(182 days)
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.
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: The Treatment Planning and Delivery System (TPDS), The 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 document is a 510(k) summary for the ViewRay (MRIdian) Linac System (K162393), which is a medical device for radiation therapy. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not necessarily to detail comprehensive acceptance criteria and a study to prove meeting them in the way a clinical trial or performance study for a novel device would.
Based on the provided text, the device itself is a radiation therapy system, not an AI/ML algorithm. Therefore, many of the typical AI/ML-specific questions (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not directly applicable or explicitly stated in this type of regulatory submission for this device. The "performance" being described is primarily related to the physical and functional characteristics of the radiation delivery system.
However, I can extract information related to demonstrating substantial equivalence and the performance characteristics presented.
Here's an interpretation based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the "Device with Change" (K162393, the MRIdian Linac System) to the "Cleared Device" (K111862, the predicate MRIdian System). The "acceptance criteria" can be inferred from the predicate device's performance, as the goal is to show the new device is "substantially equivalent." Where specific quantitative metrics are provided, those can be considered the performance reported for each device.
| Feature | Acceptance Criteria (Predicate: K111862) | Reported Device Performance (K162393) |
|---|---|---|
| Radiation Source | Cobalt-60 Sources (qty. 3) | 6MV Linear Accelerator |
| Beam | 2.0 cm dia. Cobalt 60 Gamma Ray Source, 1.332 & 1.172 MeV | 6 MV Bremsstrahlung X-Rays produced by Linear Accelerator |
| Max Dose Rate | 600 cGy/min. total (200 cGy/min. per head at installation) at Dmax at 105cm isocenter for a 10.5 cm x 10.5 cm field (three sources utilized) | 600 cGy/min. at Dmax at a 90 cm isocenter for a 10 cm x 10 cm field (Single Source) |
| Static Dose Accuracy | 90% of points evaluated in a treatment volume pass a relative gamma criteria of 3%/3mm and a high dose, low gradient absolute point measurement is within 5% of the planned dose (per AAPM TG 119) | 90% of points evaluated in a treatment volume pass a relative gamma criteria of 3%/3mm and a high dose, low gradient absolute point measurement is within 5% of the planned dose (per AAPM TG 119) |
| Moving Target Dose Accuracy | Dose delivery on a moving target is consistent within ≤ 2% to that of a stationary target with real time tumor tracking (RealTarget). | Dose delivery on a moving target is consistent within ≤ 2% to that of a stationary target with real time tumor tracking (RealTarget). |
| Collimation | Field shaping, Multi Leaf Collimator (MLC), Quantity of 3 | Field shaping, Multi Leaf Collimator (MLC), Quantity of 1 |
| Range of MLC collimated beam size | 1.05cm x 1.05cm to 27.3cm x 27.3cm projected at isocenter | 0.72 cm x 1.43 cm to 25.71 cm x 25.71 cm projected at isocenter |
| Number of leaves per 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 Dimensions (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 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 Isolation | Transformer | Transformer |
| Radiation Head Shielding | Depleted Uranium and Tungsten Alloy shield with stainless steel shell, 15,000 Curies max. capacity | Lead, Tungsten Alloy, and Steel shielding |
| Source control mechanism | Redundant timers controlling pneumatically driven linear source movement mechanisms | Redundant ion chambers and dose monitoring cards |
| Radiation Leakage when OFF | In the fully shielded BEAM OFF position, measured at survey points, is in accordance with NCRP #102. | Not applicable, no leakage when OFF |
| Radiation Transmission through head | With the source in the fully exposed BEAM ON position is less than 0.1% of the primary beam. | Less than 0.1% of the primary beam. |
| Method of IMRT | MLC based cone-beam delivery | MLC based cone-beam delivery |
| Gantry | Ring Gantry, collision with patient not possible | Ring Gantry, collision with patient not possible |
| Motion synchronized treatment | Yes | Yes |
| Integrated imaging for planning, positioning, gating | Magnetic resonance imaging system | Magnetic resonance imaging system |
| MR Physical Characteristics | (Consistent with predicate for Bore Diameter, DSV, Patient table degrees of freedom, MRI Frequency, Field Strength, Field of View, Field Homogeneity, Field Stability, 3D Imaging Volumes/Resolution, 2D Imaging Planes/Resolution, Geometric Accuracy, Signal to Noise) | (Consistent with predicate for Bore Diameter, DSV, Patient table degrees of freedom, MRI Frequency, Field Strength, Field of View, Field Homogeneity, Field Stability, 3D Imaging Volumes/Resolution, 2D Imaging Planes/Resolution, Geometric Accuracy, Signal to Noise) |
| Temporal Integrity | 0.01s or better | 0.01s or better |
| Signal to Noise | 30 | 30 |
| Dose per treatment | None | None |
| Treatment Planning and Delivery System Dose Algorithm (K102915) | Monte Carlo Dose Computation Radiation Source Model for Cobalt photons. Measurement shows fundamental radiation-transport algorithm works correctly. | Monte Carlo Dose Computation Radiation Source Model for Bremsstrahlung X-Rays, fundamental radiation-transport algorithm is unchanged. Measurement shows fundamental radiation-transport algorithm works correctly. |
| Dose Output Modeling | Dose output modeled with beam-on time | Dose output modeled with monitor units |
| Dose Display | Display of Cobalt delivery parameters | Display of Linac delivery parameters |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of patients or cases. The "testing" referred to appears to be engineering and physics verification tests on the device itself, rather than studies involving patient data or a "test set" of images/cases in the AI/ML sense. The testing verified conformance to design requirements and safety standards.
