MRIdian Linac System

K181989 · Viewray, Incorporated · IYE · Feb 20, 2019 · Radiology

Device Facts

• Record ID: K181989
• Device Name: MRIdian Linac System
• Applicant: Viewray, Incorporated
• Product Code: IYE · Radiology
• Decision Date: Feb 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Device Story

MRIdian Linac System integrates 6 MV linear accelerator radiation therapy with 0.35T magnetic resonance imaging (MRI) for real-time image-guided radiotherapy. System inputs include MR imaging data (T1, T2, Diffusion-Weighted, and True Fast Imaging sequences) used for treatment planning, patient positioning, and target tracking. Device transforms inputs via a Treatment Delivery Computer Unit (TDCU) to reconstruct and display cine images at >8 frames per second. Output is visualized by clinicians to align, adapt, and track soft tissue targets during radiation delivery. Used in clinical settings by radiation oncology staff. Benefits include improved imaging speed, resolution, and contrast for precise radiation delivery to lesions/tumors while sparing surrounding healthy tissue.

Clinical Evidence

Bench testing only. No clinical data presented. Verification testing confirmed system performance, imaging speed, and resolution improvements met design requirements. Software verification, electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) testing demonstrated compliance with safety standards.

Technological Characteristics

Image-Guided Radiation Therapy (IGRT) system; 6 MV linear accelerator; 0.35T superconducting magnet; 138-leaf Multi-leaf Collimator (MLC). Connectivity: Networked for treatment planning/delivery. Software: Major level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 60601-2-1, IEC 62304, ISO 10993-1.

Indications for Use

Indicated for patients requiring stereotactic radiosurgery or precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

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

• MRIdian Linac System (K170751)

Reference Devices

• MRIdian Linac System (K162393)
• MRIdian Linac System (K102915)

Submission Summary (Full Text)

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February 20, 2019

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.

ViewRay, Incorporated % Sean Delaney Sr. Director, Regulatory Affairs and Quality Assurance 815 E. Middlefield Road MOUNTAIN VIEW CA 94043

Re: K181989

Trade/Device Name: MRIdian Linac System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, LNH Dated: January 22, 2019 Received: January 24, 2019

Dear Sean Delaney:

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara

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) K181989

Device Name MRIdian Linac System

Indications for Use (Describe)

The MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, turnors, and conditions anywhere radiation treatment is indicated.

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

| <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------|
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/0 description: The image is a logo for ViewRay. The logo consists of a green sphere with white lines running through it on the left side. To the right of the sphere is the word "VIEWRAY" in black, bold letters. Below the word "VIEWRAY" is the phrase "Visibly Different" in a smaller, lighter font.

### Section 6: 510(k) Summary

The information below is provided for the modified MRIdian Linac system, following the format of 21 CFR 807.92.

#### Address and Contact Information: 1.

ViewRay Incorporated

815 East Middlefield Road

Mountain View, California, 94043

Contact Name: Sean A. Delaney

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Date Summary was prepared: July 13, 2017

Name of Device: MRIdian Linac System 2.

Trade/Proprietary Name: MRIdian Linac System

### Common or Usual Name:

Accelerator, Linear, Medical;

System, Nuclear Magnetic Resonance Imaging

## Regulation description/number:

21 CFR 892.5050

- Device: Accelerator, Linear, Medical ●
- Regulation Description: Medical charged-particle radiation therapy system .

21 CFR 892.1000

- Device: System, Nuclear Magnetic Resonance Imaging ●
- Requlation Description: Magnetic resonance diagnostic device .

Product Codes: IYE; LNH. Class II.

Device classification name: Accelerator, Linear, Medical; System, Nuclear Magnetic Resonance Imaging

#### 3. Substantial Equivalence

Predicate device: MRIdian Linac System - K170751

Reference device: MRIdian Linac System - K162393

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#### Description of the Device 4.

The MRIdian Linac system (K162393; K170751) delivers ionizing radiation using a magnetic resonance imaging system (MRIS) unit for image guidance. This submission describes an optional change only to the treatment planning and delivery imaging workflows of the predicate MRIdian Linac system.

