(99 days)
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.
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.
The Philips Oy MRCAT Head & Neck device, a software application for MR systems intended to provide tissue property information for radiation attenuation estimation in photon external beam radiotherapy treatment planning for soft tissue tumors in the Head and Neck region, underwent testing to demonstrate substantial equivalence to its predicate device, MRCAT Brain.
The primary study focused on validating the accuracy of simulated dose calculations and geometric accuracy when using MRCAT Head & Neck images compared to CT-based plans.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (MRCATHN) | Reported Device Performance |
|---|---|
| Dose Accuracy: - Simulated dose based on MRCAT Head & Neck images shall not differ in 95% of the indicated patients (gamma analysis criterion 2%/2mm realized in 98% of voxels within the PTV or exceeding 75% of the maximum dose) when compared with CT-based plan. - The average simulated dose based on MRCAT Head & Neck shall not deviate more than 5% or 1 Gy, whichever is greater, in 99% of the indicated patients in the volume of sensitive organs when compared with a CT-based plan. | - PTV dose differences obtained when using MRCAT in place of CT were well below 1% with a very small bias, indicating clinical insignificance. - Results for artificial PTVs (automatically placed around the head and neck region) agreed well with clinical plan results, strengthening the conclusion of accurate dose calculations. - The device met the dose accuracy criteria. |
| Geometric Accuracy: - ± 1 mm accuracy: 200 mm diameter sphere - ± 2 mm accuracy: 400 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane) - ± 5 mm accuracy: 500 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane) | - The document explicitly states: "MRCAT accuracy: - ± 1 mm accuracy: 200 mm diameter sphere - ± 2 mm accuracy: 400 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane) - ± 5 mm accuracy: 500 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane)" While the exact "reported performance" against these metrics is not detailed in the provided summary, the statement "MRCAT Head and Neck met the acceptance criteria and is adequate for this intended use" implies these geometric accuracy criteria were also met. The visibility of bone structures described as "equivalent for both products" (MRCAT Brain and MRCAT Head & Neck) also supports similar geometric performance. |
| Safety and Effectiveness: - Compliance with relevant international and FDA-recognized consensus standards (ANSI/AAMI ES60601-1, IEC 60601-1-6, IEC 60601-2-33, IEC 62304, IEC 62366-1, ISO 14971). | - The MRCAT Head and Neck complies with the aforementioned international and FDA-recognized consensus standards. Verified through non-clinical verification and validation tests. The device met the safety and effectiveness criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The summary mentions "PTV dose differences obtained when using MRCAT in place of CT" and "artificial PTV analysis". It also refers to "95% of the indicated patients" and "99% of the indicated patients," suggesting a study involving patient data or simulated patient cases. However, the exact number of patients or cases in the test set is not explicitly stated in the provided document.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- The document does not explicitly state the number of experts used to establish ground truth for the test set or their specific qualifications.
- However, it does mention that "The HU values for the MRCAT Head and Neck are calibrated using registered CT images from several sites." This implies that the CT images, which serve as the reference for HU values, were acquired and potentially interpreted by medical professionals, though their role in "ground truth establishment" for the specific test set is not detailed.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method (e.g., 2+1, 3+1). The "ground truth" seems to be primarily based on CT images and their associated dose calculations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- A MRMC comparative effectiveness study was not discussed in the provided text. The evaluation focuses on the device's performance in dose and geometric accuracy against a CT-based plan, rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
- Yes, the study appears to evaluate the standalone performance of the MRCAT Head & Neck algorithm. The dose accuracy and geometric accuracy criteria are stated as direct evaluations of the "simulated dose based on MRCAT Head & Neck images" and "MRCAT accuracy," respectively, implying no human intervention in the generation or initial interpretation of the MRCAT images for these assessments. The device provides "information of tissue properties for radiation attenuation estimation purposes," which is then used in treatment planning.
7. Type of Ground Truth Used:
- The ground truth primarily used for comparing dose accuracy and HU values is based on CT-based plans and registered CT images. CT is considered the gold standard for electron density information in radiotherapy planning.
8. Sample Size for the Training Set:
- The document states that the "CNN is trained using matched pairs of CT and MRCAT source images" and "The HU values for the MRCAT Head and Neck are calibrated using registered CT images from several sites." However, the exact sample size of the training set (number of images/patients) is not specified.
