Elekta Unity

K182076 · Elekta Limited · IYE · Dec 4, 2018 · Radiology

Device Facts

• Record ID: K182076
• Device Name: Elekta Unity
• Applicant: Elekta Limited
• Product Code: IYE · Radiology
• Decision Date: Dec 4, 2018
• 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 maging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. Images provide information that may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

Device Story

Elekta Unity is a multifunctional digital linear accelerator (linac) for intensity modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT). It integrates a gantry-mounted 7MV linear accelerator with a 1.5T Magnetic Resonance Imaging (MRI) sub-system and a Patient Positioning Sub-system (PPS). The device produces cross-sectional MRI images before, during, and after treatment to assist in therapy planning, patient positioning, and treatment delivery. Operated by clinicians in a clinical setting, the system uses dedicated software to manage imaging and radiation delivery. The 1.5T MRI provides high-resolution visualization of internal structures, allowing for precise targeting of tumors. The system is used in conjunction with compatible Oncology Information and Treatment Planning systems. By providing real-time or near-real-time imaging during the radiation delivery process, the device enables clinicians to adjust treatment plans or patient positioning, potentially improving the accuracy of radiation delivery to malignant or benign tumors while sparing surrounding healthy tissue.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing performed at sub-system, integration, and system levels to confirm conformance to design specifications and risk management requirements. Testing included software verification (Class C per IEC 62304), usability engineering, and adherence to recognized consensus standards (IEC 60601-1, 60601-2-1, 60601-2-33, etc.).

Technological Characteristics

Multifunctional digital linac with 7MV beam; 1.5T MRI sub-system; split magnet design for X-ray attenuation reduction. MLC (Tungsten Alloy) with 80 leaf pairs. GPU-based Monte Carlo dose calculation algorithm. Connectivity with compatible Oncology Information and Treatment Planning systems. Compliant with IEC 60601-1, IEC 60601-2-1, IEC 60601-2-33, IEC 61217, IEC 60976, IEC 60601-1-2, IEC 62366-1, IEC 60601-1-6, and ISO 10993-1.

Indications for Use

Indicated for radiation therapy and stereotactic radiation treatments of malignant and benign diseases anywhere in the body, as determined by a licensed medical practitioner per a defined treatment plan.

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 (K170751)

Submission Summary (Full Text)

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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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

Elekta Limited % Mr. Nicholas Power RA Manager Fleming Way CRAWLEY, WEST SUSSEX, RH10 9RR GREAT BRITAIN

Re: K182076

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 Dated: October 29, 2018 Received: November 2, 2018

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.

December 4, 2018

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara

Robert A. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) 182076

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 maging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. Images provide information that may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

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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FORM FDA 3881 (7/17)

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# K182076

## 510(k) SUMMARY

as required by 21 CFR 807.92

| Date of preparation: | July 26, 2018 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | ViewRay (MRIdian) Linac System, K170751 |

#### 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). Elekta Unity consists of a gantry-mounted 7MV linear accelerator sub-system which rotates around a 1.5T Magnetic Resonance Imaging (MRI) sub-system and a Patient Positioning Sub-system (PPS). It is controlled by dedicated system software, which incorporates patient positioning, imaging, and treatment delivery functions, and it is designed for use in conjunction with approved compatible Oncology Information and Treatment Planning systems. 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.

#### 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.

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## 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. Images provide information that may assist the therapy planning, patient positioning and treatment delivery related to radiation oncology.

#### Substantial Equivalence:

Elekta Unity is substantially equivalent (SE) to the predicate device, the ViewRay (MRIdian) Linac System (K170751) in intended use and indications for use, principles of operation, technological characteristics and labeling. The differences between the two devices have been addressed by non-clinical testing in conformance with predetermined performance criteria and recognised consensus standards.