ViewRay developed the following additional imaging modalities for use during MRIdian Linac system treatment planning and delivery workflows:

- 1. Introduction of a Treatment Delivery Computer Unit (TDCU) to increase treatment imaging reconstruction and display speed in excess of eight frames per second along with improved cine image resolution used for target tracking.
- 2. The predicate MRIdian Linac system supports the import of MR images obtained from a separate imaging system for use in treatment planning. In addition to importing additional MR images, the proposed MRIdian Linac system is also able to generate the following additional MR sequences for use during planning, positioning, and treatment delivery workflows:
- a. Turbo Spin Echo (TSE) pulse sequence family including Half Fourier Acquisition Single Shot Turbo Spin Echo (HASTE) and Diffusion Prepared Turbo Spin Echo (DP-TSE) which enables the following contrast protocols:
- i. T1-weighted (spin-lattice; magnetization in the same direction as the static magnetic field);
- ii. T2-weighted (spin-spin; magnetization transverse to the static magnetic field); and
- iii. Diffusion-Weighted Imaging (DWI) with ability to generate Apparent Diffusion Coefficient (ADC) maps to overlay and register to other images.
- b. True Fast Imaging (TRUFI) pulse sequence with radial sampling enabling higher speed imaging during treatment delivery.

The currently marketed MRIdian Linac system integrates radiation therapy with simultaneous magnetic resonance imaging of soft tissues to provide optimal alignment, adaptation, and tracking. These proposed changes to the existing system described in this section aim to improve MR imaging speed and quality and provide additional image contrast modalities.

#### Intended Use Statement 5.

The MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

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Image /page/5/Picture/0 description: The image is a logo for ViewRay. The logo consists of a green sphere with white lines running across it, and the text "VIEWRAY" in black, bold letters. Below the text is a thin gray line, and below that is the text "Visibly Different" in a smaller, gray font. The logo is clean and modern, and the colors are bright and eye-catching.

#### Indication for Use Statement 6.

The MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

#### Substantial Equivalence 7.

ViewRay has demonstrated that the proposed MRIdian Linac system performs in a substantially equivalent manner to the predicate system (K162393; K170751).

#### Technological Characteristics 8.

The cleared MRIdian Linac system (K162393; K170751) is an Image-Guided Radiation Therapy System (IGRT) that uses a 6 MV linear accelerator radiotherapy system to deliver ionizing radiation while using a magnetic resonance imaging system (MRIS) unit for image guidance in real-time. The MRIdian Linac system has equivalent functionality when employing the proposed imaging modalities described in this submission.

Like the current MRIdian Linac system (K162393; K170751) the proposed system consists of three primary subsystems:

- 1. The Treatment Planning and Delivery System (TPDS, initially cleared under K102915) modified only to support the new user interface changes during use of the new MR sequences during treatment planning and delivery workflows and support treatment image reconstruction on updated Treatment Delivery Computer Unit (TDCU) computer hardware as a replacement for the 'Services' computer in the predicate device;
- 2. The Magnetic Resonance Imaging System (MRIS) which has been updated to include additional imaging pulse sequences; and
- 3. The Radiation Therapy Delivery System (RDS) modified only to condense the equipment room footprint by combining the pulse modulator, power distribution unit, and the linac control cabinet into one pulse modulator cabinet and to support the software interfaces changes described in this submission.

In both systems these three subsystems are designed to operate concurrently for accurate targeted administration of radiation therapy.

The MRIdian Linac system with the changes proposed in this section is otherwise unchanged and functions as designed in the original predicate system so that the imaging and radiotherapy fields of view coincide permitting imaging of the patient at the radiotherapy isocenter before and during treatment.

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Image /page/6/Picture/0 description: The image shows the ViewRay logo. The logo consists of a green sphere with white lines on the left and the text "VIE WRAY" on the right. Below the text is a horizontal line and the text "Visibly Different".

### The Treatment Planning and Delivery System (TPDS initial clearance K102915)

The Treatment Planning and Delivery System software (TPDS) is capable of assisting the clinician in creating treatment delivery and QA plans for the MRIdian Linac system. The TPDS includes clinician tasks for reviewing, prescribing, tracking, and correcting the course of patient treatment. The software system has two major roles: radiotherapy treatment planning, and radiotherapy treatment delivery.

ViewRay modified the TPDS user interface to support treatment planning and delivery workflows when using the new MR sequences and support treatment image reconstruction on updated the Treatment Delivery Computer Unit (TDCU) computer hardware. The TDCU replaces the Services computer used by the predicate MRIdian Linac system in order to gain efficiencies when reconstructing MR images. There have been no changes to the Monte Carlo dose calculation alqorithm. TPDS is otherwise unchanged from the predicate device (K162393; K170751) other than changes described in Section 12.

# Magnetic Resonance Imaging System (MRIS)

The Maqnetic Resonance Imaging System (MRIS) unit incorporates an original equipment manufacturer (OEM) version of the Siemens MAGNETOM Avanto system combined with a 0.35T superconducting magnet, gradient coil, and radio frequency (RF) coil system, redesigned to be compatible with radiation therapy delivery. The MRIS system hardware remains unchanged from the current MRIdian Linac system (K162393; K170751).

