The ViewRay (MRIdian) Linac System

K162393 · Viewray, Incorporated · IYE · Feb 24, 2017 · Radiology

Device Facts

• Record ID: K162393
• Device Name: The ViewRay (MRIdian) Linac System
• Applicant: Viewray, Incorporated
• Product Code: IYE · Radiology
• Decision Date: Feb 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ViewRay (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 magnetic resonance imaging (MRI) with a 6MV linear accelerator for image-guided radiation therapy. System captures MRI data to visualize patient anatomy at the radiotherapy isocenter before and during treatment. Clinicians use the Treatment Planning and Delivery System (TPDS) to plan and deliver ionizing radiation. Real-time tumor tracking (RealTarget) enables motion-synchronized treatment. Device operates in clinical settings; used by trained clinicians. Output consists of targeted radiation beams; enables precision therapy for tumors/lesions. Benefits include improved targeting accuracy through concurrent MRI guidance and motion management, potentially sparing healthy tissue.

Clinical Evidence

Bench testing only. Verification testing confirmed conformance to design requirements, safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 60601-2-1), and risk mitigation per ISO 14971. Performance testing demonstrated substantial equivalence to the predicate in imaging resolution, geometric accuracy, and dose delivery accuracy (e.g., 90% of points pass 3%/3mm gamma criteria per AAPM TG 119). No clinical trial data presented.

Technological Characteristics

System integrates 0.345T MRI (14.7 MHz) with a 6MV linear accelerator. Features a ring gantry, 700mm bore, and 60-leaf tungsten alloy MLC. Connectivity includes TPDS for planning. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 60601-2-1, IEC 62083. Biocompatibility per ISO 10993-1. Software lifecycle per EN 62304.

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

• ViewRay (MRIdian) System for Radiation Therapy (K111862)
• ViewRay Treatment Planning and Delivery System (K102915)

Reference Devices

• TrueBeam Radiotherapy Delivery System (K111106)
• Varian Trilogy MX (K092871)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 24, 2017

ViewRay Incorporated % Sean A. Delaney Senior Manager, Regulatory Affairs 2 Thermo Fisher Way OAKWOOD VILLAGE OH 44146

Re: K162393

Trade/Device Name: The ViewRay (MRIdian) Linac System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 14, 2017 Received: February 16, 2017

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. 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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael 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) K162393

Device Name The ViewRay (MRIdian) Linac System

Indications for Use (Describe)

The ViewRay (MRIdian) Linac System, with magnetic resonance imaqinq 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)

- Prescription Use (Part 21 CFR 801 Subpart D)

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

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## Section 6: 510(k) Summary

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

- 1. Address and Contact Information: ViewRay Incorporated 2 Thermo Fisher Way Oakwood Village, OH 44146 Contact Name: Sean A. Delaney Phone: [phone] Fax: [phone] E-mail: [e-mail] Date Summary was prepared: January 13, 2017 2. Name of Device: ViewRay (MRIdian) Linac system Trade/Proprietary Name: MRIdian Linac system Common or Usual Name: Accelerator, Linear, Medical Regulation description/number: Medical charged-particle radiation therapy system 21 CFR §892.5050, Class II Product Code: IYE Device classification name: Accelerator, Linear, Medical 3. Predicate Device to claim substantial equivalence ViewRay (MRIdian) System for Radiation Therapy – K111862 ViewRay Treatment Planning and Delivery System – K102915 TrueBeam Radiotherapy Delivery System – K111106 (Reference Device) Description of the Device 4. The MRIdian Linac system delivers ionizing radiation using a magnetic resonance
imaging system (MRIS) unit for image quidance and a 6MV linear accelerator to deliver radiation therapy. The system is designed so that the imaging and radiotherapy fields of view coincide permitting imaging of the patient at the radiotherapy isocenter before and during treatment. The MRIdian Linac system is used with the ViewRay Treatment Planning and Delivery System (TPDS) (K102915). As with the predicate MRIdian System (K111862), the MRIdian Linac System consists of three primary subsystems:

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Image /page/4/Picture/0 description: The image contains the ViewRay logo. The logo consists of a green circular icon with white lines inside, followed by the text "VIEWRAY" in a bold, sans-serif font. Below the text, there is a horizontal line, and below that, the words "Visibly Different" are written in a smaller, lighter font.

