Who is the manufacturer of nordicDSC?

Nordicneurolab AS filed the 510(k) submission for nordicDSC (K212720).

What is the FDA product code for nordicDSC?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for nordicDSC?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like nordicDSC?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

nordicDSC

K212720 · Nordicneurolab AS · LLZ · Mar 3, 2022 · Radiology

Device Facts

Record ID	K212720
Device Name	nordicDSC
Applicant	Nordicneurolab AS
Product Code	LLZ · Radiology
Decision Date	Mar 3, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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.

Device Story

nordicDSC is an image analysis software module integrated as a plugin into hospital DICOM handling platforms. It processes T2* weighted dynamic susceptibility contrast (DSC) enhanced MRI data of the human brain. The device performs automated motion correction and analysis of the dynamic time course to generate parametric maps, including blood flow (CBF), cerebral blood volume (CBV), time-to-peak (TTP), and vascular leakage. It features automated arterial input function (AIF) detection using a global unsupervised search and vessel segmentation. The software operates off-line; clinicians use the output maps and generated graphs (e.g., AIF and Delta R2* curves) to assist in clinical decision-making. The device benefits patients by providing quantitative perfusion information derived from standard MRI sequences.

Clinical Evidence

Bench testing only. Verification and validation testing performed to address intended use, technical specifications, and risk management. Testing confirmed compliance with ISO 14971, IEC 62304, IEC 62366-1, and IEC 82304-1. Internal variation for the nondeterministic algorithm was verified to be within +/- 10%.

Technological Characteristics

Software-based image processing module; C++ development framework; cross-platform plugin architecture for DICOM handling platforms. Implements DSC perfusion analysis, automated motion correction, and automated AIF detection. Standards: ISO 14971 (risk management), IEC 62304 (software lifecycle), IEC 62366-1 (usability), IEC 82304-1 (health software safety).

Indications for Use

Indicated for trained professionals (physicians, radiologists, medical technicians) to analyze dynamic susceptibility contrast (DSC) enhanced MR brain data to generate parametric maps (blood flow, time-to-peak, vascular leakage).

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Nordic Image Control and Evaluation (nordicICE) Software (K090546)

Related Devices

K091444 — PERFSCAPE · Olea Medical · Jul 20, 2009
K202793 — Cercare Medical Neurosuite · Cercare Medical Aps · May 17, 2021
K090546 — MODIFICATION TO NORDICICE SOFTWARE · Nordicimaginglab AS · Jun 8, 2009
K080762 — IB NEURO, VERSION 1.0 · Imaging Biometrics, LLC · May 15, 2008
K230016 — Cercare Medical Neurosuite · Cercare Medical A/S · Jul 14, 2023

Submission Summary (Full Text)

{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}------------------------------------------------ Page 2 801); 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 {2}------------------------------------------------ #### 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) | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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: 1. Accessing image data - 2. MR image processing and analysis 3. 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.