(197 days)
No
The document describes "automated tissue characterization" and "algorithms" for image post-processing, but it does not explicitly mention or imply the use of AI or ML techniques. The description focuses on deterministic algorithms for tissue classification and density assignment.
No
The device aids in radiotherapy treatment planning by providing information for radiation estimation, but it does not directly apply therapy.
No
The device is intended to provide information on tissue properties for radiation estimation in radiotherapy treatment planning, not for diagnosing diseases or conditions.
No
The device is described as a "software add-on for Ingenia 1.5T and 3.0T MR systems" and an "option to Ingenia MR-RT package, which is a set of accessories for Ingenia systems." This indicates that the software is integrated with and dependent on specific hardware components (the MR systems and accessories) and is not a standalone software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples (like blood, urine, tissue) outside of the body to provide information about a patient's health. The description of MRCAT Pelvis clearly states it is a software add-on for MR systems that processes MR images. It does not interact with or analyze biological samples.
- The intended use is for radiation estimation in radiotherapy treatment planning. This is a diagnostic imaging and treatment planning application, not an in vitro diagnostic test.
Therefore, MRCAT Pelvis falls under the category of medical imaging software used for treatment planning, not an IVD.
N/A
Intended Use / Indications for Use
MRCAT Pelvis is a software add-on for 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 estimation purposes in photon external beam radiotherapy treatment planning.
Indications for use:
MRCAT Pelvis is indicated for radiotherapy treatment planning of soft tissue cancers in the pelvic region.
Product codes
MUJ
Device Description
MRCAT Pelvis is a software application to Ingenia 1.5T and 3T MR (807.92(a)(4)):: systems. MRCAT Pelvis 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, waterrich tissue, spongy bone and compact bone. Subsequent density 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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR (Magnetic Resonance)
Anatomical Site
pelvic region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
The robustness of the MRCAT Pelvis algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm is shown by post-processing MRCAT images from patients, and calculating dose using the MRCAT images.
In summary, the MRCAT Pelvis images are spatially accurate radiation attenuation estimates that can aid in the EBRT planning of pelvic soft tissue cancers.
Key Metrics
Not Found
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Philips Medical Systems MR Finland % Janne Marvola, Ph.D. Regulatory Engineer Ayritie 4 01510 Vantaa FINLAND
April 30, 2019
Re: K182888
Trade/Device Name: MRCAT Pelvis Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: March 22, 2019 Received: April 1, 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, 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
510(k) Number (if known) K182888
Device Name MRCAT Pelvis
Indications for Use (Describe)
MRCAT Pelvis is a software add-on for 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 estimation purposes in photon external beam radiotherapy treatment planning.
Indications for use:
MRCAT Pelvis is indicated for radiotherapy treatment planning of soft tissue cancers in the pelvic region.
| 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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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:
March 22, 2019
| 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 |
Regulatory Enginee 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
Senior Manager Q&R
Philips Medical Systems MR Finland
Phone: +358-40-552-6197
Fax: +358-9-3487-2406
E-mail: osku.ilvonen@philips.com |
| --------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Image /page/3/Picture/9 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines that resemble sound waves or water. Above and below the wavy lines are four-pointed stars. The word "PHILIPS" is written in blue at the top of the shield.
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Device names (807.92(a)(2)):
Trade Name: MRCAT Pelvis Classification: Class II Regulatory Section: 21 CFR 892.5050 Product Code: MUJ
Predicate Device(s) K151435 MRCAT (primary) (807.92(a)(3):: K013644 AcQPlan 5.0 (reference device)
Device Description MRCAT Pelvis is a software application to Ingenia 1.5T and 3T MR (807.92(a)(4)):: systems. MRCAT Pelvis 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, waterrich tissue, spongy bone and compact bone. Subsequent density assignment provides MRCAT images with CT-like density information.
Intended Use: (807.92(a)(5): 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 Pelvis is indicated for radiotherapy treatment planning of soft tissue cancers in the pelvic region.
Technology (807.92(a)(6)):: MRCAT Pelvis functionality is implemented as a software plug-in for the MR main software and it contains the following main features:
- Automatic post-processing tool delivering MRCAT images 1)
-
- Examcard with mDixon imaging protocol
Image /page/4/Picture/12 description: The image features the Philips logo, which is a shield-shaped emblem in a shade of blue. The word "PHILIPS" is displayed in white, bold, sans-serif letters at the top of the shield. Below the text, there are two wavy lines that resemble sound waves or water, and two four-pointed stars are positioned above and below the wavy lines, adding a celestial or dynamic element to the logo.
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- 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 model based segmentation of bones and soft tissues. Subsequent density assignment provides MRCAT images with CT-like 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.
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.
Image /page/5/Picture/13 description: The image shows the Philips logo, which consists of the word "PHILIPS" in blue, positioned above a blue shield-like shape. Inside the shield, there are two stylized waves and two four-pointed stars. The overall design is simple and clean, with a focus on the brand name and a symbolic representation of waves and stars.
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Hardware platform description
MRCAT Pelvis does not require any change of the hardware platform of Ingenia scanners. The new software extensions introduced by MRCAT Pelvis run on the MR console of Ingenia.
Summary of Non-Clinical Tests:
Determination of Substantial Equivalence, non-clinical (807.92(b)(1))::
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 60601-2-33:2015, 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 processes
-
- ISO 14971:2007, Medical devices. Application of risk management to medical devices
All requirements are met for the MRCAT Pelvis application.
Image /page/6/Picture/18 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a sans-serif font above a shield-like emblem. The emblem is blue and features two wavy lines and four stars. The wavy lines are positioned horizontally in the center of the shield, and the stars are placed above and below the wavy lines.
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The conclusion from these reports is:
All the tests performed for MRCAT Pelvis 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.
- Summary of Clinical Tests: Clinical (807.92(b)(2)):
The robustness of the MRCAT Pelvis algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm is shown by post-processing MRCAT images from patients, and calculating dose using the MRCAT images.
In summary, the MRCAT Pelvis images are spatially accurate radiation attenuation estimates that can aid in the EBRT planning of pelvic soft tissue cancers.
Conclusion (807.92(b)(3)):: MRCAT Pelvis software 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 pelvic cancer patients.
lt is the opinion of Philips Medical Systems MR Finland that the MRCAT Pelvis software option for Philips Ingenia MR scanners is substantially equivalent and raises no new issues of safety or effectiveness compared to the primary predicate Philips MRCAT, K151435 cleared by FDA on February 25, 2016 and the reference device AcQPlan 5.0, K013644, cleared by FDA on September 12, 2002.
Image /page/7/Picture/7 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two stars. The word "PHILIPS" is written in white at the top of the shield.