- The Treatment Planning and Delivery System (TPDS) 1.
- 2. The Magnetic Resonance Imaging System (MRIS)
- 3. The Radiation Therapy Delivery System (RDS)

These three subsystems are designed to operate concurrently for accurate targeted administration of radiation therapy.

#### 5. Intended Use Statement

The ViewRay (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.

#### 6. Indication for Use Statement

The ViewRay (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.

#### 7. Substantial Equivalence

The MRIdian Linac system submission demonstrates substantial equivalence to the predicate MRIdian device (K111862).

#### 8. Technological Characteristics

The predicate ViewRay (MRIdian) system for radiation therapy (K111862) is an Image-Guided Radiation Therapy System (IGRT) that uses a magnetic resonance imaging (MRI) unit for image guidance with a three-headed Cobalt-60 (Co-60) radiotherapy system. Like the predicate MRIdian system, the MRIdian Linac system delivers ionizing radiation using a magnetic resonance imaging system (MRIS) unit for image quidance. The primary difference between the MRIdian system and the MRIdian Linac system is in the ionizing radiation source. The MRIdian Linac system differs from the predicate only by the changes required to support a device modification to change the output Energy Type of the system from Cobalt 60 to a linear accelerator.

While there are differences in the MV photon energy spectra of the two output Energy Types (or sources), ViewRay previously demonstrated in K111862 that the Cobalt 60 ionizing radiation dose distributions delivered to the patient by the predicate MRIdian system was substantially equivalent to the 6 MV ionizinqradiation dose distributions delivered by its predicate. The predicate in K111862 was the Varian Trilogy MX (K092871) linac based therapy system. The Varian TrueBeam (K111106) which also has the Varian Trilogy MX as its predicate also provides the same output energy type as the MRIdian Linac, an unflattened 6 MV linac beam. The MRIdian Linac system replaces the three Cobalt-60 sources utilized by the predicate MRIdian system with a single 6 MV Linear Accelerator to

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Image /page/5/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 "VIEWRAY" on the right. Below the text is a horizontal line, and below the line is the text "Visibly Different".

supply ionizing radiation similar to the single linac of the Varian TrueBeam (K111106) and the shared Varian Trilogy MX (K092871) predicate.

The MRIdian Linac system functions in a manner directly analogous to the functions provided by the predicate MRIdian system. Both systems use images obtained from MRI for planning. Although the MRIdian Linac system uses a different source of radiation (linac), both systems are intended for use for radiation therapy and are used by the same user population.

The MRIdian Linac system employs two well-established technologies, MRI and radiotherapy delivery using linac with treatment planning functions to provide comprehensive image guided radiation therapy solution. The MRIdian Linac system is substantially equivalent to the imaging and therapy technologies used in the predicate MRIdian system (K111862). Both systems are used by trained clinicians to provide stereotactic radiosurgery and precision radiotherapy to patients.

