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

K183063 · Philips Medical Systems Nederland B.V. · LNH · Feb 14, 2019 · Radiology

Device Facts

• Record ID: K183063
• Device Name: Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: LNH · Radiology
• Decision Date: Feb 14, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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 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 Story

MR systems (1.5T/3.0T) acquire proton/nuclei relaxation signals via magnetic fields and RF excitation; system reconstructs signals into cross-sectional/spectroscopic images. Operated by trained clinicians in clinical settings; parameters adjusted to optimize image quality, speed, and synchronization (cardiac/respiratory). Output includes images, spectra, and physical parameter measurements used for diagnosis, therapy planning, and interventional guidance. Software features (e.g., bFFE-XD, IRIS Zoom, MEGA, SENC, SyntAc) enhance image quality, reduce artifacts, or enable specific clinical applications (cardiac strain, metabolite detection). Clinicians interpret outputs to inform clinical decisions. Benefits include improved diagnostic clarity, reduced scan times, and artifact robustness.

Clinical Evidence

Bench testing only. No clinical data required as substantial equivalence was demonstrated through verification and validation testing against consensus standards.

Technological Characteristics

1.5T and 3.0T MR systems with 60cm/70cm bores. Components: magnet, transmit body coil, gradient coil, receive coils, patient support. Connectivity: DICOM. Software: R5.6. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA MS-1, MS-4, MS-8, PS 3.1-3.20.

Indications for Use

Indicated for diagnostic imaging of head, body, or extremities in patients requiring cross-sectional MR images, spectroscopic images, or spectra. Used for diagnosis, therapy planning, and guidance of interventional/minimally invasive procedures. Contraindicated for use with non-MR Safe or non-MR Conditional instrumentation in the MR environment.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079)

Reference Devices

• Ingenia Elition S and Ingenia Elition X (K173451)
• Ingenia Ambition S and Ingenia Ambition X (K180479)

Submission Summary (Full Text)

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February 14, 2019

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

Re: K183063

Trade/Device Name: Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: November 2, 2018 Received: November 5, 2018

Dear Susan Ouick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara

- For

Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

### 510(k) Number (if known) K183063

#### Device Name

Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition

#### Indications for Use (Describe)

Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.

Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.

The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle.

The systems can use combinations of images to produce physical parameters, and related derived images. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user.

In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR

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

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: | October 26, 2018 | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Manufacturer: | Philips Medical Systems Nederland B.V.<br>Veenpluis 4-6, 5684 PC, Best, The Netherlands<br>Establishment Registration Number: 3003768277 | |
| Primary Contact<br>Person: | Jan van de Kerkhof<br>Sr. Manager Regulatory Affairs<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Secondary Contact<br>Person | Susan Quick<br>Regulatory Affairs Specialist<br>Telephone: [phone]<br>E-mail: [e-mail] | |
| Device Name: | Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems | |
| Classification: | Classification name: Magnetic Resonance Diagnostic Device (MRDD)<br>Classification Regulation: 21CFR 892.1000<br>Classification Panel: Radiology<br>Device Class: Class II<br>Primary Product Code: 90LNH<br>90LNI | |
| Primary Predicate<br>Device: | Trade name: Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4<br>Manufacturer: Philips Medical Systems Nederland B.V.<br>510(k) Clearance: K173079<br>Classification Regulation: 21CFR 892.1000<br>Classification name: Magnetic Resonance Diagnostic Device (MRDD)<br>Classification Panel: Radiology<br>Device class: Class II<br>Product Code: 90LNH<br>90LNI | |
| Reference Device: | Trade name: Ingenia Eilition S, Ingenia Elition X<br>Manufacturer: Philips Medical Systems Nederland B.V.<br>510(k) Clearance: K173451<br>Classification Regulation: 21CFR 892.1000<br>Classification name: Magnetic Resonance Diagnostic Device (MRDD)<br>Classification Panel: Radiology<br>Device class: Class II | |
| | Product Code: | 90LNH |
| | | 90LNI |
| Reference Device: | Trade name: | Ingenia Ambition S, Ingenia Ambition X |
| | Manufacturer: | Philips Medical Systems Nederland B.V. |
| | 510(k) Clearance: | K180479 |
| | Classification Regulation: | 21CFR 892.1000 |
| | Classification name: | Magnetic Resonance Diagnostic Device (MRDD) |
| | Classification Panel: | Radiology |
| | Device class | Class II |
| | Product Code: | 90LNH |
| | | 90LNI |

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| Device | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description: | Systems with bFFE-XD, IRIS Zoom, MEGA, SENC, and SyntAc software features |
| | are provided on the 60 cm and 70 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) |
| | MR systems. |
| | The systems and aforementioned software features of the proposed Ingenia,<br>Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are<br>substantially equivalent to the legally marketed predicate device, Ingenia 1.5T,<br>Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4<br>(K173079, 04/04/2018) and the legally marketed reference devices Ingenia Elition<br>S and Ingenia Elition X (K173451, 03/20.2018) and the Ingenia Ambition S and<br>Ingenia Ambition X (K180479, 08/03/2018) . |
| | Hereafter Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR<br>Systems R5.6 with SENC, bFFE XD, IRIS ZOOM, MEGA and SyntAc software<br>features will be referred to as the proposed Ingenia, Ingenia CX, Ingenia<br>Elition, and Ingenia Ambition MR Systems in this submission. |
| | This submission includes the software modifications below for the proposed<br>Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems, there<br>are no hardware changes: |
| | 1. bFFE-XD |
| | 2. IRIS Zoom |
| | 3. MEGA |
| | 4. SENC (Spiral Cardiac) |
| | 5. SyntAc (MDME)*<br>* This software feature is provided on the proposed Ingenia systems only (Ingenia |
| | 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T and Ingenia 3.0T CX). Please |
| | note that this feature is already cleared and legally marketed on Ingenia Ambition<br>and Elition systems. |
| | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR |
| | Systems submission also includes minor changes to the existing software |
| | features listed below since the clearance of the legally marketed predicate device |
| | Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX<br>R5.4 (K173079, 04/04/2018):…