(181 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or algorithms that would typically indicate the presence of AI/ML. The focus is on the integration of MRI and Linac technology for image-guided radiation therapy.
Yes
The device is intended to provide precision radiotherapy for lesions, tumors, and conditions, which is a treatment for medical conditions.
No.
The device combines MRI with radiation therapy for precision treatment delivery, primarily using MRI for patient positioning, and is not described as diagnosing diseases or conditions.
No
The device description explicitly states that Aurora-RT combines a linear accelerator and an MRI system mounted in a rotating gantry frame, which are hardware components. While it includes software, it is not a software-only device.
Based on the provided information, the Aurora-RT device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Aurora-RT's Function: The Aurora-RT is a system for delivering radiation therapy directly to a patient's body. It uses MRI for imaging within the body to guide this treatment.
- Intended Use: The intended use clearly states it's for providing precision radiotherapy for lesions, tumors, and conditions anywhere in the body. This is a therapeutic application, not a diagnostic test performed on a sample outside the body.
- Device Description: The description confirms it's an image-guided radiation therapy (IGRT) device that combines MRI and radiotherapy technology. This is a treatment delivery system.
Therefore, the Aurora-RT falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE, LNH
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.
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
radiation oncology professionals
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)
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.
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.
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
§ 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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.
9505 41 Avenue NW
Edmonton, Alberta T6E 5X7 Canada
Telephone: 587-458-1162 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------|
| Primary Contact | Michael Cook
Lead Regulatory Engineer
Telephone: 587-458-1162
michael.cook@magnettx.com |
| Secondary Contact | Brad Murray
Chief Technology Officer
Telephone: 780-886-6728
brad.murray@magnettx.com |
| 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.
Page 5-2 of 5-7
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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
MRIdian Linac System (K170751) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Linac | | |
| Radiation Source | 6 MV Linear Accelerator | 6 MV Linear Accelerator |
| Beam | 6 MV Bremsstrahlung X-Rays
produced by Linear Accelerator | 6 MV Bremsstrahlung X-Rays
produced by Linear Accelerator |
| Max Dose Rate | 600 cGy/min at Dmax at 120 cm
isocenter for a 10 x 10 cm² field | 600 cGy/min at Dmax at 90 cm
isocenter for a 10 x 10 cm² field |
| Parameter | Proposed Device: Aurora-RT | Predicate Device: ViewRay
MRIdian Linac System (K170751) |
| Static Dose Accuracy | 90% of the points evaluated in a
treatment volume pass a gamma
criteria of 3%/3mm. | 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.). |
| Collimation | Multi-Leaf Collimator (MLC) and 2
independent Y jaws | Multi-Leaf Collimator (MLC) in two
banks |
| Projected MLC Leaf
Width | 0.475 cm | 0.83 cm |
| Number of MLC Leaves | 120 (single bank) | 138 (68 in upper bank, 70 in lower
bank) |
| MLC Material | Tungsten Alloy | Tungsten Alloy |
| Isocenter Distance | 120 cm | 90 cm |
| Isocenter Accuracy | 1 mm diameter | 1 mm diameter |
| Radiation Head
Shielding | Lead and Steel Shielding | Lead, Tungsten Alloy, and Steel
Shielding |
| Dosimetry System | Redundant ion chambers and
dosimetry circuits | Redundant ion chambers and dose
monitoring cards |
| Radiation Transmission
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
dynamic MLC | MLC based cone-beam delivery |
| Gantry | Rotating Gantry with front and back
bearings | Ring Gantry, collision with patient
not possible |
| Patient table degrees of
freedom | 3 translational | 3 translational |
| Motion Synchronized
Treatment | Not applicable | Yes (Gating utilized) |
| Linac Configuration | Rotates in tandem with magnet
(fixed with respect to magnet) | Rotates about stationary magnet |
| Parameter | Proposed Device: Aurora-RT | Predicate Device: ViewRay
MRIdian Linac System (K170751) |
| Treatment Planning
System | Treatment planning with existing
cleared TPS | Treatment Planning and Delivery
System (K102915 ViewRay) Monte
Carlo Dose Computation Radiation
Source Model for Bremsstrahlung X-
Rays |
| Dose Output Modeling | Dose output modeled with monitor
units | Dose output modeled with monitor
units |
| Dose Display | Display of Linac delivery parameters | Display of Linac delivery parameters |
| MRI | | |
| Integrated imaging | Magnetic Resonance Imaging
System (for positioning only prior to
treatment start) | Magnetic Resonance Imaging
System (for planning, positioning,
and gating) |
| MR Configuration | Rotating biplanar magnet (open
magnet design) | Stationary Helmholtz-type magnet |
| Magnetic field/Linac
Beam alignment | Parallel | Perpendicular |
| Bore Diameter | 600 mm x 1100 mm (600 mm pole-
to-pole spacing) ellipse defined by
pole plates and front bearing | 700 mm circle |
| Diameter Spherical
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 | 30 | 30 |
| Imaging Dose per
treatment | None | None |
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Image /page/5/Picture/0 description: The image shows the logo for MagnetTx. The logo features a stylized letter "M" formed by three parallel lines in a light green color, with the lines converging at the bottom. To the right of the green lines, there are three parallel lines in a purple color, also converging at the bottom. Below the lines, the word "MagnetTx" is written in a sans-serif font.
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Image /page/7/Picture/0 description: The image shows a logo for MagnetTx. The logo features a stylized letter "M" formed by several parallel lines. The left side of the "M" is colored in a light green or teal shade, while the right side is colored in a purple hue. Below the graphic is the text "MagnetTx" in a simple, sans-serif font, with the first letter capitalized.
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 |
| basic safety and essential performance | ||
| IEC 60601-1-2 | 4 (2014) | Medical electrical equipment - Part 1-2: General requirements for |
| basic safety and essential performance - Collateral Standard: | ||
| Electromagnetic disturbances - Requirements and tests | ||
| IEC 60601-1-6 | 3.1 (2013) | Medical electrical equipment - Part 1-6: General requirements for |
| basic safety and essential performance - Collateral standard: | ||
| Usability | ||
| IEC 60601-2-1 | 3.1 (2014) | 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 |
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| Standard No. | Edition (Year) | Title |
|---|---|---|
| IEC 60601-2-33 | 3.2 (2015) | Medical electrical equipment - Part 2-33: Particular requirements |
| for the basic safety and essential performance of magnetic | ||
| 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 |
| 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.