(99 days)
Yes
The device description explicitly states that "Bones are segmented from mDixon in-phase and water images using machine learning based segmentation" and that "The intensity normalized images are then used as input in a convolutional neural network (CNN)."
No
This device is a software application that provides information for radiation attenuation estimation in radiotherapy treatment planning. It does not directly treat or diagnose a disease.
No
The device is intended to provide information for radiation attenuation estimation in radiotherapy treatment planning, not for diagnosis. It generates CT-like density information (HU values) from MRI images to assist in treatment planning, which is a subsequent step after diagnosis.
No
The device is described as a software application to Ingenia, Ingenia Ambition, and Ingenia Elition MR systems, and is available as an option to the Ingenia MR-RT package, which is a set of accessories for Ingenia systems. This indicates the software is integrated with and dependent on specific hardware systems (MR systems and accessories), rather than being a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The MRCAT Head & Neck device is a software application that processes MR images to generate CT-like images for radiation treatment planning. It provides information about tissue properties for radiation attenuation estimation.
- Lack of Sample Analysis: The device does not analyze biological samples taken from the patient. It processes imaging data acquired by an MR system.
- Intended Use: The intended use is for radiation treatment planning, which is a process that occurs after a diagnosis has been made and is focused on delivering therapeutic radiation, not on diagnosing a condition.
While the device uses advanced image processing and machine learning, and provides information about tissue properties, its function and intended use fall outside the scope of an In Vitro Diagnostic device. It is a medical device used in the context of radiation therapy planning.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for 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.
MRCAT Head and Neck is indicated for radiotherapy treatment planning for patients with soft tissue tumors in the Head and Neck region.
Product codes
MUJ
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.
Mentions image processing
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 Head and Neck 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 images 2) Examcard with mDixon imaging protocol 3) DICOM export of MRCAT image.
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.
Mentions AI, DNN, or ML
Bones are segmented from mDixon in-phase and water images using machine learning based segmentation.
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.
Input Imaging Modality
MR, mDixon, MRI
Anatomical Site
Head and Neck region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operator in photon external beam radiotherapy treatment planning.
Description of the training set, sample size, data source, and annotation protocol
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 HU values for the MRCAT Head and Neck are calibrated using registered CT images from several sites.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The resulting dose accuracy for MRCAT Head and Neck is similar to CT. The 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The 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, which ever is greater, in 99% of the indicated patients in the volume of sensitive organs when compared with CT based plan.
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)
Predicate Device(s):
Reference Device(s):
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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
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,
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
2
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
| Prepared: | April 05, 2022 | ||
|---|---|---|---|
| Manufacturer: | Philips Oy | ||
| Äyritie 4 | |||
| 01510 Vantaa, Finland | |||
| Establishment Registration Number: 9680194 | |||
| Primary | |||
| Contact | |||
| Person: | Jan van de Kerkhof | ||
| Sr. Manager Regulatory Affairs | |||
| Phone: +31-613300542 | |||
| E-mail: jan.van.de.kerkhof@philips.com | |||
| Secondary | |||
| Contact | |||
| Person | Anne-Sophie Glantenay | ||
| Sr. Regulatory Affairs Specialist | |||
| Phone: +31-611531002 | |||
| E-mail: anne-sophie.glantenay@philips.com | |||
| Device Name: | MRCAT Head & Neck | ||
| Classification: | Classification Name: | Medical charged-particle radiation therapy | |
| system (accessory for) | |||
| Classification Regulation: | 21 CFR §892.5050 | ||
| Classification Panel: | Radiology | ||
| Device Class: | Class II | ||
| Product code: | MUJ (System, Planning, Radiation Therapy | ||
| Treatment) | |||
| Predicate | |||
| 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 | ||
| treatment) | |||
| Reference | |||
| 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 | ||
| 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
| Use: | 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 Head and Neck is indicated for radiotherapy treatment planning for | ||
| patients with soft tissue tumors in the Head and Neck region. | ||
| Fundamental | ||
| Scientific | ||
| Technology: | MRCAT Head and Neck 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 images |
- Examcard with mDixon imaging protocol
- 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 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
and
Differences |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Philips Oy | Philips Oy | - |
| 510(k)
Number | K193109 | - | - |
| Product Code | MUJ | MUJ | Identical |
| Regulation
Number | 892.5050 | 892.5050 | Identical |
| Regulation
Name | Accelerator, Linear,
Medical | Accelerator, Linear,
Medical | Identical |
| 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. | 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. | Identical |
| Indications
for use | MRCAT Brain is
indicated for
radiotherapy treatment
planning for primary
and metastatic brain
tumor patients. | MRCAT Head and
Neck is indicated for
radiotherapy
treatment planning
for patients with soft
tissue tumors in the
Head and Neck
region | No significant
difference.
