Arterys Oncology DL

K173542 · Arterys, Inc. · LLZ · Jan 25, 2018 · Radiology

Device Facts

• Record ID: K173542
• Device Name: Arterys Oncology DL
• Applicant: Arterys, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended 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. 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.

Device Story

Arterys Oncology DL is a diagnostic software application for viewing, manipulating, and comparing CT and MR medical images. It supports 2D/3D visualization, MIP, and volume rendering. The device assists clinicians in oncological workflows by providing manual and semi-automatic volumetric segmentation of lung nodules and liver lesions, co-registration, longitudinal tracking, and lesion size quantification. It generates reports based on Lung-RADS and LI-RADS guidelines. The software is used by clinicians to confirm the presence or absence of lesions and assess morphological changes over time. It serves as a complement to standard clinical diagnostic procedures, with the clinician retaining final diagnostic responsibility.

Clinical Evidence

No clinical data. Safety and performance were established through non-clinical software verification and validation testing, including usability testing and specific validation of deep learning models for liver MR and lung MR, as well as lung longitudinal tracking.

Technological Characteristics

Software-based image processing application compliant with DICOM standards. Features include 2D/3D visualization, manual and semi-automatic volumetric segmentation, and co-registration. Developed in accordance with IEC 62304 (software lifecycle), ISO 14971 (risk management), and ISO 62366 (usability). Utilizes deep learning models for specific segmentation tasks.

Indications for Use

Indicated for use by clinicians to view, manipulate, and compare medical images (CT/MR) for oncological workflow support, including lesion confirmation, evaluation, quantification, follow-up, and documentation.

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

• syngo™ TrueD (K101749)

Reference Devices

• Arterys Cardio DL (K163253)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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) | |
|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# Section 5. 510(k) Summary

#### General Information 1.

| 510(k) Sponsor | Arterys Inc. |
|-----------------------|-----------------------------------------------------|
| Address | 51 Federal St. Suite 305<br>San Francisco, CA 94107 |
| Correspondence Person | John Axerio-Cilies<br>COO and Founder |
| Contact Information | Email: [e-mail]<br>Phone: [phone] |
| 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

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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/<br>Function | Proposed Device:<br>Arterys Oncology DL | Predicate Device<br>(Primary):<br>syngoTM TrueD<br>(K101749) | Reference<br>Device:<br>Arterys Cardio<br>DL<br>(K163253) |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------|
| Image input | Complies with<br>DICOM Standard | Complies with<br>DICOM & DICOM<br>RT Standards | |
| Type of scans | MR, CT | MR, CT, PET,<br>SPECT | |
| Feature/<br>Function | Proposed Device:<br>Arterys Oncology DL | Predicate Device<br>(Primary):<br>syngo™ TrueD<br>(K101749) | Reference<br>Device:<br>Arterys Cardio<br>DL<br>(K163253) |
| 2D and 3D Image<br>Review | Yes | Yes | |
| 2D and 3D<br>Comparative<br>Review | Yes | Yes | |
| Manual-<br>Volumetric<br>Segmentation | Yes | Yes | |
| Co-registration | Yes | Yes | |
| Longitudinal<br>Tracking | Yes, linked VOIs<br>between timepoints | Yes, linked VOIs<br>between timepoints | |
| Linear Dimension<br>Calculation for<br>Volumetric<br>Segmentation | Yes,<br>longest linear<br>dimension (mm) in<br>axial plane, and<br>orthogonal to longest<br>linear dimension | Yes, maximum<br>diameter (mm)<br>measurement | |
| Volume<br>Calculation | Yes | Yes | |
| Reporting | Yes, basic reporting<br>and<br>LI-RADS and Lung-<br>RADS observation<br>reporting based on<br>standard guidelines | Yes, basic reporting | |
| Semi-automated,<br>Volumetric<br>Segmentation | Yes, available only<br>for lung CT and liver<br>MR studies | | Yes, available for<br>ventricular<br>segmentation |

Table 5.1: Comparison Table

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## 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

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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.