(50 days)
Not Found
No
The description focuses on image post-processing, manual/semi-automatic border detection, and quantitative data aggregation without mentioning AI or ML.
No
The device is described as a software tool that supports clinical decision-making by providing quantitative data from MR images; it is not intended to provide medical advice, determine, or recommend treatment, which are functions of a therapeutic device.
Yes
The software analyzes cardiovascular images to provide quantitative data that supports qualified healthcare practitioners for clinical decision-making, which is characteristic of a diagnostic device.
Yes
The device description explicitly states "The Arterys Software is a web-accessible image post-processing analysis software device". It processes existing DICOM images and does not include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Arterys Software analyzes images acquired from MR scanners. It processes and quantifies data from these images.
- No biological samples: The device does not interact with or analyze biological samples from the patient. Its input is image data.
Therefore, while it is a medical device used for clinical decision-making, it falls under the category of image processing software rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Arterys Software consists of software that analyzes DI COM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Software specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by the Arterys Software is intended to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Arterys Software is a web-accessible image post-processing analysis software device for viewing and quantifying cardiovascular MR images. The device is intended to visualize and quantify MRI data in DICOM format. Manual and semi-automatic border detection forms the basis for the analysis. The software has features for loading, saving, generating screen displays, and aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. The Arterys Software is intended for use in both pediatric (neonate, infant, child and adolescent) and adult populations.
The following visualization, quantification and data-reporting functionalities are provided by the software:
Visualization:
- -2D image review
- 3D image review by means of MIP, Surface MinIP, Surface and Average -
- Multi-planer reconstruction (MPR) views (axial, coronal and sagittal) -
- -Image navigation tools
- Cine play -
- Cardiac view -
Quantification:
- -Anatomy and tissue segmentation
- -Linear distance and area measurements
- -Flow quantification, including net flow, forward flow, regurgitation fraction, pressure gradient and primary flow direction, at user-specified locations where contours have been created (i.e. aortic valve, pulmonary valve, mitral valve, tricuspid valve, and superior vena cava).
- -Cardiac function volume quantification including stroke volume, ejection fraction, cardiac output, end-diastolic mass and volume, end-systolic mass and volume
- -Phase correction
Data reporting:
The volume, blood flow and linear distance statistics, along with 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 clinician database, such as PACS, for review.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance (MR) scanners
Anatomical Site
Cardiovascular images: heart and its major vessels
Indicated Patient Age Range
pediatric (neonate, infant, child and adolescent) and adult populations.
Intended User / Care Setting
qualified cardiologist, radiologist, or other licensed professional healthcare practitioners
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 the Arterys Software has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing, as well as software usability 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
Arterys Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K162513
Trade/Device Name: Arterys Software v2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 14, 2016 Received: October 21, 2016
Dear Mr. Job:
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 D.'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
510(k) Number (if known) K162513
Device Name Arterys Software v2.0
Indications for Use (Describe)
The Arterys Software consists of software that analyzes DI COM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Software specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by the Arterys Software is intended to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 |
| Director of Quality and Regulatory, RAC | |
| Arterys Inc. | |
| Contact Information | Email: golnaz@arterys.com |
| Phone: 408-504-3187 | |
| Date Prepared | 08/01/2016 |
2. Proposed Device
Proposed Device:
| Proprietary Name | Arterys Software v2.0 |
|---|---|
| Common Name | Arterys Software v2.0 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
3. Predicate Device
Primary Predicate Device:
| Proprietary Name | Morpheus HeartScan |
|---|---|
| Premarket Notification | K133937 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
Secondary Predicate Device:
| Proprietary Name | Medis Imaging QMass |
|---|---|
| Premarket Notification | K140587 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
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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.
4. Device Description
The Arterys Software is a web-accessible image post-processing analysis software device for viewing and quantifying cardiovascular MR images. The device is intended to visualize and quantify MRI data in DICOM format. Manual and semi-automatic border detection forms the basis for the analysis. The software has features for loading, saving, generating screen displays, and aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. The Arterys Software is intended for use in both pediatric (neonate, infant, child and adolescent) and adult populations.
The following visualization, quantification and data-reporting functionalities are provided by the software:
Visualization:
- -2D image review
- 3D image review by means of MIP, Surface MinIP, Surface and Average -
- Multi-planer reconstruction (MPR) views (axial, coronal and sagittal) -
- -Image navigation tools
- Cine play -
- Cardiac view -
Quantification:
- -Anatomy and tissue segmentation
- -Linear distance and area measurements
- -Flow quantification, including net flow, forward flow, regurgitation fraction, pressure gradient and primary flow direction, at user-specified locations where contours have been created (i.e. aortic valve, pulmonary valve, mitral valve, tricuspid valve, and superior vena cava).
