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

Device 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.

AI/ML Overview

The provided text describes the Elekta Unity device, a medical charged-particle radiation therapy system. However, it does not contain specific acceptance criteria, reported device performance data, detailed information about study designs (like sample sizes for test or training sets, data provenance, expert adjudication, or MRMC studies), or how ground truth was established for the training set.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with performance metrics against predefined acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document states that:

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 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 recognized consensus standards (listed in the table on page 7), as well as applicable general and collateral safety and essential performance standards for medical devices.
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.

While these statements indicate that testing was done to ensure safety and performance, the specific data, acceptance criteria, and study details you've asked for are not present in this document.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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 LimitedLinac House, Fleming Way, Crawley, West SussexRH10 9RR, United KingdomTelephone: +44 (0)1293 544422Fax: +44 (0)1293 654321
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:

Intended Use:

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Indications for Use Statement:

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:

DeviceCharacteristic	Cleared Device(K170751)	Elekta Unity	Comparison
Radiation Source/ Beam	6 MV Bremsstrahlung X- RaysProduced by Linear Accelerator	7MV Bremsstrahlung X- RaysProduced by Linear Accelerator	Substantiallyequivalent (SE)energy source andoutput
Method of IMRT	MLC based cone-beam delivery	MLC based cone-beam delivery	Same
Collimation	Field shaping, Multi LeafCollimator (MLC)	Field shaping, Multi LeafCollimator (MLC)	SE MLC specifications,IEC 60601-2-1compliant
MLC material	Tungsten Alloy	Tungsten Alloy
Number of leaves	34 leaf pairs upper stack, 35 leafpairs lower stack	80 leaf pairs
Range of MLCcollimated beamsize @ isocenter	0.415 cm x 0.2 cm to27.4 cm x 24.1 cm	0.5 cm x 0.5 cm to57.4 cm x 22 cm
Gantry	Ring Gantry, collision withpatient not possible	Ring Gantry, collision withpatient not possible	Same
DeviceCharacteristic	Cleared Device(K170751)	Elekta Unity	Comparison
Radiation HeadShielding	Lead, Tungsten Alloy, and Steelshielding	Lead, Tungsten Alloy, and Steelshielding	Same
Source controlmechanism	Redundant ion chambers anddose monitoring cards	Dual channel dose monitoringsystem	SE mechanisms;IEC 60601-2-1compliant
RadiationTransmissionthrough head	Less than 0.1% of the primarybeam	0.2% of the primary beam	SE specification;IEC 60601-2-1compliant
Isocenterdistance	90 cm	143.5 cm	SE; no impact on doseaccuracy
Isocenteraccuracy (Radius)	0.5mm	0.5mm	Same
Max Dose Rate	600 cGy/minat Dmax at a 90 cm isocenter fora 10 cm x 10 cm field	Clinical use: 450 cG/min atisocentre at Dmax for a 10 cm x10 cm field(500 MU/min @ isocentremeasured at Dmax)	SE dose rate atisocenter
Static DoseAccuracy	90% of the points evaluated in atreatment volume pass a relativegamma criteria of 3%/3mm and ahigh dose, low gradient absolutepoint measurement is within 5%of the planned dose (per AAPMTG 119 based on therecommendations of Palta et al.).	>95% of points passing3%/3mm in the high dose, lowgradient region.>95% passing 5mm/5% for lowdose, high gradient points.1% agreement for outputfactors.	SE dose accuracyspecification
Motionsynchronizedtreatment	Yes	No - Manual interrupt only	No automatic gatingfunction in Unity
Patient tabledegrees offreedom	3 translational	2 (vertical & longitudinal) -positional corrections are madeusing the online adaptiveplanning interface of thetreatment planning system	SE; Position accuracyis compliant with IEC60601-2-1
Integratedimaging forplanning,positioning,gating	Magnetic resonance imagingsystem	Magnetic resonance imagingsystem - for planning,positioning and motionmonitoring during treatment	SE; No automaticgating function inUnity
MR PhysicalCharacteristics			SE physicalspecifications
Bore Diameter	700 mm	700 mm
Spherical Volume	500 mm	500mm x 500mm x 450mm
DeviceCharacteristic	Cleared Device(K170751)	Elekta Unity	Comparison
MRI Frequency	14.7 MHz	64 MHz	SE MRI system;IEC 60601-2-33compliant
Field Strength	0.345 T	1.5T	compliant
Field of View	500 mm	Up to 500 mm Sequencedependent	The effects of 1.5Tmagnetic field ondose distribution are
FieldHomogeneity	< 25 ppm measured over 45 cmdiameter spherical volume	≤ 2 ppm measured over 50 cm x50 cm x 45 cm volume	accounted for in thetreatment planningsystem
Field Stability	≤ 0.1 ppm/hr	≤ 0.1 ppm/hr
3D ImagingVolumes (cm)	RL x AP x HFMin 20 x 27 x 29Max 54 x 48 x 54	RL x AP x HFMin 0.5 x 0.5 x 0.8Max 56 x 56 x 40 (Anterior coildependent)	SE imaging volumesand geometricaccuracy; higherresolution and signalto noise performance
3D ImagingResolution (cm)	Min 0.075 x 0.075 x 0.15Max 0.3 x 0.3 x 0.3	Min 0.01 x 0.01 x 0.1Max 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 ImagingResolution (mm)	0.35 x 0.355,7, or 10	Resolution selectable:0.011 x 0.011 mm (min)8.75 x 8.75 mm (max)
		Slice thickness selectable:0.01 mm (min); 705 mm (max)
GeometricAccuracy	1 mm over 20 cm FOV2 mm over 35 cm FOV	<=1 mm over 20 cm FOV(Guaranteed)<=2 mm over 34 cm FOV(Guaranteed)<=2 mm over 42 cm FOV(Typical)
Signal to Noise	30	120
TreatmentPlanning andDelivery SystemDose Algorithm	Monte Carlo Dose ComputationRadiation Source Model forBremsstrahlung X-Rays	GPU-based Monte Carlo dosecalculation algorithm(GPUMCD) using thecompatible Elekta MONACOtreatment planning system	SE dose calculationmethods
Dose OutputModelling	Dose output modelled withmonitor units	Dose output modelled withmonitor units
Dose Display	Display of Linac deliveryparameters	Display of Linac deliveryparameters
DeviceCharacteristic	Cleared Device(K170751)	Elekta Unity	Comparison
Minimum RoomDimensions(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 operatingenvironment
Environment LineVoltage	480V	480V
Ambient RoomTemp.	65 °F to 72 °F	Treatment room: 18 to 22 °C(65 °F to 72 °F)
Relative Humidity	40 to 60%	Treatment room: 40 to 70%,non-condensing.
PowerDistributionIsolation	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.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.