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, 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.

Device Description

The proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 with MultiBand SENSE software feature are provided on the 60 cm and 70 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) Magnetic Resonance Diagnostic Devices.

Hereafter Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 with MultiBand SENSE software feature will be referred to as the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems in this submission.

This bundled abbreviated 510(k) submission will include software modifications to the following legally marketed MR systems: Ingenia 1.5T, Ingenia 1.5T S, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S and Ingenia Ambition X (K183063, 02/14/2019) and Achieva 1.5T, Achieva 3.0T, Intera 1.5T (K190461, 06/04/2019).

All of the aforementioned legally marketed systems will be brought up to the new baseline software R5.7. This submission addresses only software modifications, there are no hardware modifications made to any of the above legally marketed systems.

In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing modifications to MultiBand SENSE and one labeling change to the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems:

• Removal of contra-indication statement of Compressed SENSE with Gd contrast agent

This 510(k) submission will also address minor software enhancements contained in software R5.7 for the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems since the clearance of the last submission for each of the systems:

4D FreeBreathing
MR Elastography Extension
EPIC Brain
LOVA ADC
Computed DWI
SmartShim
VitalScreen
Extended Functionality Options

The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA:

mDIXON (K102344)
SWIp (K131241)
mDIXON-Quant (K133526)
mDIXON XD (K143128)
O-MAR K143253
3D APT (K172920)
Ingenia Coils

The proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems are substantially equivalent to the legally marketed predicate device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063, 02/14/2019).

In addition, the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems is substantially equivalent to the following legally marketed reference devices: MultiBand SENSE software application (K162940, 12/30/2016), to support MultiBand SENSE for 1.5T and to support diffusion body imaging on 1.5T and 3.0T.Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T CX, and Ingenia 3.0T CX R5.4 K173079, 04/04/2018, to support the removal of the contra-indication of the compatibility of Compressed SENSE with (dynamic) Gadolinium contrast-enhanced imaging.

AI/ML Overview

The provided text is a 510(k) Summary for Philips MR Systems, primarily addressing software modifications and enhancements. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel AI/CAD device. Therefore, much of the requested information regarding acceptance criteria specifically for AI/CAD performance, MRMC studies, and detailed ground truth establishment for a test set as typically seen for AI algorithm validation is not explicitly detailed in this document.

However, based on the non-clinical performance data section, we can infer some information about "acceptance criteria" in the context of demonstrating equivalence for the software modifications.

Here's an attempt to extract and present the information based on the provided text:

Device: Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (with software modifications R5.7, including MultiBand SENSE and Compressed SENSE with contrast among other enhancements).

Study Goal: To demonstrate substantial equivalence of the modified MR systems to legally marketed predicate devices, particularly regarding the performance of the software features.

Acceptance Criteria and Reported Device Performance

The document doesn't present a specific table of acceptance criteria with numerical performance targets typical for AI/CAD devices (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly performance characteristics demonstrating equivalence to the predicate device and proper functioning of the new features.

Acceptance Criteria (Implied)	Reported Device Performance
General Software Functionality & Performance:
Software modifications perform as intended.	Non-clinical verification and/or validation tests have been performed on all software modifications with regards to the intended use, technical claims, requirement specifications, and risk management results. The results demonstrate that the software features perform as intended.
Software is substantially equivalent to predicate devices.	The results from each set of tests demonstrate that the software features are substantially equivalent to the predicate devices to which they have been compared.
All risks are sufficiently mitigated; no new risks introduced.	Risk management activities show that all risks are sufficiently mitigated and that no new risks are introduced, and that the overall residual risks are acceptable.
MR systems meet acceptance criteria and are adequate for use.	Test results demonstrate that the proposed systems meet the acceptance criteria and are adequate for their intended use.
Specific - Compressed SENSE with Contrast:
Adequate capture of time-intensity behavior with Compressed SENSE	Bench test results (Shelley phantom), using both retrospectively and prospectively sub-sampled data, demonstrated adequate capture of time-intensity behavior.
Robustness up to higher acceleration factors.	Data from retrospective sub-sampled CE-angio data on 3 human subjects allowed for a direct comparison of SENSE and Compressed SENSE in terms of difference images relative to non-accelerated, fully sampled data. Compressed SENSE was shown to be more robust up to higher acceleration factors.
Equivalence for dynamic contrast uptake applications.	Clinical data for brain perfusion in tumor classification (using a retrospective subsampling approach) was provided. Philips believes the analysis and data from all testing demonstrates equivalence of CS-SENSE with the predicate device (non-accelerated data acquisition) for this dynamic contrast uptake application.
Specific - MultiBand SENSE:
Functionality and safety on 1.5T systems (with limitations).	MultiBand SENSE is identical to the legally marketed MultiBand and is now also implemented with minor changes on 1.5T systems, specifically limiting the allowed MultiBand factor to 2 on 1.5T systems. MultiBand SENSE Extension enables exploring diffusion imaging in the body. (Implied that this functionality performs as expected and safely within the stated limitations compared to its predicate and extension).
Other Specific Features (4D FreeBreathing, MR Elastography Extension, etc.):	Functionality as described and improved clinical utility (e.g., avoiding artifacts, more accurate maps, faster scans, extended parameter space).

