(182 days)
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data. The focus is on the integration of MRI and linear accelerator technology for image-guided radiation therapy.
Yes
The device is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions, which directly treats medical conditions, making it a therapeutic device.
No
The device is described as a Linac System intended to provide stereotactic radiosurgery and precision radiotherapy, which are treatment modalities, not diagnostic ones. It delivers ionizing radiation and uses MRI for image guidance during treatment, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a system consisting of three primary subsystems: a Treatment Planning and Delivery System (TPDS), a Magnetic Resonance Imaging System (MRIS), and a Radiation Therapy Delivery System (RDS). These are hardware components. While it includes software, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated." This describes a therapeutic device that delivers radiation to treat conditions within the body.
- Device Description: The description details a system that delivers ionizing radiation using a linear accelerator and an MRI for image guidance during treatment. This is consistent with a radiation therapy device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.) or providing diagnostic information based on such analysis. The focus is on delivering treatment guided by imaging.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver radiation therapy, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
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.
Product codes
IYE
Device Description
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)
- The Radiation Therapy Delivery System (RDS)
These three subsystems are designed to operate concurrently for accurate targeted administration of radiation therapy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic resonance imaging
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained clinicians
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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 (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
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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.
-
- 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
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- 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
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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
K111862 | Device with Change
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 are 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 the 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 based on the
recommendations of Palta et
al.). | 90% of the 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 based on the
recommendations of Palta et
al.). |
| Moving Target Dose
Accuracy | Dose delivery on a moving target
is consistent within ≤ 2 % to
that of a stationary target with
the use of real time tumor
tracking (RealTarget). | Dose delivery on a moving target
is consistent within ≤ 2 % to
that of a stationary target with
the use of 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 |
Performance specifications of the MRIdian Linac and predicate device are noted in the table below:
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| Integrated imaging for
planning, positioning,
gating | Magnetic resonance imaging
system | Magnetic resonance imaging
system | |
|------------------------------------------------------------|--------------------------------------|--------------------------------------|--|
| MR Physical
Characteristics | | | |
| Bore Diameter | 700 mm | 700 mm | |
| Diameter Spherical
Volume (DSV) | 500 mm | 500 mm | |
| Patient table degrees of
freedom | 3 translational | 3 translational | |
| MRI Frequency | 14.7 MHz | 14.7 MHz | |
| Field Strength | 0.345 T | 0.345 T | |
| Field of View
500 mm | | 500 mm | |
| Field Homogeneity |