(101 days)
No
The document describes software features for MR systems, including image processing techniques and workflow automation, but does not mention AI or ML.
No
The intended use states that the device is for diagnostic purposes, and while it may assist in therapy planning, it does not directly provide therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device." It further explains that the system "provides information that may assist diagnosis and therapy planning."
No
The device description explicitly states that the submission includes software modifications for existing MR systems and that "there are no hardware changes". This indicates the device is a combination of hardware (the MR system) and software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Philips MR systems are used to obtain cross-sectional images, spectroscopic images, and/or spectra of the internal structure of the head, body, or extremities. This is an in vivo diagnostic method, meaning it is performed on a living organism.
- Intended Use: The intended use is described as a "diagnostic device" that enables physicians to obtain images and information to assist diagnosis and therapy planning. This aligns with the function of an imaging device, not an IVD.
- Lack of Sample Analysis: There is no mention of analyzing biological samples or performing tests on specimens taken from the patient.
Therefore, the Philips MR system described is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle.
The systems can use combinations of images to produce physical parameters, and related derived images. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user.
In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.
Product codes
LNH, 90LNH, 90LNI
Device Description
The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems with bFFE-XD, IRIS Zoom, MEGA, SENC, and SyntAc software features are provided on the 60 cm and 70 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) MR systems.
The systems and aforementioned software features of the proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are substantially equivalent to the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018) and the legally marketed reference devices Ingenia Elition S and Ingenia Elition X (K173451, 03/20.2018) and the Ingenia Ambition S and Ingenia Ambition X (K180479, 08/03/2018).
Hereafter Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.6 with SENC, bFFE XD, IRIS ZOOM, MEGA and SyntAc software features will be referred to as the proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems in this submission.
This submission includes the software modifications below for the proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems, there are no hardware changes:
- bFFE-XD
- IRIS Zoom
- MEGA
- SENC (Spiral Cardiac)
- SyntAc (MDME)*
- This software feature is provided on the proposed Ingenia systems only (Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T and Ingenia 3.0T CX). Please note that this feature is already cleared and legally marketed on Ingenia Ambition and Elition systems.
The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems submission also includes minor changes to the existing software features listed below since the clearance of the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018):
- VAPOR
- sLASER
- Spiral Brain
- 3D Non-selective
- Diffusion XD TSE
- 2KDTI
- Advanced diffusion gradient control
- K-t SENSE
- Cardiac ZOOM
- Retrospective EPI
- mFFE Echo Summation*
- Contrast Card*
- Autostart*
- This software feature is provided on the proposed Ingenia systems only (Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T and Ingenia 3.0T CX). Please note that this feature is already cleared and legally marketed on Ingenia Ambition and Elition systems.
The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA:
- mDIXON (K102344)
- SWIp (K131241)
- mDIXON-Quant (K133526)
- MRE (K140666)
- mDIXON XD (K143128)
- O-MAR K143253
- MultiBand SENSE (K143606)
- 3D APT (K172920)
- Ingenia Coils, see Appendix 011
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Head, body or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians, clinical user
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 verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results. The verification and/or validation test results demonstrate that that the proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems:
- Comply with the aforementioned international and FDA recognized consensus standards and Device specific guidance document, entitled "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 18, 2016"
- Meet the acceptance criteria and is adequate for its intended use.
The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing.
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.
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.
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
§ 892.1000 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
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February 14, 2019
Philips Medical Systems Nederland B.V. Susan Quick Regulatory Affairs Specialist 595 Miner Rd Cleveland, Ohio 44143
Re: K183063
Trade/Device Name: Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: November 2, 2018 Received: November 5, 2018
Dear Susan Ouick:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) 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 mediation-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,
Michael D. O'Hara
- For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183063
Device Name
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition
Indications for Use (Describe)
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle.
The systems can use combinations of images to produce physical parameters, and related derived images. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user.
