Elekta Unity

K192482 · Elekta Limited · IYE · Dec 5, 2019 · Radiology

Device Facts

• Record ID: K192482
• Device Name: Elekta Unity
• Applicant: Elekta Limited
• Product Code: IYE · Radiology
• Decision Date: Dec 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

Device Story

Elekta Unity is a multifunctional digital linear accelerator (linac) integrating a 1.5T MRI scanner for image-guided radiation therapy (IGRT). It delivers 7MV photon beams via a split-magnet design, allowing simultaneous imaging and treatment. The device captures cross-sectional MR images before, during, and after radiation delivery to assist in patient positioning, treatment planning, and motion monitoring. New functionality includes single-shot EPI diffusion-weighted imaging (DWI) with automatic ADC/eADC map generation for off-line review. Operated by radiation oncology staff in clinical settings, the system uses GPU-based Monte Carlo dose calculation (MONACO) to guide treatment delivery. Physicians interpret MR images to verify tumor location and anatomy, enabling precise radiation targeting. The integration of real-time MRI guidance aims to improve treatment accuracy and patient outcomes by accounting for anatomical changes and tumor motion.

Clinical Evidence

Bench testing only. Verification and validation performed at sub-system, integration, and system levels per FDA guidance and consensus standards (IEC 60601 series, ISO 10993-1). Image quality validated by US Board Certified Diagnostic Radiologists confirming diagnostic utility. No clinical patient outcome data presented.

Technological Characteristics

1.5T MRI integrated with 7MV linear accelerator; split-magnet design. MLC (tungsten alloy, 80 leaf pairs). GPU-based Monte Carlo dose calculation. Connectivity: compatible with Treatment Planning and Oncology Information Systems. Standards: IEC 60601-1, IEC 60601-2-1, IEC 60601-2-33, IEC 60976, IEC 62304 (Class C software).

Indications for Use

Indicated for radiation therapy and stereotactic radiation treatments of malignant and benign diseases in patients of any age/gender, as determined by a licensed medical practitioner.

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

• Elekta Unity (K182076)

Submission Summary (Full Text)

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December 5, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

Elekta Limited % Mr. Nicholas Power RA Director Linac House Fleming Way Crawley, West Sussex RH10 9RR UNITED KINGDOM

Re: K192482

Trade/Device Name: Elekta Unity Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, LNH Dated: September 11, 2019 Received: September 13, 2019

Dear Mr. Power:

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

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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-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 mediation-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,

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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## Indications for Use

510(k) Number (if known) K192482

Device Name Elekta Unity

#### Indications for Use (Describe)

Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.

Elekta Unity is intended for use with the compatible Treatment Planning and Oncology Information Systems.

The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) SUMMARY

K192482

as required by 21 CFR 807.92

| Date of preparation: | August 28, 2019 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Elekta Limited<br>Linac House, Fleming Way, Crawley, West Sussex<br>RH10 9RR, United Kingdom<br>Telephone: [phone]<br>Fax: [phone] |
| Contact name: | Nicholas Power |
| Name of Device: | Elekta MR-Linac |
| Trade / Proprietary Name: | Elekta Unity |
| Common or Usual Name: | Image-Guided Radiation Therapy System |
| Classification Name: | Medical charged-particle radiation therapy system, 21CFR 892.5050 |
| Product Code: | IYE, LNH |
| Device classification name: | Accelerator, Linear, Medical |
| Predicate Device: | Elekta Unity, K182076 |

## Product Description:

Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT).

The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment.

When interpreted by a trained physician the images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

In addition to the MRI sequences cleared with the predicate device, the current Elekta Unity configuration has the ability to generate images using following techniques, before, during or after treatment for Off-line review:

- Single-shot EPI diffusion imaging (DWI) with 3 diffusion directions and up to 16 b-values.
- . Diffusion imaging processing with automatic generation of the ADC and/or eADC maps.

