(89 days)
No
The summary describes a software option for MR systems that performs water-fat separation and calculates fat fraction and T2* based on gradient echo acquisition and reconstruction techniques. It mentions specific parameter settings and a new calculation function, but there is no mention of AI, ML, or any learning-based algorithms. The description focuses on established MR physics and signal processing methods.
No
This device is a software option for MR systems used for diagnostic imaging and fat fraction calculation, not for treatment.
Yes
The device is indicated for magnetic resonance imaging of the liver, providing quantitative measurements of triglyceride fat fraction and transverse magnetization relaxation (T2*). These measurements are used by healthcare professionals to assess the condition of the liver, which aids in diagnosis and monitoring of liver diseases.
No
The device is described as a "software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems." While it is software, it is explicitly designed to function as part of and rely on the hardware of the MR systems for acquisition and processing, and the description mentions specific parameter settings for the mDIXON sequence to acquire MR signals.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states that mDIXON-Quant is a "non-invasive triglyceride fat fraction calculation" and is used for "magnetic resonance imaging of the liver." It works by acquiring MR signals directly from the patient's body, not by analyzing a sample (like blood, urine, or tissue) taken from the body.
- The process involves imaging and image processing. The device description focuses on MR signal acquisition, reconstruction, and image generation (Water-only, Fat-only, Fat Fraction, T2* images). While there is post-processing involving image analysis (ROI calculations), this is performed on images derived from the in-vivo MR scan, not on a biological sample.
In summary, mDIXON-Quant is a software option for an MR imaging system that performs in-vivo measurements and calculations based on MR signals acquired directly from the patient's liver. This falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
mDIXON-Quant:
- is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems
- is a non-invasive triglyceride fat fraction calculation
- is a 3D, single breath-hold acquisition and reconstruction technique
- allows for water-fat separation generating Water-only, Fat-only images as well as Out-phase and In-phase images
- is indicated for magnetic resonance imaging of the liver
Product codes (comma separated list FDA assigned to the subject device)
90LNH
Device Description
mDIXON-Quant acquisition and reconstruction is based on the mDIXON product developed previously. Acquisition relies on a gradient echo acquisition (FFE) including a large number of echoes (6 or more). Furthermore, mDIXON-Quant reconstruction includes the use of multiple spectral peaks of triglyceride fat, correction of the T2* confounding effect and reduction of T1 bias.
mDIXON-Quant allows for water-fat separation and generates Water-only, Fat-only images as well as Out-phase and In-phase images synthesized from the Water and Fat images. Additionally, mDIXON-Ouant produces images representing triglyceride fat fraction as well as images representing transverse magnetization relaxation.
The feature requires:
- Specific parameter settings for the mDIXON sequence, within cleared parameter limits, to acquire the MR signals
- A new calculation function to generate the new images for Fat Fraction, T2 *. This function uses a set of MR images as input that is generated in a cleared manner from the acquired MR signals.
- The new images need to be stored and displayed with the appropriate labels for Fat Fraction, T2 *, applying the facilities provided by the cleared platform.
The main functional units in the software are:
- (acquisition of MR signals by means of MR pulse sequences) - Methods
- Reconstruction (transforming the MR signals to images)
- Patient Administration (storing of the images in the database and providing access)
- Viewing (display of images and measuring ROI)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical testing was performed on a 1.5T Ingenia and a 3.0T Achieva TX.
Integration testing completed with passing results, with regression testing completing without error messages and greater than 90% of all scans present in the batch running successfully.
System Verification testing completed with passing results. For the System Verification testing, a dS-Torso. Posterior coil and Anterior coil were used on the Ingenia 1.5T and a Sense-XL-Torso coil was used on the Achieva 3.0T. All Acquisition and Reconstruction, Viewing, Calculation, and Performance testing passed. In the Acquisition and Reconstruction testing, there were no error messages, scan time was
§ 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/0 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word, there is handwritten text that appears to be a document or page identifier, possibly "K133526 page 1 of 5". The handwriting is in black ink and contrasts with the clean, printed font of the brand name.
Philips Medical Systems Nederland B.V.
