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.

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 facade 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 facade, 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

AI/ML Overview

The provided text describes the Philips Ingenia Ambition S and Ingenia Ambition X MRI systems. However, it does not contain specific details about acceptance criteria or a dedicated study proving device performance against those criteria in a quantitative manner, as would be expected for an AI/CADe device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Ingenia 1.5T, Ingenia 1.5T S, etc., K173079) and a reference device (Ingenia Elition S and X, K173451) through compliance with regulatory standards and non-clinical verification and validation tests. The "performance" discussed is related to the overall system functionality and safety rather than the diagnostic accuracy of a specific software feature.

Therefore, many of the requested categories for AI/CADe device performance studies cannot be directly answered from this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (General)	Reported Device Performance (General)
Compliance with international and FDA-recognized consensus standards	Complies with IEC60601-1, IEC60601-1-2, IEC60601-1-6, IEC62366-1, IEC60601-1-8, IEC60601-2-33, IEC 62304, NEMA MS-1, MS-4, MS-8, PS 3.1-PS 3.20, ISO 14971.
Compliance with device-specific guidance documents	Complies with "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices" (Nov 18, 2016).
Meeting requirements for software contained in medical devices	Complies with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
Meeting requirements for cybersecurity in medical devices	Complies with "Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (Oct 2, 2014).
Meeting requirements for human factors and usability engineering	Complies with "Guidance for Industry and FDA Staff – Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016).
Meeting requirements for biological evaluation of medical devices	Complies with "Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1" (June 16, 2016).
Meeting requirements for electromagnetic compatibility (EMC)	Complies with "Guidance for Industry and FDA Staff – Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices" (July 11, 2016).
Meeting requirements for interoperable medical devices	Complies with "Guidance for Industry and FDA Staff – Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices" (Sept 6, 2017).
Adequacy for intended use	Non-clinical verification and validation tests, and a representative set of clinical images, demonstrate adequacy for intended use.
Substantial equivalence in safety and effectiveness	Demonstrated substantial equivalence to the predicate device K173079.

2. Sample size used for the test set and the data provenance:

The document states: "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."
Sample Size: Not specified (only "a representative set").
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This was likely an internal collection for verification/validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The clinical images were "generated and provided" as part of the submission, implying they were used for internal verification, but no explicit ground truth establishment by external experts/readers is mentioned in the context of a performance study. Interpretation of images is generally stated to be "by a trained physician" (Indications for Use).

4. Adjudication method for the test set:

Not applicable as no formal reader study requiring adjudication is described.

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:

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or reported in this document. The device is a diagnostic imaging system, not an AI/CADe accessory. The "Workflow Solution" features (VitalScreen, AutoStart, VitalEye, ContrastCards) are workflow enhancements, not systems for diagnostic interpretation. SyntAc (MDME) enables image acquisition for 3rd party (Synthetic MRI) software, indicating the device itself doesn't perform diagnostic AI interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not described. The device is an MRI system. While it includes "software changes" and "Workflow Solution" features, these are not standalone diagnostic algorithms whose performance is measured independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not specified for the "representative set of clinical images." Given the context of a new MRI system, the "ground truth" for these images would likely be related to image quality metrics, artifact assessment, and general diagnostic utility as interpreted by imaging specialists, rather than a specific disease outcome or pathology.

8. The sample size for the training set:

Not applicable/Not specified. This document describes an MRI system, not a machine learning algorithm that requires a distinct training set. The "Workflow Solution" features are described as integrated features, some of which were "already cleared for the legally marketed reference device," implying they are established functionalities rather than newly trained AI models needing specific training data.

9. How the ground truth for the training set was established:

Not applicable/Not specified. (See point 8).

Summary

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August 3, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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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

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Indications for Use

510(k) Number (if known)

K181479

Device Name Ingenia Ambition S and Ingenia Ambition X

Indications for Use (Describe)

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.

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 aligned horizontally. The background is plain white, which makes the blue letters stand out.

