(273 days)
K013644 AcQPlan 5.0
No
The description mentions "MRCAT algorithms" and "automatic tissue characterization" but does not explicitly state or imply the use of AI or ML techniques. The focus is on automated image post-processing and tissue characterization based on embedded algorithms, which could be traditional image processing methods.
No.
MRCAT is a software that provides tissue characterization for radiation attenuation estimation in radiotherapy treatment planning, but it does not directly treat or diagnose cancer.
No
Explanation: The device is intended to provide estimations for radiation attenuation in radiotherapy treatment planning, which is a part of therapy delivery planning, not diagnosis of a disease.
Yes
The device is explicitly described as a "software application" that runs on existing MR systems and is available as an "option" to a hardware package, indicating it is a software component rather than a new hardware device. Its function is image post-processing and algorithm execution, which are software-based tasks.
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 intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- MRCAT's Function: MRCAT is a software application that processes MR images to estimate tissue properties for radiation attenuation in radiotherapy treatment planning. It does not examine specimens derived from the human body in vitro. It works with images acquired directly from the patient's body using an MR system.
Therefore, MRCAT falls under the category of a medical device used in the context of imaging and treatment planning, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MRCAT is used with Ingenia 1.5T and 3.0T 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 is indicated for radiotherapy treatment planning for prostate cancer patients.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
MRCAT is a software application to Ingenia 1.5T and 3T MR systems. MRCAT 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 algorithms enable automatic tissue characterization of five tissue types; air, fat, water-rich tissue, spongy bone and compact bone. Subsequent bulk-density assignment provides MRCAT images with CT-based density information.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR (Magnetic Resonance)
Anatomical Site
prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operator, for radiotherapy treatment planning
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Clinical Summary: The robustness of the MRCAT algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm is shown by postprocessing MRCAT images from prostate cancer patients, and calculating dose using the MRCAT images. In summary, the MRCAT images provide robust and spatially accurate radiation attenuation estimates that can aid in the photon EBRT planning of prostate cancer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K130992 Pinnacle 3® Radiation Therapy Planning System
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 AcQPlan 5.0
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
Philips Medical Systems MR Finland % Janne Marvola, Ph.D. Regulatory Engineer Ayritie 4 Vantaa, 01510 FINLAND
Re: K151435
Trade/Device Name: MRCAT software Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: January 15, 2016 Received: January 19, 2016
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
K151435 510(k) Number (if known): _
Device Name: MRCAT software
Indications for use:
MRCAT is used with Ingenia 1.5T and 3.0T 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 is indicated for radiotherapy treatment planning for prostate cancer patients.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Section 5: 510(k) Summary
MRCAT software
4
Philips Medical Systems MR Finland Äyritie 4 01510 Vantaa Finland T: +358-9-615-800
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Owner/Contact/Date (807.92(a)(1):
| Date: | February 24, 2016 |
|---|---|
| Owner/Submitter: | Philips Medical Systems MR Finland |
| Äyritie 4 | |
| 01510 Vantaa | |
| FINLAND | |
| Phone: +358-9-615 800 | |
| Fax: +358-9-3487 2406 | |
| Primary Contact Person: | Janne Marvola |
| Regulatory Engineer | |
| Philips Medical Systems MR Finland | |
| Phone: +358-40-126 1214 | |
| Fax: +358-9-3487 2406 | |
| E-mail: regulatory.mr.therapy@philips.com | |
| Secondary Contact Person: | Osku Ilvonen |
| Regulatory Manager | |
| Philips Medical Systems MR Finland | |
| Phone: +358-40-552-6197 | |
| Fax: +358-9-3487-2406 | |
| E-mail: osku.ilvonen@philips.com |
Device names (807.92(a)(2)):
| Trade Name: | |
|---|---|
| Classification: | |
| Regulatory Section: |
MRCAT Class II 21 CFR 892.5050
Product Code:
MUJ
Predicate Device(s) (807.92(a)(3):: K130992 Pinnacle 3® Radiation Therapy Planning System (primary) K013644 AcQPlan 5.0 (reference)
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| Device Description
(807.92(a)(4)):: | MRCAT is a software application to Ingenia 1.5T and 3T MR systems. MRCAT
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 algorithms enable automatic tissue
characterization of five tissue types; air, fat, water-rich tissue, spongy bone
and compact bone. Subsequent bulk-density assignment provides MRCAT
images with CT-based density information. |
| Intended Use: (807.92(a)(5): | MRCAT is used with Ingenia 1.5T and 3.0T 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 is indicated for radiotherapy treatment planning for prostate cancer
patients. |
| Technology (807.92(a)(6)):: | MRCAT functionality is implemented in the MR system software and it
contains the following main features:
- 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 algorithm enables
automatic tissue characterization of five tissue types; air, fat, water-rich
tissue, spongy bone and compact bone. Subsequent bulk-density assignment
provides MRCAT images with CT-based density information. 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. |
image database.
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mDIXON scan
An mDixon imaging protocol, with imaging parameters optimized for MRCAT image post-processing and for geometric accuracy, is delivered as a part of MRCAT option. MRCAT 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
MRCAT does not require any change of the hardware platform of Ingenia 1.5T and 3.0T. The new software extensions introduced by MRCAT run on the MR Host computer.
Summary of Non-Clinical Tests:
The MRCAT software complies with voluntary standards as detailed below. The following quality assurance measures were applied to the development of the system:
- . Risk Analysis
- Testing on unit level (Subsystem verification)
- Integration testing (System verification) ●
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
The MRCAT software was designed and tested for compliance to the following standards:
-
- ANSI/AAMI ES60601-1: 2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance -Third Edition
-
- IEC 60601-1-6:2006, Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
-
- IEC 60601-2-33:2010, Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
- IEC 62304:2006, Medical device software Software life-cycle 4.
Determination of Substantial Equivalence, non-clinical (807.92(b)(1))::
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processes
-
- ISO 14971:2007, Medical devices. Application of risk management to medical devices
All requirements are met for the MRCAT application.
- ISO 14971:2007, Medical devices. Application of risk management to medical devices
The conclusion from these reports is: All the tests performed for MRCAT software were successful. All defects have been analyzed and are confirmed that they are not safety defects and will not cause any hazardous situation on using this application.
Clinical (807.92(b)(2)): Summary of Clinical Tests: The robustness of the MRCAT algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm is shown by postprocessing MRCAT images from prostate cancer patients, and calculating dose using the MRCAT images. In summary, the MRCAT images provide robust and spatially accurate radiation attenuation estimates that can aid in the photon EBRT planning of prostate cancer. Conclusion (807.92(b)(3)):: MRCAT SW option is a tool to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning for prostate cancer patients.
lt is the opinion of Philips Medical Systems that the MRCAT SW option for Philips Ingenia is substantially equivalent and raises no new issues of safety or effectiveness compared to the primary predicate Pinnacle3® Radiation Therapy Planning System, K130992 cleared by FDA on June 14, 2013 and the reference device AcQPlan 5.0, K013644, cleared by FDA on September 12, 2002.