(101 days)
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.
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). 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 2. sLASER 3. Spiral Brain 4. 3D Non-selective 5. Diffusion XD TSE 6. 2KDTI 7. Advanced diffusion gradient control 8. K-t SENSE 9. Cardiac ZOOM 10. Retrospective EPI 11. mFFE Echo Summation* 12. Contrast Card* 13. 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: 1. mDIXON (K102344) 2. SWIp (K131241) 3. mDIXON-Quant (K133526) 4. MRE (K140666) 5. mDIXON XD (K143128) 6. O-MAR K143253 7. MultiBand SENSE (K143606) 8. 3D APT (K172920) 9. Ingenia Coils, see Appendix 011
This Philips K183063 510(k) premarket notification describes new software features for their Ingenia MR Systems (Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition models). The submission states that no clinical study was required to demonstrate substantial equivalence 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)). Therefore, the acceptance criteria and study details you requested for an AI/CAD-like device are not directly applicable in this context.
This submission focuses on non-clinical performance data (verification and validation tests) to prove that the proposed new software features of the MR systems meet acceptance criteria and are adequate for clinical use, and are substantially equivalent to the predicate device.
Here's a breakdown of the information provided within the context of a general medical device submission (even though it's not specifically an AI/CAD study):
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/CAD performance study, there's no table presenting sensitivity, specificity, or similar metrics. Instead, the "acceptance criteria" are compliance with established international and FDA-recognized consensus standards, and the "performance" is the device's adherence to these standards and its functional capabilities.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with International and FDA-recognized Consensus Standards (e.g., IEC, NEMA, ISO) | The proposed Ingenia MR Systems comply with: • 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 |
| Compliance with Device-Specific Guidance Documents | Complies with "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices" (Nov 18, 2016 – document 340) |
| Compliance with Software Guidance Documents | Complies with "Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005 – document 337) |
| Adequacy for Intended Use | Non-clinical verification and validation tests demonstrate that the proposed systems meet acceptance criteria and are adequate for their intended use. |
| Safety and Effectiveness Substantial Equivalence to Predicate Device | Demonstrated through non-clinical performance (verification and validation) tests, showing no different questions of safety and effectiveness compared to the predicate. |
Regarding AI/CAD-specific questions:
- 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from an AI/CAD study.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth established for an AI/CAD test set.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No MRMC study was conducted or required.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is describing new software features for an MR system, not a standalone algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/CAD study. Ground truth in this submission refers to the established standards and specifications verified through non-clinical testing.
- 8. The sample size for the training set: Not applicable. There is no mention of an AI model being trained with a dataset.
- 9. How the ground truth for the training set was established: Not applicable.
Summary from the Document:
The document states: "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."
The device's performance is demonstrated through compliance with a comprehensive list of international and FDA-recognized consensus standards (e.g., IEC, NEMA, ISO standards for medical electrical equipment, quality management systems, and specifically MR devices) and relevant FDA guidance documents. Non-clinical verification and validation tests were performed to confirm that the new software features function as intended, meet their specifications, and manage risks appropriately, thus demonstrating safety and effectiveness without requiring clinical data.
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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
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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
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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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Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue letters.
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 NetherlandsEstablishment Registration Number: 3003768277 | |
| Primary ContactPerson: | Jan van de KerkhofSr. Manager Regulatory AffairsPhone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com | |
| Secondary ContactPerson | Susan QuickRegulatory Affairs SpecialistTelephone: 440 869-4612E-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 892.1000Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: 90LNH90LNI | |
| Primary PredicateDevice: | Trade name: Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4Manufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K173079Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice class: Class IIProduct Code: 90LNH90LNI | |
| Reference Device: | Trade name: Ingenia Eilition S, Ingenia Elition XManufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K173451Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice 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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Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text.