Ingenia Ambition S and Ingenia Ambition X

Section 5

510(k) Summary

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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:	June 01, 2018
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277
Primary Contact Person:	Jan van de KerkhofSr. Manager Regulatory AffairsPhone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com
Secondary Contact Person	Susan QuickRegulatory Affairs SpecialistTelephone: (440) 869-4612E-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 892.1000Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: 90LNH90LNI
Primary Predicate Device:	Trade name: Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4Manufacturer: 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 Elition S and Ingenia Elition XManufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K173451Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)
Device class	Class II
Product Code:	90LNH90LNI
Device Description:	The proposed Ingenia Ambition S and Ingenia Ambition X R5.5 withsealed magnet, modified RF amplifier and Workflow Solution aremodifications of the 70 cm Ingenia 1.5T system, included in the legallymarketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5TCX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018).The systems and control software provided with the proposed IngeniaAmbition S and Ingenia Ambition X are substantially equivalent to thelegally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079,04/04/2018).Hereafter in this submission, Ingenia Ambition S and IngeniaAmbition X will be used to indicate the proposed device IngeniaAmbition 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 alsoincludes minor software changes since the clearance of the legallymarketed predicate device, Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5TCX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018).The following modifications to the proposed Ingenia Ambition S andIngenia Ambition X are included in this submission:1. Introduction of sealed magnet and modified RF amplifier;2. Introduction of new product name and covers;3. VitalScreen: Touch Screen for guidance for patient setup: Touchscreen at magnet fa çade to give user guidance on how to preparea patient;4. Autostart: automatic start of scanning at RF Door Closure:Possibility for an operator to start a sequence by pressing the Startbutton at the controls at the magnet fa çade, the scan will then startthe necessary preparations to be able to start the sequence(transmitting and receiving of RF-signals and generating gradientwaveforms) when the RF door is closed.5. VitalEye: automatic breathing detection using camera: A camerasolution for detecting breathing patterns of the patient. The MRscanner translates real-time camera images of the patient, to real-time breathing wave forms. The acquisition system of the MRscanner will use these breathing wave forms to synchronize theinternals of the sequence:
6. ContrastCards: offers the ability to add information on the contrastagent. After applying the contrast agent, which is done independentfrom the MR system, information on the applied contrast is addedto the DICOM images. When viewing these images on the MRsystem the images which have been taken while contrast wasapplied are marked with an indication "Contrast".The feature helps the operator to indicate which sequence needscontrast and after applying contrast it helps indicate which imagesare taken while contrast was injected. Still, the use of contrastagents for diagnostic imaging applications shall be performedconsistent 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 (SyntheticMRI) 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 thelegally marketed reference device Ingenia Elition S and Ingenia ElitionX systems (K173451) and are integrated in the proposed IngeniaAmbition S and Ingenia Ambition X without any further modificationscompared to K173451.
The proposed Ingenia Ambition S and Ingenia Ambition X areintended to be marketed with the following pulse sequences and coilsthat 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 ofprotons or other nuclei with spin. Image appearance is determined bymany different physical properties of the tissue and the anatomy, andthe MR scan technique applied. The image acquisition process can besynchronized with the patient's breathing or cardiac cycle. The systemscan use combinations of images to produce physical parameters, andrelated derived images.
	Images, spectra, and measurements of physical parameters, wheninterpreted by a trained physician, provide information that may assistthe diagnosis and therapy planning. The accuracy of determinedphysical parameters depends on system and scan parameters, andmust be controlled and validated by the clinical user. The use of contrastagents for diagnostic imaging applications should be performedconsistent with the approved labeling for the contrast agent.
	In addition the Philips MR systems provide imaging capabilities, suchas MR fluoroscopy, to guide and evaluate interventional and minimallyinvasive procedures in the head, body and extremities.
	MR Interventional procedures, performed inside or adjacent to thePhilips MR system, must be performed with MR Conditional or MR Safeinstrumentation as selected and evaluated by the clinical user for usewith the specific MR system configuration in the hospital. Theappropriateness and use of information from a Philips MR system for aspecific interventional procedure and specific MR system configurationmust be validated by the clinical user.
Design Features/FundamentalScientificTechnology:	The proposed design of the Ingenia Ambition S and Ingenia AmbitionX is based on the principle that certain atomic nuclei present in thehuman body will emit a weak relaxation signal when placed in a strongmagnetic field. These atomic nuclei are excited by a radio signal at theprecession frequency. The emitted relaxation signals are analyzed bythe system and a computed image reconstruction is displayed on avideo screen.The principal technological components (transmit body coil, gradientcoil, receive coils and patient support) of the proposed IngeniaAmbition S and Ingenia Ambition X are identical to those used in thelegally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079,04/04/2018).The magnet for the proposed Ingenia Ambition S and IngeniaAmbition X has similar superconducting coils and cryostat constructionas 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 CXR5.4 (K173079, 04/04/2018), but has a different internal cooling system.The coils are located in the vacuum space of the cryostat instead of ina helium vessel and they are cooled by helium flow through tubes thatare in thermal connection with the superconducting coils. The helium inthese tubes circulates and is cooled, via a heat exchanger, at a coldpoint at the cold head, the cold head being similar to the cold head usedin the magnet for noted predicate devices. The cooling system is filledwith helium at the time of magnet manufacturing. During steady stateoperation the liquid-equivalent amount of helium corresponds toapproximately 7 liters. The cooling system is closed and thereforehelium will generally not require replenishment over the lifecycle of thesystem. No quench vent pipe is required for the magnet.The modified RF amplifier for the proposed Ingenia Ambition S andIngenia Ambition X is an in-house development, designed for highreliability 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 predicatedevice Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, andIngenia 3.0T CX R5.4 (K173079, 04/04/2018).

