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

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. 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.

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. NovaPACS uses a vatiety of mobile platforms and browers including iPad 2 (Safari Browser), Nexus 7 (Chrome Browser), and iPad mobileRAD (Native Application). For a list of possible browser choices for one platform that are valid for diagnostic viewing see NovaPACS Diagnostic Viewer User Manual.

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, and vessel analysis.

Images and data are stored on a digital archive with multiple redundancies; 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 anterface 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the NovaPACS device, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a quantitative table format with specific thresholds. Instead, they are described qualitatively through the results of the clinical and performance testing.

Acceptance Criteria (Implied)	Reported Device Performance
Mobile Display Quality (based on AAPM TG18 guidelines):	Bench Testing:
- Acceptable Contrast Response	Results regarding measured luminance with respect to target luminance using ND plots provided. (Specific quantitative results are not provided in the summary).
- No Geometric Distortions	Evaluated but specific results not provided.
- Acceptable Resolution	Evaluated but specific results not provided.
- Acceptable Noise Levels	Evaluated but specific results not provided.
- Acceptable Non-Uniformity	Evaluated but specific results not provided.
- Acceptable Viewing Angle	Evaluated but specific results not provided.
- Acceptable Luminance Response	Evaluated but specific results not provided beyond the general statement for ND plots.
- Acceptable Specular Reflectance	Evaluated but specific results not provided.
- Acceptable Diffuse Reflectance	Evaluated but specific results not provided.
Clinical Equivalence to Predicate Workstation:	Clinical Testing:
- Image quality (contrast, sharpness, artifact, overall quality) comparable to predicate workstation	Each radiologist individually rated contrast, sharpness, artifact, and overall quality as acceptable in comparison to the predicate NovaPACS workstation.
- Adequate for clinical use/diagnostic assurance	Each radiologist agreed that the mobile devices were comparable to the predicate NovaPACS workstation across all seven modalities and of adequate quality for clinical use. They were comfortable with the diagnosis made on the mobile devices.
- Overall clinical image display quality equivalent for identification of clinically relevant details	All radiologists agreed that the overall clinical image display quality on the mobile devices were equivalent to the NovaPACS workstation for the identification of clinically relevant details.
- Acceptable for regular use	Each radiologist indicated that the software and mobile devices provide acceptable quality for regular use and they were satisfied reviewing images on the mobile devices.
- Same diagnosis made on mobile devices as on predicate workstation (across lighting conditions)	Each radiologist agreed that the same diagnosis would be made on the mobile devices with NovaPACS as on the predicate NovaPACS workstation in low lighting, office lighting, and bright light conditions.
Software Performance & Safety:	Performance Testing:
- All requirements have passed test cases	All requirements in the iteration have a test case and the test case has run and passed.
- All Acceptance tests have passed	All Acceptance tests have passed.
- All Current tests have passed	All Current tests have passed.
- All high-impact bugs corrected and verified	All high-impact bugs have been corrected and verified by Quality Assurance.
- Unresolved anomalies do not pose safety risk or substantially affect performance	Any unresolved anomalies have been assessed in a risk meeting and found not to pose a safety risk to the end user (or their patients) and not to substantially affect the performance of NovaPACS software.
- Software features operate correctly and safely, meet equivalent objectives/functions as predicate devices	Of over 1200 test cases run, 99% passed, 1% failed, 0% blocked. Failed tests were mostly minor UI errors. Conclusion: testing sufficient to conclude features/functionality are substantially equivalent to predicate devices and raise no new safety concerns.
- Functional usability across mobile platforms	Verification and validation activities performed, including functional usability across Native App (mobileRad), iOS, and Android. (Implied successful validation, as the device was cleared).
Auto-detection of Unsupported Mobile Platforms:	The new version auto-detects unsupported mobile platforms at HTML5 login to display a persistent on-screen message of "Not for diagnostic viewing". (This is a specific feature in the new version, demonstrating it meets a functional requirement for safety).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: For the clinical testing, the radiologists evaluated six typical cases for each imaging modality, across seven modalities (CT, MR, US, CR/DX, NM, PT, and XA). This means 6 cases/modality * 7 modalities = 42 cases were used in the clinical evaluation. These cases were evaluated on multiple mobile device platforms (Native App (mobileRad), iOS, Android, and Windows mobile device platforms).
Data Provenance: The clinical testing was conducted by a panel of board-certified radiologists in the United States. The description refers to "typical cases," suggesting these were retrospective cases, although it's not explicitly stated as retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Three board-certified radiologists were used.
Qualifications: They were described as "board certified radiologists in the United States." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

