(48 days)
No
The summary explicitly states "Manual and semi-automatic border detection forms the basis for analysis" and does not mention AI, ML, or deep learning in the device description or intended use. While the product name includes "DL", the summary does not provide evidence of deep learning being used.
No
The device is described as a "support tool" that analyzes images and provides data for clinical decision-making, explicitly stating it "is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient." This indicates it's a diagnostic or analytical tool, not one that directly treats a condition.
Yes
The device analyzes DICOM-compliant cardiovascular images to provide clinically-relevant and reproducible, quantitative data, intended to support healthcare practitioners for clinical decision-making, which falls under the definition of a diagnostic device.
Yes
The device description explicitly states "Arterys Cardio DL is a web-accessible image post-processing analysis software device". The summary focuses entirely on the software's functionality and validation, with no mention of accompanying 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: Arterys Cardio DL analyzes images acquired from an MR scanner. It processes and quantifies data from these images to provide information about blood flow in the heart and major vessels. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use clearly states it analyzes DICOM-compliant cardiovascular images and provides quantitative data to support clinical decision-making. This is consistent with image analysis software, not an IVD.
Therefore, while it is a medical device used in clinical decision-making, it falls under the category of medical image analysis software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL 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 Arterys Cardio DL 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
LLZ
Device Description
Arterys Cardio DL is a web-accessible image post-processing analysis software device used 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 analysis. The software has features for loading, saving, generating screen displays, and aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL 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 or Average -
- Multi-planer reconstruction (MPR) views (axial, coronal and sagittal) -
- Image navigation tools -
- -Cine play
- Cardiac views -
Quantification:
- Anatomy and tissue segmentation -
- -Distance and area measurements
- Cardiac function quantification including stroke volume, ejection fraction, cardiac output, end-diastolic mass and volume, end-systolic mass and volume
- -Flow quantification, including net flow, forward flow, reverse flow, regurgitation fraction, pressure gradient and primary flow direction, at user-specified locations where contours have been created (e.g. aortic valve, pulmonary valve, mitral valve, tricuspid valve, superior vena cava)
- -Phase correction
Data reporting:
The distance, area, volume, and blood flow 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 data to 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)
Anatomical Site
cardiovascular, heart, 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 Arterys Cardio DL 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)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5, 2017
Arterys Inc. % Ms. Golnaz Moeini, RAC Director of Quality and Regulatory 51 Federal Street, Suite 305 SAN FRANCISCO CA 94107
Re: K163253 Trade/Device Name: Arterys Cardio DL Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 17, 2016 Received: November 18, 2016
Dear Ms. Golnaz 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 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)
Device Name Arterys Cardio DL
Indications for Use (Describe)
Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL 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 Arterys Cardio DL 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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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 | 11/17/2016 |
2. Proposed Device
Proposed Device:
| Proprietary Name | Arterys Cardio DL |
|---|---|
| Common Name | Arterys Cardio DL |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
Predicate Device 3.
Primary Predicate Device:
| Proprietary Name | Arterys Software v2.0 |
|---|---|
| Premarket Notification | K162513 |
| 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 |
Device Description 4.
Arterys Cardio DL is a web-accessible image post-processing analysis software device used 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 analysis. The software has features for loading, saving, generating screen displays, and
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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.
aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL 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 or Average -
- Multi-planer reconstruction (MPR) views (axial, coronal and sagittal) -
- Image navigation tools -
- -Cine play
- Cardiac views -
Quantification:
- Anatomy and tissue segmentation -
- -Distance and area measurements
- Cardiac function quantification including stroke volume, ejection fraction, cardiac output, end-diastolic mass and volume, end-systolic mass and volume
- -Flow quantification, including net flow, forward flow, reverse flow, regurgitation fraction, pressure gradient and primary flow direction, at user-specified locations where contours have been created (e.g. aortic valve, pulmonary valve, mitral valve, tricuspid valve, superior vena cava)
- -Phase correction
Data reporting:
The distance, area, volume, and blood flow 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 data to the clinician database, such as PACS, for review.
5. Indications for Use
Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL 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 Arterys Cardio DL 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.
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 graphic consisting of three curved lines that are parallel to each other. The lines are arranged in a way that they resemble a stylized wave or a flowing pattern.
| Feature/
Function | Proposed Device:
Arterys Cardio DL | Primary Predicate
Device:
Arterys Software v2.0
(K162513) | 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 |
| Workflows | Basic 2D, Basic 3D,
4D Flow, 2D Phase
Contrast | Basic 2D, Basic 3D,
4D Flow, 2D Phase
Contrast | Not Applicable |
| Image display mode | Static and cine | Static and cine | Not Applicable |
| Image Navigation
Tools | Pan, zoom, rotate,
maximize/minimize,
slice scroll (view
multiple slices),
adjust window/level,
slab thickness, flow
direction and time
scroll (view multiple
phases), image ROI
placement; automated
2D ROI (with edit
functions); 2D speed
color map. | Pan, zoom, rotate,
maximize/minimize,
slice scroll (view
multiple slices),
adjust window/level,
slab thickness, flow
direction and time
scroll (view multiple
phases), image ROI
placement; automated
2D ROI (with edit
functions); 2D speed
color map. | Not Applicable |
| 3D (volume
rendered) image
review | Yes | Yes | Not Applicable |
| Cardiac View | Yes | Yes | Not Applicable |
| Orientation label | Yes | Yes | Not Applicable |
| Feature/
Function | Proposed Device:
Arterys Cardio DL | Primary Predicate
Device:
Arterys Software v2.0
(K162513) | Secondary Predicate
Device:
Medis Imaging
QMass
(K140587) |
| Cross-reference
indicator | Yes | Yes | 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 Capture | Yes | Yes | Not Applicable |
| Segmentation of
region of interest | Manual and semi-
automatic | Manual and semi-
automatic | Not Applicable |
| Phase error
correction | Yes | Yes | Not Applicable |
| Quantitative
Analysis, flow | Yes, 4D Flow and 2D
Phase Contrast | Yes, 4D Flow and 2D
Phase Contrast | Not Applicable |
| Quantitative
Analysis, area | Yes | Yes | Not Applicable |
| Quantitative
Analysis, distance | Yes | Yes | Not Applicable |
| Quantitative
Analysis, Volume in
4D Flow Workflow | Yes | Yes | Not Applicable |
| Quantitative
Analysis, Volume in
3D Workflow for a
short axis stack | Yes | Not Applicable | Yes |
| Directional/vector
display of the blood
particle travel | Yes | Yes | Not Applicable |
| Flow quantification
of valves | Yes | Yes | Not Applicable |
| Feature/
Function | Proposed Device:
Arterys Cardio DL | Primary Predicate
Device:
Arterys Software v2.0
(K162513) | Secondary Predicate
Device:
Medis Imaging
QMass
(K140587) |
| Automatic selection
of the Temporal
Landmark time
points | Yes | Yes | Not Applicable |
6. Comparison of Technological Characteristics with the Predicate Devices
Arterys Inc., Traditional 510(k)
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Image /page/6/Picture/0 description: The image shows the word "ARTERYS" with a stylized wave-like design to the left of the word. The word is written in a sans-serif font, with each letter evenly spaced. The wave-like design consists of three curved lines that run parallel to each other.
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Image /page/7/Picture/0 description: The image shows the word "ARTERYS" in all caps, with a stylized graphic to the left of the word. The graphic consists of three curved lines that are parallel to each other. The text is in a simple, sans-serif font and is horizontally aligned.
7. Performance Data
Safety and performance of Arterys Cardio DL 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."
8. Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, Arterys Cardio DL raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.