In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR
Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.
| 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) |
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510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | October 26, 2018 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 4-6, 5684 PC, Best, The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Primary Contact | ||
| Person: | Jan van de Kerkhof | |
| Sr. Manager Regulatory Affairs | ||
| Phone: +31 613300542 | ||
| E-mail: jan.van.de.kerkhof@philips.com | ||
| Secondary Contact | ||
| Person | Susan Quick | |
| Regulatory Affairs Specialist | ||
| Telephone: 440 869-4612 | ||
| E-mail: susan.quick@philips.com | ||
| Device Name: | Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems | |
| Classification: | Classification name: Magnetic Resonance Diagnostic Device (MRDD) | |
| Classification Regulation: 21CFR 892.1000 | ||
| Classification Panel: Radiology | ||
| Device Class: Class II | ||
| Primary Product Code: 90LNH | ||
| 90LNI | ||
| Primary Predicate | ||
| Device: | Trade name: Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 | |
| Manufacturer: Philips Medical Systems Nederland B.V. | ||
| 510(k) Clearance: K173079 | ||
| Classification Regulation: 21CFR 892.1000 | ||
| Classification name: Magnetic Resonance Diagnostic Device (MRDD) | ||
| Classification Panel: Radiology | ||
| Device class: Class II | ||
| Product Code: 90LNH | ||
| 90LNI | ||
| Reference Device: | Trade name: Ingenia Eilition S, Ingenia Elition X | |
| Manufacturer: Philips Medical Systems Nederland B.V. | ||
| 510(k) Clearance: K173451 | ||
| Classification Regulation: 21CFR 892.1000 | ||
| Classification name: Magnetic Resonance Diagnostic Device (MRDD) | ||
| Classification Panel: Radiology | ||
| Device class: Class II | ||
| Product Code: | 90LNH | |
| 90LNI | ||
| Reference Device: | Trade name: | Ingenia Ambition S, Ingenia Ambition X |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K180479 | |
| Classification Regulation: | 21CFR 892.1000 | |
| Classification name: | Magnetic Resonance Diagnostic Device (MRDD) | |
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | 90LNH | |
| 90LNI |
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| Device | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR |
|---|---|
| Description: | Systems with bFFE-XD, IRIS Zoom, MEGA, SENC, and SyntAc software features |
| are provided on the 60 cm and 70 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) | |
| MR systems. | |
| The systems and aforementioned software features of the proposed Ingenia, | |
| Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are | |
| substantially equivalent to the legally marketed predicate device, Ingenia 1.5T, | |
| Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 | |
| (K173079, 04/04/2018) and the legally marketed reference devices Ingenia Elition | |
| S and Ingenia Elition X (K173451, 03/20.2018) and the Ingenia Ambition S and | |
| Ingenia Ambition X (K180479, 08/03/2018) . | |
| Hereafter Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR | |
| Systems R5.6 with SENC, bFFE XD, IRIS ZOOM, MEGA and SyntAc software | |
| features will be referred to as the proposed Ingenia, Ingenia CX, Ingenia | |
| Elition, and Ingenia Ambition MR Systems in this submission. | |
| This submission includes the software modifications below for the proposed | |
| Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems, there | |
| are no hardware changes: | |
| 1. bFFE-XD | |
| 2. IRIS Zoom | |
| 3. MEGA | |
| 4. SENC (Spiral Cardiac) | |
| 5. SyntAc (MDME)* |
- This software feature is provided on the proposed Ingenia systems only (Ingenia |
| | 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T and Ingenia 3.0T CX). Please |
| | note that this feature is already cleared and legally marketed on Ingenia Ambition
and Elition systems. |
| | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR |
| | Systems submission also includes minor changes to the existing software |
| | features listed below since the clearance of the legally marketed predicate device |
| | Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX
R5.4 (K173079, 04/04/2018): |
| | 1. VAPOR
- sLASER
- Spiral Brain
- 3D Non-selective
- Diffusion XD TSE
- 2KDTI
- Advanced diffusion gradient control
- K-t SENSE
- Cardiac ZOOM
- Retrospective EPI
- mFFE Echo Summation*
- Contrast Card*
- Autostart*
- This software feature is provided on the proposed Ingenia systems only (Ingenia
1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T and Ingenia 3.0T CX).
