(59 days)
No
The document describes standard MR imaging capabilities and features like automatic breathing detection using a camera, which translates images to waveforms. While this involves image processing, there is no mention of AI or ML being used for image interpretation, diagnosis, or any other function. The interpretation of images is explicitly stated to be done by a trained physician.
No
The "Intended Use / Indications for Use" section explicitly states that the system is a "diagnostic device" and that images, spectra, and measurements "may assist the diagnosis and therapy planning," but it does not claim to directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This system is a Magnetic Resonance Medicated for use as a diagnostic device." It further clarifies that images, spectra, and measurements "provide information that may assist the diagnosis and therapy planning."
No
The device description explicitly mentions hardware components such as a sealed magnet, modified RF amplifier, and a touch screen at the magnet facade, indicating it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this system is a Magnetic Resonance device that produces images, spectra, and measurements of the internal structure of the head, body, or extremities. It works by detecting the spatial distribution of protons or other nuclei within the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any specimens taken from the patient. Its function is to image the patient's body directly.
Therefore, this device falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This system is a Magnetic Resonance Medicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities.
Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized 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 the 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. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
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 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 (comma separated list FDA assigned to the subject device)
LNH, LNI
Device Description
The proposed Ingenia Ambition S and Ingenia Ambition X R5.5 with sealed magnet, modified RF amplifier and Workflow Solution are modifications of the 70 cm Ingenia 1.5T system, included 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). The systems and control software provided with the proposed Ingenia Ambition S and Ingenia Ambition X 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).
Hereafter in this submission, Ingenia Ambition S and Ingenia Ambition X will be used to indicate the proposed device Ingenia Ambition S and Ingenia Ambition X R5.5 with sealed magnet, modified RF amplifier and Workflow Solution.
The proposed Ingenia Ambition S and Ingenia Ambition X also includes minor software changes 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).
The following modifications to the proposed Ingenia Ambition S and Ingenia Ambition X are included in this submission:
- Introduction of sealed magnet and modified RF amplifier;
- Introduction of new product name and covers;
- VitalScreen: Touch Screen for guidance for patient setup: Touch screen at magnet façade to give user guidance on how to prepare a patient;
- Autostart: automatic start of scanning at RF Door Closure: Possibility for an operator to start a sequence by pressing the Start button at the controls at the magnet façade, the scan will then start the necessary preparations to be able to start the sequence (transmitting and receiving of RF-signals and generating gradient waveforms) when the RF door is closed.
- VitalEye: automatic breathing detection using camera: A camera solution for detecting breathing patterns of the patient. The MR scanner translates real-time camera images of the patient, to real-time breathing wave forms. The acquisition system of the MR scanner will use these breathing wave forms to synchronize the internals of the sequence:
- ContrastCards: 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". The feature helps the operator to indicate which sequence needs contrast and after applying contrast it helps indicate which images are taken while contrast was injected. Still, the use of contrast agents for diagnostic imaging applications shall be performed consistent with the approved labeling for the contrast agent.
- SyntAc (MDME): acquisition of Multi-Dynamic Multi-Echo (MDME) images. These images can be processed by 3rd party (Synthetic MRI) software to produce the relevant radiological contrasts.
Note: The VitalScreen (3), AutoStart (4), VitalEye (5), ContrastCards (6) and SyntAc (MDME) (7) features have been already cleared for the legally marketed reference device Ingenia Elition S and Ingenia Elition X systems (K173451) and are integrated in the proposed Ingenia Ambition S and Ingenia Ambition X without any further modifications compared to K173451.
The proposed Ingenia Ambition S and Ingenia Ambition X 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
- Ingenia Coils, see Appendix 004
Mentions image processing
Yes, "Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning." and "The MR scanner translates real-time camera images of the patient, to real-time breathing wave forms. The acquisition system of the MR scanner will use these breathing wave forms to synchronize the internals of the sequence".