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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).

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Summary of Non-ClinicalPerformance Data:	The proposed Ingenia Ambition S and Ingenia Ambition X complywith the following international and FDA-recognized consensusstandards: 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 theSubmission Of Premarket Notifications for Magnetic ResonanceDiagnostic Devices" (issued November 18, 2016 – documentnumber 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 PremarketSubmissions for Management of Cybersecurity in Medical Devices(issued October 2, 2014 – document number 1825) Guidance for Industry and FDA Staff – Applying Human Factorsand Usability Engineering to Medical Devices (issued February 3,2016 – document number 1757) Guidance for Industry and FDA Staff – Use of InternationalStandard 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 aClaim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (issued July 11, 2016 – documentnumber 1400057) Guidance for Industry and FDA Staff – Design Considerations andPremarket Submission Recommendations for InteroperableMedical Devices (issued September 6, 2017 – document number 1500015)
	Non-Clinical verification and or validation tests have been performedwith regards to the intended use, the technical claims, the requirementspecifications and the risk management results.
	Additionally, a representative set of clinical images of the proposedIngenia Ambition S and Ingenia Ambition X systems have also beengenerated and provided in DICOM format together with this submission.
	The verification and/or validation test results and the set of clinicalimages demonstrate that that the proposed Ingenia Ambition S andIngenia Ambition X:
	• Comply with the aforementioned international and FDA recognizedconsensus standards and Device specific guidance document,entitled "Guidance for the Submission Of Premarket Notificationsfor 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 Xare substantially equivalent to the legally marketed predicate deviceIngenia 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 andeffectiveness.
Summary ofClinical Data:	The proposed Ingenia Ambition S and Ingenia Ambition X did notrequire a clinical study since substantial equivalence to the legallymarketed predicate device was proven with the verification/validationtesting.
SubstantialEquivalence:	The proposed Ingenia Ambition S and Ingenia Ambition X and thelegally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079,04/04/2018) have the same indications for use with respect to thefollowing:• Providing cross-sectional images based on the magneticresonance phenomenon• Interpretation of the images is the responsibility of trainedphysicians• Images can be used for interventional and treatment planningpurposes
	The proposed Ingenia Ambition S and Ingenia Ambition X aresubstantially equivalent to the legally marketed predicate device Ingenia1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0TCX R5.4 (K173079, 04/04/2018) in terms of design features,
	fundamental scientific technology, indications for use, and safety andeffectiveness.Additionally, substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which compliedwith the requirements specified in the international and FDA-recognizedconsensus standards and device-specific guidance.
Conclusion:	The results of these tests demonstrate that the proposed IngeniaAmbition S and Ingenia Ambition X meet the acceptance criteria andis adequate for its intended use.

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Regulation Number and Section

§ 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.