(77 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.
Indications for use:
MRCAT Brain is indicated for radiotherapy treatment planning for primary and metastatic brain tumor patients.
MRCAT brain is a software application to Ingenia, Ingenia Ambition, and Ingenia Elition MR systems. MRCAT brain 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 document provides information on the Philips Medical Systems MR Finland MRCAT Brain device, which is a software add-on for MR systems intended for radiotherapy treatment planning for primary and metastatic brain tumor patients.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (MRC-Brain) | Reported Device Performance |
|---|---|
| Dose Accuracy: - Simulated dose based on MRCAT Brain 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 Brain 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 CT based plan. | The robustness of the MRCAT brain algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 1%/1mm is shown by post-processing MRCAT images from patients, and calculating dose using the MRCAT images. (Though the reported criterion is 1%/1mm, the acceptance criterion specifically mentioned 2%/2mm, implying the device met or exceeded this with the 1%/1mm demonstration). The document states that MRCAT brain met the acceptance criteria and is adequate for its intended use. |
| Geometric Accuracy: - MRCAT accuracy: ± 1 mm accuracy for a 200 mm diameter sphere. - MRCAT accuracy: ± 5 mm accuracy for a 500 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane). | The document states "No significant difference" in geometric accuracy when comparing MRCAT Brain to MRCAT Pelvis, which has the same geometric accuracy criteria. It also generally states that "Non Clinical verification and or validation test results demonstrate that the MRCAT brain... Meets the acceptance criteria and is adequate for its intended use." |
| Compliance with Standards: - ANSI/AAMI ES60601-1: 2012 - IEC 60601-1-6:2010 - IEC 60601-2-33:2015 - IEC 62304:2016 - IEC 62366-1:2015 - ISO 14971:2007 (A comprehensive list of international and FDA-recognized consensus standards for medical electrical equipment, usability, safety of MR equipment, medical device software lifecycle processes, usability engineering, and risk management). | "The MRCAT brain complies with the following international and FDA-recognized consensus standards." and "Non Clinical verification and or validation test results demonstrate that the MRCAT brain: Complies with the aforementioned international and FDA-recognized consensus standards." |
| MRCAT image generation correctness: - Sanity checks to ensure imaging field of view is correctly positioned. - Sanity checks to ensure MRCAT body outline matches that of the MR. | "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 overall conclusion on non-clinical tests also states: "met the acceptance criteria and is adequate for this intended use." |
| HU value calibration: - The HU values for the MRCAT Brain are calibrated using registered CT images from several sites. | "The HU values for the MRCAT brain are calibrated using registered CT images." and "The overall conclusion on non-clinical tests also states: "met the acceptance criteria and is adequate for this intended use." |
The Study Proving Device Meets Acceptance Criteria:
The document describes a "Summary of Non-Clinical Performance Data" and a "Summary of Clinical Data" to support the device's substantial equivalence and adherence to acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that the robustness of the MRCAT brain algorithm for producing equivalent dose plans to CT using gamma analysis was shown by post-processing MRCAT images from patients. However, it does not specify the exact sample size used for this patient data (test set) or the country of origin/provenance (retrospective or prospective) of this patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not provide information regarding the number of experts used to establish ground truth or their specific qualifications for the test set.
4. Adjudication Method:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth in the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document makes no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done. The focus is on the device's technical performance in generating comparable dose plans to CT, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
Yes, a standalone performance was done. The dose accuracy and geometric accuracy criteria, as well as the comparison to CT-based plans, are direct assessments of the algorithm's performance without human intervention in the primary image generation and initial dose calculation. The "robustness of the MRCAT brain algorithm" and its ability to produce "equivalent dose plans to CT" describe standalone performance.
7. Type of Ground Truth Used:
The primary ground truth used for assessing the device's performance, particularly dose accuracy and HU value calibration, is registered CT images and CT-based treatment plans. The comparisons are made against these CT data, which are considered the established standard for radiation attenuation estimation in radiotherapy planning.
8. Sample Size for the Training Set:
The document states that the Convolutional Neural Network (CNN) used in MRCAT image generation is "trained using matched pairs of CT and MRCAT source images." However, the exact sample size used for the training set 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 implies that CT images served as the reference or ground truth against which the MRCAT source images were processed and the CNN was trained to generate CT-like density information (HU values).