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / hospital
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)
The proposed Ingenia Ambition S and Ingenia Ambition X did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing.
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 and the set of clinical images demonstrate that that the proposed Ingenia Ambition S and Ingenia Ambition X:
• 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.
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
August 3, 2018
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Philips Medical Systems Nederland B.V. % Ms. Susan Quick Regulatory Affairs Specialist Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143
Re: K181479
Trade/Device Name: Ingenia Ambition S and Ingenia Ambition X Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI Dated: May 31, 2018 Received: June 5, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara For
Robert 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)
K181479
Device Name Ingenia Ambition S and Ingenia Ambition X
Indications for Use (Describe)
This system is a Magnetic Resonance Medicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities.
Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized 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 the 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. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
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 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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Ingenia Ambition S and Ingenia Ambition X
Section 5
510(k) Summary
4
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: | June 01, 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 Ambition S and Ingenia Ambition X |
| 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 Elition S and 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) | |
| Device class | Class II |
| Product Code: | 90LNH |
| 90LNI | |
| Device Description: | The proposed Ingenia Ambition S and Ingenia Ambition X R5.5 with |
| sealed magnet, modified RF amplifier and Workflow Solution are | |
| modifications of the 70 cm Ingenia 1.5T system, included 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). | |
| The systems and control software provided with the proposed Ingenia | |
| Ambition S and Ingenia Ambition X 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). |
Hereafter in this submission, Ingenia Ambition S and Ingenia
Ambition X will be used to indicate the proposed device Ingenia
Ambition S and Ingenia Ambition X R5.5 with sealed magnet,
modified RF amplifier and Workflow Solution.
The proposed Ingenia Ambition S and Ingenia Ambition X also
includes minor software changes 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).
The following modifications to the proposed Ingenia Ambition S and
Ingenia Ambition X are included in this submission:
- Introduction of sealed magnet and modified RF amplifier;
- Introduction of new product name and covers;
- VitalScreen: Touch Screen for guidance for patient setup: Touch
screen at magnet fa çade to give user guidance on how to prepare
a patient; - Autostart: automatic start of scanning at RF Door Closure:
Possibility for an operator to start a sequence by pressing the Start
button at the controls at the magnet fa çade, the scan will then start
the necessary preparations to be able to start the sequence
(transmitting and receiving of RF-signals and generating gradient
waveforms) when the RF door is closed. - VitalEye: automatic breathing detection using camera: A camera
solution for detecting breathing patterns of the patient. The MR
scanner translates real-time camera images of the patient, to real-
time breathing wave forms. The acquisition system of the MR
scanner will use these breathing wave forms to synchronize the
internals of the sequence: |
| 6. ContrastCards: 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".
The feature helps the operator to indicate which sequence needs
contrast and after applying contrast it helps indicate which images
are taken while contrast was injected. Still, the use of contrast
agents for diagnostic imaging applications shall be performed
consistent with the approved labeling for the contrast agent. | |
| 7. SyntAc (MDME): acquisition of Multi-Dynamic Multi-Echo (MDME)
images. These images can be processed by 3rd party (Synthetic
MRI) software to produce the relevant radiological contrasts. | |
| Note: The VitalScreen (3), AutoStart (4), VitalEye (5), ContrastCards (6)
and SyntAc (MDME) (7) features have been already cleared for the
legally marketed reference device Ingenia Elition S and Ingenia Elition
X systems (K173451) and are integrated in the proposed Ingenia
Ambition S and Ingenia Ambition X without any further modifications
compared to K173451. | |
| The proposed Ingenia Ambition S and Ingenia Ambition X 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. Ingenia Coils, see Appendix 004 | |
| Indications for | This system is a Magnetic Resonance Medical Electrical Systems |
| Use: | indicated for use as a diagnostic device. The system can produce cross- |
| | |
| | sectional images, spectroscopic images and/or spectra in any |
| | orientation of the internal structure of the head, body or extremities. |
| | Magnetic Resonance images represent 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, and
the MR scan technique applied. The image acquisition process can be
synchronized 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
the 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. The use of contrast
agents for diagnostic imaging applications should be performed
consistent with the approved labeling for the contrast agent. |
| | 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 design of the Ingenia Ambition S and Ingenia Ambition
X is 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. These atomic nuclei are 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 (transmit body coil, gradient
coil, receive coils and patient support) of the proposed Ingenia
Ambition S and Ingenia Ambition X 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).