9. How the Ground Truth for the Training Set Was Established:
- The ground truth for the training set was established using "matched pairs of CT and MRCAT source images." This means that for each MR image used for training the CNN, a corresponding CT image was available. These CT images, presumably acquired as part of standard clinical practice, provided the reference Hounsfield Unit (HU) values for tissue characterization and density information that the MRCAT algorithm aims to replicate. The calibration of HU values also used "registered CT images from several sites," reinforcing the reliance on CT as the ground truth.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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FORM FDA 3881 (6/20)
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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.
| DatePrepared: | April 05, 2022 | ||
|---|---|---|---|
| Manufacturer: | Philips OyÄyritie 401510 Vantaa, Finland | ||
| Establishment Registration Number: 9680194 | |||
| PrimaryContactPerson: | Jan van de KerkhofSr. Manager Regulatory AffairsPhone: +31-613300542E-mail: jan.van.de.kerkhof@philips.com | ||
| SecondaryContactPerson | Anne-Sophie GlantenaySr. Regulatory Affairs SpecialistPhone: +31-611531002E-mail: anne-sophie.glantenay@philips.com | ||
| Device Name: | MRCAT Head & Neck | ||
| Classification: | Classification Name: | Medical charged-particle radiation therapysystem (accessory for) | |
| Classification Regulation: | 21 CFR §892.5050 | ||
| Classification Panel: | Radiology | ||
| Device Class: | Class II | ||
| Product code: | MUJ (System, Planning, Radiation TherapyTreatment) | ||
| PredicateDevice: | 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 therapytreatment) | ||
| ReferenceDevice: | 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 therapytreatment) |
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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 forUse: | Intended Use: | |
|---|---|---|
| MRCAT imaging is intended to provide the operator with information oftissue properties for radiation attenuation estimation purposes in photonexternal beam radiotherapy treatment planning. | ||
| Indications for use: | ||
| MRCAT Head and Neck is indicated for radiotherapy treatment planning forpatients with soft tissue tumors in the Head and Neck region. | ||
| FundamentalScientificTechnology: | MRCAT Head and Neck functionality is implemented as a software plug-infor the MR main software, and it contains the following main features: | |
| 1) Automatic post-processing tool delivering MRCAT images2) Examcard with mDixon imaging protocol3) DICOM export of MRCAT image. | ||
| MRCAT Image Generation | ||
| MRCAT images are generated with an ExamCard post-processing step, whichuses the images from the previous mDixon scan. | ||
| The post-processing logic takes care of launching MRCAT algorithmexecutable calculating a new 3D MRCAT image. The post-processing isstarted once the acquired mDixon MR images have been reconstructed. Thefirst step of MRCAT generation is to pre-process the images to ensure thatthe 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 | SimilaritiesandDifferences |
|---|---|---|---|
| Manufacturer | Philips Oy | Philips Oy | - |
| 510(k)Number | K193109 | - | - |
| Product Code | MUJ | MUJ | Identical |
| RegulationNumber | 892.5050 | 892.5050 | Identical |
| RegulationName | Accelerator, Linear,Medical | Accelerator, Linear,Medical | Identical |
| Intended use | MRCAT imaging isintended to provide theoperator withinformation of tissueproperties for radiationattenuation estimationpurposes in photonexternalbeam radiotherapytreatment planning. | MRCAT imaging isintended to providethe operator withinformation of tissueproperties forradiation attenuationestimation purposesin photon externalbeam radiotherapytreatment planning. | Identical |
| Indicationsfor use | MRCAT Brain isindicated forradiotherapy treatmentplanning for primaryand metastatic braintumor patients. | MRCAT Head andNeck is indicated forradiotherapytreatment planningfor patients with softtissue tumors in theHead and Neckregion | No significantdifference.MRCAT Brainand MRCATHead & Neckare bothindicated forradiotherapytreatmentplanning in adefinedregion.Brain tumorsare soft tissuetumors. |
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| Primaryimagedataset | MRCAT | MRCAT | Identical |
|---|---|---|---|
| Secondaryimagedataset | mDixon, MRI | mDixon, MRI | IdenticalMR imagesobtained inthe sameimagingsession areinherently inthe sameframe ofreference. |
| Registrationbetweenprimary andsecondaryimagedatasets | Secondary mDixon MRimage, source data toMRCAT, is inherentlyregistered as part ofMRCAT algorithm withMRCAT image, whichsimplifies workflow.Other MR images, likeT2w and fiducialmarker detectionimages are registeredusing tools available inRTP system | Secondary mDixonMR image, sourcedata to MRCAT, isinherently registeredas part of MRCATalgorithm withMRCAT image, whichsimplifies workflow.Other MR images,like T2w images areregistered using toolsavailable in RTPsystem | No significantdifferenceSecondary MRimages areobtained inthe sameimagingsessionreducing thepossibility ofpatientmotionbetweenimages. |
