MRCAT

K151435 · Philips Medical Systems MR Finland · MUJ · Feb 25, 2016 · Radiology

Device Facts

• Record ID: K151435
• Device Name: MRCAT
• Applicant: Philips Medical Systems MR Finland
• Product Code: MUJ · Radiology
• Decision Date: Feb 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

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 is used with Ingenia 1.5T and 3.0T MR systems.

Device Story

MRCAT is a software application for Philips Ingenia 1.5T and 3.0T MR systems. It processes mDixon MR scan data to generate 3D images for radiation therapy planning. The software automatically characterizes five tissue types (air, fat, water-rich tissue, spongy bone, compact bone) and assigns bulk-density values to create CT-like density information. The process runs in the background at the MR console during or after acquisition. The resulting 3D MRCAT images are stored in the MR database and exported via DICOM to treatment planning systems. Clinicians use these images to estimate radiation attenuation for photon external beam radiotherapy. The device benefits patients by enabling MR-only radiotherapy planning, potentially reducing the need for separate CT scans.

Clinical Evidence

Clinical evaluation involved processing MRCAT images from prostate cancer patients to calculate radiation dose plans. Performance was compared against CT-based plans using gamma analysis with a 3%/3mm criterion. Results showed MRCAT provides robust and spatially accurate radiation attenuation estimates equivalent to CT for EBRT planning.

Technological Characteristics

Software-based post-processing tool for Ingenia 1.5T/3.0T MR systems. Features mDixon imaging protocol, automated tissue characterization, and DICOM export. Complies with ANSI/AAMI ES60601-1, IEC 60601-1-6, IEC 60601-2-33, IEC 62304, and ISO 14971. Runs on existing MR Host computer hardware.

Indications for Use

Indicated for radiotherapy treatment planning for prostate cancer patients.

Regulatory Classification

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.

Predicate Devices

• Pinnacle 3® Radiation Therapy Planning System (K130992)

Reference Devices

• AcQPlan 5.0 (K013644)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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

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Philips Medical Systems MR Finland Äyritie 4 01510 Vantaa Finland T: [phone]

# 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<br>Äyritie 4<br>01510 Vantaa<br>FINLAND<br>Phone: [phone] |
| | Fax: [phone] |
| Primary Contact Person: | Janne Marvola<br>Regulatory Engineer<br>Philips Medical Systems MR Finland<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Secondary Contact Person: | Osku Ilvonen<br>Regulatory Manager<br>Philips Medical Systems MR Finland<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |

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<br>(807.92(a)(4)):: | MRCAT is a software application to Ingenia 1.5T and 3T MR systems. MRCAT<br>is available to the customer as an option to Ingenia MR-RT package, which is<br>a set of accessories for Ingenia systems. |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Automated generation of MRCAT images takes place at the MR console of<br>Ingenia. The embedded image post-processing runs in the background<br>parallel to image acquisition. MRCAT algorithms enable automatic tissue<br>characterization of five tissue types; air, fat, water-rich tissue, spongy bone<br>and compact bone. Subsequent bulk-density assignment provides MRCAT<br>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<br>tissue properties for radiation attenuation estimation purposes in photon<br>external beam radiotherapy treatment planning. |
| | Indications for use: |
| | MRCAT is indicated for radiotherapy treatment planning for prostate cancer<br>patients. |
| Technology (807.92(a)(6)):: | MRCAT functionality is implemented in the MR system software and it<br>contains the following main features:<br>1) Automatic post-processing tool delivering MRCAT images<br>2) Examcard with mDixon imaging protocol<br>3) DICOM export of MRCAT image. |
| | MRCAT Image Generation |
| | MRCAT images are generated with an ExamCard post-processing step, which<br>uses the images from the previous mDixon scan. |
| | The post-processing logic takes care of launching MRCAT algorithm<br>executable calculating a new 3D MRCAT image. The algorithm enables<br>automatic tissue characterization of five tissue types; air, fat, water-rich<br>tissue, spongy bone and compact bone. Subsequent bulk-density assignment<br>provides MRCAT images with CT-based density information. Once the<br>process is running, post-processing logic exchanges information with the<br>algorithm: |
| | ● Image source data to algorithm, and image output data back to the<br>post-processing step<br>● Progress notifications<br>● Error and warning notifications |
| | The 3D MRCAT image from the post-processing step is stored into the MR<br>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:

- 1. ANSI/AAMI ES60601-1: 2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance -Third Edition
- 2. IEC 60601-1-6:2006, Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
- 3. 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

- 5. ISO 14971:2007, Medical devices. Application of risk management to medical devices
All requirements are met for the MRCAT application.

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.