NovaPACS is intended for the viewing, archiving, analysis, annotation, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, including mammography.

NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images.

Mobile devices are not intended to replace a full workstation and should be used only when there is no access to a workstation. They are not to be used for mammography or fMRI. Mobile devices are used for diagnosis of medical images from different modalities including CT, MR, US, CR/DX, NM, PT, and XA. For a list of compatible mobile platforms see NovaPACS Diagnostic Viewer User Manual.

While NovaPACS full workstation provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light conditions, and to confirm image compression ratios are consistent with the generally accepted standards of the clinical application.

NovaPACS is intended for providing analysis and visualization of functional MRI data of the human brain, presenting derived properties and parameters in a clinically useful context.

Device Description

NovaPACS is a picture archiving and communication system software that retrieves, archives, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer.

The NovaPACS software makes images and data available in digital format from all common modalities. The images are viewed on a computer monitor or portable device. NovaPACS tools/features include the following: window, level, zoom, pan, digital subtraction, ejection, cross localization, note-taking ability, voice dictation, and other similar tools. It includes the capability to measure distance and image intensity values, such as standardized uptake value. NovaPACS displays measurement lines, annotations, regions of interest, and fusion blending control functionality. Advanced features include 3D image rendering, virtual fly-through, time domain imaging, vessel analysis, and blood oxygen level dependent (BOLD) fMRI.

BOLD fMRI analysis is used to highlight small susceptibility changes in the human brain in areas with altered bloodflow resulting from neuronal stimulation. The Functional Processing Software includes features such as scalp stripping, 3D motion correction, smoothing, coregistration, normalize images to MNI templates, and warping.

Images and data are stored on a digital archive with multiple redundances; images and data are available on-site and off-site. Novarad provides all software, including third party software (i.e. Windows® OS). NovaPACS software resides on third party hardware, which may vary depending on the client's PACS needs. All hardware is connected to the radiology department local area network.

NovaPACS integrates with NovaRIS and may integrate with any other third party RIS software that has HL7 interface capabilities.

NovaPACS integrates with Novarad Mobile Rad application and web viewers to display data on 3rd party mobile platforms. Mobile devices are not intended to replace full workstation and should be used only when there is no access to a workstation. They are not to be used for mammography or fMRI.

AI/ML Overview

The provided text describes NovaPACS, a picture archiving and communication system (PACS) software, and its substantial equivalence to predicate devices. However, the document does not contain a detailed study with specific acceptance criteria and reported device performance in the format requested. It mentions performance testing for the fMRI software features but lacks quantitative data for a table.

Here's a breakdown of the information that can be extracted, and where there are gaps:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in a quantifiable manner that allows for a table comparing acceptance criteria against specific performance metrics (e.g., sensitivity, specificity, accuracy, or other benchmarked values). The document states:

"Nineteen test cases were run on the NovaPACS to fulfill the fMRI requirements. All 19 test cases passed."
"NovaPACS software passes all performance requirements and meets all specifications prior to release, including:
- All requirements in the iteration have a test case and the test case has run and passed.
- All Acceptance tests have passed
- All Current tests have passed
- All high-impact bugs have been corrected and verified by Quality Assurance
- Any unresolved anomalies have been assessed in a risk meeting, and it has been found that they do not pose a safety risk to the end user (or their patients) and do not substantially affect the performance of NovaPACS software."

These are general statements about successful internal testing and meeting requirements, but they do not disclose the specific "acceptance criteria" (e.g., a specific numerical threshold for an imaging performance metric) or the "reported device performance" against those criteria.

2. Sample size used for the test set and the data provenance

Sample size for test set: The document mentions "Nineteen test cases were run on the NovaPACS to fulfill the fMRI requirements." It does not specify the number of cases (e.g., patient studies or images) within these test cases, nor does it detail the specific characteristics or provenance of the data used in these tests.
Data provenance: Not specified (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

This information is not provided. The document does not mention the involvement of experts for establishing ground truth during the performance testing.

4. Adjudication method for the test set

This information is not provided.

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

MRMC study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There are no clinical tests to compare NovaPACS and predicate devices, as they are software products that send and store images and information."
Effect size of human reader improvement: Not applicable, as no MRMC study was performed.

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

Standalone performance: The testing described focuses on the functionality and safety of the NovaPACS fMRI software features ("Nineteen test cases were run on the NovaPACS to fulfill the fMRI requirements. All 19 test cases passed."). This implies standalone testing of the algorithm's performance against predefined requirements, as no human-in-the-loop study is mentioned. However, specific metrics of this standalone performance are not shared beyond "all passed."