- Data Provenance: Not applicable in the context of this device's validation as described (i.e., not a data-driven AI/ML device in the document). The testing is on the physical system's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/mentioned. "Ground truth" in this context refers to established engineering/physics standards (e.g., AAPM TG 119) and design specifications, not expert interpretations of medical images for an AI/ML diagnostic or therapeutic algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/mentioned. This refers to consensus methods for expert labeling, which is not relevant for the type of device validation presented here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The device is a radiation therapy system, not an AI-assisted diagnostic or therapeutic interpretation tool requiring human-in-the-loop performance measurement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable as an "algorithm-only" performance in the AI/ML sense. The "standalone" performance is the device's operational characteristics as detailed in the table (e.g., dose accuracy, geometric accuracy). The document states, "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..."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance characteristics are established engineering and physics standards, such as:
- AAPM TG 119 for Static Dose Accuracy.
- IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC/EN 60601-2-1, IEC/EN 60976, IEC 60601-1-6, IEC 61217, IEC 62083, EN 62304, EN 62366, ISO 10993-1.
- The design specifications of the ViewRay (MRIdian) System (K111862) serve as the benchmark for substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that uses a "training set" in the conventional sense. The "training" for the device's design implicitly comes from decades of medical linear accelerator and MRI technology development, and experience with the predicate device.
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI/ML device with a training set, the concept of establishing ground truth for it is not relevant here.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing to the right, connected by flowing lines. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the symbol.
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.
{1}------------------------------------------------
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{2}------------------------------------------------
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)
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 shows the ViewRay logo. The logo consists of a green sphere with white lines inside, followed by the text "VIEWRAY" in a sans-serif font. Below the text "VIEWRAY" is the tagline "Visibly Different" in a smaller font.
Section 6: 510(k) Summary
The information below is provided for the ViewRay (MRIdian) Linac system, following the format of 21 CFR 807.92.
-
- Address and Contact Information: ViewRay Incorporated 2 Thermo Fisher Way Oakwood Village, OH 44146 Contact Name: Sean A. Delaney Phone: (650) 252-0969 Fax: (650) 625-9187 E-mail: sdelaney@viewray.com 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:
- Address and Contact Information: ViewRay Incorporated 2 Thermo Fisher Way Oakwood Village, OH 44146 Contact Name: Sean A. Delaney Phone: (650) 252-0969 Fax: (650) 625-9187 E-mail: sdelaney@viewray.com 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
{4}------------------------------------------------
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.
