MRCAT Head & Neck

K214081 · Philips OY · MUJ · Apr 5, 2022 · Radiology

Device Facts

• Record ID: K214081
• Device Name: MRCAT Head & Neck
• Applicant: Philips OY
• Product Code: MUJ · Radiology
• Decision Date: Apr 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning.

Device Story

MRCAT Head & Neck is a software application for Philips Ingenia, Ingenia Ambition, and Ingenia Elition MR systems. It functions as an accessory for radiotherapy treatment planning. The device takes 3D mDixon (in-phase and water) MR images as input. A convolutional neural network (CNN) processes these images to perform automatic tissue characterization, segmenting bones (skull, C-spine, jaw, shoulder girdle) and body outlines. It assigns a continuum of Hounsfield Unit (HU) values based on fat and water intensities to generate CT-like density images. The software runs on the MR console, with processing occurring in the background. The resulting MRCAT images are stored in the MR database and can be exported via DICOM to treatment planning systems. Clinicians use these images to estimate radiation attenuation for dose calculation, potentially enabling MR-only radiotherapy simulation. The device is operated by radiology/radiotherapy staff in a clinical setting.

Clinical Evidence

Bench testing only. Performance validated through comparison of simulated dose accuracy against CT-based plans. Results showed PTV dose differences well below 1% with clinically insignificant bias. Artificial PTV analysis confirmed accuracy in the head and neck region. Geometric accuracy verified to within 1-5mm depending on sphere diameter.

Technological Characteristics

Software plug-in for MR systems. Uses 3D mDixon FFE imaging protocol. Core technology: Convolutional Neural Network (CNN) for image segmentation and HU value assignment. Connectivity: DICOM export. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-6, IEC 60601-2-33, IEC 62304, IEC 62366-1, ISO 14971.

Indications for Use

Indicated for radiotherapy treatment planning for patients with soft tissue tumors in the Head and Neck region.

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

• MRCAT Brain (K193109)

Reference Devices

• AcQPlan 5.0 (K013644)

Submission Summary (Full Text)

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Philips Oy % Anne-Sophie Glantenay Sr. Regulatory Affairs Specialist Avritie 4 Vantaa, 01510 Finland

Re: K214081

Trade/Device Name: MRCAT Head & Neck Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: December 23, 2021 Received: December 27, 2021

Dear Anne-Sophie Glantenay:

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,

Julie M. Sullivan, PhD Branch Chief Nuclear Medicine and Radiation Therapy Branch 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) K214081

Device Name MRCAT Head & Neck

#### Indications for Use (Describe)

MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning.

Indication for use:

MRCAT Head and Neck is indicated for radiotherapy treatment planning for patients with soft tissue tumors in the Head and Neck region.

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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### 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

| Date<br>Prepared: | April 05, 2022 | | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--|
| Manufacturer: | Philips Oy<br>Äyritie 4<br>01510 Vantaa, Finland | | |
| | Establishment Registration Number: 9680194 | | |
| Primary<br>Contact<br>Person: | Jan van de Kerkhof<br>Sr. Manager Regulatory Affairs<br>Phone: [phone]<br>E-mail: [e-mail] | | |
| Secondary<br>Contact<br>Person | Anne-Sophie Glantenay<br>Sr. Regulatory Affairs Specialist<br>Phone: [phone]<br>E-mail: [e-mail] | | |
| Device Name: | MRCAT Head & Neck | | |
| Classification: | Classification Name: | Medical charged-particle radiation therapy<br>system (accessory for) | |
| | Classification Regulation: | 21 CFR §892.5050 | |
| | Classification Panel: | Radiology | |
| | Device Class: | Class II | |
| | Product code: | MUJ (System, Planning, Radiation Therapy<br>Treatment) | |
| Predicate<br>Device: | Trade Name: | MRCAT Brain | |
| | Manufacturer: | Philips Oy | |
| | 510(k) Clearance: | K193109 (January 24, 2020) | |
| | Classification Regulation: | 21 CFR, Part 892.5050 | |
| | Classification Name: | Radiation Therapy Planning System | |
| | Classification Panel: | Radiology | |
| | Device Class: | Class II | |
| | Product Code: | MUJ (System, planning, radiation therapy<br>treatment) | |
| Reference<br>Device: | Trade Name: | AcQPlan 5.0 | |
| | Manufacturer: | Philips Medical Systems (Cleveland), Inc. | |
| | 510(k) Clearance: | K013644 (September 12, 2002) | |
| | Classification Regulation: | 21 CFR, Part 892.5840 | |
| | Classification Name: | Radiation Therapy Planning System | |
| | Classification Panel: | Radiology | |
| | Device Class: | Class II | |
| | Product Code: | MUJ (System, planning, radiation therapy<br>treatment) | |

