MR 5300 and MR 7700 R11 MR Systems

K223442 · Philips Medical Systems Nederlands B.V. · LNH · Dec 23, 2022 · Radiology

Device Facts

• Record ID: K223442
• Device Name: MR 5300 and MR 7700 R11 MR Systems
• Applicant: Philips Medical Systems Nederlands B.V.
• Product Code: LNH · Radiology
• Decision Date: Dec 23, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: AI/ML

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 NR 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 5300 and MR 7700 R11 systems are 1.5T and 3.0T magnetic resonance diagnostic devices. Systems utilize atomic nuclei relaxation signals in strong magnetic fields to generate cross-sectional images, spectra, and physical parameter measurements. Operated by trained physicians/clinicians in clinical settings. Enhancements include SmartSpeed AI, SmartSpeed MotionFree, SmartSpeed 3D FreeBreathing, SmartSpeed Implant, SmartSpeed DWI, MR Workspace, ISP MR packages, and MR Elastography (MR 5300). Hardware upgrades include GPU-based host reconstruction and additional console monitors. Output consists of diagnostic images and data interpreted by physicians for diagnosis and therapy planning. Benefits include accelerated image acquisition, motion compensation, and interventional guidance. System supports synchronization with patient breathing/cardiac cycles.

Clinical Evidence

Bench testing only. No clinical data required as substantial equivalence was established through verification and validation testing of software and hardware modifications against predicate systems.

Technological Characteristics

1.5T and 3.0T MR systems; 60cm/70cm bore. Components: magnet, transmit body coil, gradient coil/amplifier, RF amplifier, patient support. Connectivity: networked. Software: R11 baseline. Hardware: GPU-based image reconstruction. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, NEMA MS-1/4/8, NEMA PS 3.1-3.20, ISO 14971.

Indications for Use

Indicated for diagnostic imaging of internal structures of head, body, or extremities in patients requiring cross-sectional images, spectroscopic images, or spectra. Used to guide and evaluate interventional and minimally invasive procedures. Contraindicated for use with non-MR Safe or non-MR Conditional instrumentation during interventional procedures.

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

• Achieva, Ingenia, Ingenia CX, Ingenia Elition, And Ingenia Ambition MR Systems R11 (K213583)
• Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516)
• MR 5300 (K212673)

Reference Devices

• mDIXON (K102344)
• SWIp (K131241)
• mDIXON-Quant (K133526)
• MRE (K140666)
• mDIXON XD (K143128)
• O-MAR (K143253)
• 3D APT (K172920)

Submission Summary (Full Text)

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December 23, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name reads "U.S. Food & Drug Administration".

Philips Medical Systems Nederlands B.V. % Susan Quick Regulatory Affairs Manager Veenpluis 6 Best. 5684 PC NETHERLANDS

Re: K223442

Trade/Device Name: MR 5300 and MR 7700 R11 MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI Dated: November 14, 2022 Received: November 14, 2022

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Z. H. Ke

Laurel Burk, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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)

## K223442

Device Name MR 5300 and MR 7700 R11 MR Systems

### 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. 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 cvcle.

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 NR 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)

| <span style="display:inline-block;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------------------------------------|
| <span style="display:inline-block;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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