-
- The Magnetic Resonance Imaging System (MRIS)
-
- 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
{5}------------------------------------------------
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 DeviceK111862 | Device with ChangeK162393 |
|---|---|---|
| Radiation Source | Cobalt-60 Sources (qty. 3) | 6MV Linear Accelerator |
| Beam | 2.0 cm dia. Cobalt 60 GammaRay Source, 1.332 & 1.172 MeV | 6 MV Bremsstrahlung X- Rays produced by Linear Accelerator |
| Max Dose Rate | 600 cGy/min. total200 cGy/min.per head (atinstallation) at Dmax at 105cmisocenter for a 10.5 cm x 10.5cm field(three sources are utilized ) | 600 cGy/min.at Dmax at a 90 cm isocenter fora 10 cm x 10 cm field(Single Source) |
| Static Dose Accuracy | 90% of the points evaluated in atreatment volume pass a relativegamma criteria of 3%/3mm anda high dose, low gradientabsolute point measurement iswithin 5% of the planned dose(per AAPM TG 119 based on therecommendations of Palta etal.). | 90% of the points evaluated in atreatment volume pass a relativegamma criteria of 3%/3mm anda high dose, low gradientabsolute point measurement iswithin 5% of the planned dose(per AAPM TG 119 based on therecommendations of Palta etal.). |
| Moving Target DoseAccuracy | Dose delivery on a moving targetis consistent within ≤ 2 % tothat of a stationary target withthe use of real time tumortracking (RealTarget). | Dose delivery on a moving targetis consistent within ≤ 2 % tothat of a stationary target withthe use of real time tumortracking (RealTarget). |
| Collimation | Field shaping, Multi LeafCollimator(MLC)Quantity of 3 | Field shaping, Multi LeafCollimator(MLC)Quantity of 1 |
| Range of MLCcollimated beam size | 1.05cm x 1.05cm to 27.3cm x27.3cm projected at isocenter | 0.72 cm x 1.43 cm to 25.71 cm x25.71 cm projected at isocenter |
| Number of leaves perMLC | 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 RoomDimensionsHeight/Length/Width | 2.9 m x 7.6 m x 5.9 m | 2.9 m x 7.6 m x 5.9 m |
| EnvironmentLine 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 DistributionIsolation | Transformer | Transformer |
| Radiation HeadShielding | Depleted Uranium and TungstenAlloy shield with stainless steelshell, 15,000 Curies max.capacity | Lead, Tungsten Alloy, and Steelshielding |
| Source controlmechanism | Redundant timers controllingpneumatically driven linearsource movement mechanisms | Redundant ion chambers anddose monitoring cards |
| Radiation Leakagewhen OFF | In the fully shielded BEAM OFFposition, measured at surveypoints, is in accordance withNCRP #102. | Not applicable, no leakage whenOFF |
| Radiation Transmissionthrough head | With the source in the fullyexposed BEAM ON position isless than 0.1% of the primarybeam. | Less than 0.1% of the primarybeam. |
| Method of IMRT | MLC based cone-beam delivery | MLC based cone-beam delivery |
| Gantry | Ring Gantry, collision withpatient not possible | Ring Gantry, collision withpatient not possible |
| Motion synchronizedtreatment | Yes | Yes |
Performance specifications of the MRIdian Linac and predicate device are noted in the table below:
{6}------------------------------------------------
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.
{7}------------------------------------------------
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 forplanning, positioning,gating | Magnetic resonance imagingsystem | Magnetic resonance imagingsystem | |
|---|---|---|---|
| MR PhysicalCharacteristics | |||
| Bore Diameter | 700 mm | 700 mm | |
| Diameter SphericalVolume (DSV) | 500 mm | 500 mm | |
| Patient table degrees offreedom | 3 translational | 3 translational | |
| MRI Frequency | 14.7 MHz | 14.7 MHz | |
| Field Strength | 0.345 T | 0.345 T | |
| Field of View500 mm | 500 mm | ||
| Field Homogeneity | < 25 ppm measured over 450mm DSV | < 25 ppm measured over 450mm 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 Resolutionin 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 Resolutionin 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 | |
{8}------------------------------------------------
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 andDelivery System DoseAlgorithm (K102915) | Monte Carlo Dose ComputationRadiation Source Model forCobalt photons. | Monte Carlo Dose ComputationRadiation Source Model forBremsstrahlung X-Rays,fundamental radiation-transportalgorithm is unchanged. |
| Dose Output Modeling | Dose output modeled withbeam-on time | Dose output modeled withmonitor units |
| Dose Display | Display of Cobalt deliveryparameters | Display of Linac deliveryparameters |
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.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image contains the logo for ViewRay. The logo consists of a green sphere with white lines inside, and a blue dot on the top left. To the right of the sphere is the word "VIEWRAY" in bold, black letters. Below the word is the phrase "Visibly Different" in a smaller, lighter font.
| Name | Description |
|---|---|
| IEC 60601-1: 2005 + CORR. 1 (2006) +CORR. 2 (2007) ed 3.1 | General requirements for basic safety and essentialperformance |
| 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: Particularrequirements for the basic safety and essentialperformance of electron accelerators in the range 1MeV to 50 MeV |
| IEC/EN 60976:2007 ed. 2.0 | Medical electrical equipment - Medical electronaccelerators - Functional performance characteristics |
| IEC 60601-1-6:2013 ed. 3.1 | Usability |
| IEC 61217:2011 ed. 2.0 | Radiotherapy Equipment - Coordinates, Movements &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).
§ 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.