| Feature | Cleared Device<br>K111862 | Device with Change<br>K162393 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Radiation Source | Cobalt-60 Sources (qty. 3) | 6MV Linear Accelerator |
| Beam | 2.0 cm dia. Cobalt 60 Gamma<br>Ray Source, 1.332 & 1.172 MeV | 6 MV Bremsstrahlung X- Rays produced by Linear Accelerator |
| Max Dose Rate | 600 cGy/min. total<br>200 cGy/min.per head (at<br>installation) at Dmax at 105cm<br>isocenter for a 10.5 cm x 10.5<br>cm field<br>(three sources are utilized ) | 600 cGy/min.<br>at Dmax at a 90 cm isocenter for<br>a 10 cm x 10 cm field<br>(Single Source) |
| Static Dose Accuracy | 90% of the points evaluated in a<br>treatment volume pass a relative<br>gamma criteria of 3%/3mm and<br>a high dose, low gradient<br>absolute point measurement is<br>within 5% of the planned dose<br>(per AAPM TG 119 based on the<br>recommendations of Palta et<br>al.). | 90% of the points evaluated in a<br>treatment volume pass a relative<br>gamma criteria of 3%/3mm and<br>a high dose, low gradient<br>absolute point measurement is<br>within 5% of the planned dose<br>(per AAPM TG 119 based on the<br>recommendations of Palta et<br>al.). |
| Moving Target Dose<br>Accuracy | Dose delivery on a moving target<br>is consistent within ≤ 2 % to<br>that of a stationary target with<br>the use of real time tumor<br>tracking (RealTarget). | Dose delivery on a moving target<br>is consistent within ≤ 2 % to<br>that of a stationary target with<br>the use of real time tumor<br>tracking (RealTarget). |
| Collimation | Field shaping, Multi Leaf<br>Collimator(MLC)<br>Quantity of 3 | Field shaping, Multi Leaf<br>Collimator(MLC)<br>Quantity of 1 |
| Range of MLC<br>collimated beam size | 1.05cm x 1.05cm to 27.3cm x<br>27.3cm projected at isocenter | 0.72 cm x 1.43 cm to 25.71 cm x<br>25.71 cm projected at isocenter |
| Number of leaves per<br>MLC | 60 | 60 |
| MLC material | Tungsten Alloy | Tungsten Alloy |
| Isocenter distance | 105 cm | 90 cm |
| Isocenter accuracy | 0.5mm radius (1 mm diameter) | 0.5mm radius (1 mm diameter) |
| Minimum Room<br>Dimensions<br>Height/Length/Width | 2.9 m x 7.6 m x 5.9 m | 2.9 m x 7.6 m x 5.9 m |
| Environment<br>Line Voltage | 380-480V | 480V |
| Ambient Room Temp. | 65 °F to 72 °F | 65 °F to 72 °F |
| Relative Humidity | 40 to 60% | 40 to 60% |
| Power Distribution<br>Isolation | Transformer | Transformer |
| Radiation Head<br>Shielding | Depleted Uranium and Tungsten<br>Alloy shield with stainless steel<br>shell, 15,000 Curies max.<br>capacity | Lead, Tungsten Alloy, and Steel<br>shielding |
| Source control<br>mechanism | Redundant timers controlling<br>pneumatically driven linear<br>source movement mechanisms | Redundant ion chambers and<br>dose monitoring cards |
| Radiation Leakage<br>when OFF | In the fully shielded BEAM OFF<br>position, measured at survey<br>points, is in accordance with<br>NCRP #102. | Not applicable, no leakage when<br>OFF |
| Radiation Transmission<br>through head | With the source in the fully<br>exposed BEAM ON position is<br>less than 0.1% of the primary<br>beam. | Less than 0.1% of the primary<br>beam. |
| Method of IMRT | MLC based cone-beam delivery | MLC based cone-beam delivery |
| Gantry | Ring Gantry, collision with<br>patient not possible | Ring Gantry, collision with<br>patient not possible |
| Motion synchronized<br>treatment | Yes | Yes |

Performance specifications of the MRIdian Linac and predicate device are noted in the table below:

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Image /page/6/Picture/0 description: The image contains the logo for ViewRay. The logo consists of a green circular graphic on the left, followed by the text "VIEWRAY" in a bold, sans-serif font. Below the company name is the tagline "Visibly Different" in a smaller, lighter font.

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Image /page/7/Picture/0 description: The image contains the logo for ViewRay. The logo consists of a green circular graphic on the left, followed by the word "VIEWRAY" in bold, black letters. Below "VIEWRAY" is the tagline "Visibly Different" in a smaller, lighter font. The logo is clean and professional, suggesting a company focused on clarity and innovation.