MRCAT Brain
and MRCAT
Head & Neck
are both
indicated for
radiotherapy
treatment
planning in a
defined
region.
Brain tumors
are soft tissue
tumors. |
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| Primary
image
| dataset | MRCAT | MRCAT | Identical |
|---|---|---|---|
| Secondary | |||
| image | |||
| dataset | mDixon, MRI | mDixon, MRI | Identical |
| MR images | |||
| obtained in | |||
| the same | |||
| imaging | |||
| session are | |||
| inherently in | |||
| the same | |||
| frame of | |||
| reference. | |||
| Registration | |||
| between | |||
| primary and | |||
| secondary | |||
| image | |||
| datasets | Secondary mDixon MR | ||
| image, source data to | |||
| MRCAT, is inherently | |||
| registered as part of | |||
| MRCAT algorithm with | |||
| MRCAT image, which | |||
| simplifies workflow. | |||
| Other MR images, like | |||
| T2w and fiducial | |||
| marker detection | |||
| images are registered | |||
| using tools available in | |||
| RTP system | Secondary mDixon | ||
| MR image, source | |||
| data to MRCAT, is | |||
| inherently registered | |||
| as part of MRCAT | |||
| algorithm with | |||
| MRCAT image, which | |||
| simplifies workflow. | |||
| Other MR images, | |||
| like T2w images are | |||
| registered using tools | |||
| available in RTP | |||
| system | No significant | ||
| difference | |||
| Secondary MR | |||
| images are | |||
| obtained in | |||
| the same | |||
| imaging | |||
| session | |||
| reducing the | |||
| possibility of | |||
| patient | |||
| motion | |||
| between | |||
| images. | |||
| Primary | |||
| image | |||
| density | |||
| information | MRCAT image intensity | ||
| information is provided | |||
| in Hounsfield Unit (HU) | |||
| values. | MRCAT image | ||
| intensity information | |||
| is provided in | |||
| Hounsfield Unit (HU) | |||
| values. | Identical. | ||
| MRCAT Brain | |||
| and MRCAT | |||
| Head & Neck | |||
| both have | |||
| continuous | |||
| HU value | |||
| approach. | |||
| Conversion | |||
| from primary | |||
| image to | |||
| density | |||
| values used | |||
| in dose | |||
| calculation | Primary image HU | ||
| values are converted to | |||
| densities through | |||
| density table specific | |||
| for the MRCAT. | Primary image HU | ||
| values are converted | |||
| to densities through | |||
| density table specific | |||
| for the MRCAT. | No significant | ||
| difference | |||
| MRCAT has | |||
| specific | |||
| density table | |||
| that is used in | |||
| a similar | |||
| manner to CT | |||
| specific | |||
| density tables. | |||
| MRCAT | |||
| algorithm | Bones are segmented | ||
| from mDixon in-phase | |||
| and water images using | |||
| machine learning based | |||
| segmentation. The | |||
| segmented bones are | |||
| in skull, upper C-spine | |||
| and jaw. | |||
| Body outline is | |||
| segmented using in- | |||
| phase and water | |||
| images. | |||
| Bones are assigned a | |||
| continuum of HU | |||
| values between dense | |||
| cortical bone and light | |||
| spongy bone depending | |||
| on the fat and water | |||
| intensities of the | |||
| voxels. | |||
| Soft tissue are assigned | |||
| a continuum of HU | |||
| values depending on | |||
| the fat and water | |||
| intensities of the | |||
| voxels. | |||
| The HU values for the | |||
| MRCAT Brain are | |||
| calibrated using | |||
| registered CT images | |||
| from several sites. | |||
| MRCAT Brain algorithm | |||
| is fully trained before | |||
| product release, after | Bones are segmented | ||
| from mDixon in- | |||
| phase and water | |||
| images using | |||
| machine learning | |||
| based segmentation. | |||
| The segmented | |||
| bones are in skull, C- | |||
| spine, jaw, and | |||
| shoulder girdle. | |||
| Body outline is | |||
| segmented using in- | |||
| phase and water | |||
| images. | |||
| Bones are assigned a | |||
| continuum of HU | |||
| values between | |||
| dense cortical bone | |||
| and light spongy | |||
| bone depending on | |||
| the fat and water | |||
| intensities of the | |||