| Primaryimagedensityinformation | MRCAT image intensityinformation is providedin Hounsfield Unit (HU)values. | MRCAT imageintensity informationis provided inHounsfield Unit (HU)values. | Identical.MRCAT Brainand MRCATHead & Neckboth havecontinuousHU valueapproach. |
| Conversionfrom primaryimage todensityvalues usedin dosecalculation | Primary image HUvalues are converted todensities throughdensity table specificfor the MRCAT. | Primary image HUvalues are convertedto densities throughdensity table specificfor the MRCAT. | No significantdifferenceMRCAT hasspecificdensity tablethat is used ina similarmanner to CTspecificdensity tables. |
| MRCATalgorithm | Bones are segmentedfrom mDixon in-phaseand water images usingmachine learning basedsegmentation. Thesegmented bones arein skull, upper C-spineand jaw.Body outline issegmented using in-phase and waterimages.Bones are assigned acontinuum of HUvalues between densecortical bone and lightspongy bone dependingon the fat and waterintensities of thevoxels.Soft tissue are assigneda continuum of HUvalues depending onthe fat and waterintensities of thevoxels.The HU values for theMRCAT Brain arecalibrated usingregistered CT imagesfrom several sites.MRCAT Brain algorithmis fully trained beforeproduct release, after | Bones are segmentedfrom mDixon in-phase and waterimages usingmachine learningbased segmentation.The segmentedbones are in skull, C-spine, jaw, andshoulder girdle.Body outline issegmented using in-phase and waterimages.Bones are assigned acontinuum of HUvalues betweendense cortical boneand light spongybone depending onthe fat and waterintensities of thevoxels.Soft tissue areassigned acontinuum of HUvalues depending onthe fat and waterintensities of thevoxels.The HU values for theMRCAT Head & Neckare calibrated using | No significantdifferenceSegmentationis done forboth MRCATBrain andMRCAT Head& Neck usingthe mDIXONimagecontrasts.HU valueassignment isdone basedon mDixonimageintensities.The modelsused areequivalent inrelation todose andpositioningaccuracy.Bothalgorithms arelocked; theydo not changeafterinstallationbased on newdata duringthe use. |
| which the algorithm islocked. | registered CT imagesfrom several sites.MRCAT Head & Neckalgorithm is fullytrained beforeproduct release, afterwhich the algorithmis locked. | ||
| Patientpositioning | Ingenia MR-RT withMRCAT Brain supportsMR Only simulationwith relative patientmarking.Patient positioning inthe treatment machinemust be checked eitherwith cone beamcomputed tomography(CBCT) or plainradiographs byregistering bonestructures. | Ingenia MR-RT withMRCAT Head & Necksupports MR Onlysimulation withrelative patientmarking.Patient positioning inthe treatmentmachine must bechecked either withcone beamcomputedtomography (CBCT)or plain radiographsby registering bonestructures. | No significantdifferenceThe visibilityof bonestructures isequivalent forbothproducts. |
| Doseaccuracy | The simulated dosebased on MRCAT Brainimages shall not differin 95% of the indicatedpatients (gammaanalysis criterion2%/2mm realized in98% of voxels withinthe PTV or exceeding75% of the maximumdose) when comparedwith CT-based plan.The average simulateddose based on MRCATBrain shall not deviatemore than 5% or 1 Gy,which ever is greater, in99% of the indicatedpatients in the volumeof sensitive organswhen compared withCT based plan. | The simulated dosebased on MRCATHead & Neck imagesshall not differ in95% of the indicatedpatients (gammaanalysis criterion2%/2mm realized in98% of voxels withinthe PTV or exceeding75% of the maximumdose) whencompared with CT-based plan.The averagesimulated dose basedon MRCAT Head &Neck shall notdeviate more than5% or 1 Gy, whichever is greater, in99% of the indicatedpatients in thevolume of sensitive | IdenticalThe samedoseevaluationmethodologyis used forbothproducts. Thecriteria areselectedbased on theneeds of theapplication. |
| Geometricaccuracy | MRCAT accuracy:± 1 mm accuracy: 200mm diameter sphere± 2 mm accuracy: 400mm diameter sphere(limited in the boredirection by +/- 160mm from the z=0 mmplane)± 5 mm accuracy: 500mm diameter sphere(limited in the boredirection by +/- 160mm from the z=0 mmplane) | organs whencompared with CTbased plan.MRCAT accuracy:± 1 mm accuracy:200 mm diametersphere± 2 mm accuracy:400 mm diametersphere (limited in thebore direction by +/-160 mm from the z=0mm plane)± 5 mm accuracy:500 mm diametersphere (limited in thebore direction by +/-160 mm from the z=0mm plane) | Identical |
| MRCATsourceimagingsequence | mDIXON 3D scan withacquired voxel size of1.10/1.10/1.40 mm (1.5T) and 1.1/1.1/1.1 mm(3T), andbandwidth/pixel 481Hz(1.5T) or 868Hz (3T).Most scanningparameters locked | mDIXON 3D scanwith acquired voxelsize of 1.2/1.2/1.2mm (1.5 T) and1.1/1.1/1.1 mm (3T),and bandwidth/pixel481Hz (1.5T) or868Hz (3T).Most scanningparameters locked | No significantdifferenceIn bothsolutions theessentialparametersare locked toavoid usererrorspotentiallyaffecting theaccuracy andreliability ofthe method.The voxelsizes do notdiffersignificantly. |
| DICOM RTexport | 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.
§ 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.