(141 days)
No
The description focuses on improved reconstruction algorithms and existing technologies (mDIXON, MultiVane XD) without mentioning AI or ML.
No.
The device is a software option for MRI systems that enhances imaging capabilities and reconstruction, not a device used for treating disease or conditions.
Yes
This device is a software option for MR Systems intended for use in Magnetic Resonance Imaging of the human body, providing enhanced image acquisition and reconstruction (e.g., fat-free imaging, MRA without subtraction). These functions directly contribute to the creation of medical images used by healthcare professionals to diagnose conditions, which is the definition of a diagnostic device.
No
The device is described as a "software option intended for use on Achieva, Ingenia 1.5T & 3T MR Systems." This indicates it is a software component that integrates with and relies on existing MR hardware systems, rather than being a standalone software device. The description also details its functionality within the context of MR data acquisition and reconstruction, further solidifying its role as part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that mDIXON XD is a software option for MR systems used for "Magnetic Resonance Imaging of the human body." This describes an imaging technique used on the patient, not a test performed on biological samples taken from the patient.
- Device Description: The description details how the software enhances MR image acquisition and reconstruction. It focuses on improving image quality, fat suppression, and motion correction during the MR scan itself.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. mDIXON XD is a tool that aids in the acquisition and processing of medical images, which are then interpreted by a healthcare professional.
N/A
Intended Use / Indications for Use
mDIXON XD is a software option intended for use on Achieva, Ingenia 1.5T & 3T MR Systems. It is indicated for use in Magnetic Resonance Imaging of the human body. mDIXON XD is an enhanced 2-point fat-free mDIXON technology, available for gradient echo and spin echo acquisitions. mDIXON XD enables the combination of a fat-free technology with the MultiVane XD motion-free technique for anatomies such as head. mDIXON XD also enables subtractionless MR Angiography in areas of the body where exogenous contrast media has been approved for MR imaging.
Product codes
LNH
Device Description
mDIXON XD provides an improved water/fat reconstruction algorithm (7-peak fat modeling, B0correction and fat-shift correction). mDIXON XD relies on the 2-point mDIXON fat-free technology making use of unrestricted echo times and is capable of generating four image contrasts (Water, Fat, In-Phase, Out-Phase) in one scan. mDIXON XD can be used with the following:
- Multivane XD (motion correction) for the head
- MR Angiography (subtractionless MRA), removes the need for the subtraction of the pre-● and post-contrast enhanced images.
- Gradient echo (FFE Fast Field Echo) and turbo spin echo (TSE) sequences to achieve ● efficient fat-free scanning compatibility, even at large FOV or sub-millimetric resolutions
mDIXON XD is supported on the following systems: - 3.0T Ingenia
- 3.0T Achieva ●
- 1.5T Ingenia
- 1.5T Achieva ●
The functionality is supported on all available gradient performance levels. Optimized protocols will be provided for the different performance points. mDIXON XD is supported on the centralized data acquisition systems of the Achieva systems as well as the digitally networked data acquisition system of the Ingenia systems. The data acquisition system is fully transparent to the pulse sequences and mDIXON XD reconstructions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
human body (head for MultiVane XD)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Nonclinical tests: mDIXON XD has been verified to function with the Achieva and Ingenia 1.5T and 3.0T MR systems. The verification testing showed the examcards could be loaded, the correct parameters were listed for each scan, there were no issues when turning on SENSE, the four image types could be selected, all scans ran properly and images were provided. All the tests performed for mDIXON XD were successful. Workflow was smooth and no problems occurred. All defects have been corrected.