The MRIS subsystem software has been updated to include additional imaging sequences described in Section 12. The MRIS software is otherwise unchanged from the predicate device (K162393; K170751).

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Image /page/7/Picture/0 description: The image is a logo for ViewRay. The logo consists of a green circle with white lines inside, and the word "VIEWRAY" in black, bold letters. Below the word "VIEWRAY" is a thin gray line, and below that is the phrase "Visibly Different" in a smaller, lighter font. The logo is clean and modern, and the colors are eye-catching.

# The Radiation Therapy Delivery System (RDS)

The Radiation Therapy Delivery System (RDS) of both the predicate MRIdian Linac system (K162393; K170751) and the proposed system described in this Section consist of a linear accelerator unit mounted on a ring gantry. By design, the radiation isocenter is in the middle of the imaqing field of view, permitting imaging at the radiotherapy isocenter before and during therapy. The RDS of both systems include:

- Linear Accelerator;
- . Gantry and Base Subsystem;
- 138-leaf Multi-leaf Collimator (MLC) (K170751); •
- Patient Handling System;
- Rotating Shim Gantry;
- Radiation Therapy Control System (RTCS) and Console;
- Magnetic and RF shielding sleeve technologies;
- Linac Control Cabinet; and
- . RF components required for linac functionality.

### Equipment Room Update

ViewRay developed a revised design of the Pulse Modulator to reduce the physical footprint within the system equipment room by combining the pulse modulator, the Power Distribution Unit (PDU), and Linac Control Cabinet (LCC) into one cabinet. This change does not alter the performance of the system. Refer to Section 12 for details of this change.

The RDS is otherwise unchanged from the predicate device (K162393; K170751) except for modifications necessary to support software changes associated with the new options described in this section.

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Image /page/8/Picture/0 description: The image shows the ViewRay logo. The logo consists of a green sphere with white lines on the left and the word "VIEWRAY" in black on the right. Below the word "VIEWRAY" is a horizontal line, and below the line is the phrase "Visibly Different" in a smaller font.

The proposed MRIdian Linac system functions in a substantially equivalent manner to the predicate device when employing the new MR imaging modalities described in this submission. Table 6-1 presents a comparison of specifications for the predicate and proposed MRIdian Linac systems.

### Table 6-1: Predicate Device Comparison Chart

| Attribute | Cleared Device<br>(K162393; K170751) | Device with Changes |
|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Imaging Settings | 1. PLAN—imaging for planning or<br>virtual simulation<br>2. POSITION—imaging for patient<br>positioning<br>3. TREAT—imaging for target<br>position monitoring | Same |
| MR Physical<br>Characteristics:<br>Bore Diameter | 700 mm | Same |
| Spherical Volume<br>(DSV) | 500 mm | |
| MRI Frequency | 14.7 MHz | |
| Field Strength | 0.345 T | |
| Field of View | 500 mm | Same |
| Field<br>Homogeneity | < 25 ppm measured over 450 mm<br>DSV | |
| Field Stability | ≤ 0.1 ppm/hr | |
| 3D Imaging<br>Volumes in cm | RL x AP x HF<br>Min 20 x 27 x 29<br>Max 54 x 48 x 54 | |
| 3D Imaging<br>Resolution in cm | Min 0.075 x 0.075 x 0.15<br>Max 0.3 x 0.3 x 0.3 | |
| 2D Imaging<br>Planes in cm | AP x HF<br>Min. 27 x 27<br>Max 45 x 35<br>0.35 x 0.35 | |
| 2D Imaging<br>Resolution in cm | 5,7, or 10 | Same |
| Geometric<br>Accuracy | 2 mm over 35 cm FOV<br>1 mm over 20 cm FOV | |
| Signal to Noise | 30 | |
| Temporal<br>Integrity | 0.01s or better | |
| Imaging Dose | | |
| Imaging Pulse<br>Sequences:<br>• T1 weighted<br>• T2 weighted<br>• Diffusion<br>Weighted<br>Imaging<br>(DWI) | Can be imported from an<br>alternative imaging device. | Can be acquired by the proposed<br>MRIdian Linac system or imported<br>from an alternative imaging device. |
| Imaging During<br>Radiation<br>Therapy Delivery | The MRI system supports the<br>acquisition of a single plane (axial,<br>sagittal, or coronal) in 4 frames per<br>second and up to three planes in 2<br>frames per second with an in-plane<br>resolution of 2.5 x 2.5 mm or less | The MRI system supports the<br>acquisition of a single plane (axial,<br>sagittal, or coronal) in 8 frames per<br>second and up to three planes in 2<br>frames per second with an in-plane<br>resolution of 2.5 x 2.5 mm or less |
| Localization/<br>Positioning | The MRI system acquires and<br>reconstructs a 3D volume for<br>Positioning to a maximum of 540<br>mm x 540 mm x 480 mm FOV with<br>an in-plane resolution of 3.0 x 3.0<br>mm or less. These volumes are<br>acquired with an acquisition time of<br>less than 60 seconds. | Same |
| Planning<br>Volumes | 540 mm x 465 mm x 430 mm FOV<br>with an in-plane resolution of 1.5 x<br>1.5 mm or less. | Same |
| Multi-Channel RF<br>System | Body coil SNR is ≥ 12; Uniformity<br>is ≥ 60%<br>12 Channel Torso Coil SNR is ≥ 30<br>(Sagittal, Transversal); SNR is ≥<br>25 (Coronal); Uniformity is ≥ 50%<br>10 Channel Head/Neck Coil SNR is<br>≥ 30 (Sagittal, Transversal); SNR<br>is ≥ 25 (Coronal); Uniformity is ≥<br>50% | Same with the addition of:<br>4 Channel Head Coil SNR is ≥ 30<br>(Sagittal, Transversal); SNR is ≥ 25<br>(Coronal); Uniformity is ≥ 50% |