## Summary of Technological Characteristics:

Both devices are designed specifically to facilitate IGRT; they rely on established medical linear accelerator (linac) technology to deliver comparable photon energies and dose rates for targeted external beam radiation therapy, using established magnetic resonance imaging (MRI) technology for image guidance, and specifically designed software systems for treatment planning and delivery. Both devices incorporate a split magnet design to create an area of reduced X-ray attenuation for the treatment beam. Elekta Unity incorporates a 1.5T MRI sub-system as compared to the predicate's 0.345T MRI sub-system.

Key device characteristics and performance specifications of the Elekta Unity and the predicate device are noted in the table below:

| Device<br>Characteristic | Cleared Device<br>(K170751) | Elekta Unity | Comparison |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Radiation Source<br>/ Beam | 6 MV Bremsstrahlung X- Rays<br>Produced by Linear Accelerator | 7MV Bremsstrahlung X- Rays<br>Produced by Linear Accelerator | Substantially<br>equivalent (SE)<br>energy source and<br>output |
| 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) | SE MLC specifications,<br>IEC 60601-2-1<br>compliant |
| MLC material | Tungsten Alloy | Tungsten Alloy | |
| Number of leaves | 34 leaf pairs upper stack, 35 leaf<br>pairs lower stack | 80 leaf pairs | |
| Range of MLC<br>collimated beam<br>size @ isocenter | 0.415 cm x 0.2 cm to<br>27.4 cm x 24.1 cm | 0.5 cm x 0.5 cm to<br>57.4 cm x 22 cm | |
| Gantry | Ring Gantry, collision with<br>patient not possible | Ring Gantry, collision with<br>patient not possible | Same |
| Device<br>Characteristic | Cleared Device<br>(K170751) | Elekta Unity | Comparison |
| Radiation Head<br>Shielding | Lead, Tungsten Alloy, and Steel<br>shielding | Lead, Tungsten Alloy, and Steel<br>shielding | Same |
| Source control<br>mechanism | Redundant ion chambers and<br>dose monitoring cards | Dual channel dose monitoring<br>system | SE mechanisms;<br>IEC 60601-2-1<br>compliant |
| Radiation<br>Transmission<br>through head | Less than 0.1% of the primary<br>beam | 0.2% of the primary beam | SE specification;<br>IEC 60601-2-1<br>compliant |
| Isocenter<br>distance | 90 cm | 143.5 cm | SE; no impact on dose<br>accuracy |
| Isocenter<br>accuracy (Radius) | 0.5mm | 0.5mm | Same |
| Max Dose Rate | 600 cGy/min<br>at Dmax at a 90 cm isocenter for<br>a 10 cm x 10 cm field | 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) | SE dose rate at<br>isocenter |
| Static Dose<br>Accuracy | 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%<br>of the planned dose (per AAPM<br>TG 119 based on the<br>recommendations of Palta et al.). | >95% of points passing<br>3%/3mm in the high dose, low<br>gradient region.<br>>95% passing 5mm/5% for low<br>dose, high gradient points.<br>1% agreement for output<br>factors. | SE dose accuracy<br>specification |
| Motion<br>synchronized<br>treatment | Yes | No - Manual interrupt only | No automatic gating<br>function in Unity |
| Patient table<br>degrees of<br>freedom | 3 translational | 2 (vertical & longitudinal) -<br>positional corrections are made<br>using the online adaptive<br>planning interface of the<br>treatment planning system | SE; Position accuracy<br>is compliant with IEC<br>60601-2-1 |
| Integrated<br>imaging for<br>planning,<br>positioning,<br>gating | Magnetic resonance imaging<br>system | Magnetic resonance imaging<br>system - for planning,<br>positioning and motion<br>monitoring during treatment | SE; No automatic<br>gating function in<br>Unity |
| MR Physical<br>Characteristics | | | SE physical<br>specifications |
| Bore Diameter | 700 mm | 700 mm | |
| Spherical Volume | 500 mm | 500mm x 500mm x 450mm | |
| Device<br>Characteristic | Cleared Device<br>(K170751) | Elekta Unity | Comparison |