7. The type of ground truth used

The document does not specify the type of ground truth used for performance testing (e.g., expert consensus, pathology, outcomes data). It broadly refers to "fMRI requirements," suggesting that the tests validated the software's ability to correctly process and display fMRI data according to established functional MRI analysis methodologies, rather than a diagnostic ground truth.

8. The sample size for the training set

This information is not provided. The document describes NovaPACS as "a picture archiving and communication system software," and its fMRI analysis component. It does not explicitly state that the fMRI feature relies on machine learning or AI models that would require a "training set" in the conventional sense. The focus appears to be on general software functionality and adherence to fMRI processing standards.

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

This information is not provided, as a training set is not explicitly mentioned or implied for an AI/ML model.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 28, 2017

Novarad Corporation % Mr. Doug Merrill Regulatory and Compliance Manager 752 East 1180 South #200 AMERICAN FORK UT 84003

Re: K171754 Trade/Device Name: NovaPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 5, 2017 Received: June 13, 2017

Dear Mr. Merrill:

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171754

Device Name NovaPACS

Indications for Use (Describe)

NovaPACS is intended for providing analysis and visualization of functional MRI data of the human brain, presenting derived properties and parameters in a clinically useful context.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) SUMMARY

Submitter

Novarad Corporation

752 East 1180 South, Suite 200

American Fork, UT 84003

E-mail: doug.merrill(@novarad.net

Phone: 801-642-1001

Contact Person: Doug Merrill

Date Summary Prepared: 9 January 2015

Device Name

Trade Name: NovaPACS

Common Name: PACS

Classification Name: System, Imaging Processing, Radiological

Predicate Devices

K160371	NovaPACS	Novarad Corporation
K133910	nordicBrainEx Software	NordicNeuroLab AS

Indication for Use

Novarad 510(k) Submission | 2017

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images from different modalities including CT, MR, US, CR/DX, NM, PT, and XA. For a list of compatible mobile platforms see NovaPACS Diagnostic Viewer User Manual.

NovaPACS is intended for providing analysis and visualization of functional MRI data of the human brain, presenting derived properties and parameters in a clinically useful context.

Device Description

NovaPACS integrates with NovaRIS and may integrate with any other third party RIS software that has HL7 interface capabilities.

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Substantial Equivalence

Research and testing data provide evidence that NovaPACS is substantially equivalent to the represented predicate devices: NovaPACS, a class II device under 21 CFR 892.2050 and nordicBrainEx Software, a class II device under 892.2050.

NovaPACS and all predicate devices are Radiological Image Processing Systems which retrieve, store, and display images from DICOM compliant medical imaging modalities and/or systems. All are intended to be used in healthcare settings, such as hospitals and clinics, on 3d party off-the-shelf hardware, and connected to a local area network. All are intended to provide qualified medical professionals with a variety of tools and software for the viewing, analysis, and annotation of medical images.

The new version of NovaPACS for which this submission is an upgraded version of the predicate NovaPACS device. The new version of NovaPACS software differs from the NovaPACS predicate software in intended use by providing algorithms designed to analyze functional MRI data of the brain. Although this feature was not available in the previous version of NovaPACS, this similar feature is already available in other predicate device listed.

Performance testing results show that the fMRI software features of NovaPACS operate correctly and safely and meet equivalent objectives and perform equivalent functions as those represented in the predicate devices. Performance testing also shows that the unique combination of safety features represented in NovaPACS does not raise any additional safety concerns.

There are no clinical tests to compare Noval ACS and predicate devices, as they are software products that send and store images and information.

Performance Testing

Functional MRI software testing has been performed for NovaPACS to safety and efficacy of the device. Nineteen test cases were run on the NovaPACS to fulfill the fMRI requirements. All 19 test cases passed. We believe that the testing performed so far is sufficient to conclude that the features and functionality of NovaPACS fMRI software is substantially equivalent to that of the predicate devices, and that it does not rasse any new safety concerns.

Verification and validation activites are performed on NovaPACS during software development prior to release, and in an ongoing manner for any updates. NovaPACS software passes all performance requirements and meets all specifications prior to release, including:

All requirements in the iteration have a test case and the test case has run and passed a.
b. All Acceptance tests have passed
All Current tests have passed C.
All high-impact bugs have been corrected and verified by Quality Assurance d.
e. Any unresolved anomalies have been assessed in a risk meeting, and it has been found that they do not pose a safety risk to the end user (or their patients) and do not substantially affect the performance of NovaPACS software.

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).