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# Device

description: MRCAT Head & Neck is a software application to Ingenia, Ingenia Ambition, and Ingenia Elition MR systems. MRCAT Head & Neck is available to the customer as an option to Ingenia MR-RT package, which is a set of accessories for Ingenia systems.

> Automated generation of MRCAT images takes place at the MR console of Ingenia. The embedded image post-processing runs in the background parallel to image acquisition. MRCAT algorithm enables automatic tissue characterization: Bones are segmented from mDixon in-phase and water images using machine learning based segmentation. Body outline is segmented using in-phase and water images. Tissues are then assigned a continuum of HU values depending on the fat and water intensities of the voxels. The HU assignment provides MRCAT images with CT-like density information.

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| Indications for<br>Use: | Intended Use: | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | MRCAT imaging is intended to provide the operator with information of<br>tissue properties for radiation attenuation estimation purposes in photon<br>external beam radiotherapy treatment planning. | |
| | Indications for use: | |
| | MRCAT Head and Neck is indicated for radiotherapy treatment planning for<br>patients with soft tissue tumors in the Head and Neck region. | |
| Fundamental<br>Scientific<br>Technology: | MRCAT Head and Neck functionality is implemented as a software plug-in<br>for the MR main software, and it contains the following main features: | |
| | 1) Automatic post-processing tool delivering MRCAT images<br>2) Examcard with mDixon imaging protocol<br>3) DICOM export of MRCAT image. | |
| | MRCAT Image Generation | |
| | MRCAT images are generated with an ExamCard post-processing step, which<br>uses the images from the previous mDixon scan. | |
| | The post-processing logic takes care of launching MRCAT algorithm<br>executable calculating a new 3D MRCAT image. The post-processing is<br>started once the acquired mDixon MR images have been reconstructed. The<br>first step of MRCAT generation is to pre-process the images to ensure that<br>the MRCAT source images have consistent intensities. The intensity | |

normalized images are then used as input in a convolutional neural network (CNN). The CNN is trained using matched pairs of CT and MRCAT source images. The training of the CNN is locked and is not adapted during use. The output of the CNN is post-processed to create images in CT values. The generated MRCAT images are checked for correctness to ensure validity of the generated MRCAT for radiation treatment. The sanity checks ensure that the imaging field of view has been positioned correctly and that the MRCAT body outline matches that of the MR. The HU values for the MRCAT Head and Neck are calibrated using registered CT images. Once the process is running, post-processing logic exchanges information with the algorithm:

- Image source data to algorithm, and image output data back to the ● post-processing step
- Progress notifications

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- Error and warning notifications ●
The 3D MRCAT image from the post-processing step is stored into the MR image database.

### mDIXON scan

A T1-weighted Fast Field Echo (FFE) 3D mDixon dual echo imaging protocol, with imaging parameters optimized for MRCAT image post-processing and for geometric accuracy, is delivered as a part of MRCAT Head and Neck option. The mDixon imaging sequence provides two image contrasts for the MRCAT algorithm: inphase and water images. MRCAT Head and Neck uses fixed parameters for the mDixon scan, only the image stack location is configurable. An mDixon imaging protocol, with imaging parameters optimized for MRCAT image post-processing and for geometric accuracy, is delivered as a part of MRCAT Head and Neck option. MRCAT Head and Neck uses fixed parameters for mDixon scan, only the image stack location is configurable.

### DICOM Export

The MRCAT post-processing step stores the image data returned by the MRCAT algorithm into MR database.

