Who is the manufacturer of Arterys Cardio DL?

Arterys, Inc. filed the 510(k) submission for Arterys Cardio DL (K163253).

What is the FDA product code for Arterys Cardio DL?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Arterys Cardio DL?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Arterys Cardio DL?

Arterys Software v2.0 (K162513); Medis Imaging QMass (K140587).

Who can help prepare an FDA 510(k) submission like Arterys Cardio DL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Arterys Cardio DL

K163253 · Arterys, Inc. · LLZ · Jan 5, 2017 · Radiology

Device Facts

Record ID	K163253
Device Name	Arterys Cardio DL
Applicant	Arterys, Inc.
Product Code	LLZ · Radiology
Decision Date	Jan 5, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device, Pediatric

Intended 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.

Device Story

Arterys Cardio DL is a web-accessible image post-processing software for cardiovascular MRI. It ingests DICOM-compliant cardiovascular images (multi-slice, multi-phase, velocity encoded) from 1.5T or 3.0T MR scanners. The device performs manual and semi-automatic border detection and segmentation to quantify cardiac function (stroke volume, ejection fraction, cardiac output, mass/volume) and blood flow (net/forward/reverse flow, regurgitation fraction, pressure gradient). Output includes 2D/3D visualizations (MIP, MinIP, MPR, cine) and quantitative statistics displayed in a web browser. Used by cardiologists, radiologists, or licensed practitioners in clinical settings to support decision-making. It acts as a resource tool; it does not provide medical advice or treatment recommendations. Data can be saved or exported to PACS.

Clinical Evidence

Bench testing only. The device underwent software verification and validation testing in accordance with IEC 62304:2006/AC:2008 and relevant FDA guidance documents for software and cybersecurity. No clinical study data was provided.

Technological Characteristics

Web-accessible software; client-server architecture; runs on Linux; supports DICOM 3.0; compatible with 1.5T and 3.0T MR scanners. Features include 2D/3D visualization (MIP, MinIP, MPR), manual and semi-automatic segmentation, and phase correction. Software lifecycle follows IEC 62304.

Indications for Use

Indicated for pediatric (neonate, infant, child, adolescent) and adult populations requiring analysis of cardiovascular MR images (multi-slice, multi-phase, velocity encoded) for blood flow and cardiac function quantification.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Arterys Software v2.0 (K162513)
Medis Imaging QMass (K140587)

Related Devices

K162513 — Arterys Software v2.0 · Arterys, Inc. · Oct 28, 2016
K090833 — SEGMENT · Medviso · May 12, 2009
K133937 — HEARTSCAN SOFTWARE · Morpheus Imaging, Inc. · Mar 3, 2014
K162376 — CAAS MR 4D Flow · Pie Medical Imaging BV · Dec 8, 2016
K211611 — QIR Suite · Casis Cardiac Simulation & Imaging Software · Sep 30, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them. 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) K163253 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 overall design is clean and minimalist. # 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 {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. 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) {6}------------------------------------------------ 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. {7}------------------------------------------------ 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.