MRIdian Linac System

K212958 · Viewray, Incorporated · IYE · Dec 14, 2021 · Radiology

Device Facts

• Record ID: K212958
• Device Name: MRIdian Linac System
• Applicant: Viewray, Incorporated
• Product Code: IYE · Radiology
• Decision Date: Dec 14, 2021
• 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 is an image-guided radiation therapy (IGRT) system combining a 6 MV linear accelerator with a 0.345 Tesla superconducting MRI. It integrates three subsystems: Treatment Planning and Delivery System (TPDS), Magnetic Resonance Imaging System (MRIS), and Radiation Therapy Delivery System (RDS). The device provides real-time MRI guidance during radiation delivery to target lesions, tumors, and conditions. It is operated by clinical staff in a radiation oncology setting. The system uses MRI inputs to visualize anatomy in real-time, allowing clinicians to adjust radiation delivery for precise targeting. This enables stereotactic radiosurgery and precision radiotherapy, potentially improving treatment accuracy and sparing healthy tissue. Modifications in this version include a redesigned Treatment Delivery subsystem, updated MR control system software (Siemens Avanto Dot), and support for an updated head receive coil.

Clinical Evidence

No clinical or animal testing was performed. Substantial equivalence is supported by bench testing and verification/validation activities demonstrating conformance to design specifications and relevant safety standards.

Technological Characteristics

6 MV linear accelerator; 0.345 Tesla superconducting MRI; 138-leaf MLC (0.83 cm nominal width, 0.415 cm effective width); 90 cm isocenter distance; 600 MU/min dose rate. Patient surface complies with ISO 10993-1. Software includes MR control system (Siemens Avanto Dot). Connectivity/interoperability via standard medical imaging protocols. Standards: IEC 60601-1, IEC 60601-2-1, IEC 60601-2-33, IEC 62304, IEC 62366-1.

Indications for Use

Indicated for patients requiring stereotactic radiosurgery and 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 (K181989)

Submission Summary (Full Text)

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December 14, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

ViewRay, Incorporated % Mr. Sean Delaney Senior Advisor, Continuous Improvement & Development Strategy 815 E. Middlefield Road MOUNTAIN VIEW CA 94043

Re: K212958

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: September 14, 2021 Received: September 16, 2021

Dear Mr. 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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting

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combination-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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K212958

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, tumors, and conditions anywhere in the body where radiation treatment is indicated.

| Type of Use (Select one or both, as applicable) | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <table><tr><td><div> <input checked="true" type="checkbox"/> Research Use (Part 21 CFR 601 Subpart D) </div></td></tr><tr><td><div> <input type="checkbox"/> Compassionate Use (21 CFR 601 Subpart E) </div></td></tr></table> | <div> <input checked="true" type="checkbox"/> Research Use (Part 21 CFR 601 Subpart D) </div> | <div> <input type="checkbox"/> Compassionate Use (21 CFR 601 Subpart E) </div> |
| <div> <input checked="true" type="checkbox"/> Research Use (Part 21 CFR 601 Subpart D) </div> | | |
| <div> <input type="checkbox"/> Compassionate Use (21 CFR 601 Subpart E) </div> | | |

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the ViewRay logo. The logo consists of a green sphere with white lines running through it, followed by the word "VIEWRAY" in bold, black letters. Below the word "VIEWRAY" is the tagline "Visibly Different" in a smaller, lighter font.

## Section 6: 510(k) Summary

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

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### Premarket Notification 510(k) Summary

As Required by 21 CFR 807.92

| 510(k) Number: | K212958 |
|---------------------------|--------------------------------------------------------------------------------|
| Product Name: | MRIdian Linac System |
| Date Prepared: | September 13, 2021 |
| Submitter: | ViewRay Incorporated<br>815 E. Middlefield Road<br>Mountain View, CA 94043 USA |
| Primary Contact Person: | Sean Delaney<br>[phone]<br>[e-mail] |
| Secondary Contact Person: | Elizabeth Osuna<br>[phone]<br>[e-mail] |
| Common or Usual Name: | Medical Linear Accelerator |
| Regulatory Name: | 21 CFR 892.5050 |
| Classification Name: | Medical charged-particle radiation therapy<br>system |
| Product Code: | IYE, LNH |
| Primary Predicate Device: | MRIdian Linac System<br>K181989 |

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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 word "VIEWRAY" in bold black letters. Below the word "VIEWRAY" is the tagline "Visibly Different" in a smaller, non-bold font. The logo is clean and modern, and the green color suggests a focus on health or technology.

### Device Description

The MRIdian Linac system is an image-quided radiation therapy (IGRT) system that uses a 6 MV linear accelerator radiotherapy system to deliver ionizing radiation while using a magnetic resonance imaging system for image guidance in real time. The MRIdian consists of the Treatment Planning and Delivery System (TPDS), Magnetic Resonance Imaging System (MRIS) and the Radiation Therapy Delivery System (RDS). These three subsystems are designed to operate concurrently for accurate targeted administration of radiation therapy.

