AI Segmentation

K203469 · Varian Medical Systems, Inc. · MUJ · Apr 19, 2021 · Radiology

Device Facts

• Record ID: K203469
• Device Name: AI Segmentation
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Apr 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

AI Segmentation uses CT images to segment patient anatomy for use in radiation therapy treatment planning. AI Segmentation utilizes a pre-defined set of organ structures in the following regions: head and neck, thorax, pelvis, abdomen. Segmentation results are subject to review and editing by qualified, expert radiation therapy treatment planners. Results of AI Segmentation are utilized in the Eclipse Treatment Planning System where it is the responsibility of a qualified physician to further review, edit as needed, and approve each structure.

Device Story

AI Segmentation is a cloud-based software application for automated organ-at-risk (OAR) contouring in radiation therapy. Input: CT images. Processing: Combined deep learning and classical algorithms generate anatomical segmentations. Output: Contoured structures for visualization and export to Eclipse Treatment Planning System. Usage: Clinical setting; operated by trained medical professionals (treatment planners/physicians). Workflow: User uploads CT data to cloud; system performs automated segmentation; user reviews and selects results for export to treatment planning system. Clinical impact: Assists in contouring efficiency; does not provide clinical decisions or medical advice. Benefit: Streamlines treatment planning preparation; ensures physician oversight via mandatory review/editing of all structures.

Clinical Evidence

No clinical data or animal studies were included. Substantial equivalence is supported by non-clinical software verification and validation testing, demonstrating conformance to functional, usability, and safety requirements.

Technological Characteristics

Web-based, cloud-hosted software. Combines deep learning and classical-based segmentation algorithms. Compatible with Eclipse Treatment Planning System. Conforms to IEC 62304 (software life cycle), IEC 62366-1 (usability), IEC 62083 (radiotherapy safety), and IEC 82304-1 (health software safety). Software level of concern: Major.

Indications for Use

Indicated for use by qualified radiation therapy treatment planners and physicians to segment patient anatomy on CT images for radiation therapy treatment planning in the head and neck, thorax, pelvis, and abdomen regions.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Smart Segmentation Knowledge Based Contouring v2.2 (K141248)

Reference Devices

• Ethos Treatment Planning v1.0 (K192377)

Submission Summary (Full Text)

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Varian Medical Systems Inc. % Mr. Peter Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304

April 19, 2021

### Re: K203469

Trade/Device Name: AI Segmentation Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: March 18, 2021 Received: March 19, 2021

Dear Mr. Coronado:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K203469

Device Name AI Segmentation

#### Indications for Use (Describe)

AI Segmentation uses CT images to segment patient anatomy for use in radiation therapy treatment planning. AI Segmentation utilizes a pre-defined set of organ structures in the following regions: head and neck, thorax, pelvis, abdomen. Segmentation results are subject to review and editing by qualified, expert radiation therapy treatment planners. Results of AI Segmentation are utilized in the Eclipse Treatment Planning System where it is the responsibility of a qualified physician to further review, edit as needed, and approve each structure.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## varian

Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304

# 510(K) SUMMARY

The following information is provided as required by 21 CFR 807.92.

| SUBMITTER | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name and Address: | Varian Medical Systems<br>3100 Hansen Way, m/s E110<br>Palo Alto, CA 94304 |
| Contact Person: | Peter J. Coronado<br>Sr. Director, Regulatory Affairs<br>Phone: [phone] Fax: [phone]<br>[e-mail] |
| Date Prepared: | 18 March 2021 |
| DEVICE | |
| Subject Device Name:<br>Common/Usual Name:<br>Product Code and Classification: | Al Segmentation<br>medical image segmentation software<br>Medical charged-particle radiation therapy system<br>MUJ 21 CFR 892.5050 Class II |
| PREDICATE DEVICE | |
| Predicate Device Name:<br>Reference Device: | Smart Segmentation Knowledge Based Contouring v2.2 (K141248)<br>Ethos Treatment Planning v1.0 (K192377)<br>Note: Referenced for the use of existing, established methods to<br>evaluate performance of Al-based algorithms and technology |

#### DEVICE DESCRIPTION

Al segmentation is a web-based application, running in the cloud, that provides a combined deep learning and classical-based approach for automated segmentation of organs at risk, along with tools for structure visualization. This software medical device product is used by trained medical professionals and consists of a web application user interface where the results from the automated segmentation can be reviewed and selected for export into the compatible treatment planning system. Al Segmentation is not intended to provide clinical decisions, medical advice, or evaluations of radiation plans or treatment procedures.

#### INDICATIONS FOR USE

Al Segmentation uses CT images to segment patient anatomy for use in radiation therapy treatment planning. Al Segmentation utilizes a pre-defined set of organ structures in the following regions: head and neck, thorax, pelvis, abdomen. Segmentation results are subject to review and editing by qualified, expert radiation therapy

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treatment planners. Results of Al Segmentation are utilized in the Eclipse Treatment Planning System where it is the responsibility of a qualified physician to further review, edit as needed, and approve each structure.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The new device, referred to as the "subject device" throughout this summary, is release version v1.0 (version 1.0) of Al Segmentation. The subject device has some technological and functional similarity and differences with the predicate device, Smart Segmentation Knowledge Based Contouring version v2.2 (K141248),

#### At a high level, both the predicate device and the subject device are based on the same characteristics:

- Both devices are software-only medical devices. .
- 9 Both devices are intended for use by medical professionals within the context of supporting radiotherapy treatment planning.
- . Both devices contain automated segmentation algorithms used to process radiological images in order to generate contouring of structures for a variety of anatomical sites.
- . Both devices include review interfaces and tools for users to independently assess the output.
- . Both devices are compatible with the Eclipse Treatment Planning System, which is Varian's radiotherapy treatment planning software.

#### The significant differences in the subject device compared with the predicate device are:

- 1. Use of Al-based algorithms for automated segmentation and contouring
- Note: These algorithms are static and non-adaptive; they do not alter their behavior over time a. based on user input.
- 2. Cloud deployment and hosting of software components and algorithms
- 3. Absence of manual editing or contouring tools

#### PERFORMANCE DATA

The following performance data was provided in support of the substantial equivalence determination.

#### Software Verification and Validation Testing

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.

Test results demonstrate conformance to applicable requirements and specifications. No animal studies or clinical tests have been included in this pre-market submission.

#### Standards Conformance

The subject device conforms in whole or in part with the following standards that address software development, safety, and usability:

- . IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes

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- . IEC 62366-1 Edition 1.0 2015-02 Application of usability engineering to medical devices
- . IEC 62083 Edition 2.0 2009-09 Requirements for the safety of radiotherapy treatment planning systems
- IEC 82304-1 Edition 1.0 2016-10 Health software Part 1: General requirements for product safety .

#### Argument for substantial equivalence to the predicate device

A subset of software features and characteristics of the subject device are different from the predicate device. However, Varian considers these differences to be enhancements of the predicate, while the principle of operation of the subject device is the same as that of the existing predicate device. Verification and validation testing demonstrate that the subject device performs its intended use as designed through the product's functional, usability, and safety requirements. Varian therefore believes that the subject device is substantially equivalent to the predicate device.

#### CONCLUSION

The predicate device was cleared based only on non-clinical testing, and no animal or clinical studies were performed for the subject device. The non-clinical data supports the safety of the device, and verification and validation testing demonstrate that the subject device should perform as intended in the specified use conditions. There were no remaining discrepancy reports (DRs) which could be classified as Safety or Customer Intolerable.

Therefore, Varian considers AI Segmentation to be substantially equivalent to the predicate device, Smart Segmentation Knowledge Based Contouring (K141248).