| voxels. | |||
| Soft tissue are | |||
| assigned a | |||
| continuum of HU | |||
| values depending on | |||
| the fat and water | |||
| intensities of the | |||
| voxels. | |||
| The HU values for the | |||
| MRCAT Head & Neck | |||
| are calibrated using | No significant | ||
| difference | |||
| Segmentation | |||
| is done for | |||
| both MRCAT | |||
| Brain and | |||
| MRCAT Head | |||
| & Neck using | |||
| the mDIXON | |||
| image | |||
| contrasts. | |||
| HU value | |||
| assignment is | |||
| done based | |||
| on mDixon | |||
| image | |||
| intensities. | |||
| The models | |||
| used are | |||
| equivalent in | |||
| relation to | |||
| dose and | |||
| positioning | |||
| accuracy. | |||
| Both | |||
| algorithms are | |||
| locked; they | |||
| do not change | |||
| after | |||
| installation | |||
| based on new | |||
| data during | |||
| the use. | |||
| which the algorithm is | |||
| locked. | registered CT images | ||
| from several sites. |
MRCAT Head & Neck
algorithm is fully
trained before
product release, after
which the algorithm
is locked. | |
| Patient
positioning | Ingenia MR-RT with
MRCAT Brain supports
MR Only simulation
with relative patient
marking.
Patient positioning in
the treatment machine
must be checked either
with cone beam
computed tomography
(CBCT) or plain
radiographs by
registering bone
structures. | Ingenia MR-RT with
MRCAT Head & Neck
supports MR Only
simulation with
relative patient
marking.
Patient positioning in
the treatment
machine must be
checked either with
cone beam
computed
tomography (CBCT)
or plain radiographs
by registering bone
structures. | No significant
difference
The visibility
of bone
structures is
equivalent for
both
products. |
| Dose
accuracy | The 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,
which ever is greater, in
99% of the indicated
patients in the volume
of sensitive organs
when compared with
CT based plan. | The 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, which
ever is greater, in
99% of the indicated
patients in the
volume of sensitive | Identical
The same
dose
evaluation
methodology
is used for
both
products. The
criteria are
selected
based on the
needs of the
application. |
| Geometric
accuracy | 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) | organs when
compared with CT
based plan.
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) | Identical |
| MRCAT
source
imaging
sequence | mDIXON 3D scan with
acquired voxel size of
1.10/1.10/1.40 mm (1.5
T) and 1.1/1.1/1.1 mm
(3T), and
bandwidth/pixel 481Hz
(1.5T) or 868Hz (3T).
Most scanning
parameters locked | mDIXON 3D scan
with acquired voxel
size of 1.2/1.2/1.2
mm (1.5 T) and
1.1/1.1/1.1 mm (3T),
and bandwidth/pixel
481Hz (1.5T) or
868Hz (3T).
Most scanning
parameters locked | No significant
difference
In both
solutions the
essential
parameters
are locked to
avoid user
errors
potentially
affecting the
accuracy and
reliability of
the method.
The voxel
sizes do not
differ
significantly. |
| DICOM RT
export | yes | yes | Identical |
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Image /page/9/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
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Image /page/10/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
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Image /page/11/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
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Image /page/12/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The background is white, providing a strong contrast to the blue letters.
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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Image /page/13/Picture/0 description: The image shows the text "Philips Oy" in a simple, sans-serif font. The text is black and appears against a white background. The letters are evenly spaced and clearly legible.
Image /page/13/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white.
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.