Aurora-RT

K213526 · Magnettx Oncology Solutions , Ltd. · IYE · May 4, 2022 · Radiology

Device Facts

• Record ID: K213526
• Device Name: Aurora-RT
• Applicant: Magnettx Oncology Solutions , Ltd.
• Product Code: IYE · Radiology
• Decision Date: May 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aurora-RT, with magnetic resonance imaging capabilities, is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Device Story

Aurora-RT is an image-guided radiation therapy (IGRT) system combining a 6 MV medical linear accelerator (Linac) and a 0.5 T cryogenless superconducting MRI system. The device features a rotating gantry frame with a rotating biplanar magnet design, aligning the magnetic field parallel to the radiation beam. Operated by radiation oncology professionals in a clinical setting, the system uses MRI for patient positioning prior to radiation delivery, replacing CT-based positioning. The MRI provides superior soft tissue contrast without ionizing radiation. The Linac delivers intensity-modulated radiotherapy (IMRT) using a tungsten alloy multi-leaf collimator (MLC) and sliding window/step-and-shoot dynamic delivery. The healthcare provider uses the integrated imaging to verify patient position, ensuring precise radiation targeting. The device benefits patients by enabling high-precision treatment of tumors while minimizing exposure to surrounding healthy tissue through improved soft tissue visualization.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included verification and validation of design requirements, software verification, and conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-1, IEC 60601-2-33, IEC 61217, IEC 62304, and IEC 62366-1. Dosimetry accuracy was verified against AAPM TG 119 recommendations.

Technological Characteristics

Linac-MR system; 6 MV linear accelerator; 0.5 T cryogenless superconducting MRI; rotating biplanar magnet; tungsten alloy MLC (120 leaves); 120 cm isocenter distance; 600 cGy/min max dose rate. Connectivity: Integrated imaging for positioning. Software: Major level of concern. Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-1, 60601-2-33, 61217, 62304, 62366-1.

Indications for Use

Indicated for patients requiring precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Regulatory Classification

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.

Predicate Devices

• ViewRay MRIdian Linac System with 138-leaf Collimator (K170751)

Reference Devices

• ViewRay Treatment Planning and Delivery System (K102915)

Submission Summary (Full Text)

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MagnetTx Oncology Solutions Ltd. % Mr. Michael Cook Lead Regulatory Engineer 9505 41 Avenue NW Edmonton, Alberta T6E 5X7 CANADA

## Re: K213526

Trade/Device Name: Aurora-RT Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, LNH Dated: April 1, 2022 Received: April 4, 2022

Dear Mr. Cook:

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

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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-reportingcombination-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Julie Sullivan, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K213526

Device Name Aurora-RT

Indications for Use (Describe)

The Aurora-RT, with magnetic resonance imaging capabilities, is intended to provide 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(K) SUMMARY 5

The following information is provided for Aurora-RT in accordance with 21 CFR 807.92.

| Submitter | MagnetTx Oncology Solutions Ltd.<br>9505 41 Avenue NW<br>Edmonton, Alberta T6E 5X7 Canada<br>Telephone: [phone] |
|-----------------------|----------------------------------------------------------------------------------------------------------------------|
| Primary Contact | Michael Cook<br>Lead Regulatory Engineer<br>Telephone: [phone]<br>[e-mail] |
| Secondary Contact | Brad Murray<br>Chief Technology Officer<br>Telephone: [phone]<br>[e-mail] |
| Date Summary Prepared | March 31, 2022 |

#### Submitter Information 5.1

#### Device Identification 5.2

| Trade Name | Aurora-RT |
|----------------------|--------------------------------------------------------------------------|
| Common Name | Medical Linear Accelerator with Magnetic Resonance Image Guidance |
| Classification Name | Accelerator, Linear, Medical; System, Nuclear Magnetic Resonance Imaging |
| Classification Panel | Radiology |
| Regulation | 21 CFR 892.5050, 21 CFR 892.1000 |
| Device Class | Class II |
| Product Code | IYE, LNH |

#### Predicate Device 5.3

ViewRay MRIdian Linac System with 138-leaf Collimator (K170751)

#### 5.4 Device Description

Aurora-RT is a medical device for image-guided radiation therapy (IGRT) that combines magnetic resonance imaging (MRI) with radiotherapy technology. It combines a 6 MV medical linear accelerator (Linac) and 0.5 T cryogenless superconducting MRI system mounted in a rotating gantry frame. The MR imaging capability is utilized for positioning the patient at the start of radiation therapy in place of computed tomography (CT) imaging that is commonly used in radiation therapy. MR imaging offers superior soft tissue contrast compared to CT and does not utilize ionizing radiation as with CT images.

