(188 days)
Not Found
No
The summary describes standard image processing and analysis techniques for DSC-enhanced MR data, without mentioning AI, ML, or related concepts. The description of the algorithm as "inherently nondeterministic" does not necessarily imply AI/ML; it could refer to other computational factors.
No.
The device is a medical image post-processing software that provides information for clinical applications. It does not exert any direct therapeutic effect on a patient.
Yes
Explanation: The device is intended to be used by trained professionals to "yield information useful in clinical applications" and analyze "DSC perfusion data" to generate "information regarding blood flow, time to peak, and leakage," which is indicative of a diagnostic purpose.
Yes
The device is described as "medical image post-processing software" and an "image analysis module" that can be integrated into existing hospital infrastructure and deployed as a plugin. The description focuses solely on software functionalities (accessing data, processing, generating output) and does not mention any accompanying hardware components developed or included with the device itself. While it interacts with existing hardware (MRI, DICOM platform), the device being cleared is the software.
Based on the provided information, 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.
- Device function: nordicDSC is a software that processes medical images (MR data) of the human brain. It analyzes the dynamic time course of the data to provide information about blood flow, time to peak, and leakage.
- No sample analysis: The software does not analyze any biological samples taken from the patient. It operates solely on image data acquired through an imaging modality (MRI).
Therefore, while it is a medical device used in clinical applications and provides information useful for diagnosis, it does not fit the definition of an In Vitro Diagnostic device. It is a medical image post-processing software.
N/A
Intended Use / Indications for Use
nordicDSC is a medical image post-processing software is intended for the analysis of the dynamic time course of the dynamic susceptibility contrast (DSC) enhanced MR data of the human brain and to generate parametric maps including, but not limited to, blood flow, time-to-peak, and vascular leakage.
The software is intended to be used off-line and in combination with a DICOM handling platform that can allow for user interactions, sending, and viewing of data, data quality control, and network connection. The output of nordicDSC is intended to be interpreted by trained professionals such as physicians, radiologists, and medical technicians to yield information useful in clinical applications.
Product codes
LLZ
Device Description
nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynamic susceptibility contrast-enhanced (DSC) perfusion data obtained from Magnetic Resonance Imaging (MRI). The product can be deployed as a plugin to a DICOM handling platform.
The program functionality can be divided into three main categories:
- Accessing image data
-
- MR image processing and analysis
- Generating output, including information regarding blood flow, time to peak, and leakage.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dynamic Susceptibility Contrast-Enhanced (DSC) MR data
Anatomical Site
Human brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals such as physicians, radiologists, and medical technicians.
Used off-line and in combination with a DICOM handling platform.
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
Non-clinical performance testing has been performed on the nordicDSC Software. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results. The algorithm is inherently nondeterministic, so head-to-head comparisons have to consider the internal variation, which has been found to be within +/- 10%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The nordicDSC Software was tested in accordance with verification processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results. The algorithm is inherently nondeterministic, so head-to-head comparisons have to consider the internal variation, which has been found to be within +/- 10%.
The test results in this 510(k)premarket notification demonstrates that nordicDSC:
- Complies with the international and FDA-recognized consensus standards and FDA guidance document, and
- . Meets the acceptance criteria and is adequate for its intended use and specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
NordicNeuroLab AS % Chandana Gurung Bhandari VP Quality Moellendalsveien 1 Bergen, Vestland N-5009 NORWAY
March 3, 2022
Re: K212720
Trade/Device Name: nordicDSC Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: January 18, 2022 Received: January 21, 2022
Dear Chandana Gurung 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212720
Device Name nordicDSC
Indications for Use (Describe)
nordicDSC is a medical image post-processing software for the dynamic time course of the dynamic susceptibility contrast (DSC) enhanced MR data of the human brain to be used by trained professionals such as physicians, radiologists, and medical technicians to yield information useful in clinical applications.
The software is intended to be used off-line and in combination with a DICOM handling platform that can allow for user interactions, sending, receiving, and viewing of data, data quality control, and connection to network.
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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510(k) Summary NordicNeuroLab AS nordicDSC Software
- Submitter: NordicNeuroLab AS Møllendalsveien 1 N-5009 Bergen Norway Phone: +47 55 70 70 95
Primary Contact: Chandana Gurung Bhandari (chandana@nordicneurolab.com)
| Proprietary Name: | nordicDSC Software |
|---|---|
| Device: | System, image processing, radiological |
| Classification Name: | Medical image management and process 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
nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynamic susceptibility contrast-enhanced (DSC) perfusion data obtained from Magnetic Resonance Imaging (MRI). The product can be deployed as a plugin to a DICOM handling platform.
The program functionality can be divided into three main categories:
- Accessing image data
-
- MR image processing and analysis
- Generating output, including information regarding blood flow, time to peak, and leakage.
