(70 days)
Yes
The summary explicitly mentions "Deep Learning Model" in the context of testing and refers to "Semi-automatic volumetric segmentation" which is often implemented using ML techniques.
No.
The device is a diagnostic application for viewing, manipulating, and comparing medical images, and provides analytical tools to assess and document changes, which supports diagnosis rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "medical diagnostic application" and that it "supports the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions." This functionality clearly indicates a diagnostic purpose.
Yes
The device description explicitly states it is "Arterys Oncology DL which is intended for viewing, manipulation, 3D-visualization and comparison of medical images". It describes software features and functionalities related to image processing and analysis, without mentioning any accompanying hardware components that are part of the regulated device itself. While it processes images from hardware modalities (CT, MR), the device being cleared is the software application.
Based on the provided information, Arterys Oncology DL is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is typically used for diagnosis, monitoring, or screening.
- Arterys Oncology DL's Function: Arterys Oncology DL works with medical images (CT and MR) of anatomical sites (lung and liver). It processes and analyzes these images to help clinicians visualize, quantify, and track lesions. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "viewing, manipulation and comparison of medical images." While it aids in diagnosis and follow-up, it does so by processing images, not biological samples.
- Device Description: The device description reinforces its function as image processing and analysis software.
Therefore, Arterys Oncology DL falls under the category of medical image analysis software, which is distinct from In Vitro Diagnostics.
No
The provided text does not contain any explicit statement 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 Oncology DL is a medical diagnostic application for viewing, manipulation and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
Arterys Oncology DL enables visualization of information that would otherwise have to be visually compared disjointedly. Arterys Oncology DL provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations.
Arterys Oncology DL is designed to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Arterys Oncology DL is a complement to these standard procedures.
Product codes
LLZ
Device Description
This traditional 510(k) is being submitted for Arterys Oncology DL which is intended for viewing, manipulation, 3D-visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering. The software supports the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, follow-up and documentation of any such lesions.
Key features of the software are:
- 2D and 3D visualization and comparative review
- . Manual volumetric segmentation
- Semi-automatic volumetric segmentation of lung nodules and liver lesions
- Co-registration
- Longitudinal tracking
- Nodule/lesion size quantifications
- Data reporting based on Lung-RADS and LI-RADS guidelines
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR
Anatomical Site
lung, liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician / Not Found
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
The safety and performance of Arterys Oncology DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Non-clinical verification and validation test results established that the device meets its design requirements and intended use, that it is as safe and as effective as the predicate devices, and that no new issues of safety and effectiveness were raised. Arterys non-clinical V&V testing included Testing for Liver MR Deep Learning Model, Lung MR Deep Learning Model, Lung Longitudinal Tracking and usability. The Verification, validation and usability testing data demonstrate that the device meets all its specifications.
Further, during the development, potential hazards were controlled by a risk management plan including risk analysis, risk mitigation, verification and risk-benefit analysis. Additionally, the software verification and validation activities were performed in accordance with the following standards, in addition to the FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices":
- Digital Imaging and Communications in Medicine (DICOM); PS 3.1 3.20 (2011) .
- . Medical device software - Software life cycle process, IEC 62304: First edition 2006-05. 2015
- . Medical devices - Application of risk management to medical devices, ISO 14971; Second edition 2007-03-01, 2012
- . Medical Devices - Application of usability engineering to medical devices, ISO 62366: 2007/(R) 2013
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
January 25, 2018
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Arterys Inc. % Mr. John Axerio-Cilies Chief Operating Officer and Founder 51 Federal Street, Suite 305 SAN FRANCISCO CA 94107
Re: K173542
Trade/Device Name: Arterys Oncology DL Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 15, 2017 Received: November 16, 2017
Dear Mr. Axerio-Cilies:
We have reviewed vour 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 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
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.
For comprehensive regulatory information about mediation-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 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)
K173542
Device Name Arterys Oncology DL
Indications for Use (Describe)
Arterys Oncology DL is a medical diagnostic application for viewing, manipulation and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
Arterys Oncology DL enables visualization of information that would otherwise have to be visually compared disjointedly. Artervs Oncology DL provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations.