### 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.

### Indication for 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.

#### Significant Differences

- The Treatment Planning and Delivery System modified with a redesigned . Treatment Delivery subsystem (TDS) and the same Treatment Planning subsystem (TPS) modified only to support the new TDS implementation;
- The Magnetic Resonance Imaging System (MRIS) which has been updated to . support an end-of-life replacement of the MR control system software (Siemens Avanto Dot) and include additional support for an updated head (receive) coil; and
- The Radiation Therapy Delivery System (RDS) modified only to support the TDS ● software interfaces changes.

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# Summary of Technological Characteristics

| Device<br>Characteristic | Predicate Device | Subject Device | Comparison |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Radiation Source | | | |
| Nominal Beam<br>Energy | 6 MV | 6 MV | Same |
| Isocenter Distance | 90 cm | 90 cm | Same |
| Nominal Dose Rate | 600 MU/min | 600 MU/min | Same |
| Collimation | | | |
| Radiation Field<br>Sizes | 2 mm x 4.15 mm<br>to 27.4 x 24.1 cm<br>projected by<br>isocenter | 2 mm x 4.15 mm<br>to 27.4 x 24.1 cm<br>projected by<br>isocenter | Same |
| Primary<br>Collimation Method | 138-leaf MLC | 138-leaf MLC | Same |
| Resolution at<br>isocenter | Each leaf projects<br>with a nominal<br>width of 0.83 cm<br>at 90 cm SAD. The<br>double- stack MLC<br>uses an offset<br>between the top<br>and bottom stack<br>to achieve a<br>nominal effective<br>leaf width of 0.415<br>cm at 90 cm SAD. | Each leaf projects<br>with a nominal<br>width of 0.83 cm<br>at 90 cm SAD. The<br>double- stack MLC<br>uses an offset<br>between the top<br>and bottom stack<br>to achieve a<br>nominal effective<br>leaf width of 0.415<br>cm at 90 cm SAD. | Same |
| Collimation<br>Transition Time | MLC leaf speed of<br>4 cm/s at isocenter | MLC leaf speed of<br>4 cm/s at isocenter | Same |
| Imaging | | | |
| Energy/Type | 0.345 Tesla<br>superconducting<br>MRI | 0.345 Tesla<br>superconducting<br>MRI | Same |
| Device<br>Characteristic | Predicate Device | Subject Device | Comparison |
| Field of View Size | 50 cm diameter<br>spherical volume<br>(DSV) | 50 cm diameter<br>spherical volume<br>(DSV) | Same |
| Contrast<br>Resolution | Complies with IEC<br>60601-2-33 | Complies with IEC<br>60601-2-33 | Same |
| Spatial Resolution | Volume scans:<br>Min 0.075 x 0.075<br>x 0.15 | Volume scans:<br>Min 0.075 x 0.075<br>x 0.075 | Volume scans:<br>Minimum<br>longitudinal<br>resolution from<br>0.15 to 0.75. |
| | Max 0.3 x 0.3 x<br>0.3 | Max 0.3 x 0.3 x<br>0.3 | |
| | Ciné scans:<br>Slice thickness 5,<br>7, or 10 mm | Ciné scans:<br>Slice thickness 5,<br>7, or 10 mm | Ciné scans: |
| | One plane: Sagittal | One, two, or three<br>planes: Axial,<br>sagittal, or coronal | |
| | Pixel size: | Pixel size: | Pixel size: |
| | 0.24 x 0.24 | 0.13 x 0.13; head | 0.13 x 0.13; head |
| | 0.35 x 0.35 | 0.20 x 0.20; body | 0.20 x 0.20; body |
| | | 0.24 x 0.24; body<br>0.35 x 0.35; body | |
| Dose | None | None | Same |
| Physical<br>Geometry | | | |
| Bore size | The system has a<br>diameter of 70 cm<br>nominal | The system has a<br>diameter of 70 cm<br>nominal | Same |
| Room Dimensions | The MRIdian Linac<br>minimum vault<br>size with finishes is | The MRIdian Linac<br>minimum vault<br>size with finishes is | Same |
| Device<br>Characteristic | Predicate Device | Subject Device | Comparison |
| | 19' 2" wide by x<br>24' 8" long [5.9 m<br>x 6.93 m]. The<br>minimum finished<br>ceiling height over<br>the footprint of<br>system is 9' 6"<br>[2.9 m] to allow<br>for clearance of<br>system covers<br>which are 9' 4" | 19' 2" wide by x<br>24' 8" long [5.9 m<br>x 6.93 m]. The<br>minimum finished<br>ceiling height over<br>the footprint of<br>system is 9' 6"<br>[2.9 m] to allow<br>for clearance of<br>system covers<br>which are 9' 4" | |
| Patient Couch -<br>Degrees of<br>Freedom | 3D shifts and<br>shifted values are<br>within ± 0.1 cm in<br>each dimension | 3D shifts and<br>shifted values are<br>within ± 0.1 cm in<br>each dimension | Same |
| Patient Surface -<br>Biocompatibility | Complies with ISO<br>10993-1 | Complies with ISO<br>10993-1 | Same |

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Image /page/7/Picture/0 description: The image contains the ViewRay logo. The logo consists of a green sphere with white lines and a blue dot on the top left. To the right of the sphere is the word "VIEWRAY" in black, with the words "Visibly Different" in a smaller font below.