Clinical tests: Clinical user needs are tested as part of validation testing showed that for total body and head/neck examinations, the Image Quality, fat suppression and fat suppression over large FOV was similar or better with mDIXON XD compared to e-Thrive. For cardiac examinations the image quality and fat suppression were better with mDIXON XD. For MultiVane XD in combination with mDIXON TSE, the motion related artifacts were reduced compared to mDIXON TSE alone and the MultiVane XD with mDIXON XD can be used with T2 in head imaging. The clinical validation of mDIXON XD has completed successfully. All clinical user needs have passed for mDIXON XD on the Achieva and Ingenia 1.5T and 3T systems. All defects have been analyzed and are verified to be solved and will be closed, no new hazards were identified.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
Philips Medical Systems Nederland B.V. Susan Ouick Regulatory Affairs Specialist 595 Miner Rd CLEVELAND OH 44094
Re: K143128
Trade/Device Name: mDIXON XD Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: February 06, 2015 Received: February 20, 2015
Dear Ms. Quick:
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.
1
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,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K143128 |
| Device Name | mDIXON XD |
| Indications for Use (Describe) | |
| mDIXON XD is a software option intended for use on Achieva, Ingenia 1.5T & 3T MR Systems. It is indicated for use in Magnetic Resonance Imaging of the human body. mDIXON XD is an enhanced 2-point fat-free mDIXON technology, available for gradient echo and spin echo acquisitions. mDIXON XD enables the combination of a fat-free technology with the MultiVane XD motion-free technique for anatomies such as head. mDIXON XD also enables subtractionless MR Angiography in areas of the body where exogenous contrast media has been approved for MR imaging. | |
| 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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PHILI
Philips Medical Systems Nederland B.V.
510(k) Summary
mDIXON XD
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
- I. General Information 21 CFR 807.92 (a)(1), (2)
| Company Name: | Philips Medical Systems Nederland B.V. |
|---|---|
| Address: | Veenpluis 4-6 |
| 5684 PC Best | |
| The Netherlands | |
| Registration No .: | 3003768277 |
| Contact Person: | Susan Quick |
| 595 Miner Rd | |
| Cleveland, Oh 44143 | |
| Tel: (440)-483-2291 | |
| Fax: (440)-483-4799 | |
| E-mail: susan.quick@philips.com | |
| Prepared (date): | 2014 October 29 |
| Trade Name of Device: | mDIXON XD |
| Classification: | Class II |
| Regulatory Section: | Magnetic Resonance Diagnostic Device. |
| 892.1000 | |
| Product Code: | 90LNH |
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510(k) Summary mDIXON XD
21 CFR 807.92(a)(3):Legally marketed predicate device to which substantial equivalence is claimed:
| 1. Primary Predicate Device: mDIXON | |
|---|---|
| Manufacturer: | Philips Healthcare |
| Predicate Device k#: | K102344 |
| 2. Reference Devices: | MultiVane and e-THRIVE (Ingenia MR System) |
| Manufacturer: | Philips Healthcare |
| Predicate Device k#: | K110151 |
21 CFR 807.92(a)(4): Description of the device that is the subject of this premarket notification:
Summary of functions of the device and its major components
mDIXON XD provides an improved water/fat reconstruction algorithm (7-peak fat modeling, B0correction and fat-shift correction). mDIXON XD relies on the 2-point mDIXON fat-free technology making use of unrestricted echo times and is capable of generating four image contrasts (Water, Fat, In-Phase, Out-Phase) in one scan. mDIXON XD can be used with the following:
- Multivane XD (motion correction) for the head
- MR Angiography (subtractionless MRA), removes the need for the subtraction of the pre-● and post-contrast enhanced images.
- Gradient echo (FFE Fast Field Echo) and turbo spin echo (TSE) sequences to achieve ● efficient fat-free scanning compatibility, even at large FOV or sub-millimetric resolutions
mDIXON XD is supported on the following systems:
- 3.0T Ingenia
- 3.0T Achieva ●
- 1.5T Ingenia
- 1.5T Achieva ●
The functionality is supported on all available gradient performance levels. Optimized protocols will be provided for the different performance points. mDIXON XD is supported on the centralized data acquisition systems of the Achieva systems as well as the digitally networked data acquisition system of the Ingenia systems. The data acquisition system is fully transparent to the pulse sequences and mDIXON XD reconstructions.