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Image /page/9/Picture/0 description: The image contains the ViewRay logo. The logo consists of a green sphere with white lines running across it. To the right of the sphere is the word "VIEWRAY" in bold, black letters, with the tagline "Visibly Different" underneath.

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Image /page/10/Picture/0 description: The image is a logo for ViewRay. The logo consists of a green sphere with white lines running across it, and the text "VIEWRAY" in bold black letters. Below the text is a thin gray line, and below that is the text "Visibly Different" in a smaller, lighter font. The logo is clean and modern, and the colors are bright and eye-catching.

#### Summary of Performance Testing 9.

Design Verification testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards presented below.

The imaging capabilities of the proposed MRIdian Linac system showed substantial equivalence to the predicate system (K162393; K170751). Testing executed on the system verified conformance to design requirements and ensured all identified risks and hazards were mitigated, and demonstrated conformance to relevant safety standards. The MRIdian Linac system described in this premarket notification passed all verification testing, and the system conformed to all applicable sections of the standards presented below.

Software verification testing was conducted 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 MRIdian Linac software is considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Electrical safety and electromagnetic compatibility (EMC) testinq were conducted on the MRIdian Linac system which verified the system complies with the IEC 60601-1-2 EMC standard and continues to meet IEC 60601-1 safety standards.

| Name | Description |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1:2005 (Third<br>Edition) + CORR. 1 (2006) +<br>CORR. 2 (2007) + AM1<br>(2012) ed. 3.1 | Medical electrical equipment - Part 1: General requirements for basic<br>safety and essential performance |
| IEC 60601-1-2:2014 ed. 4.0 | Medical electrical equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests |
| IEC 60601-2-33: 2010 (Third<br>Edition) + A1: 2013 + A2:<br>2015 ed. 3.2 | Medical electrical equipment - Part 2-33: Particular requirements for the<br>basic safety and essential performance of magnetic resonance equipment<br>for medical diagnosis |
| IEC 60601-2-1:2009,<br>AMD1:2014 2014 ed. 3.1 | Medical electrical equipment - Part 2-1: Particular requirements for the<br>basic safety and essential performance of electron accelerators in the<br>range 1 MeV to 50 MeV |
| IEC/EN 60976:2007 ed. 2.0 | Medical electrical equipment - Medical electron accelerators - Functional<br>performance characteristics |
| IEC 60601-1-6:2013 ed. 3.1 | Medical electrical equipment - Part 1-6: General requirements for basic<br>safety and essential performance - Collateral standard: Usability |
| IEC 61217:2011 ed. 2.0 | Radiotherapy Equipment - Coordinates, Movements & Scales |
| IEC 62083:2009 ed. 2.0 | Medical electrical equipment - Requirements for the safety of<br>radiotherapy treatment planning systems |
| IEC 62304:2006 (First<br>Edition) + A1:2015 ed. 1.1 | Medical device software - Software life cycle processes |
| IEC 62366:2007, A1:2014 ed.<br>1.1 | Medical devices - Part 1: Application of usability engineering to medical<br>devices |
| ISO 10993-1:2009 ed. 4.0 | Biological evaluation of medical devices -- Part 1: Evaluation and testing<br>within a risk management process |

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#### 10. Conclusion

Verification testing of the MRIdian Linac system with proposed enhance imaging modalities demonstrated that the device met established standards and design requirements. System performance was found to be substantially equivalent in function to the predicate device MRIdian Linac system (K162393; K170751). Therefore, the proposed MRIdian Linac system performs in a substantially equivalent manner as the predicate device when using the enhanced imaging modalities described in this submission.