(53 days)
No
The summary describes standard image viewing, processing, and measurement functionalities typical of a PACS or medical image viewer, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as an image and data management system for medical professionals to review images and information to render findings and/or diagnosis; it does not directly generate diagnosis or potential findings, or provide or support treatment.
No
The device is a data management system that displays, processes, stores, and transfers medical data. While it provides tools for visualization and quantitative measurements that can aid a professional in diagnosis, it explicitly states that "it does not directly generate any diagnosis or potential findings." The interpretation for rendering findings and/or diagnosis is performed by a trained professional.
Yes
The device description explicitly states that the client software is designed to run on standard personal and business computers and describes functionalities that are purely software-based (displaying, processing, storing, transferring, filtering, digital manipulation, quantitative measurements, visualization, quantification, data reporting). There is no mention of proprietary hardware being part of the device itself.
Based on the provided information, the Arterys Viewer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Arterys Viewer's Function: The Arterys Viewer primarily deals with medical images (DICOM and non-DICOM) and related patient data. It displays, processes, stores, and transfers this information. While it performs quantitative measurements on these images, it does not analyze biological specimens.
- Intended Use: The intended use explicitly states that it provides image and related information that is interpreted by a trained professional to render findings and/or diagnosis. It does not directly generate any diagnosis or potential findings. This further reinforces that it's a tool for interpreting existing medical data, not a device that analyzes biological samples to produce diagnostic information.
Therefore, the Arterys Viewer falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, rather than an IVD.
N/A
Intended Use / Indications for Use
Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.
The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
Product codes
LLZ
Device Description
Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.
The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis. but it does not directly generate any diagnosis or potential findings.
The following visualization, quantification and data-reporting functionalities are provided by the software:
Visualization:
- 2D image review
- 3D image review by means of MIP, MinIP, Surface or Average
- Multi-planar reconstruction (MPR) views (axial, coronal, sagittal, and oblique)
- Image navigation tools
- Cine play
Quantification:
- Distance and area measurements
Data reporting:
The distance, area, and user-selected annotated images are displayed to the user within the software client web browser. The user has the option to save the data for later use. The user can also send the data to PACS, for review.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM and non-DICOM
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals, including but not limited to radiologists, oncologists, and physicians.
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)
Safety and performance of Arterys Viewer has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2008- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
Public Health Service
Image /page/0/Picture/2 description: The image is a 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 a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
Arterys, Inc. % Ms. Golnaz Moeini Director of Quality and Regulatory Affairs 51 Federal Street, Suite 305 SAN FRANCISCO CA 94107
Re: K171544
Trade/Device Name: Arterys Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 24, 2017 Received: May 26, 2017
Dear Ms. Moeini:
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
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ResourcesforYou/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,
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
510(k) Number (if known) K171544
Device Name Arterys Viewer
Indications for Use (Describe)
Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.
The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines running parallel to each other. The lines appear to be of equal thickness and are black.
Section 5. 510(k) Summary
1. General Information
| 510(k) Sponsor | Arterys Inc. |
|---|---|
| Address | 51 Federal St. Suite 305 |
| San Francisco, CA 94107 | |
| Correspondence Person | Golnaz Moeini, RAC |
| Director of Quality and Regulatory | |
| Arterys Inc. | |
| Contact Information | Email: quality@arterys.com |
| Phone: 408-504-3187 | |
| Date Prepared | May 24, 2017 |
2. Proposed Device
| Proprietary Name | Arterys Viewer |
|---|---|
| Common Name | Viewer |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
3. Predicate Device
Primary Predicate
| Proprietary Name | HealthMyne PACS |
|---|---|
| Premarket Notification | K152186 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
Reference Device
| Proprietary Name | Arterys Software 2.0 |
|---|---|
| Premarket Notification | K162513 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
4. Device Description
Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides
4
Image /page/4/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines that are parallel to each other. The lines appear to be of equal thickness and are arranged in a way that suggests movement or flow.
the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.
The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis. but it does not directly generate any diagnosis or potential findings.