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#### 5.5 Intended Use

The Aurora-RT, with magnetic resonance imaging capabilities, is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

#### Indications for Use 5.6

The Aurora-RT, with magnetic resonance imaging capabilities, is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

#### 5.7 Substantial Equivalence

The Aurora-RT is substantially equivalent to the predicate device, the ViewRay MRIdian Linac System with 138-leaf Collimator (K170751), based on the intended use, indications for use, technological comparison, and performance data.

#### Technological Characteristics 5.8

The Aurora-RT uses the same fundamental technology as that of the ViewRay MRIdian Linac System: they are both Linac-MR devices that combine a 6 MV Linac and MRI system. The Aurora-RT and ViewRay MRIdian Linac System both use the same 6 MV photon energy for treatment delivery and the MRI systems have substantially equivalent magnetic fields (0.5 T for Aurora-RT vs 0.345 T for ViewRay MRIdian Linac System). The Aurora-RT, like the ViewRay MRIdian Linac System, provides intensitymodulated radiotherapy (IMRT) and is intended to be used by radiation oncology professionals.

The main technological difference between the two devices is that Aurora-RT utilizes a rotating biplanar magnet, which puts the main magnetic field parallel to the radiation beam. The ViewRay MRIdian Linac System uses a stationary Helmholtz-type magnet where the magnetic field is perpendicular to the radiation beam.

The main technological characteristics of Aurora-RT are compared to the ViewRay MRIdian Linac System in the table below, with the technological characteristics organized by the two main functionalities of the devices: Linac and MRI.

| Parameter | Proposed Device: Aurora-RT | Predicate Device: ViewRay<br>MRIdian Linac System (K170751) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Linac | | |
| Radiation Source | 6 MV Linear Accelerator | 6 MV Linear Accelerator |
| Beam | 6 MV Bremsstrahlung X-Rays<br>produced by Linear Accelerator | 6 MV Bremsstrahlung X-Rays<br>produced by Linear Accelerator |
| Max Dose Rate | 600 cGy/min at Dmax at 120 cm<br>isocenter for a 10 x 10 cm² field | 600 cGy/min at Dmax at 90 cm<br>isocenter for a 10 x 10 cm² field |
| Parameter | Proposed Device: Aurora-RT | Predicate Device: ViewRay<br>MRIdian Linac System (K170751) |
| Static Dose Accuracy | 90% of the points evaluated in a<br>treatment volume pass a gamma<br>criteria of 3%/3mm. | 90% of the points evaluated in a<br>treatment volume pass a relative<br>gamma criteria of 3%/3mm and a<br>high dose, low gradient absolute<br>point measurement is within 5% of<br>the planned dose (per AAPM TG<br>119 based on the recommendations<br>of Palta et al.). |
| Collimation | Multi-Leaf Collimator (MLC) and 2<br>independent Y jaws | Multi-Leaf Collimator (MLC) in two<br>banks |
| Projected MLC Leaf<br>Width | 0.475 cm | 0.83 cm |
| Number of MLC Leaves | 120 (single bank) | 138 (68 in upper bank, 70 in lower<br>bank) |
| MLC Material | Tungsten Alloy | Tungsten Alloy |
| Isocenter Distance | 120 cm | 90 cm |
| Isocenter Accuracy | 1 mm diameter | 1 mm diameter |
| Radiation Head<br>Shielding | Lead and Steel Shielding | Lead, Tungsten Alloy, and Steel<br>Shielding |
| Dosimetry System | Redundant ion chambers and<br>dosimetry circuits | Redundant ion chambers and dose<br>monitoring cards |
| Radiation Transmission<br>through the head | Less than 0.1% of the primary beam | Less than 0.1% of the primary beam |
| Method of IMRT | Sliding Window and Step and Shoot<br>dynamic MLC | MLC based cone-beam delivery |
| Gantry | Rotating Gantry with front and back<br>bearings | Ring Gantry, collision with patient<br>not possible |
| Patient table degrees of<br>freedom | 3 translational | 3 translational |
| Motion Synchronized<br>Treatment | Not applicable | Yes (Gating utilized) |
| Linac Configuration | Rotates in tandem with magnet<br>(fixed with respect to magnet) | Rotates about stationary magnet |
| Parameter | Proposed Device: Aurora-RT | Predicate Device: ViewRay<br>MRIdian Linac System (K170751) |
| Treatment Planning<br>System | Treatment planning with existing<br>cleared TPS | Treatment Planning and Delivery<br>System (K102915 ViewRay) Monte<br>Carlo Dose Computation Radiation<br>Source Model for Bremsstrahlung X-<br>Rays |
| Dose Output Modeling | Dose output modeled with monitor<br>units | Dose output modeled with monitor<br>units |
| Dose Display | Display of Linac delivery parameters | Display of Linac delivery parameters |
| MRI | | |
| Integrated imaging | Magnetic Resonance Imaging<br>System (for positioning only prior to<br>treatment start) | Magnetic Resonance Imaging<br>System (for planning, positioning,<br>and gating) |
| MR Configuration | Rotating biplanar magnet (open<br>magnet design) | Stationary Helmholtz-type magnet |
| Magnetic field/Linac<br>Beam alignment | Parallel | Perpendicular |
| Bore Diameter | 600 mm x 1100 mm (600 mm pole-<br>to-pole spacing) ellipse defined by<br>pole plates and front bearing | 700 mm circle |
| Diameter Spherical<br>Volume (DSV) | 400 mm | 500 mm |
| MRI Frequency | 20.6 MHz | 14.7 MHz |
| Field Strength | 0.5 T | 0.345 T |
| Field of View | 400 mm | 500 mm |
| Field Homogeneity | < 38 ppm (VRMS) measured over<br>400 mm DSV | < 25 ppm measured over 450 mm<br>DSV |
| Field Stability Control | Active control | Persistent superconducting magnet |
| Field Stability | < 0.1 ppm/min under active power<br>supply control | < 0.1 ppm/hour |
| 3D Imaging Volumes<br>[cm] | RL x AP x HF | RL x AP x HF |
| | Min 10 x 10 x 4 | Min 20 x 27 x 29 |
| | Max 40 x 40 x 30 | Max 54 x 48 x 54 |
| 3D Imaging Resolution<br>[cm] | RL x AP x HF | RL x AP x HF |
| | Min 0.04 x 0.04 x 0.04 | Min 0.075 x 0.075 x 0.15 |
| | Max 0.16 x 0.16 x 0.27 | Max 0.3 x 0.3 x 0.3 |
| Parameter | Proposed Device: Aurora-RT | Predicate Device: ViewRay<br>MRIdian Linac System (K170751) |
| Geometric Accuracy | < 1.0 mm VRMS over 20 cm DSV | 2 mm over 35 cm FOV<br>1 mm over 20 cm FOV |
| Signal to Noise Ratio | > 30 | 30 |
| Imaging Dose per<br>treatment | None | None |