Please note that this feature is already cleared and legally marketed on Ingenia
Ambition and Elition systems. |
| | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR
Systems are intended to be marketed with the following pulse sequences and
coils that were previously cleared by FDA:
- mDIXON (K102344)
- SWIp (K131241)
- mDIXON-Quant (K133526)
- MRE (K140666)
- mDIXON XD (K143128)
- O-MAR K143253
- MultiBand SENSE (K143606)
- 3D APT (K172920)
- Ingenia Coils, see Appendix 011 |
| Indications for
Use: | There are minor modifications to the indications for use statement for the proposed
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems for
clarity, but the intended use has not changed. |
| | Philips Magnetic Resonance (MR) systems are Medical Electrical Systems
indicated for use as a diagnostic device. |
| | This MR system enables trained physicians to obtain cross-sectional images,
spectroscopic images and/or spectra of the internal structure of the head, body or
extremities, in any orientation, representing the spatial distribution of protons or
other nuclei with spin. |
| | Image appearance is determined by many different physical properties of the
tissue and the anatomy, the MR scan technique applied, and presence of contrast
agents. The use of contrast agents for diagnostic imaging applications should be
performed consistent with the approved labeling for the contrast agent. |
| | The trained clinical user can adjust the MR scan parameters to customize image
appearance, accelerate image acquisition, and synchronize with the patient's
breathing or cardiac cycle.
The systems can use combinations of images to produce physical parameters,
and related derived images, spectra, and measurements of physical
parameters, when interpreted by a trained physician, provide information that may
assist diagnosis and therapy planning. The accuracy of determined physical
parameters depends on system and scan parameters, and must be controlled and
validated by the clinical user.
In addition the Philips MR systems provide imaging capabilities, such as MR
fluoroscopy, to guide and evaluate interventional and minimally invasive
procedures in the head, body and extremities. |
| | MR Interventional procedures, performed inside or adjacent to the Philips MR
system, must be performed with MR Conditional or MR Safe instrumentation as
selected and evaluated by the clinical user for use with the specific MR system
configuration in the hospital. The appropriateness and use of information from a
Philips MR system for a specific interventional procedure and specific MR system
configuration must be validated by the clinical user. |
| Design Features/
Fundamental
Scientific
Technology: | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR
Systems are based on the principle that certain atomic nuclei present in the
human body will emit a weak relaxation signal when placed in a strong magnetic
field and excited by a radio signal at the precession frequency. The emitted
relaxation signals are analyzed by the system and a computed image
reconstruction is displayed on a video screen. |
| | The principal technological components (magnet, transmit body coil, gradient coil,
receive coils and patient support) of the proposed Ingenia, Ingenia CX, Ingenia
Elition, and Ingenia Ambition MR Systems are identical to those used in the
legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX,
Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018), and the legally
marketed reference devices Ingenia Elition S and Ingenia Elition X (K173451,
3/20.2018) and the Ingenia Ambition S and Ingenia Ambition X (K180479,
08/03/2018). |
| | The following are descriptions of the modified or minor enhanced software
features. |
| | The main application of bFFE XD is to reduce banding artifacts, resulting from the
B0 sensitivity of balanced Fast Field Echo (bFFE) sequences. Those black band
artifacts can obscure information in the images. The main clinical application
targeted by bFFE XD is high resolution 3D inner ear (auditory canal) imaging. |
| | IRIS ZOOM is an improvement of Zoom Diffusion Imaging in the spine. Due to the
multi-shot capability, IRIS ZOOM delivers a higher resolution, lower distortion and
improved fat suppression in spine when compared to Zoom Diffusion Imaging. |
| | |
| MEGA is a feature that allows for detection of J-coupled metabolite signals like
GABA (gamma-butyric acid) in the brain. MEGA is spectral editing technique and
intended for single voxel 1H spectroscopy in the brain on 3T systems. | |
| SENC (Strain ENCoding) is intended for cardiac imaging, to measure cardiac
muscle contraction as a function of time within the cardiac cycle.