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## Intended Use:

Elekta Unity using information from Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

## Indications for Use Statement:

Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during and after the radiotherapy treatment.

When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

## Substantial Equivalence:

Elekta Unity is substantially equivalent (SE) to the predicate device, Elekta Unity (K182076), in intended use and indications for use, principles of operation, technological characteristics and labeling. The differences in imaging functionality between the two devices do not affect the fundamental scientific technology. The device safety and performance have been addressed by non-clinical testing in conformance with predetermined performance criteria, FDA guidance, and recognised consensus standards.

## Summary of Technological Characteristics:

Elekta Unity is designed specifically to facilitate IGRT. Both, current and predicate device configurations use the same medical linear accelerator (linac) to deliver photon energies and dose rates for targeted external beam radiation therapy using established magnetic resonance imaging technology for image guidance. Both devices rely on the same split magnet design to create an area of reduced X-ray attenuation for the treatment beam. Both devices use the same specifically designed software systems for treatment planning and delivery.

The similarities and differences in key device characteristics and performance specifications of the current and predicate Elekta Unity device configuration are noted in the table below:

| Device<br>Characteristic | Elekta Unity<br>(Predicate Device, K182076) | Elekta Unity<br>(Current Device) | Comparison |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Radiation Source /<br>Beam | 7MV Bremsstrahlung X- Rays<br>Produced by Linear Accelerator | 7MV Bremsstrahlung X- Rays<br>Produced by Linear Accelerator | Same |
| Method of IMRT | MLC based cone-beam delivery | MLC based cone-beam delivery | Same |
| Collimation | Field shaping, Multi Leaf<br>Collimator (MLC) | Field shaping, Multi Leaf<br>Collimator (MLC) | Same |
| MLC material | Tungsten Alloy | Tungsten Alloy | Same |
| Device<br>Characteristic | Elekta Unity<br>(Predicate Device, K182076) | Elekta Unity<br>(Current Device) | Comparison |
| Number of leaves | 80 leaf pairs | 80 leaf pairs | Same |
| Range of MLC<br>collimated beam<br>size @ isocenter | 0.5 cm x 0.5 cm to<br>57.4 cm x 22 cm | 0.5 cm x 0.5 cm to<br>57.4 cm x 22 cm | Same |
| Gantry | Ring Gantry, collision with<br>patient not possible | Ring Gantry, collision with patient<br>not possible | Same |
| Radiation Head<br>Shielding | Lead, Tungsten Alloy, and Steel<br>shielding | Lead, Tungsten Alloy, and Steel<br>shielding | Same |
| Source control<br>mechanism | Dual channel dose monitoring<br>system | Dual channel dose monitoring<br>system | Same |
| Radiation<br>Transmission<br>through head | 0.2% of the primary beam | 0.2% of the primary beam | Same |
| Isocenter distance | 143.5 cm | 143.5 cm | Same |
| Isocenter accuracy<br>(Radius) | 0.5mm | 0.5mm | Same |
| Max Dose Rate | Clinical use: 450 cG/min at<br>isocentre at Dmax for a 10 cm x<br>10 cm field<br>(500 MU/min @ isocentre<br>measured at Dmax) | Clinical use: 450 cG/min at<br>isocentre at Dmax for a 10 cm x<br>10 cm field<br>(500 MU/min @ isocentre<br>measured at Dmax) | Same |
| Static Dose<br>Accuracy | >95% of points passing 3%/3mm<br>in the high dose, low gradient<br>region.<br>>95% passing 5mm/5% for low<br>dose, high gradient points. | >95% of points passing 3%/3mm<br>in the high dose, low gradient<br>region.<br>>95% passing 5mm/5% for low<br>dose, high gradient points.<br>1% agreement for output factors. | Same |
| Motion<br>synchronized<br>treatment | No - Manual interrupt only | No - Manual interrupt only | Same |
