(79 days)
Not Found
Yes
The document explicitly mentions "Cardio AI module" and "Oncology AI module" as optional components of the Arterys MICA software, indicating the incorporation of Artificial Intelligence technology.
No
The device is described as a medical diagnostic application and a support tool for trained healthcare professionals to aid in diagnosis, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Arterys® MICA software is a medical diagnostic application." It also mentions that the software is "intended to be used as a support tool by trained healthcare professionals to aid in diagnosis."
Yes
The device description explicitly states that Arterys MICA is a "dedicated software application" with client and server components running on standard computing platforms and web browsers. It processes pre-existing images and does not include any hardware components for image acquisition or patient interaction.
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 examine these samples outside of the body.
- Arterys MICA's Function: Arterys MICA processes and analyzes medical images (MR and CT) that are acquired from within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data." It's a tool for interpreting existing medical images, not for analyzing biological samples.
- Device Description: The description focuses on image processing and analysis of CT and MR images.
Therefore, Arterys MICA falls under the category of medical imaging software or a picture archiving and communication system (PACS) with advanced analysis capabilities, rather than an in vitro diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Arterys® MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data, with the exception of mammography. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers.
Arterys MICA includes an optional Cardio Al module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners.
Arterys MICA includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions.
Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. 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 MICA is a dedicated software application used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. Arterys MICA can also be used for analyzing multi-slice and multi-phase computed tomography (CT) or magnetic resonance (MR) image. Pre-existing CT or MR images are uploaded into Arterys MICA in a DICOM format from PACS or a scanner. The software has two components: i) client, and ii) server. The client software (i) can be used in a Chrome desktop web browser. The server software (ii) runs on the Linux operating system.
The basic image Viewer application of Arterys MICA is designed around a modular architecture of separate components that make up the basic image Viewer. These components include the Worklist, from which studies are selected and opened, the Uploads list that displays all uploaded studies for the current organization and the basic image Viewer itself, which allows for viewing and working with 2D and 3D images.
Functionality provided by the basic image Viewer is extended by additional Cardio Al and Oncology AI application modules and can add support for specific clinical workflows. The Cardio module adds support for flow-4D studies and provides additional functionality specific to cardiac studies. The Oncology module adds functionality specific to evaluating and measuring lesions, including lung and liver lesions/nodules.
NOTE: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of images. Arterys MICA software is a complement to these standard procedures.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
MR, CT
Anatomical Site
Heart and its major vessels, lesions (lung and liver)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professionals
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 MICA has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software verification activities were performed in accordance with IEC 62304:2006/AC: 2015- Medical device software - Software life cycle processes and ISO 14971:2007 Medical devices -- Application of risk management to medical devices, 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arterys Inc. Sharon Cholowsky Director of Regulatory and Compliance 51 Federal Street, Suite 305 SAN FRANCISCO. CA 94107
October 17, 2018
Re: K182034
Trade/Device Name: Arterys MICA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 22, 2018 Received: September 25, 2018
Dear Sharon Cholowsky:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. 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 MICA
Indications for Use (Describe)
Arterys® MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data, with the exception of mammography. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers.
Arterys MICA includes an optional Cardio Al module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners.
Arterys MICA includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions.
Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. 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 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image contains 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 uniform thickness and are arranged in a way that suggests movement or flow.
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 | Sharon Cholowsky |
| Contact Information | Email: regulatory@arterys.com |
| Phone: 403-923-9688 | |
| Date Prepared | July 26, 2018 |
Proposed Device
| Proprietary Name | Arterys® MICA |
|---|---|
| Common Name | MICA |
| Model Number | AMM5 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
Predicate Devices
| Primary Predicate Device | Arterys Viewer, K171544 |
|---|---|
| Secondary Predicate Device | Arterys Cardio DL, K163253 |
| Tertiary Predicate Device | Arterys Oncology DL, K173542 |
2. Device Description
Arterys MICA is a dedicated software application used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. Arterys MICA can also be used for analyzing multi-slice and multi-phase computed tomography (CT) or magnetic resonance (MR) image. Pre-existing CT or MR images are uploaded into Arterys MICA in a DICOM format from PACS or a scanner. The software has two components: i) client, and ii) server. The client software (i) can be used in a Chrome desktop web browser. The server software (ii) runs on the Linux operating system.
The basic image Viewer application of Arterys MICA is designed around a modular architecture of separate components that make up the basic image Viewer. These components include
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Image /page/4/Picture/0 description: The image shows the word "ARTERYS" with a stylized graphic to the left. The graphic consists of three curved lines that are parallel to each other. The text is in a simple, sans-serif font and is all uppercase. The overall impression is clean and modern.
the Worklist, from which studies are selected and opened, the Uploads list that displays all uploaded studies for the current organization and the basic image Viewer itself, which allows for viewing and working with 2D and 3D images.
Functionality provided by the basic image Viewer is extended by additional Cardio Al and Oncology AI application modules and can add support for specific clinical workflows. The Cardio module adds support for flow-4D studies and provides additional functionality specific to cardiac studies. The Oncology module adds functionality specific to evaluating and measuring lesions, including lung and liver lesions/nodules.