MRCAT images can be exported in DICOM format enabling the use as primary images in the treatment planning systems

### Hardware platform description

The new software extensions introduced by MRCAT Head and Neck run on the MR console of Ingenia.

Based on the information provided above, the MRCAT Head and Neck is considered substantially equivalent to the primary currently marketed and predicate device (K193109, January 24, 2020) in terms of fundamental scientific technology.

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## Comparison of technological characteristics with the predicate device:

# Table 1 Comparison of the primary currently marketed and predicate device, MRCAT Brain versus the proposed MRCAT Head & Neck

| Device | MRCAT Brain | MRCAT Head & Neck | Similarities<br>and<br>Differences |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Philips Oy | Philips Oy | - |
| 510(k)<br>Number | K193109 | - | - |
| Product Code | MUJ | MUJ | Identical |
| Regulation<br>Number | 892.5050 | 892.5050 | Identical |
| Regulation<br>Name | Accelerator, Linear,<br>Medical | Accelerator, Linear,<br>Medical | Identical |
| Intended use | MRCAT imaging is<br>intended to provide the<br>operator with<br>information of tissue<br>properties for radiation<br>attenuation estimation<br>purposes in photon<br>external<br>beam radiotherapy<br>treatment planning. | MRCAT imaging is<br>intended to provide<br>the operator with<br>information of tissue<br>properties for<br>radiation attenuation<br>estimation purposes<br>in photon external<br>beam radiotherapy<br>treatment planning. | Identical |
| Indications<br>for use | MRCAT Brain is<br>indicated for<br>radiotherapy treatment<br>planning for primary<br>and metastatic brain<br>tumor patients. | MRCAT Head and<br>Neck is indicated for<br>radiotherapy<br>treatment planning<br>for patients with soft<br>tissue tumors in the<br>Head and Neck<br>region | No significant<br>difference.<br>MRCAT Brain<br>and MRCAT<br>Head & Neck<br>are both<br>indicated for<br>radiotherapy<br>treatment<br>planning in a<br>defined<br>region.<br>Brain tumors<br>are soft tissue<br>tumors. |