The following visualization, quantification and data-reporting functionalities are provided by the software:
Visualization:
- 2D image review -
- 3D image review by means of MIP, MinIP, Surface or Average -
- Multi-planar reconstruction (MPR) views (axial, coronal, sagittal, and oblique) -
- Image navigation tools -
- Cine play -
Quantification:
- Distance and area measurements -
Data reporting:
The distance, area, and user-selected annotated images are displayed to the user within the software client web browser. The user has the option to save the data for later use. The user can also send the data to PACS, for review.
5. Indications for Use
Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.
The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
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Image /page/5/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines running parallel to each other. The lines appear to be of equal thickness and are black in color, contrasting with the white background.
6. Comparison of Technological Characteristics with the Predicate and Reference Device
| Feature/
Function | Proposed Device:
Arterys Viewer | Primary Predicate
Device:
HealthMyne PACS
(K152186) | Reference Device:
Arterys Software v2.0
(K162513) |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Support
Mammography | No | No | No |
| Operating System | Client server
architecture using
Linux server and web
browser client
(Web-based only) | Client server
architecture utilizing
Windows and Linux
Platforms
(Installed-client only) | Client server
architecture using
Linux server and web
browser client
(Web-based only) |
| Image storage/
compression | Support JPEG2000
and compression | Support JPEG2000
and compression | Support JPEG2000
and compression |
| DICOM
Compliant | Yes | Yes | Yes |
| Worklists | Yes | Yes | |
| Filter and Search
capabilities | Yes | Yes | |
| Ability to search
studies | Yes | Yes. Dynamic
(freeform) search and
matching. Also
customized, indexed
search parameters. | |
| View study-related
documents | Yes. Can view
reports/documents
(except RT Struct) | Yes. Presentation
states and RT Struct
(regions of interest) | |
| Priority "stat"
studies | No | Yes. Studies with a
DICOM priority tag
("Stat" studies) are
given priority order
(top of the list) in the
exam view. | No |
| Managed pushed
studies | Yes. This product
supports only pushed
studies. No studies
originate within the
product | Yes. This product
support only pushed
studies. No studies
originate within the
product | |
| View current and
prior studies at the
same time | No | Yes. Called current
study and prior study.
Prior studies have a
large "PRIOR" label in
each viewport. | No |
| Feature/
Function | Proposed Device:
Arterys Viewer | Primary Predicate
Device:
HealthMyne PACS
(K152186) | Reference Device:
Arterys Software v2.0
(K162513) |
| Re-organize series
in a study (for
viewing) | Yes | Yes. Has a thumbnail
view with the ability to
drag and drop the
thumbnail into a
viewport. Cannot save
the order. | |
| Create separate
displays | Yes | Yes. Can display a
viewport as a single
viewport, can select a
viewport layout and
add series to it. | |
| Cycle through
series | Yes | Yes. Can show the
"next" and "previous"
sets of series | |
| Image display
modes | Yes. Static and cine | Yes. Static and manual
cine. | |
| Select images | Yes. The images
currently being viewed
are highlighted, and
can be chosen by the
user. | Yes. There is an active
image indicator. The
active image can be
chosen or is
automatically set based
on tool use. | |
| Delete Images | No | Yes. Only with PACS
admin privileges and
from the admin
console. | No |
| Sort Images | Yes | Yes. Sorting and
grouping are by
system-defined rules | |
| Scrolling through
slices | Yes | Yes. Linked series are
scrolled together. Can
"swipe" on a scroll bar
to move through slices
quickly. Can
lock/unlock scrolling
through every image. | |
| Zoom in/out | Yes. Default settings
can zoom interactively | Yes. Default settings
can zoom interactively | |
| Feature/
Function | Proposed Device:
Arterys Viewer | Primary Predicate
Device:
HealthMyne PACS
(K152186) | Reference Device:
Arterys Software v2.0
(K162513) |
| Pan an image | Yes | Yes | |
| Standard viewport
layouts | Yes | Yes. Viewport layouts
that are independent of
any modality or
common features of
series | |
| Labels | Yes | Yes. There are labels
in the viewport for
patient, study, and
image information. | |
| Orientation labels | Yes | Yes | |
| Cross-reference
indicator | Yes | Yes. There is a cutline
in linked viewports to
indicate intersection | |
| View DICOM data | Yes. You can view the
DICOM information
about the patient and
study, and the pixel
information | Yes. You can view the
DICOM information
about the patient and
study, and the pixel
information | |
| Create MPR
images | Yes | No. MPRs from the
external source are
supported/displayed. | Yes |
