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.

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).

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Elekta Unity device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria (Predicate Device)	Reported Device Performance (Current Device)	Comparison
Radiation Source/Beam	7MV Bremsstrahlung X- Rays Produced by Linear Accelerator	7MV Bremsstrahlung X- Rays Produced by Linear Accelerator	Same
Method of IMRT	MLC based cone-beam delivery	MLC based cone-beam delivery	Same
Collimation	Field shaping, Multi Leaf Collimator (MLC)	Field shaping, Multi Leaf Collimator (MLC)	Same
MLC Material	Tungsten Alloy	Tungsten Alloy	Same
Number of Leaves	80 leaf pairs	80 leaf pairs	Same
Range of MLC collimated beam size @ isocenter	0.5 cm x 0.5 cm to 57.4 cm x 22 cm	0.5 cm x 0.5 cm to 57.4 cm x 22 cm	Same
Gantry	Ring Gantry, collision with patient not possible	Ring Gantry, collision with patient not possible	Same
Radiation Head Shielding	Lead, Tungsten Alloy, and Steel shielding	Lead, Tungsten Alloy, and Steel shielding	Same
Source Control Mechanism	Dual channel dose monitoring system	Dual channel dose monitoring system	Same
Radiation Transmission 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 (Radius)	0.5mm	0.5mm	Same
Max Dose Rate	Clinical use: 450 cG/min at isocentre at Dmax for a 10 cm x 10 cm field (500 MU/min @ isocentre measured at Dmax)	Clinical use: 450 cG/min at isocentre at Dmax for a 10 cm x 10 cm field (500 MU/min @ isocentre measured at Dmax)	Same
Static Dose Accuracy	>95% of points passing 3%/3mm in the high dose, low gradient region. >95% passing 5mm/5% for low dose, high gradient points.	>95% of points passing 3%/3mm in the high dose, low gradient region. >95% passing 5mm/5% for low dose, high gradient points. 1% agreement for output factors.	Same
Motion synchronized treatment	No - Manual interrupt only	No - Manual interrupt only	Same
Patient Table Degrees of Freedom	2 (vertical & longitudinal) – positional corrections are made using the online adaptive planning interface of the treatment planning system	2 (vertical & longitudinal) – positional corrections are made using the online adaptive planning interface of the treatment planning system	Same
Integrated Imaging for planning, positioning, gating	Magnetic resonance imaging system - for planning, positioning and motion monitoring during treatment	Magnetic resonance imaging system - for planning, positioning and motion monitoring during treatment	Same
MR Physical Characteristics	Not explicitly detailed for all, but overall performance metrics are compared.	Not explicitly detailed for all, but overall performance metrics are compared.	Primarily "Same" across various listed characteristics (Bore Diameter, MRI Frequency, Field Strength, Field of View, Field Homogeneity, Field Stability, 3D Imaging Volumes, 3D Imaging Resolution, 2D Imaging Planes, 2D Imaging Resolution, Geometric Accuracy, Signal to Noise).
Diffusion Weighted Imaging	Diffusion Weighted Images can be imported from an alternative magnetic resonance imaging device for Off-line review	Diffusion Weighted Images can be acquired on the Unity system 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.	SE image quality (indicates the new functionality meets equivalence standards)
Treatment Planning and Delivery System Dose Algorithm	GPU-based Monte Carlo dose calculation algorithm (GPUMCD) using the compatible Elekta MONACO treatment planning system	GPU-based Monte Carlo dose calculation algorithm (GPUMCD) using the compatible Elekta MONACO treatment planning system	Same
Dose Output Modelling	Dose output modelled with monitor units	Dose output modelled with monitor units	Same
Dose Display	Display of Linac delivery parameters	Display of Linac delivery parameters	Same
Minimum Room Dimensions (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 Voltage	480V	480V	Same
Ambient Room Temp.	Treatment room: 18 to 22 °C (65 °F to 72 °F)	Treatment room: 18 to 22 °C (65 °F to 72 °F)	Same
Relative Humidity	Treatment room: 40 to 70%, non-condensing.	Treatment room: 40 to 70%, non-condensing.	Same
Power Distribution Isolation	Transformer	Transformer	Same
Image Quality (Diagnostic)	Clinical criteria for diagnostic MRI as determined by US Board Certified Diagnostic Radiologists.	Anonymized images, obtained on Elekta Unity, were reviewed by US Board Certificated Diagnostic Radiologists. Consensus among expert reviewers that imaging with Elekta Unity met the clinical criteria for diagnostic MRI.	Met.
General Safety and Performance	Conformance with design and risk management requirements, FDA guidance, and recognized consensus standards (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, ISO 10993-1).	Non-clinical testing evaluated device performance and functionality against design and risk management requirements. Software verification tested conforming to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, " May 2005 (Major level of concern). Basic safety and essential performance satisfied through conformance with listed standards.	Met.
Usability/Human Factors	Validation and usability testing under clinically representative conditions by competent and professionally qualified personnel.	Validation and usability testing of the integrated system performed in accordance on human factors and usability engineering under clinically representative conditions by competent and professionally qualified personnel.	Met.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for the "test set" used in the image validation study. It only mentions "anonymized images" from Elekta Unity.
Data Provenance: The images were "obtained on Elekta Unity," implying they were internally generated or acquired from the device itself. Given the context of a 510(k) summary, it's highly likely these were retrospective images produced during internal testing or early clinical use for device characterization, rather than a prospective, formal diagnostic study with patient consent for external use. The country of origin is not specified, but the submission is from Elekta Limited in the UK.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: More than one expert, specified as "US Board Certificated Diagnostic Radiologists." The exact number is not provided, but it implies a panel.
Qualifications of Experts: "US Board Certificated Diagnostic Radiologists." No specific experience level (e.g., 10 years) is given.