The magnet for the proposed Ingenia Ambition S and Ingenia
Ambition X has similar superconducting coils and cryostat construction
as the magnet of legally marketed predicate devices 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), but has a different internal cooling system.
The coils are located in the vacuum space of the cryostat instead of in
a helium vessel and they are cooled by helium flow through tubes that
are in thermal connection with the superconducting coils. The helium in
these tubes circulates and is cooled, via a heat exchanger, at a cold
point at the cold head, the cold head being similar to the cold head used
in the magnet for noted predicate devices. The cooling system is filled
with helium at the time of magnet manufacturing. During steady state
operation the liquid-equivalent amount of helium corresponds to
approximately 7 liters. The cooling system is closed and therefore
helium will generally not require replenishment over the lifecycle of the
system. No quench vent pipe is required for the magnet.
The modified RF amplifier for the proposed Ingenia Ambition S and
Ingenia Ambition X is an in-house development, designed for high
reliability and with the same:
system requirements, peak power, average power, signal fidelity, and system behavior as the existing RF amplifier provided with 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). |
5
6
7
8
9
The new colors (coils, positioning aids) and new covers are the same as provided with the legally marketed reference device (Ingenia Elition X and Ingenia Elition S) and are incorporated in the proposed Ingenia Ambition S and Ingenia Ambition X without further changes.
The Workflow Solution (VitalScreen, AutoStart, VitalEye, and ContrastCards) provided with the proposed Ingenia Ambition S and Ingenia Ambition X adds workflow enhancements in patient preparation as well as data administration enhancements. This combination of features (VitalEye, VitalScreen, Autostart and Contrast Card) has been already cleared for the legal marketed reference device Ingenia Elition S and Ingenia Elition X systems (K173451) and is integrated in the proposed Ingenia Ambition S and Ingenia Ambition X without any further modifications compared to K173451.
The SyntAc (MDME) feature provided with the proposed Ingenia Ambition S and Ingenia Ambition X gives possibility to acquire Multi-Dynamic Multi-Echo (MDME) images. These images can be processed by 3d party (Synthetic MRI) software to produce the relevant radiological contrasts. This feature has been already cleared for the leqally marketed reference device Ingenia Elition S and Ingenia Elition X systems (K173451) and is integrated in the proposed Ingenia Ambition S and Ingenia Ambition X without any further modifications compared to K173451.
Based on the information provided above, the proposed Ingenia Ambition S and Ingenia Ambition X 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).
10
| Summary of Non-
Clinical
Performance Data: | The proposed Ingenia Ambition S and Ingenia Ambition X comply
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. |
| | Additionally, a representative set of clinical images of the proposed
Ingenia Ambition S and Ingenia Ambition X systems have also been
generated and provided in DICOM format together with this submission. |
| | The verification and/or validation test results and the set of clinical
images demonstrate that that the proposed Ingenia Ambition S and
Ingenia Ambition X: |
| | • 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 Ambition S and Ingenia Ambition X
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 Ambition S and Ingenia Ambition X 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 Ambition S and Ingenia Ambition X and 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) 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 Ambition S and Ingenia Ambition X 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 was demonstrated with non-
clinical performance (verification and validation) tests, which complied
with the requirements specified in the international and FDA-recognized
consensus standards and device-specific guidance. |
| Conclusion: | The results of these tests demonstrate that the proposed Ingenia
Ambition S and Ingenia Ambition X meet the acceptance criteria and
is adequate for its intended use. |
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