Study Details

Sample sizes used for the test set and the data provenance:
- For Compressed SENSE with Contrast:
  - "Bench test results (Shelley phantom)" - number of phantom acquisitions not specified.
  - "Retrospectively and prospectively sub-sampled data" - not specified if this refers to phantom or human data for prospectively sub-sampled.
  - "Data from retrospective sub-sampled CE-angio data, on 3 human subjects."
  - "Clinical data for brain perfusion in tumor classification was provided." (Number of subjects not specified, but this refers to another retrospective subsampling approach.)
- For other features, the document states "Non-Clinical verification and or validation tests have been performed on all of the software modifications" but does not specify sample sizes for test images or subjects.
- Data Provenance: Not explicitly stated regarding country of origin. The data appears to be retrospective (e.g., "retrospective sub-sampled CE-angio data"). It's a non-clinical submission, so no large-scale clinical trial data is expected.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information provided regarding experts establishing ground truth for a test set. This submission focuses on demonstrating substantial equivalence based on technical and performance characteristics of the MR sequences, not on diagnostic accuracy of an AI interpreting images for specific conditions. The "ground truth" here is implied to be the established performance of the predicate device (non-accelerated acquisition) or physical properties measured by phantoms.
- The document implies that "interpreted by a trained physician" is crucial for clinical use, but this is not about ground truth for the device's performance testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This type of submission does not detail an adjudication process for a diagnostic interpretative task.
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 was not performed and is not described in this 510(k) summary. This submission pertains to modifications of the MR scanner's acquisition capabilities, not an AI or CAD system that assists human readers with diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The studies mentioned (bench tests, subsampled data comparisons) were essentially "standalone" evaluations of the image reconstruction algorithms' technical performance (e.g., temporal and spatial resolution, contrast appearance, robustness) against a reference (fully sampled or non-accelerated data). No specific metrics like sensitivity/specificity for a diagnostic task are provided, as the device is the scanner itself, not an interpretative AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the technical performance evaluations appears to be:
  - Phantom data: For assessing properties like time-intensity behavior (Shelley phantom).
  - Fully sampled (non-accelerated) MR acquisition data: Used as a reference for comparison with accelerated acquisition (Compressed SENSE) to assess image quality, spatial/temporal resolution, and contrast appearance.
  - Implied clinical utility/diagnostic information: The "clinical data for brain perfusion in tumor classification" might have relied on clinical diagnosis or other established medical information for the "tumor classification" aspect, but the primary comparison was the technical quality of the MR images generated by the new sequence versus the predicate.
The sample size for the training set:
- Not applicable/Not specified. This document describes improvements to existing MR sequences and software, not a de novo AI model that requires a distinct "training set." The development of the algorithms would have involved internal testing and validation, but not in the sense of a machine learning training dataset for a specific diagnostic task from a large, labeled dataset.
How the ground truth for the training set was established:
- Not applicable, as no external "training set" in the context of machine learning model development is described.

Summary

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April 10, 2020

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Philips Medical Systems Nederland BV % Ms. Susan Quick Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143

Re: K193215

Trade/Device Name: Achieva, Intera, Ingenia, Ingneia 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, LNI Dated: March 11, 2020 Received: March 12, 2020

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193215

Device Name

Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems

Indications for Use (Describe)

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.

