241//
510(k) Summary
NOV 21 2008
| 510(k) Type: | Traditional |
|---|---|
| Submission Date: | 08.22.2008 |
| Submitter: | NordicImagingLab ASMøllendalsveien 65CN-5009 BergenNorway |
| Phone: +47 55 70 70 95Fax: +47 55 70 70 96Email: stian@nordicimaginglab.com | |
| Contact: | Stian Scisly SagevikMøllendalsveien 65CN-5009 BergenNorway |
| Direct: +47 95 20 37 87Phone: +47 55 70 70 95 |
Predicate device name and 510(k) number: Nordic Image Control and Evaluation (nordiclCE) Software, коезезд
.
.
| Trade/Proprietary Name: | nordicICE Software |
|---|---|
| Device Common Name: | PACS |
| Classification Regulation: | 892.2050 |
| Class: | II |
| Panel: | Radiology |
| Product Code: | LLZ |
Fax:
+47 55 70 70 96 Email: stian@nordicimaginglab.com
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Device Description
nordiclCE (nlCE) - 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" 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.
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, showing properties of changes in contrast over time where such techniques are useful or necessary.
Substantial Equivalence
nordicICE has been verified and validated according to NIL's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by nordicICE was found to be substantially equivalent with the predicate device Nordic Image Control and Evaluation (nordicICE) Software (K063539).
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 21 2008
Ms. Stian Scisly Sagevik Quality Manager NordicimagingLab AS Møllendalsveien 65C N-5009 Bergen NORWAY
Re: K082441
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: September 24, 2008
Received: October 14, 2008
Dear Ms. Sagevik:
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
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 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 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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.
hoque Mr. Whang
Joyce M. Whang, Ph.D. 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):
Device Name: Nordic Image Control and Evaluation (nordicICE) Software
Indications for Use:
nordic!CE 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.
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, showing properties of changes in contrast over time where such techniques are useful or necessary.
Prescription Use_ X (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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and Radiological Devices | |
| NordicImagingLab AS – Special 510(k) | |
| 510(k) Number | K082441 |
| Indications for Use | |
| nordicICE Software | |
| 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).