4D Integrated Treatment Console

K203766 · Varian Medical Systems, Inc. · MUJ · Feb 12, 2021 · Radiology

Device Facts

• Record ID: K203766
• Device Name: 4D Integrated Treatment Console
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Feb 12, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The 4D Integrated Treatment Console provides assistance for accurate treatment delivery for each patient by monitoring linear accelerator parameters and by preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

Device Story

4D Integrated Treatment Console (4DITC) retrieves treatment plans/images from Oncology Information System (OIS) and transmits them to Treatment Console System (TCS); verifies planned parameters against delivery parameters; prevents irradiation if parameters mismatch; records treatment history to OIS post-session. Used in clinical radiation therapy settings by trained personnel. Enhances patient safety by ensuring treatment delivery strictly adheres to prescribed plans; prevents accidental use of QA/verification plans in clinical mode.

Clinical Evidence

No clinical or animal studies were performed. Substantial equivalence is supported by non-clinical software verification and validation testing conducted in accordance with FDA guidance for major level of concern software.

Technological Characteristics

Software-based record and verify system. Operates on Microsoft Windows Embedded Standard 7. Hardware includes IGMA 8110D workstation. Conforms to IEC 62304 (software lifecycle), IEC 62366-1 (usability), IEC 61217 (coordinates/movements), and IEC 62274 (safety of record and verify systems). Cybersecurity controls include application whitelisting (Applocker) and USB mass storage hardening.

Indications for Use

Indicated for patients undergoing radiation therapy, assisting in accurate treatment delivery by monitoring linear accelerator parameters and preventing irradiation if parameters deviate from the treatment plan.

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

• 4D Integrated Treatment Console v13.0 (K133331)

Submission Summary (Full Text)

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February 12, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Varian Medical Systems, Inc. % Mr. Peter J. Coronado Senior Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

### Re: K203766

Trade/Device Name: 4D Integrated Treatment Console v13.0 MR4 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: December 22, 2020 Received: December 23, 2020

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/cfpmp/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 and Part 809); 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

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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 medical devices and radiation-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) K203766

Device Name 4D Integrated Treatment Console v13.0 MR4

#### Indications for Use (Describe)

The 4D Integrated Treatment Console provides assistance for accurate treatment delivery for each patient by monitoring linear accelerator parameters and by preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

| 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) |

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Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038 Telephone: [phone] Toll Free: 800.544.4636 www.varian.com

# 510(k) Summary

| The following information is provided as required by 21 CFR 807.92 | | K203766 |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------|
| SUBMITTER | | |
| Name and Address: | Varian Medical Systems, Inc.<br>3100 Hansen Way, m/s E110<br>Palo Alto, CA 94304 | |
| Contact Person: | Peter J. Coronado<br>Senior Director of Regulatory Affairs<br>Phone: [phone] Fax: [phone]<br>[e-mail] | |
| Date Prepared: | December 22, 2020 | |
| DEVICE | | |
| Subject Device Name: | 4D Integrated Treatment Console v13.0 MR4 | |
| Common/Usual Name: | 4D Integrated Treatment Console | |
| Product Code and Classification: | Medical charged-particle radiation therapy system<br>MUJ 21 CFR 892.5050 Class II | |
| PREDICATE DEVICE | | |
| Predicate Device Name:<br>Reference Device(s): | 4D Integrated Treatment Console v13.0 (K133331)<br>No reference devices were used in this submission | |

### DEVICE DESCRIPTION

4D Integrated Treatment Console (4DITC) allows the user to retrieve treatment plans and images from the Oncology Information System (OIS) and send the plan and images to the Treatment Console System (TCS). The planned treatment parameters from the OIS are verified against the TCS delivery parameters for accuracy. All treatment parameters on the TCS must match the treatment parameters on the 4DITC before treatment can be delivered. After the treatment has been completed for the session, the user closes the session and treatment history is sent to the OIS to be recorded. The recorded treatment history can then be displayed and reviewed in the Oll.

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Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038 Telephone: [phone] Toll Free: 800.544.4636 www.varian.com

#### INDICATIONS FOR USE

The 4D Integrated Treatment Console provides assistance for accurate treatment delivery for each patient by monitoring linear accelerator parameters and by preventing therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The modified device, referred to as the "subject device" throughout this summary, is release version v13.0 MR4 (Version 13.0 Minor Release 4) of the 4D Integrated Treatment Console with additional software changes incorporated since the release version of the predicate device, v13.0 (version 13.0; K133331).

### The Changes in the subject device compared with the predicate device are as follows:

- Risk control measure of accidentally treating with a Quality Assurance (QA) / verification . plan changed from a warning message to blocking the use of QA / verification plans for treatment in clinical mode
- Shared Framework Integration ●
- Microsoft Windows Embedded Standard (WES) 7 Support ●
- IGMA 8913 workstation updated to IGMA 8110D ●
- Cybersecurity Enhancements ●
- WES7 Knowledge Base (KB) updates O
- o Application whitelisting (Applocker)
- USB mass storage hardening O
- MICAP firmware upgrade o
- Minor enhancements and bug fixes ●

### PERFORMANCE DATA

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

### Software Verification and Validation Testing

Software verification and validation were 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.

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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:

- IEC 62304:2006+A1:2015 Medical device software - Software lifecycle processes
- IEC 62366-1:2015 Medical device – Part 1: Application of usability engineering to medical devices
- IEC 61217:2011 Radiotherapy Equipment Coordinates, Movements and Scales .
- IEC 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems

# 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 verification and validation data demonstrates that the subject device should perform as intended in the specified use conditions.

Therefore, Varian considers the subject device, 4D Integrated Treatment Console v13.0 MR4, is substantially equivalent to the predicate device 4D Integrated Treatment Console v13.0 (K133331).