SENC produces strain encoded images. Those images are processed by 3rd
party software MyoStrain to produce strain analysis and reporting. | |
| The SyntAc (MDME) gives possibility to acquire Multi-Dynamic Multi-Echo
(MDME) images. These images can be processed by 3rd party (Synthetic MRI)
software to produce the relevant radiological contrasts. | |
| VAPOR is an enhancement of the Philips Excitation implementation and is
designed to be less sensitive to T1 variations and B1 inhomogeneities. | |
| sLASER is a modification of 1H SE (PRESS) localized spectroscopy and can be
applied to Single Voxel Spectroscopy (SV) as well as Spectroscopic Imaging
(MRSI). The sLASER sequence uses slice selective adiabatic pairs of refocusing
RF pulses to reduce the chemical shift displacement up to a factor 4 when
compared to PRESS-localized spectroscopy at 3T. | |
| Spiral Brain uses a spiral readout, which is applied as an alternative to the
Cartesian k-space traversal pattern. Some of the general benefits of spiral vs.
Cartesian MRI include (1) faster scans, due to longer readout time and (2) image
artifact robustness, due to reduced flow sensitivity). Spiral Brain leverages those
benefits to enhance T1 SE sequences in the brain at 1.5T and 3T. | |
| 3D Non-selective excites the entire volume using a very short RF pulse in 3D
FFE brain imaging. Due to the resulting shorter TR and shorter TE, 3D Non-
selective delivers a faster protocol and improved grey-white matter contrast in 3D
TFE. | |
| Diffusion XD TSE technique is an enhancement of Diffusion TSE. It introduces
the SPLICE technique and enables the combination with a MultiVane readout. By
allowing the combination with MultiVane, a multi-shot readout can be achieved,
which contributes to the sharpness of the resulting image and includes intrinsic
motion correction. | |
| 2KDTI is a technical enhancement of the maximal number of diffusion encodings
that can be collected in one diffusion scan. 2KDTI provides up to 2048
independent diffusion encodings (vectors) with up to 1024 different weightings and
1024 different directions. | |
| Advanced diffusion gradient control allows the scientific user to select from
multiple diffusion encoding gradient waveforms. Advanced diffusion gradient
control enables the user to define manually the duration of the diffusion encoding
gradients. | |
| k-t SENSE is a spatio-temporal acceleration technique that combines the benefits
of k-t BLAST with the better image uniformity capabilities of SENSE. | |
| | Reconstruction-wise, the k-t BLAST works on a coil by coil basis. k-t SENSE
processes the coils (coil elements) integrally with the help of which the
homogeneity of the images are enhanced. |
| | Cardiac ZOOM is a small FOV imaging technique which performs the excitation
and refocussing pulses orthogonally. Cardiac ZOOM enhances black blood
imaging, by providing accelerated and single beat imaging. This allows scanning
of patients who cannot hold their breath. |
| | Retrospective cardiac gating synchronizes pulse sequence with cardiac rhythm
so that cardiac motion related artifacts are removed. Retrospective gating is
enhanced by allowing the combination with EPI and TFE-EPI sequences, which
are used to explore 4D flow imaging. |
| | Multiple echoes from an FFE scan can be summed to calculate a new image.
mFFE Echo Summation automates this echo combination via a root-sum-of-
squares echo summation in reconstruction SW. This delivers an enhanced
workflow when compared to the existing manual post-processing that is available
in Image Algebra post-processing package. |
| | The Contrast Card enhancement offers the ability to add information on the
contrast agent. After applying the contrast agent, which is done independent from
the MR system, information on the applied contrast is added to the DICOM
images. When viewing these images on the MR system the images, which have
been taken while contrast was applied, are marked with an indication "Contrast".