- -Cardiac function volume quantification including stroke volume, ejection fraction, cardiac output, end-diastolic mass and volume, end-systolic mass and volume
- -Phase correction
Data reporting:
The volume, blood flow and linear distance statistics, along with 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 clinician database, such as PACS, for review.
5
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 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.
5. Indications for Use
The Arterys Software consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Software specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by the Arterys Software is intended to be used to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
| Feature/
Function | Proposed Device:
Arterys Software | Primary Predicate
Device:
Morpheus HeartScan
(K133937) | Secondary
Predicate Device:
Medis Imaging
QMass
(K140587) |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Operating
System | Linux | Linux | Not Applicable |
| Platform | Client-server, Chrome
Desktop | Client-server, Chrome
Desktop | Not Applicable |
| Scanners | Both 1.5T and 3.0T | Both 1.5T and 3.0T | Not Applicable |
| Image input | Supports DICOM 3.0 | Supports DICOM 3.0 | Not Applicable |
| Data acquisition
protocol for flow
and volume
analysis | Cardiovascular
images: multi-phase,
multi-slice and
velocity encoded
images acquired from
MRI scanners | Cardiovascular
images: multi-phase,
multi-slice and
velocity encoded
images acquired from
MRI scanners | Not Applicable |
| Image display
mode | Static and cine | Static and cine | Not Applicable |
| Image
Navigation
Tools1 | Pan, zoom, rotate,
maximize/minimize,
slice scroll (view
multiple slices),
adjust window/level,
slab thickness, flow
direction and time
scroll (view multiple | Pan, zoom, rotate,
maximize/minimize,
slice scroll (view
multiple slices),
adjust window/level,
time scroll (view
multiple phases),
image ROI placement; | Not Applicable |
| Feature/
Function | Proposed Device:
Arterys Software | Primary Predicate
Device:
Morpheus HeartScan
(K133937) | Secondary
Predicate Device:
Medis Imaging
QMass
(K140587) |
| | phases), image ROI
placement; automated
2D ROI (with edit
functions); 2D speed
color map. | automated 2D ROI
(with edit functions);
2D speed color map. | |
| 2D image
review | Yes | Yes | Not Applicable |
| 3D (volume
rendered) image
review | Yes | Yes | Not Applicable |
| Cardiac View2 | Yes | No | Not Applicable |
| Orientation label | Yes | Yes | Not Applicable |
| Cross-reference
indicator3 | Yes | No | Not Applicable |
| View DICOM
data | Yes, users can view
the DICOM
information about the
patient, study and
current image | Yes, users can view
the DICOM
information about the
patient, study and
current image | Not Applicable |
| Secondary
Capture4 | Yes | No | Not Applicable |
| Segmentation of
region of interest | Manual and semi-
automatic | Manual and semi-
automatic | Not Applicable |
| Phase error
correction | Yes, Eddy Current
Correction | Yes, Eddy Current
Correction | Not Applicable |
| Quantitative
Analysis, flow | Yes | Yes | Not Applicable |
| Quantitative
Analysis, area | Yes | Yes | Not Applicable |
| Feature/
Function | Proposed Device:
Arterys Software | Primary Predicate
Device:
Morpheus HeartScan
(K133937) | Secondary
Predicate Device:
Medis Imaging
QMass
(K140587) |
| Quantitative
Analysis, linear
distance5 | Yes | Yes | Not Applicable |
| Quantitative
Analysis,
volume | Yes | Not Applicable | Yes |
| 2D Phase
Contrast6 | Yes | No | Not Applicable |
| Directional/vec
tor display of
the blood
particle travel8 | Blood flow and flow
direction are available
by means of color
overlay and vectors
and/or streamlines | Blood flow is
available by means
of color overlay.
Vector component
information is
displayed. | Not Applicable |
| Flow
quantification
of valves9 | Option to adjust
plane at each
Timepoint for flow
measurement. Same
flow algorithm as
predicate. | Flow measurement
in a static plane,
with the option to
create a separate
flow measurement at
different planes for
each Timepoint. | Not Applicable |
| Automatic
selection of the
Temporal
Landmark
Timepoints10 | Available as a
prerequisite step to
volume
measurement. | Not Applicable | Available as a
prerequisite step
to volume
measurement. |
6. Comparison of Technological Characteristics with the Predicate Device
Arterys, Inc., Traditional 510(k)
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Image /page/6/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 black.
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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 of three curved lines that are parallel to each other. The lines appear to be flowing or waving, adding a dynamic element to the otherwise static text.
Performance Data 7.
Safety and performance of the Arterys Software has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing, as well as software usability 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
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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 curve upwards and to the right.
Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."
8. Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the Arterys Software raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy and performanc