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January 24, 2020
Philips Medical Systems MR Finland % Janne Marvola, Ph.D. Regulatory Engineer Ayritie 4 01510 Vantaa FINLAND
Re: K193109
Trade/Device Name: MRCAT brain Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: November 4, 2019 Received: November 8, 2019
Dear Dr. Marvola:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 (OS) 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 medical devices and radiation-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,
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
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Indications for Use
510(k) Number (if known) K193109
Device Name MRCAT Brain
Indications for Use (Describe)
MRCAT Brain is a software add-on for Ingenia, Ingenia Ambition, and Ingenia Elition MR systems.
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.
Indications for use:
MRCAT Brain is indicated for radiotherapy treatment planning for primary and metastatic brain tumor patients.
| Type of Use (Select one or both , as applicable) | |
|---|---|
| ---------------------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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6. 510(k) Summary
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 Prepared: | January 20, 2020 |
|---|---|
| Manufacturer: | Philips Medical Systems MR FinlandÄyritie 401510 Vantaa, Finland |
| Establishment Registration Number: 9680194 | |
| Primary ContactPerson: | Janne MarvolaRegulatory EngineerPhone: +358-40-126 1214Fax: +358-9-3487 2406E-mail: regulatory.mr.therapy@philips.com |
| SecondaryContact Person | Osku IlvonenHead of Q&RPhone: +358-40-552 6197Fax: +358-9-3487 2406E-mail: osku.ilvonen@philips.com |
| Device Name: | MRCAT brain |
| Classification: | Classification Name: Medical charged-particle radiation therapysystem |
| ClassificationRegulation: 21 CFR §892.5050 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Product code: MUJ (System, Planning, Radiation TherapyTreatment) |
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| Predicate Device: | Trade Name: | MRCAT Pelvis | |
|---|---|---|---|
| Manufacturer: | Philips Medical Systems MR Finland | ||
| 510(k) Clearance: | K182888 (April 30, 2019) | ||
| ClassificationRegulation: | 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) | ||
| Reference Device: | Trade Name: | AcQPlan 5.0 | |
| Manufacturer: | Philips Medical Systems MR Finland | ||
| 510(k) Clearance: | K013644 (September 12, 2002) | ||
| ClassificationRegulation: | 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) | ||
| Devicedescription: | MRCAT brain is a software application to Ingenia, Ingenia Ambition,and Ingenia Elition MR systems. MRCAT brain is available to thecustomer as an option to Ingenia MR-RT package, which is a set ofaccessories for Ingenia systems. | ||
| Automated generation of MRCAT images takes place at the MRconsole of Ingenia. The embedded image post-processing runs in thebackground parallel to image acquisition. MRCAT algorithm enablesautomatic tissue characterization: Bones are segmented from mDixonin-phase and water images using machine learning based segmentation.Body outline is segmented using in-phase and water images. Tissuesare then assigned a continuum of HU values depending on the fat and |
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| water intensities of the voxels. The HU assignment provides MRCAT images with CT-like density information. | |
|---|---|
| Indications for Use: | MRCAT Brain is a software add-on for Ingenia, Ingenia Ambition, and Ingenia Elition MR systems. |
| 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. | |
| Indications for use: | |
| MRCAT brain is indicated for radiotherapy treatment planning for primary and metastatic brain tumor patients. | |
| Fundamental Scientific Technology: | MRCAT brain functionality is implemented as a software plug-in for 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, which uses the images from the previous mDixon scan. | |
| The post-processing logic takes care of launching MRCAT algorithm executable calculating a new 3D MRCAT image. The post-processing is started once the acquired mDixon MR images have been reconstructed. The first step of MRCAT generation is to pre-process the images to ensure that 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 |
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MRCAT brain 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 ●
- 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 postprocessing and for geometric accuracy, is delivered as a part of MRCAT brain option. The mDixon imaging sequence provides two image contrasts for the MRCAT algorithm: inphase and water images. MRCAT brain 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 brain option. MRCAT brain 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 brain run on the MR console of Ingenia.
Based on the information provided above, the MRCAT brain is considered substantially equivalent to the primary currently marketed and predicate device (K182888, April 30, 2019) in terms of fundamental scientific technology.
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| Summary of Non-Clinical Performance Data: | The MRCAT brain 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 62366-1:2015, Medical devices – Application of usability engineering to medical devices ISO 14971:2007, Medical devices – Application of risk management to medical devices | |
| 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 brain:Complies with the aforementioned international and FDA-recognized consensus standards Meets the acceptance criteria and is adequate for its intended |
Therefore, the MRCAT brain is substantially equivalent to the primary currently marketed and predicate device (K182888, April 30, 2019) in terms of safety and effectiveness. Detailed comparison for selected features is presented in Table 6-1 below.