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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Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging Bundled Abbreviated 510(k)

K193215

Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems

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:	November 14, 2019
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:	Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Classification:	Classification name: Magnetic Resonance Diagnostic Device (MRDD) Classification Regulation: 21CFR 892.1000 Classification Panel: Radiology Device Class: Class II Primary Product Code: 90LNH90LNI
Primary Predicate Device:	Trade name: Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K183063 Classification Regulation: 21CFR 892.1000 Classification name: Magnetic Resonance Diagnostic Device (MRDD) Classification Panel: Radiology Device class Class II Product Code: 90LNH90LNI
Reference Device:	Trade name: MultiBand SENSE Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K162940 Classification Regulation: 21CFR 892.1000 Classification name: Magnetic Resonance Diagnostic Device (MRDD) Classification Panel: Radiology Device class Class II

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	Product Code:	90LNH
		90LNI
Reference Device:	Trade name:	Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX,Ingenia 3.0T CX, 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

DeviceDescription:	The proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, andIngenia Ambition MR Systems R5.7 with MultiBand SENSE software featureare provided on the 60 cm and 70 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T)Magnetic Resonance Diagnostic Devices.
	Hereafter Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and IngeniaAmbition MR Systems R5.7 with MultiBand SENSE software feature will bereferred to as the proposed Achieva, Intera, Ingenia, Ingenia CX, IngeniaElition, and Ingenia Ambition MR Systems in this submission.
	This bundled abbreviated 510(k) submission will include software modificationsto the following legally marketed MR systems: Ingenia 1.5T, Ingenia 1.5T S,Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia ElitionX, Ingenia Ambition S and Ingenia Ambition X (K183063, 02/14/2019) andAchieva 1.5T, Achieva 3.0T, Intera 1.5T (K190461, 06/04/2019).
	All of the aforementioned legally marketed systems will be brought up to the newbaseline software R5.7. This submission addresses only software modifications,there are no hardware modifications made to any of the above legally marketedsystems.
	In this 510(k) submission, Philips Medical Systems Nederland B.V. will beaddressing modifications to MultiBand SENSE and one labeling change to theproposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and IngeniaAmbition MR Systems:
	• Removal of contra-indication statement of Compressed SENSE with Gdcontrast agent
	This 510(k) submission will also address minor software enhancementscontained in software R5.7 for the proposed Achieva, Intera, Ingenia, IngeniaCX, Ingenia Elition, and Ingenia Ambition MR Systems since the clearance ofthe last submission for each of the systems:
	1. 4D FreeBreathing

	2. MR Elastography Extension
	3. EPIC Brain
	4. LOVA ADC
	5. Computed DWI
	6. SmartShim
	7. VitalScreen
	8. Extended Functionality Options
	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. mDIXON XD (K143128)5. O-MAR K1432536. 3D APT (K172920)7. Ingenia Coils
	The proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems are substantially equivalent to the legally marketed predicate device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063, 02/14/2019).
	In addition, the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems is substantially equivalent to the following legally marketed reference devices:MultiBand SENSE software application (K162940, 12/30/2016), to support MultiBand SENSE for 1.5T and to support diffusion body imaging on 1.5T and 3.0T.Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T CX, and Ingenia 3.0T CX R5.4 K173079, 04/04/2018, to support the removal of the contra-indication of the compatibility of Compressed SENSE with (dynamic) Gadolinium contrast-enhanced imaging.
Indications for Use:	There are no modifications to the indications for use statement for the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems.Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast
	agents. The use of contrast agents for diagnostic imaging applications should 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. 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 Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, andIngenia Ambition MR Systems are based on the principle that certain atomicnuclei present in the human body will emit a weak relaxation signal when placedin a strong magnetic field and excited by a radio signal at the precessionfrequency. The emitted relaxation signals are analyzed by the system and acomputed image reconstruction is displayed on a video screen.
	The principal technological components (magnet, transmit body coil, gradient coil,receive coils and patient support) of the proposed Achieva, Intera, Ingenia,Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are identicalto those used in the legally marketed predicate device Ingenia, Ingenia CX,Ingenia Elition, and Ingenia Ambition MR Systems (K183063, 02/14/2019.
	The following are descriptions of the labeling change or descriptions of themodified or minor enhanced software features.
	Compressed SENSE with ContrastFaster scanning in the presence of Gadolinium-based contrast agents can beachieved using Compressed SENSE . The sequence and reconstructionimplementations are identical to those used for previously-cleared CompressedSENSE for native contrasts, and do not include sparse sampling and signalcombination in the temporal domain. Compressed SENSE provides accuratetemporal and spatial resolution, and contrast appearance. The contra-indicationfor compatibility of Compressed SENSE with (dynamic) Gadolinium contrast-enhanced imaging will be removed from the Instructions for Use.

