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 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 R 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

This submission covers the proposed Achieva 1.5T, Achieva 3.0T, and the Intera 1.5T MR Systems R5.6, hereafter to be known as Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems. The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems are 60 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) Magnetic Resonance Diagnostic Devices. This submission of the proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems contains a description of the software and hardware modifications made since the last 510(k) clearance of the primary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007). The Achieva 1.5T and Intera 1.5T systems differ in outside covers only, both systems function in an identical manner. The proposed Achieva 1.5T, 3.0T and Intera 1.5T MR Systems are substantially equivalent to the primary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007), and the 1st legally marketed reference device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition (K183063, 02/14/2019) and the 2nd legally marketed reference device Achieva R4 1.5T and Achieva R4 3.0T (aka Ingenia, K110151, 03/22/2011). The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA: 1. mDIXON (K102344) 2. SWIp (K131241) 3. mDIXON-Quant (K133526) 4. MRE (K140666) 5. mDIXON XD (K143128) 6. O-MAR (K143253) 7. MultiBand SENSE (K143606) 8. 3D APT (K172920) 9. Achieva and Intera Coils

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Philips Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for a novel device. As such, information typically found in a clinical study report (like detailed statistical methods, effect sizes for human readers with and without AI, or specific ground truth methodologies for a novel algorithm) is not present in this type of submission. The device described is a Magnetic Resonance (MR) system, which is a diagnostic imaging device, not a specific AI-powered diagnostic algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with listed standards	The systems comply with IEC 62304, ISO 14971, and various FDA guidance documents.
Meets requirement specifications	Demonstrated through Non-Clinical verification and/or validation tests.
Adequacy for intended use	Demonstrated through Non-Clinical verification and/or validation tests.
Safety and effectiveness comparable to predicate	Achieved through substantial equivalence to predicate devices (K063559, K183063, K110151).
Software additions/modifications cleared	All software additions and modifications were previously cleared via 510(k)s or with a reference device (K183063).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. This submission relies on non-clinical verification and validation tests rather than a separate clinical test set with patient data for assessing a new algorithm's performance. The device is an MR system, and the evaluation focuses on its technical performance and safety, not on the diagnostic accuracy of a new AI algorithm processing patient data.
Data Provenance: Not applicable for a separate clinical test set. The non-clinical tests would involve engineering and performance evaluations in a controlled environment, not patient data from a specific country or collected retrospectively/prospectively for a new algorithm's evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts/Qualifications: Not applicable. As this involves non-clinical verification and validation testing of an MR system's performance and safety features (e.g., image quality, electromagnetic compatibility, software functionality), the "ground truth" would be established by engineering and quality assurance standards, benchmarks, and regulatory requirements, not by expert interpretation of patient images for diagnostic accuracy.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Since there's no clinical test set requiring expert interpretation and consensus, there's no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. An MRMC study is typically performed to evaluate the impact of a new diagnostic algorithm on human reader performance (e.g., radiologists interpreting images with and without AI assistance). This submission pertains to an MR system, which is the imaging hardware and associated software to acquire images. The document explicitly states: "The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems did not require a clinical study since substantial equivalence to the primary predicate device was proven with the verification/validation testing."
Effect Size of Human Readers with vs. without AI: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done: No. The device is an MR imaging system; it is not a standalone AI algorithm designed to provide diagnostic outputs independently. The output of the MR system (images, spectra, measurements) is intended to be interpreted by a trained physician.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable in the context of diagnostic accuracy for a specific algorithm. For the non-clinical verification and validation, the ground truth would be defined by engineering specifications, regulatory standards, and established benchmarks for parameters like image quality, signal-to-noise ratio, spatial resolution, gradient linearity, safety limits (e.g., SAR), and software functionality.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. The document describes an MR imaging system, not a machine learning or AI algorithm that would typically require a training set of data. While the system's software components were developed and tested, the information provided does not indicate the use of a data-driven training set in the context of an FDA-cleared AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no mention of a training set or an AI/ML algorithm requiring such.