5
21 CFR 807.92(a)(5): Intended Use
mDIXON XD is a software option intended for use on Achieva. Ingenia I .5T & 3T MR Systems. It is indicated for use in Magnetic Resonance Imaging of the human body. mDIXON XD is an enhanced 2-point fat-free mDIXON technology, available for gradient echo and spin echo acquisitions. mDIXON XD enables the combination of a fat-free technology with the MultiVane XD motion-free technique for anatomies such as head. mDIXON XD also enables subtractionless MR Angiography in areas of the body where exogenous contrast media has been approved for MR imaging.
21 CFR 807.92(a)(6): Technological Characteristics:
The main functional units in the software are:
- (software for controlling and diagnosing the hardware) - MRChains
- Methods (acquisition of MR signals by means of MR pulse sequences)
- Reconstruction (transforming the MR signals to images)
- Patient Administration (storing of the images in the database and providing access)
- Viewing (display of images)
The impact of mDIXON XD on these functional units are:
- MRChains: Provide static B0-field information, as measured at system installation time. -
- Methods: Use an existing multi-echo (usually 2 echoes) FFE, TFE or multi-acquisition TSE for mDIXON XD, within the cleared limits provided by the basic MR system. The requested output image types can be specified by the user in the scan protocol.
- -Reconstruction: Add a new calculation function that calculates water, fat, IP and OP images. Apply a fat-peak-model and B0-field information to separate water from fat. Make use of water-fat shift correction and geometry correction.
- -Patient Administration and Viewing: enable storage and display of the output images with appropriate labels (water, fat, IP, OP)
No off-the-shelf software is used for mDIXON XD. The off-the-shelf software used in the basic MR system is cleared. mDIXON XD is not designed to be connected to an external network. mDIXON XD does not require any change of the hardware platform. The major extensions introduced by mDIXON XD are in methods pulse sequence code, and in reconstruction for the enhanced calculation. Those run on the host computer:
Computer characteristics:
- Manufacturer: HP; Model: Z420; Processor clock: 3.5 GHz; RAM: 64 GB RAM; -Processors: six core with hyper threading
- Operating system: Windows 7, 64 bits -
Changes to operator workflow for mDIXON XD are:
- Protocol selection: The operator selects an ExamCard with mDIXON XD protocols -
- Planscan phase: Optionally the operator may want to change the predefined selection of output image-types.
- For mDIXON XD MRA: During scanning no pre-contrast baseline has to be scanned, saving one multi-station table-stroke, compared to conventional MRA.
All other steps are not changed. The generated image types can be viewed, post-processed, printed
6
and archived as any other image type.
21 CFR 807.92(b)(1): Brief discussion of nonclinical tests submitted, referenced or relied on in this premarket notification:
mDIXON XD has been verified to function with the Achieva and Ingenia 1.5T and 3.0T MR systems.
The verification testing showed the examcards could be loaded, the correct parameters were listed for each scan, there were no issues when turning on SENSE, the four image types could be selected, all scans ran properly and images were provided.
The conclusion from this report is:
All the tests performed for mDIXON XD were successful. Workflow was smooth and no problems occurred.
All defects have been corrected.
21 CFR 807.92(b)(2): Brief discussion of clinical tests submitted, referenced or relied on in this premarket notification:
Clinical user needs are tested as part of validation testing showed that for total body and head/neck examinations, the Image Quality, fat suppression and fat suppression over large FOV was similar or better with mDIXON XD compared to e-Thrive. For cardiac examinations the image quality and fat suppression were better with mDIXON XD. For MultiVane XD in combination with mDIXON TSE, the motion related artifacts were reduced compared to mDIXON TSE alone and the MultiVane XD with mDIXON XD can be used with T2 in head imaging.
The conclusion from testing the device is:
The clinical validation of mDIXON XD has completed successfully. All clinical user needs have passed for mDIXON XD on the Achieva and Ingenia 1.5T and 3T systems. All defects have been analyzed and are verified to be solved and will be closed, no new hazards were identified.
21 CFR 807.92(b)(3): The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section:
The nonclinical and clinical tests have demonstrated that the device is safe and works according to its intended use.
mDIXON XD software does not introduce new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers mDIXON XD Software to be substantially equivalent to the above mentioned predicate device.