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.

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.

AI/ML Overview

The NordicNeuroLab AS nordicDSC Software underwent non-clinical performance testing to demonstrate its compliance with established standards and its suitability for its intended use. However, the provided document does not contain a detailed study proving the device meets specific acceptance criteria in terms of performance metrics. Instead, it primarily focuses on comparing the nordicDSC software with a predicate device (nordicICE Software, K090546) and verifying its compliance with general regulatory and software development standards.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of specific quantitative acceptance criteria alongside corresponding performance metrics for the nordicDSC device. It states, "The test results in this 510(k)premarket notification demonstrates that nordicDSC: ... Meets the acceptance criteria and is adequate for its intended use and specifications." This is a general statement of compliance, not a report of specific performance against defined criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document provides no information regarding the sample size used for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the number of experts used to establish ground truth for any test set, nor does it specify their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method used for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not explicitly state that a standalone performance study (algorithm only without human-in-the-loop) was conducted. While it refers to "non-clinical performance testing" and "verification and validation tests," these are primarily framed around compliance to standards and comparison to a predicate device's features rather than a direct, quantitative standalone performance evaluation against a gold standard.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The document does not specify the type of ground truth used for any testing.

8. The sample size for the training set

The document does not mention any training set or its sample size. The primary focus is on performance testing and comparison to a predicate, not on a machine learning model training process that would typically involve a "training set."

9. How the ground truth for the training set was established

Since no training set is mentioned, there is no information on how its ground truth was established.

Summary of what the document does provide regarding testing:

Non-clinical performance testing: "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, IEC 62304, IEC 62366-1, IEC 82304-1 Edition 1.0 2016-10."
Verification and Validation: "Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results."
Nondeterministic algorithm variation: "The algorithm is inherently nondeterministic, so head-to-head comparisons have to consider the internal variation, which has been found to be within +/- 10%." This provides a very general statement about the algorithm's consistency but not its accuracy or specific performance against a clinical gold standard.
Substantial Equivalence: The primary method of demonstrating safety and effectiveness appears to be through showing substantial equivalence to a predicate device (nordicICE Software, K090546) based on intended use, indications for use, and technical/operational characteristics.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and compliance with general software and risk management standards. It explicitly states that "The test results in this 510(k)premarket notification demonstrates that nordicDSC: ... Meets the acceptance criteria and is adequate for its intended use and specifications." This implies that acceptance criteria were defined and met. However, the document does not disclose the specific quantitative acceptance criteria, the detailed study design (including sample sizes, data provenance, ground truth establishment, or expert involvement), or the specific performance results that would allow for a complete answer to your request. The "Brief discussion of the nonclinical tests" refers to general compliance rather than specific clinical performance metrics.

Summary

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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

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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)

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

The program functionality can be divided into three main categories:

Accessing image data

1. 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

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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

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
Development framework	C++, CMake	Embarcadero C++ Builder2010
Programming language	C++	C++
Operating environment	Cross-platform, is run asplugin to a DICOMhandling platform	"Off-the-shelf" windowsPC workstation
Input data	DICOM compliant MRdata:T2* weighted dynamicsusceptibility contrast-enhanced data sets	DICOM compliant MRdata:T2* weighted dynamicsusceptibility contrast-enhanced data sets
Dynamic analysis	Dynamic susceptibilitycontrast (DSC) MRperfusion	Dynamic susceptibilitycontrast (DSC) MRperfusion
Fully automaticprocessing	Yes	No
Automatic motioncorrection	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

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Leakage correction	Yes (2 methods)	Yes (2 methods)	Same methods inboth 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 unsupervisedsearch)	Yes (supervised searchfrom user selected slice)	Quality control ofAIF is advised
Manual AIF selection	No	Yes
Predefined AIF	Yes	Yes	Same selection inboth devices
Vessel segmentation	Yes	Yes
Provide graph output foruser inspection	Yes	Yes	For example, AIFcurve 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%.

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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.

Regulation Number and Section

§ 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).