The text states: "For each study the radiologist individually rated the contrast, sharpness, artifact and overall quality..." and "Each radiologist agreed that the Native App (mobileRad), IOS, Android, and Windows mobile devices were comparable..." and "Each radiologist agreed that the same diagnosis would be made..."
This indicates a consensus-based approach among the three radiologists rather than a formal pre-defined adjudication method like 2+1 or 3+1. It appears they reached a unanimous agreement on the comparability and diagnostic quality.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Yes, a form of MRMC comparative effectiveness study was done. The clinical testing involved multiple readers (3 radiologists) evaluating multiple cases across different mobile platforms against a predicate workstation.
Effect Size: The study's primary conclusion regarding effect size is qualitative: the radiologists agreed that the mobile devices were "comparable," "adequate quality for clinical use," and "equivalent" to the predicate workstation for diagnostic purposes. A quantitative effect size (e.g., specific metrics like AUC difference or sensitivity/specificity improvement) is not provided in this summary, as the study focused on demonstrating non-inferiority/equivalence qualitatively for diagnostic performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. NovaPACS is a PACS system designed for human use (viewing, analysis, annotation) and its evaluation focused on its utility with a human user, not as an autonomous diagnostic algorithm. While there's "performance testing" of the software itself (99% passed), this is system-level functional testing, not a diagnostic accuracy assessment in a standalone manner.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on expert consensus (the agreement of the three board-certified radiologists) regarding the image quality, diagnostic assurance, and the ability to make the same diagnosis compared to the predicate workstation. The predicate NovaPACS workstation itself serves as the de facto "ground truth" or reference standard for comparison in this 510(k) submission, as the goal is to show substantial equivalence.
There's no mention of pathology or outcomes data being used as ground truth.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. This is because NovaPACS is a Picture Archiving and Communications System (PACS), not an AI/ML-driven diagnostic algorithm that typically relies on a distinct training phase with labeled data. Its "training" would primarily involve software development, bug fixing, and internal quality assurance, rather than machine learning model training on specific image datasets.

9. How the Ground Truth for the Training Set Was Established

As NovaPACS is not an AI/ML diagnostic algorithm, the concept of a "training set" with established ground truth for diagnostic purposes (e.g., presence/absence of disease) is not applicable in the context of this 510(k) summary. The "ground truth" for its development would be its functional specifications, software requirements, and the expected behavior of a PACS system relative to established standards and predicate devices.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

October 14, 2016

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

Re: K160371 Trade/Device Name: NovaPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 26, 2016 Received: September 26, 2016

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.

{1}------------------------------------------------

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 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

{2}------------------------------------------------

INDICATIONS FOR USE FORM

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160371 Device Name NovaPACS

Indications for Use (Describe)

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

즈 Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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)

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."

FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

XII

{3}------------------------------------------------

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: 4 February 2016

Device Name

Trade Name: NovaPACS

Common Name: PACS

Classification Name: System, Imaging Processing, Radiological

Predicate Devices

K132853	NovaPACS	Novarad Corporation
K103785	Mobile MIM	MIM Software Inc. (formerlyMIMvista Corp.)

Indication for Use

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, etc.

{4}------------------------------------------------

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

Device Description

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

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 MobileMIM, 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

{5}------------------------------------------------

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 auto-detecting unsupported mobile platforms at HTML5 login to display a persistent on-screen message of "Not for diagnostic viewing". Although this feature was not available in the previous version of NovaPACS, this similar feature is already available in other predicate devices.

Performance testing results show that the 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.

Bench Testing

Mobile display performance testing was performed in accordance with the description and requirements described in the AAPM Assessment of Display Performance for Medical Imaging Systems (April 2005) document by a third party testing facility to ensure high quality laboratory results. The test equipment and calibration was certified traceable to NIST. Testing measured contrast response and evaluated test patterns for geometric distortions, resolution, noise, non-uniformity, viewing angle, luminance response, specular reflectance, and diffuse reflectance according to TG18 guidelines.

The specific results regarding the measured luminance from the mobile devices with respect to the target luminance response using [ND plots was provided to the FDA.

Clinical Testing

Clinical testing was conducted independently by a panel of three board certified radiologists in the United States. The radiologists conducted a comparative evaluation of the Native App (mobileRad), IOS, Android, and Windows mobile device platforms running NovaPACS with the predicate NovaPACS workstation. Each radiologists followed the same criteria of instructions to ensure the study was standardized. For each study the radiologist individually rated the contrast, sharpness, artifact and overall quality as either acceptable in comparison to the predicate NovaPACS workstation. Testing was conducted using six typical cases for each imaging modatlity including CT, MR, US, CR/DX, NM, PT, and XA on each mobile device. Comparative results of image quality and diagnostic assurance were made by each radiologist.

Each radiologist agreed that the Native App (mobileRad), IOS, Android, and Windows mobile devices were comparable to the predicate NovaPACS workstation across all seven modalities and of adequate quality for clinical use. They were comfortable with the diagnosis made on the mobile devices using the NovaPACS software. All agreed that the overall clinical image display quality on the Native App (mobileRad), IOS, Android, and Windows mobile devices were equivalent to the NovaPACS workstation for the identification of clinically relevant details.

Each radiologist indicated that the software and mobile devices provide acceptable quality for regular use and they were satisfied reviewing images on the mobile devices.

{6}------------------------------------------------

Each radiologist agreed that the same diagnosis would be made on the mobile devices with NovaPACS as on the predicate NovaPACS workstation in low lighting conditions, office lighting conditions, and in bright light conditions.

Performance Testing

Thorough software testing has been performed for NovaPACS to safety and efficacy of the device. Of over 1200 test cases run on the NovaPACS Software, 99% passed, 1% failed, and 0% were blocked on their latest run. Of the failed tests, the majority represent minor user interface errors. We believe that the testing performed so far is sufficient to conclude that the features and functionality of NovaPACS software is substantially equivalent to that of the predicate devices, and that it does not raise any new safety concerns.

Verification and validation activities 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.
All Acceptance tests have passed b.
All Current tests have passed C.
d. 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 e. not pose a safety risk to the end user (or their patients) and do not substantially affect the performance of NovaPACS software.

Verification and validation includes functional usability across three mobile platforms; Native App (mobileRad), IOS, and Android.

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).