(209 days)
No
The summary focuses on improvements to imaging speed, quality, and additional image contrast modalities, with no mention of AI or ML algorithms for image processing, analysis, or treatment planning.
Yes.
The device is intended to provide 'stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere radiation treatment is indicated,' which directly treats medical conditions.
No
The device is a radiation therapy system with integrated MRI for image guidance during treatment delivery. Its primary purpose specified in "Intended Use / Indications for Use" is to "provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions," which describes a therapeutic function, not a diagnostic one. While it uses MRI for imaging, this imaging is explicitly for guiding treatment, not for diagnosing conditions.
No
The device is described as a "MRIdian Linac system" which delivers ionizing radiation using a magnetic resonance imaging system (MRIS) unit. The submission describes changes to the treatment planning and delivery imaging workflows, including the introduction of a Treatment Delivery Computer Unit (TDCU) and additional MR sequences. While software is a component and undergoes verification, the core device is a physical system involving a linear accelerator and an MRI unit, not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere radiation treatment is indicated." This describes a therapeutic device that delivers radiation treatment, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the system's ability to deliver ionizing radiation and use magnetic resonance imaging for image guidance during treatment. It describes imaging modalities used for planning, positioning, and treatment delivery workflows, all of which are related to the therapeutic process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
The device is clearly a therapeutic radiation delivery system with integrated imaging for guidance, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications 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 radiation treatment is indicated.
Product codes
IYE, LNH
Device Description
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:
- 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.
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 other FDA recognized consensus standards. The imaging capabilities of the proposed MRIdian Linac system showed substantial equivalence to the predicate system (K162393; K170751). Testing verified conformance to design requirements, mitigated identified risks and hazards, and demonstrated conformance to relevant safety standards. The MRIdian Linac system passed all verification testing and conformed to all applicable sections of the presented standards.
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 a "major" level of concern.
Electrical safety and electromagnetic compatibility (EMC) testing verified the system complies with the IEC 60601-1-2 EMC standard and continues to meet IEC 60601-1 safety standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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February 20, 2019
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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):
| ☑ 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 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: (650) 252-0969
Fax: (650) 625-9187
E-mail: sdelaney@viewray.com
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:
-
- 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.
-
- 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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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:
-
- 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;
-
- The Magnetic Resonance Imaging System (MRIS) which has been updated to include additional imaging pulse sequences; and
-
- 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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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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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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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
(K162393; K170751) | Device with Changes |
|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Imaging Settings | 1. PLAN—imaging for planning or
virtual simulation
2. POSITION—imaging for patient
positioning
3. TREAT—imaging for target
position monitoring | Same |
| MR Physical
Characteristics:
Bore Diameter | 700 mm | Same |
| Spherical Volume
(DSV) | 500 mm | |
| MRI Frequency | 14.7 MHz | |
| Field Strength | 0.345 T | |
| Field of View | 500 mm | Same |
| Field
Homogeneity |