| Feature/
Function | Proposed Device:
Arterys Viewer | Primary Predicate
Device:
HealthMyne PACS
(K152186) | Reference Device:
Arterys Software v2.0
(K162513) |
| Window/level
determination | Yes
Same approach as
predicate but we let
the user adjust W/L | Determined by a
lookup table function
(linear) and the W/L
values of the image. If
the image has a custom
lookup table or a fixed
W/L, those settings are
used instead of
allowing changing of
W/L. If no W/L, then a
histogram is used. | |
| Window/level
access series | Yes | Yes. W/L settings are
applied to the active
image and any linked
images. | |
| Window/level
presets | Yes | Yes. Factory default | |
| Adjust
window/level | Yes. Can interactively
adjust the window and
level | Yes. Can interactively
adjust the window and
level | |
| Annotation | Yes. Display Only | Yes. Display Only | |
| Measuring tools | Yes. Linear, area, and
pixel intensity and
location of a point | No. Pixel intensity and
location. | Yes. Linear, area, and
pixel intensity and
location of a point |
| Feature/
Function | Proposed Device:
Arterys Viewer | Primary Predicate
Device:
HealthMyne PACS
(K152186) | Reference Device:
Arterys Software v2.0
(K162513) |
| Detect
image/patient
issues | No | Yes. Can view patients
and studies with errors | No |
| Custom filters | Yes. Can set filters to
affect the studies listed | Yes. Can set filters to
affect the studies listed | |
| Set reading state | Yes | Yes. Can mark a study
as read. | |
| Custom search
groups | Yes | Yes. Can set "codes"
to index elements for
searching (for
example, referring
physician or sets of
exam types_ for faster
auto-complete during
search | |
| Display radiation
therapy
information | No | Yes. Supports DICOM
RT Structures | No |
| Surface Rendering | Yes | No | Yes |
| Annotation
Propagation | Yes | No | Yes |
| Feature/
Function | Proposed Device:
Arterys Viewer | Primary Predicate
Device:
HealthMyne PACS
(K152186) | Reference Device:
Arterys Software v2.0
(K162513) |
| Time Curve
Display | Yes | No | Yes |
| Contour Creation | Yes | No | Yes |
| Report Creation | Yes | No | Yes |
Arterys Inc., Traditional 510(k)
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Image /page/6/Picture/0 description: The image shows the logo for Arterys. The logo consists of three curved lines on the left side, followed by the word "ARTERYS" in a simple, sans-serif font. The logo is black and white.
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Image /page/7/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines that are parallel to each other. The lines appear to be of equal thickness and are arranged in a way that suggests movement or flow.
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Image /page/8/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a graphic of three curved lines that are parallel to each other. The lines are thin and black, and they create a sense of movement.
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Image /page/9/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines that are parallel to each other. The lines appear to be flowing or waving, adding a dynamic element to the logo.
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Image /page/10/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a stylized graphic consisting of three curved lines that are parallel to each other. The lines appear to be of equal thickness and are arranged in a way that suggests movement or flow.
7. Substantial Equivalence Summary
Arterys Viewer has the same intended use, indications for use and technological characteristics as the HealthMyne PACS predicate device (K152186). The added features to allow for usability enhancements is similar to the features in the reference device, Arterys Software v2.0, which was cleared by the FDA under K162513. Any noted minor differences have been explained and do not raise any different questions of safety or effectiveness. The implemented design controls, risk management activities, labeling and performed verification and validation tests demonstrate the safety and efficacy of the proposed device. Based on the comparison information provided above. Artervs Viewer is substantially equivalent to the predicate device.
8. Performance Data
Safety and performance of Arterys Viewer has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2008- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."
9. Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, Arterys Viewer raises no new
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Image /page/11/Picture/0 description: The image shows the word "ARTERYS" in a simple, sans-serif font. To the left of the word is a graphic consisting of three curved lines that are parallel to each other. The lines appear to be of equal thickness and are arranged in a way that suggests movement or flow.
questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy and performance.