Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly states that "Bones are segmented from mDixon in-phase and water images using machine learning based segmentation."

Therapeutic

No.

The device is intended to provide information for radiation attenuation estimation in radiotherapy treatment planning, not to directly treat or diagnose a disease.

Diagnostic

No

The device is intended to provide information on tissue properties for radiation attenuation estimation in radiotherapy treatment planning, not to diagnose a disease or condition.

SaMD (Software as a Medical Device)

No

The device is described as a "software add-on for Ingenia, Ingenia Ambition, and Ingenia Elition MR systems" and an "option to Ingenia MR-RT package, which is a set of accessories for Ingenia systems." This indicates it is integrated with and dependent on specific hardware systems (MR systems and accessories), rather than being a standalone software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The MRCAT Brain software processes MR images of the brain to generate CT-like density information (HU values) for use in radiotherapy treatment planning. It does not analyze biological samples from the patient.
Intended Use: The intended use is specifically for "radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning," which is a process performed on the patient's body, not on a sample taken from the body.
Indications for Use: The indications for use are for "radiotherapy treatment planning for primary and metastatic brain tumor patients," again focusing on a treatment planning process, not a diagnostic test on a sample.

The device is a software tool that aids in the planning of a medical treatment (radiotherapy) by processing medical images. This falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

MUJ

Device Description

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.

Mentions image processing

Yes. "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." and "The first step of MRCAT generation is to pre-process the images to ensure that the MRCAT source images have consistent intensities."

Mentions AI, DNN, or ML

Yes. "Bones are segmented from mDixon in-phase and water images using machine learning based segmentation." and "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 (Magnetic Resonance)

Anatomical Site

Brain

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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.

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 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.

In summary, the MRCAT brain images are spatially accurate radiation attenuation estimates that can aid in the EBRT planning of primary and metastatic brain tumors.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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.
Geometric accuracy: MRCAT accuracy: ± 1 mm accuracy: 200 mm diameter sphere, ± 5 mm accuracy: 500 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane )

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K182888

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K013644

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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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

1

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 Finland
Äyritie 4
01510 Vantaa, Finland
	Establishment Registration Number: 9680194
Primary Contact
Person:	Janne Marvola
Regulatory Engineer
Phone: +358-40-126 1214
Fax: +358-9-3487 2406
E-mail: regulatory.mr.therapy@philips.com
Secondary
Contact Person	Osku Ilvonen
Head of Q&R
Phone: +358-40-552 6197
Fax: +358-9-3487 2406
E-mail: osku.ilvonen@philips.com
Device Name:	MRCAT brain
Classification:	Classification Name: Medical charged-particle radiation therapy
system
	Classification
Regulation: 21 CFR §892.5050
	Classification Panel: Radiology
	Device Class: Class II
	Product code: MUJ (System, Planning, Radiation Therapy
Treatment)

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Predicate Device:	Trade Name:	MRCAT Pelvis
	Manufacturer:	Philips Medical Systems MR Finland
	510(k) Clearance:	K182888 (April 30, 2019)
	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 MR Finland
	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)
Device
description:	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

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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 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 |

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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 predicate
device, MRCAT Pelvis versus the proposed MRCAT Brain
Device	MRCAT Pelvis	MRCAT Brain	Similarities
and
Differences
Manufacturer	Philips Medical
Systems MR
Finland	Philips Medical
Systems MR
Finland	-
510(k)
Number	K182888	K193109	N/A
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

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| Indications
for use | MRCAT Pelvis is
indicated for
radiotherapy
treatment
planning of soft
tissue cancers in
the pelvic region. | MRCAT Brain is
indicated for
radiotherapy
treatment
planning for
primary and
metastatic brain
tumor patients. | No significant
difference.
MRCAT Pelvis
and MRCAT
Brain are
both
indicated for
radiotherapy
treatment
planning in a
defined
region.
Brain tumors
are soft tissue
tumors. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary
image
dataset | MRCAT | MRCAT | No significant
difference |
| Secondary
image
dataset | mDixon, MRI | mDixon, MRI | No significant
difference
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. | No significant
difference.
MRCAT Pelvis
and MRCAT
Brain 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 inphase
and water images
using model based | Bones are
segmented from
mDixon inphase
and water images
using machine | No significant
difference
Segmentation
is done for
both MRCAT |
| | | | |
| segmentation. The
segmented bones
are the femurs,
pelvic bones and
lumbar vertebrae
L5 and L1.

