Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or components that would typically indicate the use of AI/ML.

Therapeutic

Yes
The device is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions, which are therapeutic interventions.

Diagnostic

No

Explanation: The device is described as a "Linac system" and "radiotherapy system" intended for "radiation treatment" and "targeted administration of radiation therapy." Its purpose is to deliver treatment, not to diagnose conditions. While it uses imaging (MRI) for guidance, this is for real-time treatment delivery, not for diagnosing the initial lesion or tumor.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "system" consisting of a linear accelerator, a magnetic resonance imaging system, and a treatment planning and delivery system, all of which are hardware components.

IVD (In Vitro Diagnostic)

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 uses a linear accelerator to deliver ionizing radiation and an MRI system for image guidance during treatment. This is consistent with a radiation therapy device, not a device that analyzes samples in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The focus is on delivering treatment guided by imaging.

IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to treat disease using radiation, not to diagnose it by analyzing samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 in the body where radiation treatment is indicated.

Product codes (comma separated list FDA assigned to the subject device)

IYE, LNH

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.

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

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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."

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

MRIdian Linac System K181989

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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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

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K212958

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)

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Section 6: 510(k) Summary

The information provided for the modified MRIdian Linac system, following the format of 21 CFR 807.92.

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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 Incorporated
815 E. Middlefield Road
Mountain View, CA 94043 USA
Primary Contact Person:	Sean Delaney
(650) 252-0969
sdelaney@viewray.com
Secondary Contact Person:	Elizabeth Osuna
(408) 431-1046
eosuna@viewray.com
Common or Usual Name:	Medical Linear Accelerator
Regulatory Name:	21 CFR 892.5050
Classification Name:	Medical charged-particle radiation therapy
system
Product Code:	IYE, LNH
Primary Predicate Device:	MRIdian Linac System
K181989

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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.

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Summary of Technological Characteristics

| Device

Characteristic	Predicate Device	Subject Device	Comparison
Radiation Source
Nominal Beam
Energy	6 MV	6 MV	Same
Isocenter Distance	90 cm	90 cm	Same
Nominal Dose Rate	600 MU/min	600 MU/min	Same
Collimation
Radiation Field
Sizes	2 mm x 4.15 mm
to 27.4 x 24.1 cm
projected by
isocenter	2 mm x 4.15 mm
to 27.4 x 24.1 cm
projected by
isocenter	Same
Primary
Collimation Method	138-leaf MLC	138-leaf MLC	Same
Resolution at
isocenter	Each leaf projects
with a nominal
width of 0.83 cm
at 90 cm SAD. The
double- stack MLC
uses an offset
between the top
and bottom stack
to achieve a
nominal effective
leaf width of 0.415
cm at 90 cm SAD.	Each leaf projects
with a nominal
width of 0.83 cm
at 90 cm SAD. The
double- stack MLC
uses an offset
between the top
and bottom stack
to achieve a
nominal effective
leaf width of 0.415
cm at 90 cm SAD.	Same
Collimation
Transition Time	MLC leaf speed of
4 cm/s at isocenter	MLC leaf speed of
4 cm/s at isocenter	Same
Imaging
Energy/Type	0.345 Tesla
superconducting
MRI	0.345 Tesla
superconducting
MRI	Same
Device
Characteristic	Predicate Device	Subject Device	Comparison
Field of View Size	50 cm diameter
spherical volume
(DSV)	50 cm diameter
spherical volume
(DSV)	Same
Contrast
Resolution	Complies with IEC
60601-2-33	Complies with IEC
60601-2-33	Same
Spatial Resolution	Volume scans:
Min 0.075 x 0.075
x 0.15	Volume scans:
Min 0.075 x 0.075
x 0.075	Volume scans:
Minimum
longitudinal
resolution from
0.15 to 0.75.
	Max 0.3 x 0.3 x
0.3	Max 0.3 x 0.3 x
0.3
	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 three
planes: 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; body
0.35 x 0.35; body
Dose	None	None	Same
Physical
Geometry
Bore size	The system has a
diameter of 70 cm
nominal	The system has a
diameter of 70 cm
nominal	Same
Room Dimensions	The MRIdian Linac
minimum vault
size with finishes is	The MRIdian Linac
minimum vault
size with finishes is	Same
Device
Characteristic	Predicate Device	Subject Device	Comparison
	19' 2" wide by x
24' 8" long [5.9 m
x 6.93 m]. The
minimum finished
ceiling height over
the footprint of
system is 9' 6"
[2.9 m] to allow
for clearance of
system covers
which are 9' 4"	19' 2" wide by x
24' 8" long [5.9 m
x 6.93 m]. The
minimum finished
ceiling height over
the footprint of
system is 9' 6"
[2.9 m] to allow
for clearance of
system covers
which are 9' 4"
Patient Couch -
Degrees of
Freedom	3D shifts and
shifted values are
within ± 0.1 cm in
each dimension	3D shifts and
shifted values are
within ± 0.1 cm in
each dimension	Same
Patient Surface -
Biocompatibility	Complies with ISO
10993-1	Complies with ISO
10993-1	Same

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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.

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| Rec. # | Standards
Developing
Organization | Standard
Designation
Number and
Date | Title of Standard |
|--------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | ANSI AAMI | ES60601-
1:2005/(R)20
12 and
A1:2012,
C1:2009/(R)2
012 and
A2:2010/(R)2
012
(Consolidated
Text) | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD) |
| 19-8 | ANSI AAMI
IEC | 60601-1-
2:2014 | Medical electrical equipment -- Part 1-2: General
requirements for basic safety and essential
performance -- Collateral Standard: Electromagnetic
disturbances -- Requirements and tests |
| 19-8 | EC | 60601-1-2
Edition 4.0
2014-02 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests |
| 12-285 | IEC | 60601-2-1
Edition 3.0 | Medical electrical equipment - Part 2-1: Particular
requirements for the basic safety and essential
performance of electron accelerators in the range 1
MeV to 50 MeV |
| 12-295 | IEC | 60601-2-33
Ed. 3.2
b:2015 | Medical electrical equipment - Part 2-33: Particular
requirements for the basic safety and essential
performance of magnetic resonance equipment for
medical diagnosis |
| 12-267 | IEC | 61217 Edition
2.0 2011-12 | Radiotherapy equipment - Coordinates, movements,
and scales |
| 12-217 | IEC | 62083 Edition
2.0 2009-09 | Medical electrical equipment - Requirements for the
safety of radiotherapy treatment planning systems |
| 13-79 | ANSI AAMI
IEC | 62304:2006/A
1:2016 | Medical device software - Software life cycle
processes [Including Amendment 1 (2016)] |
| 13-79 | IEC | 62304 Edition
1.1 2015-06
CONSOLIDAT
ED VERSION | Medical device software - Software life cycle
processes |
| 5-114 | ANSI AAMI
IEC | 62366-1:2015 | Medical devices - Part 1: Application of usability
engineering to medical devices |
| Rec. # | Standards
Developing
Organizatio
n | Standard
Designation
Number and
Date | Title of Standard |
| | IEC | 62366-1
Edition 1.0
2015-02 | Medical devices - Part 1: Application of usability
engineering to medical devices [Including
CORRIGENDUM 1 (2016)] |
| 5-89 | IEC | 60601-1-6
Edition 3.1
2013-10 | Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability |
| 12-253 | IEC | 60976 Edition
2.0 2007-10 | Medical electrical equipment - Medical electron
accelerators - Functional performance characteristics |
| 2-258 | ANSI AAMI
ISO | 10993-1:
2018 | Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process |
| | ISO | 10993-1 Fifth
edition 2018-
08 | Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process |

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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.