(89 days)
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.
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.
The provided text is a 510(k) summary for the MRIdian Linac System. It outlines the device's technical specifications, intended use, and its comparison to a predicate device to establish substantial equivalence. However, it does not contain acceptance criteria, reported device performance figures, or details of a study (like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) that would typically be used to prove a device meets specific acceptance criteria related to a new functionality or performance claim.
Instead, this document focuses on demonstrating that the modified MRIdian Linac System is substantially equivalent to its predicate device based on:
- Identical Intended Use and Indications for Use.
- Substantially equivalent technological characteristics, with minor differences that do not raise new questions of safety or effectiveness.
- Conformance to design specifications and satisfaction of intended users' needs, including risk mitigations.
- Compliance with various regulatory and recognized standards (e.g., medical electrical equipment safety, electromagnetic compatibility, software life cycle, usability, biocompatibility).
The document states: "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."" This implies that internal verification and validation testing was conducted, but the specific acceptance criteria and the detailed results of these tests are not provided in this public summary.
Therefore, I cannot extract the requested information regarding detailed acceptance criteria and a study proving those criteria are met from the provided text in the format you specified. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with explicit acceptance metrics for a novel AI or diagnostic functionality.
The closest information related to performance that is provided is in the "Summary of Technological Characteristics" table, which compares various physical and imaging parameters of the subject device to the predicate device. This table effectively shows that the characteristics are either "Same" or have minor, non-significant differences (e.g., spatial resolution for volume scans and cine scans).
If this were a submission for a new AI feature, the acceptance criteria would typically involve metrics like sensitivity, specificity, AUC, and the study details would describe how these were measured against a ground truth. None of that is present here.
{0}------------------------------------------------
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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) | ||
|---|---|---|
| Research Use (Part 21 CFR 601 Subpart D) Compassionate Use (21 CFR 601 Subpart E) | Research Use (Part 21 CFR 601 Subpart D) | Compassionate Use (21 CFR 601 Subpart E) |
| Research Use (Part 21 CFR 601 Subpart D) | ||
| Compassionate Use (21 CFR 601 Subpart E) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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.
{4}------------------------------------------------
Image /page/4/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 upper left side. To the right of the sphere is the word "VIEWRAY" in bold, black letters, and below that is the phrase "Visibly Different" in a smaller, lighter font.
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 Incorporated815 E. Middlefield RoadMountain View, CA 94043 USA |
| Primary Contact Person: | Sean Delaney(650) 252-0969sdelaney@viewray.com |
| Secondary Contact Person: | Elizabeth Osuna(408) 431-1046eosuna@viewray.com |
| Common or Usual Name: | Medical Linear Accelerator |
| Regulatory Name: | 21 CFR 892.5050 |
| Classification Name: | Medical charged-particle radiation therapysystem |
| Product Code: | IYE, LNH |
| Primary Predicate Device: | MRIdian Linac SystemK181989 |
{5}------------------------------------------------
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.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image contains the ViewRay logo. The logo consists of a green sphere with white lines inside, followed by the text "VIEWRAY" in black, with the words "Visibly Different" underneath. The text is separated by a horizontal line.
Summary of Technological Characteristics
| DeviceCharacteristic | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Radiation Source | |||
| Nominal BeamEnergy | 6 MV | 6 MV | Same |
| Isocenter Distance | 90 cm | 90 cm | Same |
| Nominal Dose Rate | 600 MU/min | 600 MU/min | Same |
| Collimation | |||
| Radiation FieldSizes | 2 mm x 4.15 mmto 27.4 x 24.1 cmprojected byisocenter | 2 mm x 4.15 mmto 27.4 x 24.1 cmprojected byisocenter | Same |
| PrimaryCollimation Method | 138-leaf MLC | 138-leaf MLC | Same |
| Resolution atisocenter | Each leaf projectswith a nominalwidth of 0.83 cmat 90 cm SAD. Thedouble- stack MLCuses an offsetbetween the topand bottom stackto achieve anominal effectiveleaf width of 0.415cm at 90 cm SAD. | Each leaf projectswith a nominalwidth of 0.83 cmat 90 cm SAD. Thedouble- stack MLCuses an offsetbetween the topand bottom stackto achieve anominal effectiveleaf width of 0.415cm at 90 cm SAD. | Same |