| MRI Frequency | 14.7 MHz | 64 MHz | SE MRI system;<br>IEC 60601-2-33<br>compliant |
| Field Strength | 0.345 T | 1.5T | compliant |
| Field of View | 500 mm | Up to 500 mm Sequence<br>dependent | The effects of 1.5T<br>magnetic field on<br>dose distribution are |
| Field<br>Homogeneity | < 25 ppm measured over 45 cm<br>diameter spherical volume | ≤ 2 ppm measured over 50 cm x<br>50 cm x 45 cm volume | accounted for in the<br>treatment planning<br>system |
| Field Stability | ≤ 0.1 ppm/hr | ≤ 0.1 ppm/hr | |
| 3D Imaging<br>Volumes (cm) | RL x AP x HF<br>Min 20 x 27 x 29<br>Max 54 x 48 x 54 | 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) | SE imaging volumes<br>and geometric<br>accuracy; higher<br>resolution and signal<br>to noise performance |
| 3D Imaging<br>Resolution (cm) | Min 0.075 x 0.075 x 0.15<br>Max 0.3 x 0.3 x 0.3 | Min 0.01 x 0.01 x 0.1<br>Max 0.875 x 0.875 x 1 | with 1.5T MRI |
| 2D Imaging | AP x HF | AP x HF | |
| Planes (cm) | Min. 27 x 27 | Min 0.5 x 0.5 | |
| | Max 45 x 35 | Max 56 x 56 | |
| 2D Imaging<br>Resolution (mm) | 0.35 x 0.35<br>5,7, or 10 | 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) | |
| Geometric<br>Accuracy | 1 mm over 20 cm FOV<br>2 mm over 35 cm FOV | <=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 | 30 | 120 | |
| Treatment<br>Planning and<br>Delivery System<br>Dose Algorithm | Monte Carlo Dose Computation<br>Radiation Source Model for<br>Bremsstrahlung X-Rays | GPU-based Monte Carlo dose<br>calculation algorithm<br>(GPUMCD) using the<br>compatible Elekta MONACO<br>treatment planning system | SE dose calculation<br>methods |
| 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 | |
| Device<br>Characteristic | Cleared Device<br>(K170751) | Elekta Unity | Comparison |
| Minimum Room<br>Dimensions<br>(H/L/W) | 2.9 m x 7.6 m x 5.9 m | 3.25 m x 6.7 m x 6.7 m | SE operating<br>environment |
| Environment Line<br>Voltage | 480V | 480V | |
| Ambient Room<br>Temp. | 65 °F to 72 °F | Treatment room: 18 to 22 °C<br>(65 °F to 72 °F) | |
| Relative Humidity | 40 to 60% | Treatment room: 40 to 70%,<br>non-condensing. | |
| Power<br>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 FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard, IEC 62304 Software life-cycle processes, and the other FDA recognised consensus standards presented below. 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 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 applicable general and collateral safety and essential performance standards for medical devices.

| Standard Title | Standard No. |
|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | IEC 60601-1 |
| Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron 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 magnetic resonance equipment for medical diagnosis | IEC 60601-2-33 |
| Radiotherapy equipment - Coordinates, movements and scales | IEC 61217 |
| Medical electrical equipment. Medical electron accelerators. Functional performance characteristics | IEC 60976 |
| Medical electrical equipment - Part 1-2: General requirements for basic safety and 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 essential performance - Collateral standard: Usability | IEC 60601-1-6 |
| Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | ISO 10993-1 |

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Validation and usability testing of the integrated system was performed in accordance with FDA guidance on human factors and usability engineering under clinically representative conditions by competent and professionally qualified personnel. The results from verification testing demonstrate device conformance to stated design specifications and standards.

#### Conclusion

The results of verification, 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.