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| Table 6-1 | |||
|---|---|---|---|
| Comparison of the primary currently marketed and predicatedevice, MRCAT Pelvis versus the proposed MRCAT Brain | |||
| Device | MRCAT Pelvis | MRCAT Brain | SimilaritiesandDifferences |
| Manufacturer | Philips MedicalSystems MRFinland | Philips MedicalSystems MRFinland | - |
| 510(k)Number | K182888 | K193109 | N/A |
| Product Code | MUJ | MUJ | Identical |
| RegulationNumber | 892.5050 | 892.5050 | Identical |
| RegulationName | Accelerator,Linear, Medical | Accelerator,Linear, Medical | Identical |
| Intended use | MRCAT imaging isintended toprovide theoperator withinformation oftissue propertiesfor radiationattenuationestimationpurposesin photon externalbeam radiotherapytreatmentplanning. | MRCAT imaging isintended toprovide theoperator withinformation oftissue propertiesfor radiationattenuationestimationpurposesin photon externalbeam radiotherapytreatmentplanning. | Identical |
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| Indicationsfor use | MRCAT Pelvis isindicated forradiotherapytreatmentplanning of softtissue cancers inthe pelvic region. | MRCAT Brain isindicated forradiotherapytreatmentplanning forprimary andmetastatic braintumor patients. | No significantdifference.MRCAT Pelvisand MRCATBrain arebothindicated forradiotherapytreatmentplanning in adefinedregion.Brain tumorsare soft tissuetumors. |
|---|---|---|---|
| Primaryimagedataset | MRCAT | MRCAT | No significantdifference |
| Secondaryimagedataset | mDixon, MRI | mDixon, MRI | No significantdifferenceMR imagesobtained inthe sameimagingsession areinherently inthe sameframe ofreference. |
| Registrationbetweenprimary andsecondaryimagedatasets | Secondary mDixonMR image, sourcedata to MRCAT, isinherentlyregistered as partof MRCATalgorithm withMRCAT image,which simplifiesworkflow.Other MR images,like T2w andfiducial markerdetection imagesare registeredusing toolsavailable in RTPsystem | Secondary mDixonMR image, sourcedata to MRCAT, isinherentlyregistered as partof MRCATalgorithm withMRCAT image,which simplifiesworkflow.Other MR images,like T2w imagesare registeredusing toolsavailable in RTPsystem | No significantdifferenceSecondaryMR imagesare obtainedin the sameimagingsessionreducing thepossibility ofpatientmotionbetweenimages. |
| Primaryimagedensityinformation | MRCAT imageintensityinformation isprovided inHounsfield Unit(HU) values. | MRCAT imageintensityinformation isprovided inHounsfield Unit(HU) values. | No significantdifference.MRCAT Pelvisand MRCATBrain bothhavecontinuousHU valueapproach. |
| Conversionfrom primaryimage todensityvalues usedin dosecalculation | Primary image HUvalues areconverted todensities throughdensity tablespecific for theMRCAT. | Primary image HUvalues areconverted todensities throughdensity tablespecific for theMRCAT. | No significantdifferenceMRCAT hasspecificdensity tablethat is used ina similarmanner to CTspecificdensitytables. |
| MRCATalgorithm | Bones aresegmented frommDixon inphaseand water imagesusing model based | Bones aresegmented frommDixon inphaseand water imagesusing machine | No significantdifferenceSegmentationis done forboth MRCAT |
| segmentation. Thesegmented bonesare the femurs,pelvic bones andlumbar vertebraeL5 and L1.Body outline issegmented usinginphase and waterimages. | learning basedsegmentation. Thesegmented bonesare in skull, upperC-spine and jaw.Body outline issegmented usinginphase and waterimages. | Pelvis andBrain usingthe mDIXONimagecontrasts.HU valueassignment isdone basedon mDixonimageintensities. | |
| Bones are assigneda continuum of HUvalues betweendense corticalbone and lightspongy bonedepending on thefat and waterintensities of thevoxels.Soft tissue areassigned acontinuum of HUvalues between fatand muscle tissuedepending on thefat and waterintensities of thevoxels.The HU values forthe MRCAT Pelvisare calibratedusing registered CTimages fromseveral sites. | Bones are assigneda continuum of HUvalues betweendense corticalbone and lightspongy bonedepending on thefat and waterintensities of thevoxels.Soft tissue areassigned acontinuum of HUvalues dependingon the fat andwater intensities ofthe voxels.The HU values forthe MRCAT Brainare calibratedusing registered CTimages fromseveral sites.MRCAT Brainalgorithm is fullytrained beforeproduct release,after which thealgorithm islocked. | The modelsused areequivalent inrelation todose andpositioningaccuracy.Bothalgorithmsare locked;they do notchange afterinstallationbased on newdata duringthe use. | |