510(k) Summary
FEB 1222014
mDIXON-Quant
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
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 |
| Tel: (440)-483-2291 | |
| Fax: (440)-483-4799 | |
| E-mail: susan.quick@philips.com | |
| Prepared (date): | 2013 November 14, Revised 2014 January 24, |
| 2014 February 06 | |
| Trade Name of Device: | mDIXON-Quant |
| Classification: | Class II |
| Regulatory Section: | Magnetic Resonance Diagnostic Device. |
| 892.1000 | |
| Product Code: | 90LNH |
1
` 21 CFR 807.92(a)(3):Legally marketed predicate device to which substantial equivalence is claimed:
| Predicate Device: | IDEAL Software Option |
|---|---|
| Manufacturer: | GE Healthcare |
| Predicate Device k#: | K103411 |
| Reference Device: | mDIXON |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| Reference Device k#: | K102344 |
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-Quant acquisition and reconstruction is based on the mDIXON product developed previously. Acquisition relies on a gradient echo acquisition (FFE) including a large number of echoes (6 or more). Furthermore, mDIXON-Quant reconstruction includes the use of multiple spectral peaks of triglyceride fat, correction of the T2* confounding effect and reduction of T1 bias.
mDIXON-Quant allows for water-fat separation and generates Water-only, Fat-only images as well as Out-phase and In-phase images synthesized from the Water and Fat images. Additionally, mDIXON-Ouant produces images representing triglyceride fat fraction as well as images representing transverse magnetization relaxation.
The feature requires:
- · Specific parameter settings for the mDIXON sequence, within cleared parameter limits, to acquire the MR signals
- · A new calculation function to generate the new images for Fat Fraction, T2 *. This function uses a set of MR images as input that is generated in a cleared manner from the acquired MR signals.
- · The new images need to be stored and displayed with the appropriate labels for Fat Fraction, T2 *, applying the facilities provided by the cleared platform.
21 CFR 807.92(a)(5): Intended Use
mDIXON-Quant:
- · is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems
- · is a non-invasive triglyceride fat fraction calculation
- · is a 3D, single breath-hold acquisition and reconstruction technique
- · allows for water-fat separation generating Water-only, Fat-only images as well as Outphase and In-phase images
- · is indicated for magnetic resonance imaging of the liver
2
21 CFR 807.92(a)(6): Technological Characteristics:
The main functional units in the software are:
- (acquisition of MR signals by means of MR pulse sequences) - Methods
- Reconstruction (transforming the MR signals to images)
- Patient Administration (storing of the images in the database and providing access)
- Viewing (display of images and measuring ROI)
The technical impact of the feature mDJXON-Quant comprises:
- Methods: modify an existing sequence to acquire the data required for mDIXON-Quant, within the cleared limits provided by the basic MR system.
- Reconstruction: add a new calculation function that generates the new output images (Fat Fraction, T2*-maps and R2* (=1/T2*).
- Patient Administration and Viewing: enable storage and display of the new output images with appropriate labels (SW-M and SW-P).
No off-the-shelf software is used for the feature mDIXON-Quant. The off-the-shelf software used in the basic MR system for the Ingenia and Achieva 1.5T and 3.0T MR systems is cleared by K110151.
The basic MR system provides the features for interoperability and internet connections. which are already cleared. The feature mDIXON-Quant does not have any additions or modifications related to interoperability and connections to an external network.
Hardware platform description
mDIXON-Ouant does not require any change of the hardware platform. The main extension introduced by mDIXON-Quant, the new reconstruction algorithm, runs on the Reconstructor computer.
Computer characteristics:
- · Manufacturer: HP; Model: Z400 or Z420; Processor speed: ≥3.6 GHz; Memory: 16-32 GB RAM, 1-2 x quad core processors
- · Operating system: Windows 7, 64 bits
The mDIXON-Ouant algorithm does not add specific requirements to the Ingenia and Achieva 1.5T and 3.0T MR systems as cleared by K110151.
Workflow
For the operator the only new element for the mDIXON-Quant-feature in this clinical routine workflow is:
Protocol selection: The operator selects an ExamCard with mD1XON-Quant protocols
All other steps are not changed. Only in the planscan phase the user may want to change the predefined selection of output image-types. The newly generated image types can be viewed, post-processed, printed and archived as any other image type. The display of the images on the console can be switched between grey-scale and color scale. During post processing the operator can do further analysis (such as calculation of average values in a ROI) using the image processing facilities as provided by the standard platform.
3
21 CFR 807.92(b)(1): Brief discussion of nonclinical tests submitted, referenced or relied on in this premarket notification:
All non-clinical testing was performed on a 1.5T Ingenia and a 3.0T Achieva TX.
All Integration testing completed with passing results, with regression testing completing without error messages and greater than 90% of all scans present in the batch running successfully.
All System Verification testing completed with passing results. For the System Verification testing, a dS-Torso. Posterior coil and Anterior coil were used on the Ingenia 1.5T and a Sense-XL-Torso coil was used on the Achieva 3.0T. All Acquisition and Reconstruction, Viewing, Calculation, and Performance testing passed. In the Acquisition and Reconstruction testing, there were no error messages, scan time was Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."