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| Primary<br>image<br>dataset | MRCAT | MRCAT | Identical |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary<br>image<br>dataset | mDixon, MRI | mDixon, MRI | Identical<br>MR images<br>obtained in<br>the same<br>imaging<br>session are<br>inherently in<br>the same<br>frame of<br>reference. |
| Registration<br>between<br>primary and<br>secondary<br>image<br>datasets | Secondary mDixon MR<br>image, source data to<br>MRCAT, is inherently<br>registered as part of<br>MRCAT algorithm with<br>MRCAT image, which<br>simplifies workflow.<br>Other MR images, like<br>T2w and fiducial<br>marker detection<br>images are registered<br>using tools available in<br>RTP system | Secondary mDixon<br>MR image, source<br>data to MRCAT, is<br>inherently registered<br>as part of MRCAT<br>algorithm with<br>MRCAT image, which<br>simplifies workflow.<br>Other MR images,<br>like T2w images are<br>registered using tools<br>available in RTP<br>system | No significant<br>difference<br>Secondary MR<br>images are<br>obtained in<br>the same<br>imaging<br>session<br>reducing the<br>possibility of<br>patient<br>motion<br>between<br>images. |
| Primary<br>image<br>density<br>information | MRCAT image intensity<br>information is provided<br>in Hounsfield Unit (HU)<br>values. | MRCAT image<br>intensity information<br>is provided in<br>Hounsfield Unit (HU)<br>values. | Identical.<br>MRCAT Brain<br>and MRCAT<br>Head & Neck<br>both have<br>continuous<br>HU value<br>approach. |
| Conversion<br>from primary<br>image to<br>density<br>values used<br>in dose<br>calculation | Primary image HU<br>values are converted to<br>densities through<br>density table specific<br>for the MRCAT. | Primary image HU<br>values are converted<br>to densities through<br>density table specific<br>for the MRCAT. | No significant<br>difference<br>MRCAT has<br>specific<br>density table<br>that is used in<br>a similar<br>manner to CT<br>specific<br>density tables. |
| MRCAT<br>algorithm | Bones are segmented<br>from mDixon in-phase<br>and water images using<br>machine learning based<br>segmentation. The<br>segmented bones are<br>in skull, upper C-spine<br>and jaw.<br>Body outline is<br>segmented using in-<br>phase and water<br>images.<br>Bones are assigned a<br>continuum of HU<br>values between dense<br>cortical bone and light<br>spongy bone depending<br>on the fat and water<br>intensities of the<br>voxels.<br>Soft tissue are assigned<br>a continuum of HU<br>values depending on<br>the fat and water<br>intensities of the<br>voxels.<br>The HU values for the<br>MRCAT Brain are<br>calibrated using<br>registered CT images<br>from several sites.<br>MRCAT Brain algorithm<br>is fully trained before<br>product release, after | Bones are segmented<br>from mDixon in-<br>phase and water<br>images using<br>machine learning<br>based segmentation.<br>The segmented<br>bones are in skull, C-<br>spine, jaw, and<br>shoulder girdle.<br>Body outline is<br>segmented using in-<br>phase and water<br>images.<br>Bones are assigned a<br>continuum of HU<br>values between<br>dense cortical bone<br>and light spongy<br>bone depending on<br>the fat and water<br>intensities of the<br>voxels.<br>Soft tissue are<br>assigned a<br>continuum of HU<br>values depending on<br>the fat and water<br>intensities of the<br>voxels.<br>The HU values for the<br>MRCAT Head & Neck<br>are calibrated using | No significant<br>difference<br>Segmentation<br>is done for<br>both MRCAT<br>Brain and<br>MRCAT Head<br>& Neck using<br>the mDIXON<br>image<br>contrasts.<br>HU value<br>assignment is<br>done based<br>on mDixon<br>image<br>intensities.<br>The models<br>used are<br>equivalent in<br>relation to<br>dose and<br>positioning<br>accuracy.<br>Both<br>algorithms are<br>locked; they<br>do not change<br>after<br>installation<br>based on new<br>data during<br>the use. |
| | | | |
| | which the algorithm is<br>locked. | registered CT images<br>from several sites.<br><br>MRCAT Head & Neck<br>algorithm is fully<br>trained before<br>product release, after<br>which the algorithm<br>is locked. | |
| Patient<br>positioning | Ingenia MR-RT with<br>MRCAT Brain supports<br>MR Only simulation<br>with relative patient<br>marking.<br><br>Patient positioning in<br>the treatment machine<br>must be checked either<br>with cone beam<br>computed tomography<br>(CBCT) or plain<br>radiographs by<br>registering bone<br>structures. | Ingenia MR-RT with<br>MRCAT Head & Neck<br>supports MR Only<br>simulation with<br>relative patient<br>marking.<br><br>Patient positioning in<br>the treatment<br>machine must be<br>checked either with<br>cone beam<br>computed<br>tomography (CBCT)<br>or plain radiographs<br>by registering bone<br>structures. | No significant<br>difference<br><br>The visibility<br>of bone<br>structures is<br>equivalent for<br>both<br>products. |
| Dose<br>accuracy | The simulated dose<br>based on MRCAT Brain<br>images shall not differ<br>in 95% of the indicated<br>patients (gamma<br>analysis criterion<br>2%/2mm realized in<br>98% of voxels within<br>the PTV or exceeding<br>75% of the maximum<br>dose) when compared<br>with CT-based plan.<br>The average simulated<br>dose based on MRCAT<br>Brain shall not deviate<br>more than 5% or 1 Gy,<br>which ever is greater, in<br>99% of the indicated<br>patients in the volume<br>of sensitive organs<br>when compared with<br>CT based plan. | The simulated dose<br>based on MRCAT<br>Head & Neck images<br>shall not differ in<br>95% of the indicated<br>patients (gamma<br>analysis criterion<br>2%/2mm realized in<br>98% of voxels within<br>the PTV or exceeding<br>75% of the maximum<br>dose) when<br>compared with CT-<br>based plan.<br>The average<br>simulated dose based<br>on MRCAT Head &<br>Neck shall not<br>deviate more than<br>5% or 1 Gy, which<br>ever is greater, in<br>99% of the indicated<br>patients in the<br>volume of sensitive | Identical<br>The same<br>dose<br>evaluation<br>methodology<br>is used for<br>both<br>products. The<br>criteria are<br>selected<br>based on the<br>needs of the<br>application. |
| Geometric<br>accuracy | MRCAT accuracy:<br>± 1 mm accuracy: 200<br>mm diameter sphere<br>± 2 mm accuracy: 400<br>mm diameter sphere<br>(limited in the bore<br>direction by +/- 160<br>mm from the z=0 mm<br>plane)<br>± 5 mm accuracy: 500<br>mm diameter sphere<br>(limited in the bore<br>direction by +/- 160<br>mm from the z=0 mm<br>plane) | organs when<br>compared with CT<br>based plan.<br>MRCAT accuracy:<br>± 1 mm accuracy:<br>200 mm diameter<br>sphere<br>± 2 mm accuracy:<br>400 mm diameter<br>sphere (limited in the<br>bore direction by +/-<br>160 mm from the z=0<br>mm plane)<br>± 5 mm accuracy:<br>500 mm diameter<br>sphere (limited in the<br>bore direction by +/-<br>160 mm from the z=0<br>mm plane) | Identical |
| MRCAT<br>source<br>imaging<br>sequence | mDIXON 3D scan with<br>acquired voxel size of<br>1.10/1.10/1.40 mm (1.5<br>T) and 1.1/1.1/1.1 mm<br>(3T), and<br>bandwidth/pixel 481Hz<br>(1.5T) or 868Hz (3T).<br>Most scanning<br>parameters locked | mDIXON 3D scan<br>with acquired voxel<br>size of 1.2/1.2/1.2<br>mm (1.5 T) and<br>1.1/1.1/1.1 mm (3T),<br>and bandwidth/pixel<br>481Hz (1.5T) or<br>868Hz (3T).<br>Most scanning<br>parameters locked | No significant<br>difference<br>In both<br>solutions the<br>essential<br>parameters<br>are locked to<br>avoid user<br>errors<br>potentially<br>affecting the<br>accuracy and<br>reliability of<br>the method.<br>The voxel<br>sizes do not<br>differ<br>significantly. |
| DICOM RT<br>export | yes | yes | Identical |