| Patientpositioning | Ingenia MR-RTwith MRCAT Pelvissupports MR Onlysimulation withrelative patientmarking. | Ingenia MR-RTwith MRCAT Brainsupports MR Onlysimulation withrelative patientmarking. | No significantdifferenceThe visibilityof bonestructures isequivalent forbothproducts.Internalmarkers arenot used forbrain tumors. |
| Patient positioningin the treatmentmachine must bechecked eitherwith cone beamcomputedtomography(CBCT) or plainradiographs byregistering bonestructures orinternal fiducialmarkers. | Patient positioningin the treatmentmachine must bechecked eitherwith cone beamcomputedtomography(CBCT) or plainradiographs byregistering bonestructures. | ||
| Dose | The simulated | The simulated | No significant |
| accuracy | dose based onMRCAT imagesshall not differ in95% of prostatecancer patients(gamma analysiscriterion 3%/3mmrealized in 99% ofvoxels within thePTV or exceeding75% of themaximum dose)when comparedwith CT basedplan. | dose based onMRCAT Brainimages shall notdiffer in 95% of theindicated patients(gamma analysiscriterion 2%/2mmrealized in 98% ofvoxels within thePTV or exceeding75% of themaximum dose)when comparedwith CT-basedplan. | difference.The samedoseevaluationmethodologyis used forbothproducts. Thecriteria areselectedbased on theneeds of theapplication. |
| The averagesimulated dosebased on MRCATimages shall notdeviate more than10% for voxelsexceeding 5Gy in99% of theindicated patientsin the volume ofsensitive organswhen comparedwith CT basedplan. | The averagesimulated dosebased on MRCATBrain shall notdeviate more than5% or 1 Gy, whichever is greater, in99% of theindicated patientsin the volume ofsensitive organswhen comparedwith CT basedplan. | ||
| Geometricaccuracy | MRCAT accuracy:± 1 mm accuracy:200 mm diametersphere± 5 mm accuracy:500 mm diametersphere (limited inthe bore directionby +/- 160 mmfrom the z=0 mmplane ) | MRCAT accuracy:± 1 mm accuracy:200 mm diametersphere± 5 mm accuracy:500 mm diametersphere (limited inthe bore directionby +/- 160 mmfrom the z=0 mmplane ) | No significantdifference |
| MRCATsourceimagingsequence | mDIXON 3D scanwith acquiredvoxel size of1.40/1.40/1.40mm, andbandwidth/pixel430Hz (1.5T) or860Hz (3T).Most scanningparameters locked | mDIXON 3D scanwith acquiredvoxel size of1.10/1.10/1.40mm (1.5 T) and1.1/1.1/1.1 mm(3T), andbandwidth/pixel481Hz (1.5T) or868Hz (3T).Most scanningparameters locked | No significantdifferenceEspecially,the sensitivityto B0 induceddistortion inthe readdirection isabout 0.2mm/ppm inboth MRCATPelvis andMRCAT Brain.In bothsolutions theessentialparametersare locked toavoid usererrorspotentiallyaffecting theaccuracy andreliability ofthe method. |
| DICOM RTexport | yes | yes | No significantdifference |
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Philips Medical Systems MR Finland
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Philips Medical Systems MR Finland
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| Summary ofClinical Data: | The robustness of the MRCAT brain algorithm for producingequivalent dose plans to CT using gamma analysis with criterion of1%/1mm is shown by post-processing MRCAT images from patients,and calculating dose using the MRCAT images. |
|---|---|
| In summary, the MRCAT brain images are spatially accurate radiationattenuation estimates that can aid in the EBRT planning of primary andmetastatic brain tumors. | |
| SubstantialEquivalenceConclusion: | The MRCAT brain is substantially equivalent to the primary currentlymarketed and predicate device (K182888, April 30, 2019) in terms ofdesign features, fundamental scientific technology, indications for use,and safety and effectiveness. Additionally, substantial equivalence was |
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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 brain 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.