Body outline is
segmented using
inphase and water
images. | learning based
segmentation. The
segmented bones
are in skull, upper
C-spine and jaw.

Body outline is
segmented using
inphase and water
images. | Pelvis and
Brain using
the mDIXON
image
contrasts.

HU value
assignment is
done based
on mDixon
image
intensities. | |
| 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 between fat
and muscle tissue
depending on the
fat and water
intensities of the
voxels.

The HU values for
the MRCAT Pelvis
are calibrated
using registered CT
images from
several sites. | 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 which the
algorithm is
locked. | 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. | |
| Patient
positioning | Ingenia MR-RT
with MRCAT Pelvis
supports MR Only
simulation with
relative patient
marking. | Ingenia MR-RT
with MRCAT Brain
supports MR Only
simulation with
relative patient
marking. | No significant
difference
The visibility
of bone
structures is
equivalent for
both
products.
Internal
markers are
not used for
brain tumors. |
| | Patient positioning
in the treatment
machine must be
checked either
with cone beam
computed
tomography
(CBCT) or plain
radiographs by
registering bone
structures or
internal fiducial
markers. | Patient positioning
in the treatment
machine must be
checked either
with cone beam
computed
tomography
(CBCT) or plain
radiographs by
registering bone
structures. | |
| Dose | The simulated | The simulated | No significant |
| accuracy | dose based on
MRCAT images
shall not differ in
95% of prostate
cancer patients
(gamma analysis
criterion 3%/3mm
realized in 99% of
voxels within the
PTV or exceeding
75% of the
maximum dose)
when compared
with CT based
plan. | 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. | difference.
The same
dose
evaluation
methodology
is used for
both
products. The
criteria are
selected
based on the
needs of the
application. |
| | The average
simulated dose
based on MRCAT
images shall not
deviate more than
10% for voxels
exceeding 5Gy in
99% of the
indicated patients
in the volume of
sensitive organs
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. | |
| Geometric
accuracy | MRCAT accuracy:
± 1 mm accuracy:
200 mm diameter
sphere
± 5 mm accuracy:
500 mm diameter
sphere (limited in
the bore direction
by +/- 160 mm
from the z=0 mm
plane ) | MRCAT accuracy:
± 1 mm accuracy:
200 mm diameter
sphere
± 5 mm accuracy:
500 mm diameter
sphere (limited in
the bore direction
by +/- 160 mm
from the z=0 mm
plane ) | No significant
difference |
| MRCAT
source
imaging
sequence | mDIXON 3D scan
with acquired
voxel size of
1.40/1.40/1.40
mm, and
bandwidth/pixel
430Hz (1.5T) or
860Hz (3T).
Most scanning
parameters locked | 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 | No significant
difference
Especially,
the sensitivity
to B0 induced
distortion in
the read
direction is
about 0.2
mm/ppm in
both MRCAT
Pelvis and
MRCAT Brain.
In both
solutions the
essential
parameters
are locked to
avoid user
errors
potentially
affecting the
accuracy and
reliability of
the method. |
| DICOM RT
export | yes | yes | No significant
difference |

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Philips Medical Systems MR Finland

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Philips Medical Systems MR Finland

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| Summary of
Clinical Data: | 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. |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | In summary, the MRCAT brain images are spatially accurate radiation
attenuation estimates that can aid in the EBRT planning of primary and
metastatic brain tumors. |
| Substantial
Equivalence
Conclusion: | The MRCAT brain is substantially equivalent to the primary currently
marketed and predicate device (K182888, April 30, 2019) in terms of
design 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.