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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 running across it on the left side. To the right of the sphere is the word "VIEWRay" in black, with the words "Visibly Different" in a smaller font below it.

### Performance Data

The MRIdian Linac System was tested according to the FDA Quality System Regulation (21 CFR §820). Test results demonstrate that the device conforms to design specifications and meets the needs of the intended users, including assuring risk mitigations were implemented and functioned properly. Software testing was performed and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

### Standards

The MRIdian Linac System conforms to the following regulatory standards including FDA recognized standards and references additional standards as applicable.

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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 inside, followed by the word "VIEWRAY" in bold, black letters. Below the word "VIEWRAY" is the tagline "Visibly Different" in a smaller, lighter font.

| Rec. # | Standards<br>Developing<br>Organization | Standard<br>Designation<br>Number and<br>Date | Title of Standard |
|--------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | ANSI AAMI | ES60601-<br>1:2005/(R)20<br>12 and<br>A1:2012,<br>C1:2009/(R)2<br>012 and<br>A2:2010/(R)2<br>012<br>(Consolidated<br>Text) | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance (IEC 60601-1:2005, MOD) |
| 19-8 | ANSI AAMI<br>IEC | 60601-1-<br>2:2014 | Medical electrical equipment -- Part 1-2: General<br>requirements for basic safety and essential<br>performance -- Collateral Standard: Electromagnetic<br>disturbances -- Requirements and tests |
| 19-8 | EC | 60601-1-2<br>Edition 4.0<br>2014-02 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests |
| 12-285 | IEC | 60601-2-1<br>Edition 3.0 | Medical electrical equipment - Part 2-1: Particular<br>requirements for the basic safety and essential<br>performance of electron accelerators in the range 1<br>MeV to 50 MeV |
| 12-295 | IEC | 60601-2-33<br>Ed. 3.2<br>b:2015 | Medical electrical equipment - Part 2-33: Particular<br>requirements for the basic safety and essential<br>performance of magnetic resonance equipment for<br>medical diagnosis |
| 12-267 | IEC | 61217 Edition<br>2.0 2011-12 | Radiotherapy equipment - Coordinates, movements,<br>and scales |
| 12-217 | IEC | 62083 Edition<br>2.0 2009-09 | Medical electrical equipment - Requirements for the<br>safety of radiotherapy treatment planning systems |
| 13-79 | ANSI AAMI<br>IEC | 62304:2006/A<br>1:2016 | Medical device software - Software life cycle<br>processes [Including Amendment 1 (2016)] |
| 13-79 | IEC | 62304 Edition<br>1.1 2015-06<br>CONSOLIDAT<br>ED VERSION | Medical device software - Software life cycle<br>processes |
| 5-114 | ANSI AAMI<br>IEC | 62366-1:2015 | Medical devices - Part 1: Application of usability<br>engineering to medical devices |
| Rec. # | Standards<br>Developing<br>Organizatio<br>n | Standard<br>Designation<br>Number and<br>Date | Title of Standard |
| | IEC | 62366-1<br>Edition 1.0<br>2015-02 | Medical devices - Part 1: Application of usability<br>engineering to medical devices [Including<br>CORRIGENDUM 1 (2016)] |
| 5-89 | IEC | 60601-1-6<br>Edition 3.1<br>2013-10 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential<br>performance - Collateral standard: Usability |
| 12-253 | IEC | 60976 Edition<br>2.0 2007-10 | Medical electrical equipment - Medical electron<br>accelerators - Functional performance characteristics |
| 2-258 | ANSI AAMI<br>ISO | 10993-1:<br>2018 | Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management<br>process |
| | ISO | 10993-1 Fifth<br>edition 2018-<br>08 | Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management<br>process |

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Image /page/10/Picture/0 description: The image shows the ViewRay logo. The logo consists of a green circle with white lines inside, and the word "VIEWRAY" in black letters to the right of the circle. Below the word "VIEWRAY" is the phrase "Visibly Different" in a smaller font. The logo is simple and modern, and the colors are eye-catching.

## Bench Testing

The performance data demonstrate that the MRIdian Linac System is as safe and effective and performs as well as the predicate device.

## Clinical Testing

No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device.

### Conclusion

The MRIdian Linac System is substantially equivalent to the predicate device. The intended use and indications for use are the same. The major technological characteristics are substantially equivalent to the predicate device, and the differences do not raise new questions of safety and effectiveness. The results of testing as well as conformance to relevant safety standards demonstrate that MRIdian Linac System meets the safety and performance criteria and is substantially equivalent to the predicate device.