4. Adjudication Method for the Test Set

The adjudication method was consensus. The document states, "There was consensus among the expert reviewers that imaging with Elekta Unity met the clinical criteria for diagnostic MRI."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not explicitly stated or described. The study focused on the standalone performance and image quality of the Elekta Unity's MR imaging capabilities. It did not compare human readers with and without AI assistance; rather, it evaluated the diagnostic quality of the images generated by the device itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone performance evaluation of the imaging component was done. The image validation study assessed the quality of images produced by the Elekta Unity's MR scanner, interpreted by radiologists without any indication of AI assistance in the interpretation loop for the purpose of validating the device's inherent imaging capabilities. The main purpose of this 510(k) is the device itself (hardware and core software), not an AI diagnostic algorithm. The new features for diffusion imaging (DWI and ADC/eADC maps) are outputs of the device's imaging capabilities, which are then evaluated for their standalone image quality.

7. The Type of Ground Truth Used

Expert Consensus. For the image validation, the ground truth was established by the "consensus among the expert reviewers that imaging with Elekta Unity met the clinical criteria for diagnostic MRI." For the device's overall safety and performance, the ground truth was established through conformance with recognized consensus standards and internal design and risk management requirements.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set size. This submission is for the Elekta Unity hardware and its associated imaging capabilities, not primarily an AI/ML algorithm that would typically have a separate training set. The mention of "Diffusion imaging processing with automatic generation of the ADC and/or eADC maps" implies some algorithmic processing, but no details on training data for this specific processing are given.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for the direct evaluation described, no information is provided on how its ground truth would have been established.

Summary

{0}------------------------------------------------

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

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192482

Device Name Elekta Unity

Indications for Use (Describe)

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

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

K192482

as required by 21 CFR 807.92

Date of preparation:	August 28, 2019
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:	Elekta Unity, K182076

Product Description:

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.

{4}------------------------------------------------

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:

