(208 days)
No
The summary describes standard image processing and analysis techniques for dynamic MRI data, focusing on calculating functional parameters based on signal intensity changes over time. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML models.
No
The device is image processing software for diagnostic support, not for direct treatment or therapy.
Yes
The device processes medical images (dynamic MR imaging datasets of the brain) to generate parametric images and extract properties that "support the diagnostic process." This suggests it aids in identifying or characterizing a disease or condition, which is the definition of a diagnostic device.
Yes
The device is described as a "software package" and a "post-processing application" that runs on a standard PC workstation. It processes data acquired from separate imaging devices and does not include any hardware components itself.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- nordicTumorEx Function: nordicTumorEx is an image processing software that analyzes medical images (specifically dynamic MR images of the brain) acquired from a patient in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use describes the software as supporting the diagnostic process by processing and visualizing medical images. This is consistent with a medical image analysis device, not an IVD.
Therefore, nordicTumorEx falls under the category of a medical device, specifically a medical image processing and analysis software, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
nordicTumorEx 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.
nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast over time. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be used to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The nordicTumorEx Software is a post-processing application for dynamic MRI data developed with a view to ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for dynamic image analysis and visualization of MRI data, where signal changes over time are analyzed to determine various modality dependent functional parameters. The software encompass well-established analysis methods and dedicated visualization tools for dynamic contrast enhanced imaging data from MRI 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 intracellular space. These parameters and their derived properties together with anatomical/structural MR images are presented to support the diagnostic process.
The application workflow has been optimized to ensure efficiency and high throughput in a clinical environment.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
dynamic MR imaging datasets
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" PC workstation.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Prospectively defined verification and validation activities for the nordicTumorEx Software assure that the nordicTumorEx Software meets design and performance specifications as well as user needs when operated according to the operating instructions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
nordicICE Software (K090546)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
PERFSCAPE V2.0 (K111161)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K1233 06
MAY 2 0 2013
510(k) Summary NordicNeuroLab AS nordicTumorEx Software
Submitter: NordicNeuroLab AS Møllendalsveien 65C N-5009 Bergen Norway Phone: +47 55 70 70 95 +47 55 70 70 96 Fax:
Primary Contact: Chandana Gurung Bhandari (Chandana@nordicneurolab.com)
| Proprietary Name: | nordicTumorEx Software |
|---|---|
| Device Common Name: | PACS |
| Device: | System, image processing, radiological |
| Classification Name: | Picture archiving and communication system |
| Classification Regulation: | 892.2050 |
| Class: | II |
| Panel: | Radiology |
| Product Code: | LLZ |
| Predicate device name: | nordic Image Control and Evaluation (nordicICE) Software, K090546 |
Device Description
The nordicTumorEx Software is a post-processing application for dynamic MRI data developed with a view to ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for dynamic image analysis and visualization of MRI data, where signal changes over time are analyzed to determine various modality dependent functional parameters. The
1
software encompass well-established analysis methods and dedicated visualization tools for dynamic contrast enhanced imaging data from MRI 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 intracellular space. These parameters and their derived properties together with anatomical/structural MR images are presented to support the diagnostic process.
The application workflow has been optimized to ensure efficiency and high throughput in a clinical environment.
Intended Use
nordicTumorEx 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.
nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast over time. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be used to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.
Technological Characteristics and Substantial Equivalence
The nordicTumorEx Software is substantially equivalent to the nordicICE Software (K090546) and PERFSCAPE V2.0 (K111161) in intended use, indications for use, technological characteristics and operational characteristics.
Performance Testing
Prospectively defined verification and validation activities for the nordicTumorEx Software assure that the nordicTumorEx Software meets design and performance specifications as well as user needs when operated according to the operating instructions.
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 features the department's symbol, which is a stylized representation of a human form. The symbol is composed of three curved lines that suggest a person's head, body, and legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2013
NordicNeuroLab AS % Mr. Chandana G. Bhandari Quality Manager Mollendalsveien 65C N-5009 Bergen, Hordaland NORWAY
Re: K123306
Trade/Device Name: nordicTumorEx Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 7, 2013 Received: April 10, 2013
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
3
Page 2 - Mr. Chandana Bhandari
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.
Sincerely yours,
Michael D. D'Hara for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123306
Device Name: nordicTumorEx Software
Indications for Use:
nordicTumorEx 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.
nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast over time. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be used to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) of
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K123306
Page 1 of 1