NOTE: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of images. Arterys MICA software is a complement to these standard procedures.
3. Indications for Use
Indications for Use Statement for Arterys MICA with optional Cardio and Oncology modules:
Arterys® MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data, with the exception of mammography. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers.
Arterys MICA includes an optional Cardio AI module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners.
Arterys MICA includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions.
Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. 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 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 Indications for Use Statement is a unification of the statements of the three previously cleared devices. The first and fourth paragraphs contain information about the base image Viewer as well as information that is applicable for all three areas of the product, while the second and third paragraphs contain information about the Cardio module and Oncology module, respectively. This unification is because of the similar architecture and device use of the three cleared products. The intended use is the same between the predicates and new products and there are no new diagnostic claims involved in the wording change.
4. Comparison of Technological Characteristics with the Predicate Device
The Arterys MICA software has the same technological characteristics as the predicate Arterys devices and has the same uses and applications as the predicate devices. There have been incremental minor updates to some of the software features for user experience improvements; these software changes do not impact safety or efficacy of the device. Both the device and predicates are used by the clinician as a support tool to aid in diagnosis of radiological images.
| Feature/
Function | Proposed Device
Arterys MICA | Primary
Predicate
Arterys Viewer
(K171544) | Secondary
Predicate
Arterys Cardio
DL (K163253) | Tertiary Predicate
Arterys Oncology
DL (K173542) |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------|
| Ability to load
different
optional modules
from same
worklist | Yes - all three modules
are in drop down menu | No - Cardio
module included
in Viewer | No - Module
included in
Viewer | No - Module loaded
separately |
| Operating
System | Client server architecture
using Linux server and
web browser client | Same | Same | Same |
| Image storage/
compression | Support JPEG2000 and
compression | Same | Same | Same |
| DICOM
compliant | Yes | Same | Same | Same |
| Type of scans/
Modality | Viewer: MR, CT
Cardio: MR
Onco: MR and CT | Same | Same | Same |
| Worklist with
filter and
searching | Yes. Added tags for
further identification. | Yes. | N/A | N/A |
| Image upload | Yes | Same | N/A | N/A |
| 2D, 3D, MIP,
MPR image
display | Yes | Same | Same | Same |
| Cine play | Yes | Same | Same | Same |
| Image navigation
tools | Pan, zoom, rotate,
maximize/minimize, slice
scroll (view multiple
slices), adjust
window/level, slab
thickness, time scroll
(view multiple phases) | Same | Same | Same |
| Image navigation
- Cardio | Yes. Flow direction and
2D speed color map | N/A | Same | N/A |
| Image layouts;
side-by-side
viewing | Yes. Added multi-study
and that images are now
commonly aligned. | Yes. | Yes. | Yes. |
| View DICOM
data | Patient, study,
orientation, and pixel
information | Same | Same | Same |
| Measuring tools | Yes - linear, area, and
volume for all three
modules. | Yes - linear and
area only. | Yes - linear and
area only. | Yes - linear, area,
and volume. |
| Semi-automated
segmentation of
region of interest | Yes. Cardio and
Oncology only. | No | Yes | Yes |
| Cardio -
identification of
landmarks | Yes - Automatically
identified + user editable | N/A | Yes - Manually
identified +
editable | N/A |
| Cardio
Visualization,
Quantification,
Volume in 4D
Flow | Yes. Added normalized
volume measurements
based on age and gender.
Added ability to edit the
valve plane to adjust
volume. | N/A | Yes | N/A |
| Cardio - 2D
Contour
inference | Yes - Automatically
identified + user editable.
Added ability to edit the
valve plane to adjust
volume. | N/A | Yes - Manually
identified +
editable | N/A |
| Cardio
Visualization,
Quantification,
Volume in 3D
Workflow for a
short axis stack | Yes. Added normalized
volume measurements
based on age and gender.
Added ability to edit the
valve plane to adjust
volume. | N/A | Same | N/A |
| Eddy current
correction | Yes. Added ability to
download data. | N/A | Same | N/A |
| Cardio
Reporting | Yes. Added minimal
content configurability. | N/A | Yes | N/A |
| Co-registration | Yes | N/A | N/A | Same |
| Onco
Longitudinal
tracking - linked
VOIs between
timepoints | Yes | N/A | N/A | Same |
| Onco Reporting - LI-RADS and
Lung-RADS | Yes | N/A | N/A | Same |
| Secondary
Capture | Yes | Same | Same | Same |
| Download report | Yes - to PACS and
computer | Yes - to PACS
only | N/A | N/A |
Table 5.1: Technological characteristics of the proposed device and predicate devices
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Image /page/6/Picture/0 description: The image contains 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/7/Picture/0 description: The image shows the logo for Arterys. The logo consists of a stylized wave-like graphic on the left, followed by the word "ARTERYS" in a simple, sans-serif font. The logo is in black and white.
ડ. Performance Data
Safety and performance of Arterys MICA has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software verification activities were performed in accordance with IEC 62304:2006/AC: 2015- Medical device software - Software life cycle processes and ISO 14971:2007 Medical devices -- Application of risk management to medical devices, 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."
6. Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, Arterys MICA raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.