DeviceCharacteristic	Elekta Unity(Predicate Device, K182076)	Elekta Unity(Current Device)	Comparison
Radiation Source /Beam	7MV Bremsstrahlung X- RaysProduced by Linear Accelerator	7MV Bremsstrahlung X- RaysProduced by Linear Accelerator	Same
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)	Same
MLC material	Tungsten Alloy	Tungsten Alloy	Same
DeviceCharacteristic	Elekta Unity(Predicate Device, K182076)	Elekta Unity(Current Device)	Comparison
Number of leaves	80 leaf pairs	80 leaf pairs	Same
Range of MLCcollimated beamsize @ isocenter	0.5 cm x 0.5 cm to57.4 cm x 22 cm	0.5 cm x 0.5 cm to57.4 cm x 22 cm	Same
Gantry	Ring Gantry, collision withpatient not possible	Ring Gantry, collision with patientnot possible	Same
Radiation HeadShielding	Lead, Tungsten Alloy, and Steelshielding	Lead, Tungsten Alloy, and Steelshielding	Same
Source controlmechanism	Dual channel dose monitoringsystem	Dual channel dose monitoringsystem	Same
RadiationTransmissionthrough 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(Radius)	0.5mm	0.5mm	Same
Max Dose Rate	Clinical use: 450 cG/min atisocentre at Dmax for a 10 cm x10 cm field(500 MU/min @ isocentremeasured at Dmax)	Clinical use: 450 cG/min atisocentre at Dmax for a 10 cm x10 cm field(500 MU/min @ isocentremeasured at Dmax)	Same
Static DoseAccuracy	>95% of points passing 3%/3mmin the high dose, low gradientregion.>95% passing 5mm/5% for lowdose, high gradient points.	>95% of points passing 3%/3mmin the high dose, low gradientregion.>95% passing 5mm/5% for lowdose, high gradient points.1% agreement for output factors.	Same
Motionsynchronizedtreatment	No - Manual interrupt only	No - Manual interrupt only	Same
Patient tabledegrees offreedom	2 (vertical & longitudinal) –positional corrections are madeusing the online adaptiveplanning interface of thetreatment planning system	2 (vertical & longitudinal) –positional corrections are madeusing the online adaptiveplanning interface of thetreatment planning system	Same
Integrated imagingfor planning,positioning, gating	Magnetic resonance imagingsystem - for planning, positioningand motion monitoring duringtreatment	Magnetic resonance imagingsystem - for planning, positioningand motion monitoring duringtreatment	Same
MR PhysicalCharacteristics			Same
DeviceCharacteristic	Elekta Unity(Predicate Device, K182076)	Elekta Unity(Current Device)	Comparison
Bore Diameter	700 mm	700 mm
Diameter SphericalVolume	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 Sequencedependent	Up to 500 mm Sequencedependent
Field Homogeneity	≤ 2 ppm measured over 50 cm x50 cm x 45 cm volume	≤ 2 ppm measured over 50 cm x50 cm x 45 cm volume
Field Stability	≤ 0.1 ppm/hr	≤ 0.1 ppm/hr
3D ImagingVolumes (cm)	RL x AP x HFMin 0.5 x 0.5 x 0.8Max 56 x 56 x 40 (Anterior coildependent)	RL x AP x HFMin 0.5 x 0.5 x 0.8Max 56 x 56 x 40 (Anterior coildependent)	Same
3D ImagingResolution (cm)	Min 0.01 x 0.01 x 0.1Max 0.875 x 0.875 x 1	Min 0.01 x 0.01 x 0.1Max 0.875 x 0.875 x 1
2D Imaging Planes(cm)	AP x HFMin 0.5 x 0.5Max 56 x 56	AP x HFMin 0.5 x 0.5Max 56 x 56
2D ImagingResolution (mm)	Resolution selectable:0.011 x 0.011 mm (min)8.75 x 8.75 mm (max)	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)	Slice thickness selectable:0.01 mm (min); 705 mm (max)
GeometricAccuracy	<=1 mm over 20 cm FOV(Guaranteed)<=2 mm over 34 cm FOV(Guaranteed)<=2 mm over 42 cm FOV(Typical)	<=1 mm over 20 cm FOV(Guaranteed)<=2 mm over 34 cm FOV(Guaranteed)<=2 mm over 42 cm FOV(Typical)
Signal to Noise	120	120
Diffusion WeightedImaging	Diffusion Weighted Images canbe imported from an alternativemagnetic resonance imaging	Diffusion Weighted Images can beacquired on the Unity system forOff-line review.	SE image quality
	device for Off-line review	Single-shot EPI diffusion imaging(DWI) with 3 diffusion directionsand up to 16 b-values.
		Diffusion imaging processing withautomatic generation of the ADCand/or eADC maps.
DeviceCharacteristic	Elekta Unity(Predicate Device, K182076)	Elekta Unity(Current Device)	Comparison
TreatmentPlanning andDelivery SystemDose Algorithm	GPU-based Monte Carlo dosecalculation algorithm (GPUMCD)using the compatible ElektaMONACO treatment planningsystem	GPU-based Monte Carlo dosecalculation algorithm (GPUMCD)using the compatible ElektaMONACO treatment planningsystem	Same
Dose OutputModelling	Dose output modelled withmonitor units	Dose output modelled withmonitor units
Dose Display	Display of Linac deliveryparameters	Display of Linac deliveryparameters
Minimum RoomDimensions(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 LineVoltage	480V	480V
Ambient RoomTemp.	Treatment room: 18 to 22 °C(65 °F to 72 °F)	Treatment room: 18 to 22 °C(65 °F to 72 °F)
Relative Humidity	Treatment room: 40 to 70%, non-condensing.	Treatment room: 40 to 70%, non-condensing.
Power DistributionIsolation	Transformer	Transformer

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

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 essentialperformance	IEC 60601-1
Medical electrical equipment - Part 2-1: Particular requirements for the safety of electronaccelerators in the range of 1 MeV to 50 MeV	IEC 60601-2-1
Medical electrical equipment - Part 2-33: Particular requirements for the safety ofmagnetic resonance equipment for medical diagnosis	IEC 60601-2-33
Radiotherapy equipment - Coordinates, movements and scales	IEC 61217

{8}------------------------------------------------

Standard Title	Standard No.
Medical electrical equipment. Medical electron accelerators. Functional performancecharacteristics	IEC 60976
Medical electrical equipment - Part 1-2: General requirements for basic safety andessential 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 andessential performance - Collateral standard: Usability	IEC 60601-1-6
Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement 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.

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.