Summary

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Philips Medical Systems Nederland B.V. Susan Quick Regulatory Affairs Specialist 595 Miner Road Cleveland, Ohio 44143

June 4, 2019

Re: K190461

Trade/Device Name: Achieva 1.5T, 3.0T and Intera 1.5T MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: April 29, 2019 Received: April 30, 2019

Dear Susan 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 medical devices and radiation-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)

K190461

Device Name

Achieva 1.5T, 3.0T and Intera 1.5T MR Systems

Indications for Use (Describe)

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 R Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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

K190461

Achieva 1.5T, 3.0T and Intera 1.5T MR Systems

Section 5

510(k) Summary

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510(k) Summary of Safety and Effectiveness

K190461

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:	February 25, 2019
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277
Primary ContactPerson:	Jan van de KerkhofSr. Manager Regulatory AffairsPhone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com
Secondary ContactPerson	Susan QuickRegulatory Affairs SpecialistTelephone: 440 869-4612E-mail: susan.quick@philips.com
Device Name:	Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
Classification:	Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Regulation: 21CFR 892.1000Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: 90LNH90LNI
Primary PredicateDevice:	Trade name: Achieva, Intera & Panorama 1.0T R2.5Manufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K063559Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice class Class IIProduct Code: 90LNH90LNI
1st ReferenceDevice:	Trade name: Ingenia, Ingenia CX, Ingenia Elition, and IngeniaAmbitionManufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K183063Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice class Class II
	Product Code:	90LNH
		90LNI
2nd ReferenceDevice:	Trade name:	Achieva R4 1.5T and Achieva R4 3.0T (aka Ingenia)
	Manufacturer:	Philips Medical Systems Nederland B.V.
	510(k) Clearance:	K110151
	Classification Regulation:	21CFR 892.1000
	Classification name:	Magnetic Resonance Diagnostic Device (MRDD)
	Classification Panel:	Radiology
	Device class	Class II
	Product Code:	90LNH
		90LNI