| Patient table<br>degrees of<br>freedom | 2 (vertical & longitudinal) –<br>positional corrections are made<br>using the online adaptive<br>planning interface of the<br>treatment planning system | 2 (vertical & longitudinal) –<br>positional corrections are made<br>using the online adaptive<br>planning interface of the<br>treatment planning system | Same |
| Integrated imaging<br>for planning,<br>positioning, gating | Magnetic resonance imaging<br>system - for planning, positioning<br>and motion monitoring during<br>treatment | Magnetic resonance imaging<br>system - for planning, positioning<br>and motion monitoring during<br>treatment | Same |
| MR Physical<br>Characteristics | | | Same |
| Device<br>Characteristic | Elekta Unity<br>(Predicate Device, K182076) | Elekta Unity<br>(Current Device) | Comparison |
| Bore Diameter | 700 mm | 700 mm | |
| Diameter Spherical<br>Volume | 500mm x 500mm x 450mm | 500mm x 500mm x 450mm | |
| MRI Frequency | 64 MHz | 64 MHz | Same |
| Field Strength | 1.5T | 1.5T | |
| Field of View | Up to 500 mm Sequence<br>dependent | Up to 500 mm Sequence<br>dependent | |
| Field Homogeneity | ≤ 2 ppm measured over 50 cm x<br>50 cm x 45 cm volume | ≤ 2 ppm measured over 50 cm x<br>50 cm x 45 cm volume | |
| Field Stability | ≤ 0.1 ppm/hr | ≤ 0.1 ppm/hr | |
| 3D Imaging<br>Volumes (cm) | RL x AP x HF<br>Min 0.5 x 0.5 x 0.8<br>Max 56 x 56 x 40 (Anterior coil<br>dependent) | RL x AP x HF<br>Min 0.5 x 0.5 x 0.8<br>Max 56 x 56 x 40 (Anterior coil<br>dependent) | Same |
| 3D Imaging<br>Resolution (cm) | Min 0.01 x 0.01 x 0.1<br>Max 0.875 x 0.875 x 1 | Min 0.01 x 0.01 x 0.1<br>Max 0.875 x 0.875 x 1 | |
| 2D Imaging Planes<br>(cm) | AP x HF<br>Min 0.5 x 0.5<br>Max 56 x 56 | AP x HF<br>Min 0.5 x 0.5<br>Max 56 x 56 | |
| 2D Imaging<br>Resolution (mm) | Resolution selectable:<br>0.011 x 0.011 mm (min)<br>8.75 x 8.75 mm (max) | Resolution selectable:<br>0.011 x 0.011 mm (min)<br>8.75 x 8.75 mm (max) | |
| | Slice thickness selectable:<br>0.01 mm (min); 705 mm (max) | Slice thickness selectable:<br>0.01 mm (min); 705 mm (max) | |
| Geometric<br>Accuracy | <=1 mm over 20 cm FOV<br>(Guaranteed)<br><=2 mm over 34 cm FOV<br>(Guaranteed)<br><=2 mm over 42 cm FOV<br>(Typical) | <=1 mm over 20 cm FOV<br>(Guaranteed)<br><=2 mm over 34 cm FOV<br>(Guaranteed)<br><=2 mm over 42 cm FOV<br>(Typical) | |
| Signal to Noise | 120 | 120 | |
| Diffusion Weighted<br>Imaging | Diffusion Weighted Images can<br>be imported from an alternative<br>magnetic resonance imaging | Diffusion Weighted Images can be<br>acquired on the Unity system for<br>Off-line review. | SE image quality |
| | device for Off-line review | Single-shot EPI diffusion imaging<br>(DWI) with 3 diffusion directions<br>and up to 16 b-values. | |
| | | Diffusion imaging processing with<br>automatic generation of the ADC<br>and/or eADC maps. | |
| Device<br>Characteristic | Elekta Unity<br>(Predicate Device, K182076) | Elekta Unity<br>(Current Device) | Comparison |
| Treatment<br>Planning and<br>Delivery System<br>Dose Algorithm | GPU-based Monte Carlo dose<br>calculation algorithm (GPUMCD)<br>using the compatible Elekta<br>MONACO treatment planning<br>system | GPU-based Monte Carlo dose<br>calculation algorithm (GPUMCD)<br>using the compatible Elekta<br>MONACO treatment planning<br>system | Same |
| Dose Output<br>Modelling | Dose output modelled with<br>monitor units | Dose output modelled with<br>monitor units | |
| Dose Display | Display of Linac delivery<br>parameters | Display of Linac delivery<br>parameters | |
| Minimum Room<br>Dimensions<br>(H/L/W) | 3.25 m x 6.7 m x 6.7 m | 3.25 m x 6.7 m x 6.7 m | Same |
| Environment Line<br>Voltage | 480V | 480V | |
| Ambient Room<br>Temp. | Treatment room: 18 to 22 °C<br>(65 °F to 72 °F) | Treatment room: 18 to 22 °C<br>(65 °F to 72 °F) | |
| Relative Humidity | Treatment room: 40 to 70%, non-<br>condensing. | Treatment room: 40 to 70%, non-<br>condensing. | |
| Power Distribution<br>Isolation | Transformer | Transformer | |