| CollimationTransition Time | MLC leaf speed of4 cm/s at isocenter | MLC leaf speed of4 cm/s at isocenter | Same |
| Imaging | |||
| Energy/Type | 0.345 TeslasuperconductingMRI | 0.345 TeslasuperconductingMRI | Same |
| DeviceCharacteristic | Predicate Device | Subject Device | Comparison |
| Field of View Size | 50 cm diameterspherical volume(DSV) | 50 cm diameterspherical volume(DSV) | Same |
| ContrastResolution | Complies with IEC60601-2-33 | Complies with IEC60601-2-33 | Same |
| Spatial Resolution | Volume scans:Min 0.075 x 0.075x 0.15 | Volume scans:Min 0.075 x 0.075x 0.075 | Volume scans:Minimumlongitudinalresolution from0.15 to 0.75. |
| Max 0.3 x 0.3 x0.3 | Max 0.3 x 0.3 x0.3 | ||
| Ciné scans:Slice thickness 5,7, or 10 mm | Ciné scans:Slice thickness 5,7, or 10 mm | Ciné scans: | |
| One plane: Sagittal | One, two, or threeplanes: Axial,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; body0.35 x 0.35; body | |||
| Dose | None | None | Same |
| PhysicalGeometry | |||
| Bore size | The system has adiameter of 70 cmnominal | The system has adiameter of 70 cmnominal | Same |
| Room Dimensions | The MRIdian Linacminimum vaultsize with finishes is | The MRIdian Linacminimum vaultsize with finishes is | Same |
| DeviceCharacteristic | Predicate Device | Subject Device | Comparison |
| 19' 2" wide by x24' 8" long [5.9 mx 6.93 m]. Theminimum finishedceiling height overthe footprint ofsystem is 9' 6"[2.9 m] to allowfor clearance ofsystem coverswhich are 9' 4" | 19' 2" wide by x24' 8" long [5.9 mx 6.93 m]. Theminimum finishedceiling height overthe footprint ofsystem is 9' 6"[2.9 m] to allowfor clearance ofsystem coverswhich are 9' 4" | ||
| Patient Couch -Degrees ofFreedom | 3D shifts andshifted values arewithin ± 0.1 cm ineach dimension | 3D shifts andshifted values arewithin ± 0.1 cm ineach dimension | Same |
| Patient Surface -Biocompatibility | Complies with ISO10993-1 | Complies with ISO10993-1 | Same |
{7}------------------------------------------------
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.
{8}------------------------------------------------
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.
{9}------------------------------------------------
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. # | StandardsDevelopingOrganization | StandardDesignationNumber andDate | Title of Standard |
|---|---|---|---|
| 19-4 | ANSI AAMI | ES60601-1:2005/(R)2012 andA1:2012,C1:2009/(R)2012 andA2:2010/(R)2012(ConsolidatedText) | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD) |
| 19-8 | ANSI AAMIIEC | 60601-1-2:2014 | Medical electrical equipment -- Part 1-2: Generalrequirements for basic safety and essentialperformance -- Collateral Standard: Electromagneticdisturbances -- Requirements and tests |
| 19-8 | EC | 60601-1-2Edition 4.02014-02 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Electromagneticdisturbances - Requirements and tests |
| 12-285 | IEC | 60601-2-1Edition 3.0 | Medical electrical equipment - Part 2-1: Particularrequirements for the basic safety and essentialperformance of electron accelerators in the range 1MeV to 50 MeV |
| 12-295 | IEC | 60601-2-33Ed. 3.2b:2015 | Medical electrical equipment - Part 2-33: Particularrequirements for the basic safety and essentialperformance of magnetic resonance equipment formedical diagnosis |
| 12-267 | IEC | 61217 Edition2.0 2011-12 | Radiotherapy equipment - Coordinates, movements,and scales |
| 12-217 | IEC | 62083 Edition2.0 2009-09 | Medical electrical equipment - Requirements for thesafety of radiotherapy treatment planning systems |
| 13-79 | ANSI AAMIIEC | 62304:2006/A1:2016 | Medical device software - Software life cycleprocesses [Including Amendment 1 (2016)] |
| 13-79 | IEC | 62304 Edition1.1 2015-06CONSOLIDATED VERSION | Medical device software - Software life cycleprocesses |
| 5-114 | ANSI AAMIIEC | 62366-1:2015 | Medical devices - Part 1: Application of usabilityengineering to medical devices |
| Rec. # | StandardsDevelopingOrganization | StandardDesignationNumber andDate | Title of Standard |
| IEC | 62366-1Edition 1.02015-02 | Medical devices - Part 1: Application of usabilityengineering to medical devices [IncludingCORRIGENDUM 1 (2016)] | |
| 5-89 | IEC | 60601-1-6Edition 3.12013-10 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability |
| 12-253 | IEC | 60976 Edition2.0 2007-10 | Medical electrical equipment - Medical electronaccelerators - Functional performance characteristics |
| 2-258 | ANSI AAMIISO | 10993-1:2018 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess |
| ISO | 10993-1 Fifthedition 2018-08 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess |
{10}------------------------------------------------
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.
§ 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.