Arterys Oncology DL is designed to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Arterys Oncology DL is a complement to these standard procedures.
| 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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Section 5. 510(k) Summary
General Information 1.
| 510(k) Sponsor | Arterys Inc. |
|---|---|
| Address | 51 Federal St. Suite 305 |
| San Francisco, CA 94107 | |
| Correspondence Person | John Axerio-Cilies |
| COO and Founder | |
| Contact Information | Email: quality@arterys.com |
| Phone: 650-391-7111 | |
| Date Prepared | Nov. 15, 2017 |
2. Proposed Device
| Proprietary Name | Arterys Oncology DL |
|---|---|
| Common Name | Oncology |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
3. Predicate Device
| Proprietary Name | syngo™ TrueD |
|---|---|
| Premarket Notification | K101749 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
Reference Device 4.
| Proprietary Name | Arterys Cardio DL |
|---|---|
| Premarket Notification | K163253 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
Device Description 5.
This traditional 510(k) is being submitted for Arterys Oncology DL which is intended for viewing, manipulation, 3D-visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering. The software supports the oncological workflow by helping the user to
4
confirm the absence or presence of lesions, including evaluation, follow-up and documentation of any such lesions.
Key features of the software are:
- 2D and 3D visualization and comparative review
- . Manual volumetric segmentation
- Semi-automatic volumetric segmentation of lung nodules and liver lesions
- Co-registration
- Longitudinal tracking
- Nodule/lesion size quantifications
- Data reporting based on Lung-RADS and LI-RADS guidelines
6. Indications for Use
Arterys Oncology DL is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
Arterys Oncology DL enables visualization of information that would otherwise have to be visually compared disjointedly. Arterys Oncology DL provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations.
Arterys Oncology DL is designed to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Arterys Oncology DL is a complement to these standard procedures.
7. Comparison of Technological Characteristics with the Predicate Device
| Feature/
Function | Proposed Device:
Arterys Oncology DL | Predicate Device
(Primary):
syngoTM TrueD
(K101749) | Reference
Device:
Arterys Cardio
DL
(K163253) |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------|
| Image input | Complies with
DICOM Standard | Complies with
DICOM & DICOM
RT Standards | |
| Type of scans | MR, CT | MR, CT, PET,
SPECT | |
| Feature/
Function | Proposed Device:
Arterys Oncology DL | Predicate Device
(Primary):
syngo™ TrueD
(K101749) | Reference
Device:
Arterys Cardio
DL
(K163253) |
| 2D and 3D Image
Review | Yes | Yes | |
| 2D and 3D
Comparative
Review | Yes | Yes | |
| Manual-
Volumetric
Segmentation | Yes | Yes | |
| Co-registration | Yes | Yes | |
| Longitudinal
Tracking | Yes, linked VOIs
between timepoints | Yes, linked VOIs
between timepoints | |
| Linear Dimension
Calculation for
Volumetric
Segmentation | Yes,
longest linear
dimension (mm) in
axial plane, and
orthogonal to longest
linear dimension | Yes, maximum
diameter (mm)
measurement | |
| Volume
Calculation | Yes | Yes | |
| Reporting | Yes, basic reporting
and
LI-RADS and Lung-
RADS observation
reporting based on
standard guidelines | Yes, basic reporting | |
| Semi-automated,
Volumetric
Segmentation | Yes, available only
for lung CT and liver
MR studies | | Yes, available for
ventricular
segmentation |
Table 5.1: Comparison Table
5
8. Performance Data
The safety and performance of Arterys Oncology DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Non-clinical verification and validation test results established that the device meets its design requirements and intended use, that it is as safe and
6
as effective as the predicate devices, and that no new issues of safety and effectiveness were raised. Arterys non-clinical V&V testing included Testing for Liver MR Deep Learning Model, Lung MR Deep Learning Model, Lung Longitudinal Tracking and usability. The Verification, validation and usability testing data demonstrate that the device meets all its specifications.
Further, during the development, potential hazards were controlled by a risk management plan including risk analysis, risk mitigation, verification and risk-benefit analysis. Additionally, the software verification and validation activities were performed in accordance with the following standards, in addition to the FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices":
- Digital Imaging and Communications in Medicine (DICOM); PS 3.1 3.20 (2011) .
- . Medical device software - Software life cycle process, IEC 62304: First edition 2006-05. 2015
- . Medical devices - Application of risk management to medical devices, ISO 14971; Second edition 2007-03-01, 2012
- . Medical Devices - Application of usability engineering to medical devices, ISO 62366: 2007/(R) 2013
9. Conclusion
Based on the information submitted in this premarket notification and on the indications for use, technological characteristics, and performance testing, Arterys Oncology DL raises no new questions of safety or effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy, and performance.