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.

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.

NovaPACS is not intended for diagnostic image review on a mobile platform.

While NovaPACS provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light 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.

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 colonoscopy, and vessel analysis.

Images and data are stored on a digital archive with multiple redundancies; images and data are 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 to display data on 3rd party mobile platforms. Mobile Rad is not intended to replace a full diagnostic workstation.

AI/ML Overview

This K132853 510(k) summary for NovaPACS does not contain the specific information required to complete the request thoroughly. The document describes the device, its intended use, and substantial equivalence to predicate devices, but lacks detailed performance data and study specifics.

Here's a breakdown of what can and cannot be extracted from the provided text regarding acceptance criteria and a study proving fulfillment:

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

The document mentions "performance requirements" and "specifications" but does not provide a specific table of acceptance criteria with corresponding device performance values. It states:

"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"
- "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."

It also states: "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."

And more broadly: "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."

Lacking Information: Specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, processing speed, image quality metrics) are not provided. The phrase "All Acceptance tests have passed" confirms the existence of such tests and their successful completion, but not the content of those tests or their specific targets.

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

Test set sample size: The document mentions "over 1200 test cases run on the NovaPACS Software." It does not specify if these test cases correspond to a specific number of patient cases or images, nor does it detail the nature of the data used in these tests. It seems to refer more to functional and system-level tests rather than a clinical dataset.
Data provenance: Not specified. It's likely internal testing data related to software function.
Retrospective or prospective: Not specified, but given the nature of the "test cases," it's likely part of a software development and validation process rather than a traditional clinical study with patient data collected retrospectively or prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not specified.
Qualifications of experts: Not specified.

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

Not specified. The document primarily discusses software testing for functionality and bug resolution, not expert review of medical images.

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:

Not performed. 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." This implies no MRMC study or study comparing human performance with or without AI assistance was conducted or deemed necessary for this type of PACS device. NovaPACS is described as a system for viewing, archiving, and processing, not as an AI diagnostic aid.

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

Not applicable in the typical AI sense. While the software has "features" like 3D rendering and vessel analysis, it's presented as a tool for "trained healthcare professionals" to "display, manipulate, archive, and evaluate images." It's not an autonomous diagnostic algorithm. The performance described ("99% passed" of 1200 test cases) relates to the correct functioning of the software itself, not its diagnostic accuracy in a standalone mode.

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

Not explicitly stated in terms of diagnostic ground truth. For the stated "test cases," the ground truth would be the expected functional behavior of the software feature (e.g., whether an image loads correctly, a measurement tool accurately calculates distance, or a 3D rendering displays as designed). It's not referring to ground truth for clinical diagnoses on patient images.

8. The sample size for the training set:

Not applicable/Not provided. This document describes a PACS software system, which typically does not involve a "training set" in the machine learning sense for pattern recognition or diagnostic AI. The software's capabilities are based on coded algorithms and functionalities, not on learning from a dataset.

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

Not applicable/Not provided. (See point 8).

In summary, the provided K132853 document focuses on demonstrating the functional equivalence and safety of the NovaPACS software as a Picture Archiving and Communication System (PACS) through software testing, rather than reporting on a clinical study of diagnostic performance using AI, which would typically involve detailed acceptance criteria, ground truth, and reader studies.

Summary

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

October 30, 2014

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

Re: K132853 Trade/Device Name: NovaPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 10, 2014 Received: October 15, 2014

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,

Smh. 7)

for

Janine M. Morris 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) K132853

Device Name NovaPACS

Indications for Use (Describe)

NovaPACS is not intended for diagnostic image review on a mobile platform.

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)

| X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

Submitter

Novarad Corporation

752 East 1180 South, Suite 200

American Fork, UT 84003

E-mail: info@novarad.net

Phone: 801-642-1001

Contact Person: Doug Merrill

Date Summary Prepared: 6 September 2013

Device Name

Trade Name: NovaPACS

Common Name: PACS

Classification Name: System, Imaging Processing, Radiological

Predicate Devices

K063153	NovaPACS	Novarad Corporation
K043194	Voxar 3D	Voxar Enterprise
K061214	TeraRecon Aquarius APS	TeraRecon
K072821	Vitrea 4DCT	Vital Images
K103785	Mobile MIM	MIM Software Inc. (formerlyMIMvista Corp.)

Indication for Use

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NovaPACS is not intended for diagnostic image review on a mobile platform.

While NovaPACS 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 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 to display data on 3rd party mobile platforms. Mobile Rad is not intended to replace a full diagnostic workstation.

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; Voxar 3D, a class II device under 892.2050; to the TeraRecon Aquarius APS, a class II device under 892.2050; MobileMIM, a class II device under 892.2050; and Virea 4DCT.

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

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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 offering additional software features such as virtual fly-through, time domain imaging, vessel analysis, and 3D image rendering. Although these features were not available in the previous version of NovaPACS, similar features are already available in the other predicate devices listed.

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.

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

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.

All failed tests are logged as unresolved anomalies (i.e. bugs), which are sent through additional verification and validation tasks prior to release. Justification of safety and/or mitigation or work around are provided for residual unresolved anomalies and can be found in the Software: Unresolved Anomalies section of this submission. 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.

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).