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## Summary of performance testing (non-clinical):

Design verification and performance testing were carried out in accordance with design controls of FDA's Quality System Regulation (21 CFR §820.30), applicable ISO 13485 Quality Management System requirements, ISO 14971 risk management requirements, IEC 62304 requirements for software life-cycle processes, and FDA guidance for the "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices," November 2016. Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system, integration and system levels. Software verification testing was conducted and documented in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, " May 2005, for devices that pose a major level of concern (Class C per IEC 62304). Basic safety and essential performance have been satisfied through conformance with device-specific recognised consensus standards, as well as the general and collateral safety and essential performance standards for medical devices listed below.

| Standard Title | Standard No. |
|---------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Medical electrical equipment - Part 1: General requirements for basic safety and essential<br>performance | IEC 60601-1 |
| Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron<br>accelerators in the range of 1 MeV to 50 MeV | IEC 60601-2-1 |
| Medical electrical equipment - Part 2-33: Particular requirements for the safety of<br>magnetic resonance equipment for medical diagnosis | IEC 60601-2-33 |
| Radiotherapy equipment - Coordinates, movements and scales | IEC 61217 |

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| Standard Title | Standard No. |
|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Medical electrical equipment. Medical electron accelerators. Functional performance<br>characteristics | IEC 60976 |
| Medical electrical equipment - Part 1-2: General requirements for basic safety and<br>essential performance - Collateral Standard: Electromagnetic | IEC 60601-1-2 |
| Medical devices - Application of usability engineering to medical devices | IEC 62366-1 |
| Medical electrical equipment - Part 1-6: General requirements for basic safety and<br>essential performance - Collateral standard: Usability | IEC 60601-1-6 |
| Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk<br>management process | ISO 10993-1 |

Validation and usability testing of the integrated system were performed in accordance on human factors and usability engineering under clinically representative conditions by competent and professionally qualified personnel.

Image validation was performed in accordance with FDA Guidance for Magnetic Resonance Diagnostic Devices, whereby anonymized images, obtained on Elekta Unity were reviewed by US Board Certificated Diagnostic Radiologists to asses image quality for diagnostic purposes. There was consensus among the expert reviewers that imaging with Elekta Unity met the clinical criteria for diagnostic MRI.

The results from verification and validation testing demonstrate device conformance to stated design specifications and recognized consensus safety and performance standards.

## Conclusion

The results of verification and validation and safety standards testing demonstrate that Elekta Unity fulfills the established safety and performance criteria and it is substantially equivalent to the predicate device.

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