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# Summary of

Non-Clinical Performance Data:

The MRCAT Head and Neck complies with the following international and FDA-recognized consensus standards:

International and FDA-recognized consensus standards:

- . ANSI/AAMI ES60601-1: 2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-6:2010, Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
- IEC 60601-2-33:2015, Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
- . IEC 62304:2016, Medical device software - Software life-cycle processes
- IEC 62366-1:2020, Medical devices – Application of usability engineering to medical devices
- . ISO 14971:2019, Medical devices – Application of risk management to medical devices

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Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results.

Non-Clinical verification and or validation test results demonstrate that the MRCAT Head and Neck:

- Complies with the aforementioned international and FDA-recognized consensus standards
- . Meets the acceptance criteria and is adequate for its intended use.

Therefore, the MRCAT Head and Neck is substantially equivalent to the primary currently marketed and predicate device (K193109, January 24, 2020) in terms of safety and effectiveness.

Summary of The resulting dose accuracy for MRCAT Head and Neck is similar to CT. The Clinical Data: PTV dose differences obtained when using MRCAT in place of CT are well below 1% with a very small bias, and therefore clinically insignificant.

> The dose analysis was further expanded with artificial PTV analysis, using PTVs that were automatically placed around the head and neck region. The results for the artificial PTVs agreed well with the clinical plan results and strengthen the conclusion that MRCAT provides accurate dose calculations for the head and neck region.

In summary, the MRCAT Head and Neck images are spatially accurate radiation attenuation estimates that can aid in the EBRT planning of soft tissue tumors in the head and neck region.

### Substantial Equivalence

The MRCAT Head and Neck is substantially equivalent to the primary currently marketed and predicate device (K193109, January 24, 2020) in Conclusion: terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 62304, IEC 62366-1 and ISO 14971. The results of these tests demonstrate that MRCAT Head and Neck met the acceptance criteria and is adequate for this intended use.