(413 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard PACS functionalities and image processing tools, not AI/ML-driven analysis.
No
The device description and intended use state that NovaPACS is for viewing, archiving, analyzing, and processing medical images, which are functions related to image management rather than directly treating or preventing disease.
No
Explanation: The "Intended Use / Indications for Use" section states, "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." This indicates it processes data from diagnostic devices, but is not, in itself, a diagnostic device. Furthermore, it explicitly mentions, "While NovaPACS provides tools to assist the healthcare professional determine diagnostic viability..." which suggests it aids in diagnosis rather than performing it.
Yes
The device is described as "picture archiving and communication system software" and explicitly states that the "NovaPACS software resides on third party hardware". While it interacts with hardware and displays images on monitors or portable devices, the core medical device functionality is presented as the software itself.
Based on the provided text, NovaPACS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- NovaPACS Function: NovaPACS is a Picture Archiving and Communication System (PACS) software. Its primary function is the viewing, archiving, analysis, annotation, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices (like X-ray, CT, MRI, etc.). It works with images, not biological specimens.
- Intended Use: The intended use clearly states it's for working with digital medical images and data from imaging devices. It assists healthcare professionals in evaluating these images.
- Device Description: The description reinforces that it retrieves, archives, and displays images and data from modalities. It doesn't mention any interaction with biological samples.
Therefore, NovaPACS falls under the category of medical imaging software or a PACS system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital medical images and data acquired from diagnostic imaging devices and all DICOM devices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images.
healthcare settings, such as hospitals and clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K063153, K043194, K061214, K072821, K103785
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles 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 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 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.
| 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. (formerly |
| MIMvista 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.
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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 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.
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.
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.