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Bundled Abbreviated 510(k)

MultiBand SENSE
Multiband SENSE allows acceleration factors in single shot EPI sequence in DWI, DTI and fMRI. MultiBand SENSE is allowed on 3.0T and 1.5T DDAS systems. This function is the identical as the legally marketed device MultiBand and is now also implemented with minor changes on the 1.5T systems. The minor change is limiting the allowed MultiBand factor to 2 on 1.5T systems.
MultiBand SENSE Extension
MultiBand SENSE Extension is an extension of MultiBand SENSE which enables exploring diffusion imaging in the body.
VitalScreen
The Coil and Accessories Guidance was added to guide the user to correctly position mattresses and connecting coils.
4D FreeBreathing
4D FreeBreating technology uses 3D FFE and TFE radial acquisitions (like in 3D Vane XD) to avoid image artifacts typically seen with Cartesian imaging (Like 4D Thrive) when the patient cannot hold their breath. The MR technique enables dynamic imaging multiple contrast phases of the body without the need for the patient to hold their breath.
MR Elastography Specialist
Elastography Specialist has been enhanced with the SE-EPI sequence. The SE- EPI sequence is an alternative to the already available FFE sequence to perform elasticity assessment of the liver with MR.
Epic Brain
EPIC Brain corrects for geometrical distortions in EPI scans.
LOVA ADC
LOVA ADC corrects for gradient non-linearities so to produce more accurate ADC maps.
Computed DWI
Computed DWI is used to compute high b-value diffusion images, so to save scan time.
SmartShim
SmartShim is an automated shimming technology to correct for B0 inhomogenieties.
SmartExam Packages
The SmartExam Packages for Brain, Spine, Shoulder, Knee and Breast have been enhanced by providing a faster SmartSurvey scan, so to save examination time. The SmartSurvey is accelerated by using Compressed SENSE technology.
FFE Extensions
Extends the parameter space for m-FFE to allow more than 32 echoes.

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TFE Extensions	Extends the parameter space for product TFE to enable randomized k-space segmentation and CENTRA turbo-direction.
SE Extensions	Extends the parameter space to enable LIPO for non-DWI SE.
TSE Extensions	Extends the parameter space for TSE to enable DRIVE pre-pulse extensions and to enable user-defined contrasts for 3DView.
Diffusion Extensions	Extends the parameter space for DWI/DTI with dynamic imaging.
Angio Extensions	Extends the parameter space for eTHRIVE and 4D TRAK with profile order CENTRA.
Weighted Gating Navigator Extensions	Extends the parameter space for respiratory gating by allowing k-space weighting.
EPI/GraSE Extensions	Extends the parameter space for GraSE to allow more TSE profile orders (low-high or asymmetric).
Spiral Extensions	Extends the parameter space for Spiral Brain to allow use without brain coils, and to allow the combination with quantitative flow or diffusion.
Respiratory Gating	Extends the parameter space for respiratory gating for cardiac triggered scans.
Fast Next Scan Extensions	Extends the parameter space of BolusTrak by allowing a MS or 3D in the BolusTrak scan.
Custom Prepulse	Extends the parameter space for Prepulse by allowing the user to specify the pre-pulse or specify a Multi-pulse off-resonance MTC pulse.
B0 map & Shim Extensions	Extends the parameter space for BO field mapping, used for breast and brain, to other applications. Extends the parameter space for higher order shimming at 3.0T by allowing user to set shim values.
K-t Blast/k-t SENSE Extensions	Extends the parameter space for product k-t BLAST/k-t SENSE by allowing extension of acceleration factor allowing Qflow.