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# 5.9 Summary of Performance Testing

Comprehensive performance testing has shown that the few differences in technological characteristics between Aurora-RT and the predicate device do not affectiveness of Aurora-RT for its intended use. Design control procedures applied to the development of Aurora-RT, including verification and validation testing, are in compliance with 21 CFR 820 FDA Quality System Regulation, ISO 13485 Medical devices – Quality management systems – Requirements for requlatory purposes, and ISO 14971 Medical devices – Application of risk management to medical devices.

The performed testing demonstrated conformance to design requirements and recognized consensus standards and ensured all identified risks and hazards were mitigated.

Software verification testing was conducted and documented in accordance with the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for devices that pose a major level of concern.

Basic safety and essential performance have been satisfied through conformance with device-specific recognised consensus standards, as well as applicable general and collateral safety and essential performance standards for medical devices. The Aurora-RT has been found to conform to the medical device safety standards presented in the table below.

| Standard No. | Edition (Year) | Title |
|---------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 | 3.1 (2012) | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance |
| IEC 60601-1-2 | 4 (2014) | Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral Standard:<br>Electromagnetic disturbances - Requirements and tests |
| IEC 60601-1-6 | 3.1 (2013) | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability |
| IEC 60601-2-1 | 3.1 (2014) | Medical electrical equipment - Part 2-1: Particular requirements<br>for the basic safety and essential performance of electron<br>accelerators in the range 1 MeV to 50 MeV |

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| Standard No. | Edition (Year) | Title |
|----------------|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-33 | 3.2 (2015) | Medical electrical equipment - Part 2-33: Particular requirements<br>for the basic safety and essential performance of magnetic<br>resonance equipment for medical diagnosis |
| IEC 61217 | 2 (2011) | Radiotherapy equipment - Coordinates, movements and scales |
| IEC 62304 | 1.1 (2015) | Medical device software - Software life cycle processes |
| IEC 62366-1 | 1 (2015) | Medical devices - Part 1: Application of usability engineering to<br>medical devices |

## 5.10 Conclusion

Verification and validation testing demonstrated that the Aurora-RT met established standards and design requirements. The differences between the Aurora-RT and the predicate device do not raise any new concerns of safety or effectiveness and do not negatively impact the device's performance for its intended use. Therefore, the Aurora-RT is substantially equivalent to the predicate device.