| Integrated imaging for<br>planning, positioning,<br>gating | Magnetic resonance imaging<br>system | Magnetic resonance imaging<br>system | |
|------------------------------------------------------------|--------------------------------------|--------------------------------------|--|
| MR Physical<br>Characteristics | | | |
| Bore Diameter | 700 mm | 700 mm | |
| Diameter Spherical<br>Volume (DSV) | 500 mm | 500 mm | |
| Patient table degrees of<br>freedom | 3 translational | 3 translational | |
| MRI Frequency | 14.7 MHz | 14.7 MHz | |
| Field Strength | 0.345 T | 0.345 T | |
| Field of View<br>500 mm | | 500 mm | |
| Field Homogeneity | < 25 ppm measured over 450<br>mm DSV | < 25 ppm measured over 450<br>mm DSV | |
| Field Stability | < 0.1 ppm/hr | < 0.1 ppm/hr | |
| 3D Imaging Volumes in | RL x AP x HF | RL x AP x HF | |
| cm | Min 20 x 27 x 29 | Min 20 x 27 x 29 | |
| | Max 54 x 48 x 54 | Max 54 x 48 x 54 | |
| 3D Imaging Resolution<br>in cm | Min 0.075 x 0.075 x 0.15 | Min 0.075 x 0.075 x 0.15 | |
| | Max 0.3 x 0.3 x 0.3 | Max 0.3 x 0.3 x 0.3 | |
| 2D Imaging Planes in | AP x HF | AP x HF | |
| cm | Min. 27 x 27 | Min. 27 x 27 | |
| | Max 45 x 35 | Max 45 x 35 | |
| | 0.35 x 0.35 | 0.35 x 0.35 | |
| 2D Imaging Resolution<br>in cm | 5,7, or 10 | 5,7, or 10 | |
| Geometric Accuracy | 2 mm over 35 cm FOV | 2 mm over 35 cm FOV | |
| | 1 mm over 20 cm FOV | 1 mm over 20 cm FOV | |
| Signal to Noise | 30 | 30 | |
| | | | |

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Image /page/8/Picture/0 description: The image shows the ViewRay logo. The logo consists of a green circular graphic on the left and the word "VIEWRAY" in bold, uppercase letters on the right. Below "VIEWRAY" is the tagline "Visibly Different" in a smaller, lighter font. The logo is clean and modern, with a focus on the company name and its unique selling proposition.

| Temporal Integrity | 0.01s or better | 0.01s or better |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Signal to Noise | 30 | 30 |
| Dose per treatment | None | None |
| Treatment Planning and<br>Delivery System Dose<br>Algorithm (K102915) | Monte Carlo Dose Computation<br>Radiation Source Model for<br>Cobalt photons. | Monte Carlo Dose Computation<br>Radiation Source Model for<br>Bremsstrahlung X-Rays,<br>fundamental radiation-transport<br>algorithm is unchanged. |
| Dose Output Modeling | Dose output modeled with<br>beam-on time | Dose output modeled with<br>monitor units |
| Dose Display | Display of Cobalt delivery<br>parameters | Display of Linac delivery<br>parameters |

#### 9. Summary of Performance Testing

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

The imaging and radiation therapy capabilities of the MRIdian Linac system showed substantial equivalence to the predicate device. 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 required 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) testing were conducted on the MRIdian Linac system which verified complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 EMC standard.

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| Name | Description |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1: 2005 + CORR. 1 (2006) +<br>CORR. 2 (2007) ed 3.1 | General requirements for basic safety and essential<br>performance |
| IEC 60601-1-2:2007 ed. 3.0 | Electromagnetic compatibility (EMC) |
| IEC 60601-2-33:2015 ed. 3.2 | MR for Medical Diagnosis |
| IEC/EN 60601-2-1:2009 ed. 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 |
| IEC/EN 60976:2007 ed. 2.0 | Medical electrical equipment - Medical electron<br>accelerators - Functional performance characteristics |
| IEC 60601-1-6:2013 ed. 3.1 | Usability |
| IEC 61217:2011 ed. 2.0 | Radiotherapy Equipment - Coordinates, Movements &<br>Scales |
| IEC 62083:2009 ed. 2.0 | Radiotherapy Treatment Planning Systems |
| EN 62304:2006 ed. 1.0 | Software Lifecycle Processes |
| EN 62366:2014 ed. 1.1 | Usability |
| ISO 10993-1:2009 | Biocompatibility |

#### 10. Conclusion

Verification testing of the MRIdian Linac system demonstrated that the device met established standards and design requirements. System performance was found to be equivalent in function to the predicate MRIdian device. Therefore, the MRIdian Linac system is substantially equivalent to the indicated predicate device (MRIdian System K111862).