| 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 aresubstantially 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 ElitionS and Ingenia Elition X (K173451, 03/20.2018) and the Ingenia Ambition S andIngenia Ambition X (K180479, 08/03/2018) . | |
| Hereafter Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MRSystems R5.6 with SENC, bFFE XD, IRIS ZOOM, MEGA and SyntAc softwarefeatures will be referred to as the proposed Ingenia, Ingenia CX, IngeniaElition, and Ingenia Ambition MR Systems in this submission. | |
| This submission includes the software modifications below for the proposedIngenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems, thereare 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 Ambitionand 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 CXR5.4 (K173079, 04/04/2018): | |
| 1. VAPOR2. sLASER3. Spiral Brain4. 3D Non-selective5. Diffusion XD TSE6. 2KDTI7. Advanced diffusion gradient control8. K-t SENSE9. Cardiac ZOOM10. Retrospective EPI11. mFFE Echo Summation*12. Contrast Card*13. Autostart** This software feature is provided on the proposed Ingenia systems only (Ingenia1.5T, 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 IngeniaAmbition and Elition systems. | |
| The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MRSystems are intended to be marketed with the following pulse sequences andcoils that were previously cleared by FDA:1. mDIXON (K102344)2. SWIp (K131241)3. mDIXON-Quant (K133526)4. MRE (K140666)5. mDIXON XD (K143128)6. O-MAR K1432537. MultiBand SENSE (K143606)8. 3D APT (K172920)9. Ingenia Coils, see Appendix 011 | |
| Indications forUse: | There are minor modifications to the indications for use statement for the proposedIngenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems forclarity, but the intended use has not changed. |
| Philips Magnetic Resonance (MR) systems are Medical Electrical Systemsindicated 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 orextremities, in any orientation, representing the spatial distribution of protons orother nuclei with spin. | |
| Image appearance is determined by many different physical properties of thetissue and the anatomy, the MR scan technique applied, and presence of contrastagents. The use of contrast agents for diagnostic imaging applications should beperformed consistent with the approved labeling for the contrast agent. | |
| The trained clinical user can adjust the MR scan parameters to customize imageappearance, accelerate image acquisition, and synchronize with the patient'sbreathing or cardiac cycle.The systems can use combinations of images to produce physical parameters,and related derived images, spectra, and measurements of physicalparameters, when interpreted by a trained physician, provide information that mayassist diagnosis and therapy planning. The accuracy of determined physicalparameters depends on system and scan parameters, and must be controlled andvalidated by the clinical user.In addition the Philips MR systems provide imaging capabilities, such as MRfluoroscopy, to guide and evaluate interventional and minimally invasiveprocedures in the head, body and extremities. | |
| MR Interventional procedures, performed inside or adjacent to the Philips MRsystem, must be performed with MR Conditional or MR Safe instrumentation asselected and evaluated by the clinical user for use with the specific MR systemconfiguration in the hospital. The appropriateness and use of information from aPhilips MR system for a specific interventional procedure and specific MR systemconfiguration must be validated by the clinical user. | |
| Design Features/FundamentalScientificTechnology: | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MRSystems are based on the principle that certain atomic nuclei present in thehuman body will emit a weak relaxation signal when placed in a strong magneticfield and excited by a radio signal at the precession frequency. The emittedrelaxation signals are analyzed by the system and a computed imagereconstruction 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, IngeniaElition, and Ingenia Ambition MR Systems are identical to those used in thelegally 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 legallymarketed 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 softwarefeatures. | |
| The main application of bFFE XD is to reduce banding artifacts, resulting from theB0 sensitivity of balanced Fast Field Echo (bFFE) sequences. Those black bandartifacts can obscure information in the images. The main clinical applicationtargeted 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 themulti-shot capability, IRIS ZOOM delivers a higher resolution, lower distortion andimproved fat suppression in spine when compared to Zoom Diffusion Imaging. | |
| MEGA is a feature that allows for detection of J-coupled metabolite signals likeGABA (gamma-butyric acid) in the brain. MEGA is spectral editing technique andintended for single voxel 1H spectroscopy in the brain on 3T systems. | |
| SENC (Strain ENCoding) is intended for cardiac imaging, to measure cardiacmuscle contraction as a function of time within the cardiac cycle.SENC produces strain encoded images. Those images are processed by 3rdparty 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 isdesigned to be less sensitive to T1 variations and B1 inhomogeneities. | |
| sLASER is a modification of 1H SE (PRESS) localized spectroscopy and can beapplied to Single Voxel Spectroscopy (SV) as well as Spectroscopic Imaging(MRSI). The sLASER sequence uses slice selective adiabatic pairs of refocusingRF pulses to reduce the chemical shift displacement up to a factor 4 whencompared to PRESS-localized spectroscopy at 3T. | |
| Spiral Brain uses a spiral readout, which is applied as an alternative to theCartesian 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) imageartifact robustness, due to reduced flow sensitivity). Spiral Brain leverages thosebenefits 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 3DFFE 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 3DTFE. | |