After pressing Start Scan at the controls at the magnet façade the scan will
automatically start (Autostart feature) when the RF door is closed. This function
is the same as the legally marketed reference device Ingenia Elition S and Ingenia
Elition X systems (K173451, 03/20/2018) and for the Ingenia Ambition S and Ingenia
Ambition X systems (K180479, 08/03/2018) and is implemented without further
changes. |
| | Based on the information provided above, the proposed Ingenia, Ingenia CX,
Ingenia Elition, and Ingenia Ambition MR Systems do not raise different
questions of safety and effectiveness compared to the legally marketed predicate
device Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia
3.0T CX R5.4 (K173079, 04/04/2018). |
| Summary of Non- | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR |
| Clinical
Performance Data: | Systems complies with the following international and FDA-recognized
consensus standards: |
| | • IEC60601-1 Edition 3 |
| | • IEC60601-1-2 Edition 4 |
| | • IEC60601-1-6 Edition 3
• IEC62366-1 Edition 1 |
| | • IEC60601-1-8 Edition 2 |
| | • IEC60601-2-33 Edition 3 |
| | • IEC 62304 Edition 1
• NEMA MS-1 2008 |
| | • NEMA MS-4 2010 |
| NEMA MS-8 2008 NEMA PS 3.1-PS 3.20 ISO 14971 Edition 2 Device specific guidance document, entitled "Guidance for the Submission
Of Premarket Notifications for Magnetic Resonance Diagnostic Devices"
(issued November 18, 2016 – document number 340) Guidance for Industry and FDA Staff Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices
(issued May 11, 2005 – document number 337) Guidance for Industry and FDA Staff – Content of Premarket Submissions
for Management of Cybersecurity in Medical Devices (issued October 2,
2014 - document number 1825) Guidance for Industry and FDA Staff Applying Human Factors and
Usability Engineering to Medical Devices (issued February 3, 2016 –
document number 1757) Guidance for Industry and FDA Staff – Use of International Standard ISO
10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process" (issued June 16, 2016 –
document number 1811) Guidance for Industry and FDA Staff – Information to Support a Claim of
Electromagnetic Compatibility (EMC) of Electrically-Powered Medical
Devices (issued July 11, 2016 – document number 1400057) Guidance for Industry and FDA Staff Design Considerations and
Premarket Submission Recommendations for Interoperable Medical
Devices (issued September 6, 2017 – document number 1500015)
Non-Clinical verification and or validation tests have been performed with regards
to the intended use, the technical claims, the requirement specifications and the
risk management results.
The verification and/or validation test results demonstrate that that the proposed
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems: Comply with the aforementioned international and FDA recognized
consensus standards and Device specific guidance document, entitled
"Guidance for the Submission Of Premarket Notifications for Magnetic
Resonance Diagnostic Devices – November 18, 2016" Meet the acceptance criteria and is adequate for its intended use.
Therefore, the proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia
Ambition MR Systems are substantially equivalent to the legally marketed
predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and
Ingenia 3.0T CX R5.4 (K173079, 04/04/2018) in terms of safety and effectiveness. | |
| Summary of
Clinical Data: | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR
Systems did not require a clinical study since substantial equivalence to the
legally marketed predicate device was proven with the verification/validation
testing. |
| Substantial
Equivalence: | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR
Systems and the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, |
| Conclusion: | Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018)
have the same indications for use with respect to the following:
Providing cross-sectional images based on the magnetic resonance phenomenon Interpretation of the images is the responsibility of trained physicians Images can be used for interventional and treatment planning purposes |
| | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR
Systems are substantially equivalent to the legally marketed predicate device
Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX
R5.4 (K173079, 04/04/2018) in terms of design features, fundamental scientific
technology, indications for use, and safety and effectiveness.
Additionally, substantial equivalence is demonstrated with non-clinical
performance (verification and validation) tests, which complied with the
|
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