Intended Use
nordicDSC is a medical image post-processing software is intended for the analysis of the dynamic time course of the dynamic susceptibility contrast (DSC) enhanced MR data of the human brain and to generate parametric maps including, but not limited to, blood flow, time-to-peak, and vascular leakage.
nordicDSC 510(k) summary
4
The software is intended to be used off-line and in combination with a DICOM handling platform that can allow for user interactions, sending, and viewing of data, data quality control, and network connection. The output of nordicDSC is intended to be interpreted by trained professionals such as physicians, radiologists, and medical technicians to yield information useful in clinical applications.
Indications for Use
nordicDSC is a medical image post-processing software for the dynamic time course of the dynamic susceptibility contrast (DSC) enhanced MR data of the human brain to be used by trained professionals such as physicians, radiologists, and medical technicians to yield information useful in clinical applications.
The software is intended to be used off-line and in combination with a DICOM handling platform that can allow for user interactions, sending, receiving, and viewing of data, data quality control, and connection to network.
Technological Characteristics and Substantial Equivalence
The nordicDSC software is substantially equivalent to the previously cleared Nordic Image Control and Evaluation (nordicICE) software, with the premarket clearance K090546. A short side-by-side comparison of the fundamental characteristics of nordicDSC and nordicICE is provided in the table below.
| Feature | nordicDSC | nordicICE | Comment |
|---|---|---|---|
| Development framework | C++, CMake | Embarcadero C++ Builder | |
| 2010 | |||
| Programming language | C++ | C++ | |
| Operating environment | Cross-platform, is run as | ||
| plugin to a DICOM | |||
| handling platform | "Off-the-shelf" windows | ||
| PC workstation | |||
| Input data | DICOM compliant MR | ||
| data: | |||
| T2* weighted dynamic | |||
| susceptibility contrast- | |||
| enhanced data sets | DICOM compliant MR | ||
| data: | |||
| T2* weighted dynamic | |||
| susceptibility contrast- | |||
| enhanced data sets | |||
| Dynamic analysis | Dynamic susceptibility | ||
| contrast (DSC) MR | |||
| perfusion | Dynamic susceptibility | ||
| contrast (DSC) MR | |||
| perfusion | |||
| Fully automatic | |||
| processing | Yes | No | |
| Automatic motion | |||
| correction | Yes | Yes | |
| Visualization of results | No | Yes | |
| Reading of DICOM data | Yes | Yes | |
| Saving of DICOM data | Yes | Yes | |
| Sending of DICOM data | No | Yes |
nordicDSC 510(k) summary
5
| Leakage correction | Yes (2 methods) | Yes (2 methods) | Same methods in
both devices |
|---------------------------------------------|-------------------------------------|-----------------------------------------------------|--------------------------------------------------|
| CBV map | Yes | Yes | |
| CBF map | Yes | Yes | |
| Tmax map | Yes | Yes (called "Delay map") | |
| TTP map | Yes | Yes | |
| Leakage map | Yes | Yes | |
| Automatic AIF detection | Yes (global unsupervised
search) | Yes (supervised search
from user selected slice) | Quality control of
AIF is advised |
| Manual AIF selection | No | Yes | |
| Predefined AIF | Yes | Yes | Same selection in
both devices |
| Vessel segmentation | Yes | Yes | |
| Provide graph output for
user inspection | Yes | Yes | For example, AIF
curve and Delta R2*
curve |
The rationale for determining the substantial equivalence between nordicDSC and nordiclCE is based on the defined intended use, indications for use, and the technical and operational characteristics of the two applications. To verify that nordicDSC fulfils the defined characteristics and requirements, it has been subject to extensive in-house testing. The successful completion of said tests verifies the claimed characteristics of nordicDSC, and thus supports the determination of substantial equivalence.
Brief discussion of the nonclinical tests submitted, referenced, or relied on
Non-clinical performance testing has been performed on the nordicDSC Software and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ISO 14971 Medical devices – Application of risk management to medical devices
- IEC 62304 Medical device software – Software life cycle processes
- IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 82304-1 Edition 1.0 2016-10 Health software – Part 1: General requirements for product safety
The nordicDSC Software was tested in accordance with verification processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results. The algorithm is inherently nondeterministic, so head-to-head comparisons have to consider the internal variation, which has been found to be within +/- 10%.
6
The test results in this 510(k)premarket notification demonstrates that nordicDSC:
- Complies with the international and FDA-recognized consensus standards and FDA guidance document, and
- . Meets the acceptance criteria and is adequate for its intended use and specifications.
Overall conclusion
The nordicDSC Software is substantially equivalent to the identified predicate device, nordicICE Software (K090546)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, verification and validation testing demonstrate the safety and efficacy of the device to meet its intended use and specifications.
NordicNeuroLab AS believes that the proposed device, nordicDSC Software, is substantially equivalent to its identified predicate device and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.