| Diffusion XD TSE technique is an enhancement of Diffusion TSE. It introducesthe SPLICE technique and enables the combination with a MultiVane readout. Byallowing the combination with MultiVane, a multi-shot readout can be achieved,which contributes to the sharpness of the resulting image and includes intrinsicmotion correction. | |
| 2KDTI is a technical enhancement of the maximal number of diffusion encodingsthat can be collected in one diffusion scan. 2KDTI provides up to 2048independent diffusion encodings (vectors) with up to 1024 different weightings and1024 different directions. | |
| Advanced diffusion gradient control allows the scientific user to select frommultiple diffusion encoding gradient waveforms. Advanced diffusion gradientcontrol enables the user to define manually the duration of the diffusion encodinggradients. | |
| k-t SENSE is a spatio-temporal acceleration technique that combines the benefitsof 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 SENSEprocesses the coils (coil elements) integrally with the help of which thehomogeneity of the images are enhanced. | |
| Cardiac ZOOM is a small FOV imaging technique which performs the excitationand refocussing pulses orthogonally. Cardiac ZOOM enhances black bloodimaging, by providing accelerated and single beat imaging. This allows scanningof patients who cannot hold their breath. | |
| Retrospective cardiac gating synchronizes pulse sequence with cardiac rhythmso that cardiac motion related artifacts are removed. Retrospective gating isenhanced by allowing the combination with EPI and TFE-EPI sequences, whichare 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 enhancedworkflow when compared to the existing manual post-processing that is availablein Image Algebra post-processing package. | |
| The Contrast Card enhancement offers the ability to add information on thecontrast agent. After applying the contrast agent, which is done independent fromthe MR system, information on the applied contrast is added to the DICOMimages. When viewing these images on the MR system the images, which havebeen taken while contrast was applied, are marked with an indication "Contrast".After pressing Start Scan at the controls at the magnet façade the scan willautomatically start (Autostart feature) when the RF door is closed. This functionis the same as the legally marketed reference device Ingenia Elition S and IngeniaElition X systems (K173451, 03/20/2018) and for the Ingenia Ambition S and IngeniaAmbition X systems (K180479, 08/03/2018) and is implemented without furtherchanges. | |
| Based on the information provided above, the proposed Ingenia, Ingenia CX,Ingenia Elition, and Ingenia Ambition MR Systems do not raise differentquestions of safety and effectiveness compared to the legally marketed predicatedevice Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia3.0T CX R5.4 (K173079, 04/04/2018). | |
| Summary of Non- | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR |
| ClinicalPerformance Data: | Systems complies with the following international and FDA-recognizedconsensus 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 SubmissionOf Premarket Notifications for Magnetic Resonance Diagnostic Devices"(issued November 18, 2016 – document number 340) Guidance for Industry and FDA Staff Guidance for the Content ofPremarket Submissions for Software Contained in Medical Devices(issued May 11, 2005 – document number 337) Guidance for Industry and FDA Staff – Content of Premarket Submissionsfor Management of Cybersecurity in Medical Devices (issued October 2,2014 - document number 1825) Guidance for Industry and FDA Staff Applying Human Factors andUsability Engineering to Medical Devices (issued February 3, 2016 –document number 1757) Guidance for Industry and FDA Staff – Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process" (issued June 16, 2016 –document number 1811) Guidance for Industry and FDA Staff – Information to Support a Claim ofElectromagnetic Compatibility (EMC) of Electrically-Powered MedicalDevices (issued July 11, 2016 – document number 1400057) Guidance for Industry and FDA Staff Design Considerations andPremarket Submission Recommendations for Interoperable MedicalDevices (issued September 6, 2017 – document number 1500015)Non-Clinical verification and or validation tests have been performed with regardsto the intended use, the technical claims, the requirement specifications and therisk management results.The verification and/or validation test results demonstrate that that the proposedIngenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems: Comply with the aforementioned international and FDA recognizedconsensus standards and Device specific guidance document, entitled"Guidance for the Submission Of Premarket Notifications for MagneticResonance 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 marketedpredicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, andIngenia 3.0T CX R5.4 (K173079, 04/04/2018) in terms of safety and effectiveness. | |
| Summary ofClinical Data: | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems did not require a clinical study since substantial equivalence to thelegally marketed predicate device was proven with the verification/validationtesting. |
| SubstantialEquivalence: | 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 MRSystems are substantially equivalent to the legally marketed predicate deviceIngenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CXR5.4 (K173079, 04/04/2018) in terms of design features, fundamental scientifictechnology, indications for use, and safety and effectiveness.Additionally, substantial equivalence is demonstrated with non-clinicalperformance (verification and validation) tests, which complied with the |
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§ 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.