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Device Description:	This submission covers the proposed Achieva 1.5T, Achieva 3.0T, and theIntera 1.5T MR Systems R5.6, hereafter to be known as Achieva 1.5T, 3.0T,and Intera 1.5T MR Systems. The proposed Achieva 1.5T, 3.0T, and Intera1.5T MR Systems are 60 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T)Magnetic Resonance Diagnostic Devices. This submission of the proposedAchieva 1.5T, 3.0T, and Intera 1.5T MR Systems contains a description of thesoftware and hardware modifications made since the last 510(k) clearance of theprimary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559,01/04/2007). The Achieva 1.5T and Intera 1.5T systems differ in outside coversonly, both systems function in an identical manner.The proposed Achieva 1.5T, 3.0T and Intera 1.5T MR Systems aresubstantially equivalent to the primary predicate Achieva, Intera & Panorama1.0T R2.5 (K063559, 01/04/2007), and the 1st legally marketed reference deviceIngenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition (K183063,02/14/2019) and the 2nd legally marketed reference device Achieva R4 1.5T andAchieva R4 3.0T (aka Ingenia, K110151, 03/22/2011).The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems are intended tobe marketed with the following pulse sequences and coils that were previouslycleared by FDA:1. mDIXON (K102344)2. SWIp (K131241)3. mDIXON-Quant (K133526)4. MRE (K140666)5. mDIXON XD (K143128)6. O-MAR (K143253)7. MultiBand SENSE (K143606)8. 3D APT (K172920)9. Achieva and Intera Coils
Indications for Use:	The indications for use of the proposed Achieva 1.5T, 3.0T and Intera 1.5T MRSystems adds more detail to the primary predicate Achieva, Intera & Panorama1.0T R2.5 (K063559, 01/04/2007) indications for use statement for clarity and is
	currently cleared with the 1st legally marketed reference device Ingenia, IngeniaCX, Ingenia Elition, and Ingenia Ambition (K183063, 02/14/2019).
	Philips Magnetic Resonance (MR) systems are Medical Electrical Systemsindicated for use as a diagnostic device.
	This MR system enables trained physicians to obtain cross-sectional images,spectroscopic images and/or spectra of the internal structure of the head, body orextremities, in any orientation, representing the spatial distribution of protons orother nuclei with spin.
	Image appearance is determined by many different physical properties of thetissue and the anatomy, the MR scan technique applied, and presence of contrastagents. The use of contrast agents for diagnostic imaging applications should beperformed consistent with the approved labeling for the contrast agent.
	The trained clinical user can adjust the MR scan parameters to customize imageappearance, accelerate image acquisition, and synchronize with the patient'sbreathing or cardiac cycle.
	The systems can use combinations of images to produce physical parameters,and related derived images. 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 1.5T, 3.0T, and Intera 1.5T MR Systems are based onthe principle that certain atomic nuclei present in the human body will emit a weakrelaxation signal when placed in a strong magnetic field and excited by a radiosignal at the precession frequency. The emitted relaxation signals are analyzedby the system and a computed image reconstruction is displayed on a videoscreen.
	The principal technological components (magnet, transmit body coil, gradientcoil, receive coils and patient support) of the proposed Achieva 1.5T, 3.0T, andIntera 1.5T MR Systems are identical to those used in the primary predicateAchieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007), and the 2ndlegally marketed reference device Achieva R4 1.5T and Achieva R4 3.0T (akaIngenia, K110151, 03/22/2011).
	The proposed Achieva 1.5T, 3.0T and Intera 1.5T MR Systems includes proposed software feature additions and modifications that were made to the primary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007). All software additions and modifications are cleared with previous 510K)s or with the 1st legally marketed reference device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition (K183063, 02/14/2019).
	Based on the information provided, the proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems do not raise different questions of safety and effectiveness compared to the primary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007).
Summary of Non-ClinicalPerformance Data:	The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems comply with the following international and FDA-recognized consensus standards:IEC 62304 Edition 1 ISO 14971 Edition 2 Device specific guidance document, entitled "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices" (issued November 18, 2016 – document number 340) Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005 – document number 337) Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014 - document number 1825) Guidance for Industry and FDA Staff Applying Human Factors and Usability Engineering to Medical Devices (issued February 3, 2016 – document number 1757) Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016 – document number 1811) Guidance for Industry and FDA Staff - Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (issued July 11, 2016 - document number 1400057) Guidance for Industry and FDA Staff Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices (issued September 6, 2017 – document number 1500015) Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results.The verification and/or validation test results demonstrate that the proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems:Comply with the aforementioned international and FDA recognized consensus standards and Device specific guidance document, entitled "Guidance for the Submission Of Premarket Notifications for Magnetic
	• Meet the acceptance criteria and is adequate for its intended use.
	Therefore, the proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems aresubstantially equivalent to the primary predicate Achieva, Intera & Panorama 1.0TR2.5 (K063559, 01/04/2007) in terms of safety and effectiveness.
Summary ofClinical Data:	The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems did not requirea clinical study since substantial equivalence to the primary predicate device wasproven with the verification/validation testing.
SubstantialEquivalence:	The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems and theprimary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007)and the 1st legally marketed reference device Ingenia, Ingenia CX, IngeniaElition, and Ingenia Ambition (K183063, 02/14/2019) have the same indicationsfor 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
	The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems are substantiallyequivalent to the primary predicate Achieva, Intera & Panorama 1.0T R2.5(K063559, 01/04/2007) and the 1st legally marketed reference device Ingenia,Ingenia CX, Ingenia Elition, and Ingenia Ambition (K183063, 02/14/2019) and the2nd legally marketed reference device Achieva R4 1.5T and Achieva R4 3.0T (akaIngenia, K110151, 03/22/2011) in terms of design features, fundamental scientifictechnology, indications for use, and safety and effectiveness.
Conclusion:	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 1.5T, 3.0T,and Intera 1.5T MR Systems meet the acceptance criteria and are adequate fortheir 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.