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Summary of Non-ClinicalPerformance Data:	Radial ExtensionsExtends the parameter space for radial to enable multi slice scans and to enableultra-short echo times.mDIXON TSE ExtensionsExtends the parameter interface for mDIXON TSE to enable the combination with3D, cardiac triggering and respiratory compensation.Multivane XD ExtensionsExtends the parameter interface to MultiVane to combine with cardiacsynchronization and with respiratory navigator compensation.Automatic Planning ExtensionsExtends the parameter interface for SmartExam by allowing user to define theSmartScout scan.mDIXON CENTRA KeyholeExtends the parameter interface for 4D Trak XD by allowing the combination withmDIXON.Based on the information provided above, the proposed Achieva, Intera, Ingenia,Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems do not raisedifferent questions of safety and effectiveness compared to the legally marketedpredicate device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MRSystems (K183063, 02/14/2019), therefore demonstrating substantialequivalence.Please note that the Achieva and Intera MR Systems are no longer beingmanufactured but at the time of manufacture and release of these systems, theAchieva and Intera MR Systems were in compliance with the international andFDA recognized consensus standards. This proposed submission is to releasethe updated software features to the install base of the Achieva and Intera MRSystems.Philips Medical Systems Nederland B.V. declares that the proposed Ingenia,Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are incompliance with all applicable requirements of the following international and FDArecognized consensus standards:Ingenia, Ingenia CX, Ingenia Elition, Ingenia AmbitionIEC60601-1 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 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)
Guidance for Industry and FDA Staff - Guidance for the Content of●Premarket Submissions for Software Contained in Medical Devices
(issued May 11, 2005)
Guidance for Industry and FDA Staff - Content of Premarket Submissions●for Management of Cybersecurity in Medical Devices (issued October 182018)
Guidance for Industry and FDA Staff - Applying Human Factors and●Usability Engineering to Medical Devices (issued February 3, 2016)
Guidance for Industry and FDA Staff – Use of International Standard ISO●10993-1, "Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process" (issued June 16, 2016)
Guidance for Industry and FDA Staff - Information to Support a Claim of●Electromagnetic Compatibility (EMC) of Electrically-Powered MedicalDevices (issued July 11, 2016)
Guidance for Industry and FDA Staff -(issued September 6, 2017)●
All software modifications were tested across MR system families (Achieva,Ingenia, Elition and Ambition).
Non-Clinical verification and or validation tests have been performed on all of thesoftware modifications with regards to the intended use, the technical claims, therequirement specifications and the risk management results.
The results from each set of tests demonstrate that the software featuresperform as intended and are therefore substantially equivalent to the predicatedevices to which they have been compared.
For Compressed SENSE with contrast, bench test results (Shelley phantom),using both retrospectively and prospectively sub-sampled data, demonstratingadequate capture of time-intensity behavior were provided. Philips provideddata from retrospective sub-sampled CE-angio data, on 3 human subjects. Thisallowed for a direct comparison of SENSE and Compressed SENSE in terms ofdifference images relative to non-accelerated, fully sampled data. CompressedSENSE was shown to be more robust up to higher acceleration factors. Using aretrospective subsampling approach, clinical data for brain perfusion in tumorclassification was provided. Philips believes that the analysis and data from alltesting demonstrates equivalence of CS-SENSE with the predicate device (non-accelerated data acquisition) for this dynamic contrast uptake application.
Test results demonstrate that the proposed Achieva, Intera, Ingenia, Ingenia CX,Ingenia Elition and Ingenia Ambition MR Systems meet the acceptance criteriaand are adequate for its intended use. Additionally, the risk management activitiesshow that all risks are sufficiently mitigated and that no new risks are introduced,and that the overall residual risks are acceptable.

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	Therefore, the proposed Achieva, Intera Ingenia, Ingenia CX, Ingenia Elition,and Ingenia Ambition MR Systems are substantially equivalent to the legallymarketed predicate device Ingenia, Ingenia CX, Ingenia Elition, and IngeniaAmbition MR Systems (K183063, 02/14/2019) in terms of safety andeffectiveness.
Summary ofClinical Data:	The proposed Achieva, Interan, Ingenia, Ingenia CX, Ingenia Elition, andIngenia Ambition MR Systems did not require a clinical study since substantialequivalence to the legally marketed predicate device was proven with theverification/validation testing.
SubstantialEquivalence:	The proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, andIngenia Ambition MR Systems and the legally marketed predicate deviceIngenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063,02/14/2019) have the same indications for use with respect to the following:Providing cross-sectional images based on the magnetic resonancephenomenon Interpretation of the images is the responsibility of trained physicians Images can be used for interventional and treatment planning purposes
Conclusion:	The proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, andIngenia Ambition MR Systems are substantially equivalent to the legallymarketed predicate device Ingenia, Ingenia CX, Ingenia Elition, and IngeniaAmbition MR Systems (K183063, 02/14/2019) in terms of design features,fundamental scientific technology, indications for use, and safety andeffectiveness.Additionally, substantial equivalence is demonstrated with non-clinicalperformance (verification and validation) tests, which complied with therequirements specified in the international and FDA-recognized consensusstandards and device-specific guidance.The results of these tests demonstrate that the proposed Achieva, Intera,Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems meetthe acceptance criteria and are adequate for their intended use.

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.