### 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: | Nov. 14, 2022 | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Manufacturer: | Philips Medical Systems Nederland B.V.<br>Veenpluis 6, 5684 PC, Best, The Netherlands<br>Establishment Registration Number: 3003768277 | |
| Primary Contact Person: | Susan Quick<br>Regulatory Affairs Manager<br>Telephone: [phone]<br>E-mail: [e-mail] | |
| Secondary Contact Person | Jan van de Kerkhof<br>Associate Director Regulatory Affairs<br>Telephone: [phone]<br>E-mail: [e-mail] | |
| Device Name: | MR 5300 and MR 7700 R11 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 Device: | Trade name: Achieva, Ingenia, Ingneia CX, Ingenia Elition, And Ingenia Ambition MR Systems R11<br>Manufacturer: Philips Medical Systems Nederland B.V.<br>510(k) Clearance: K213583<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 | |
| Secondary Predicate Device: | Trade name: Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei<br>Manufacturer: Philips Medical Systems Nederland B.V.<br>510(k) Clearance: K213516 | |
| | Classification<br>Regulation: | 21CFR 892.1000 |
| | Classification name: | Magnetic Resonance Diagnostic Device<br>(MRDD) |
| | Classification Panel: | Radiology |
| | Device class | Class II |
| | Product Code: | 90LNH<br>90LNI |
| Secondary<br>Predicate Device: | Trade name: | MR 5300 |
| | Manufacturer: | Philips Medical Systems Nederland B.V. |
| | 510(k) Clearance: | K212673 |
| | Classification<br>Regulation: | 21CFR 892.1000 |
| | Classification name: | Magnetic Resonance Diagnostic Device<br>(MRDD) |
| | Classification Panel: | Radiology |
| | Device class | Class II |
| | Product Code: | 90LNH<br>90LNI |

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| Device | Description: | The proposed MR 5300 and MR 7700 R11 MR Systems are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices, hereafter to be known as MR 5300 and MR 7700 MR Systems. |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | This Special 510(k) submission will include modifications of the proposed MR 5300 and MR 7700 R11 MR Systems as compared to our legally marketed devices, primary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 05/16/2022) and the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021). |
| | | The proposed MR 5300 and MR 7700 MR systems will be brought up to the new baseline software R11. This R11 software is cleared on the Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems in the following primary predicate 510(k) Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022). Both the proposed MR 5300 and MR 7700 MR systems are already cleared with the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021). |
| Indications for<br>Use: | In this 510(k) submission, Philips Medical Systems Nederland B.V. will<br>be addressing the following minor software enhancements to the<br>proposed <b>MR 5300</b> and <b>MR 7700 R11 MR Systems</b> when compared<br>to the legally marketed primary predicate, <i>Achieva, Ingenia, Ingenia<br/>CX, Ingenia Elition and Ingenia Ambition MR Systems R11<br/>(K213583, 05/16/2022)</i> and the secondary predicate devices <i>Ingenia<br/>3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with<br/>distributed Multi Nuclei (K213516, 03/03/2022)</i> and <i>MR 5300<br/>(K212673, 11/19/2021)</i> : | |
| | 1. SmartSpeed AI<br>2. SmartSpeed MotionFree<br>3. SmartSpeed 3D FreeBreathing<br>4. SmartSpeed Implant<br>5. SmartSpeed DWI<br>6. MR Workspace<br>7. ISP MR Packages<br>8. MR Elastography (MR 5300 only) | |
| | This 510(k) submission will also address the following minor hardware<br>enhancements: | |
| | 1. Introduction of a graphical processing unit in the host recon<br>computer for image reconstruction<br>2. Additional monitor as part of the operating console | |
| | The supporting documentation provided for the proposed <b>MR 5300</b> and<br><b>MR 7700 R11 MR Systems</b> , includes software and hardware<br>modifications that are addressed in test reports for system level<br>development project, Voyager R11.1. | |
| | The proposed <b>MR 5300</b> and <b>MR 7700 R11 MR Systems</b> are intended<br>to be marketed with the following pulse sequences and coils that are<br>previously cleared by FDA: | |
| | 1. mDIXON (K102344)<br>2. SWIp (K131241)<br>3. mDIXON-Quant (K133526)<br>4. MRE (K140666)<br>5. mDIXON XD (K143128)<br>6. O-MAR (K143253)<br>7. 3D APT (K172920)<br>8. Compatible System Coils | |
| | There are no changes to the indications for use statement, provided<br>below, of the proposed <b>MR 5300</b> and <b>MR 7700 R11 MR Systems</b><br>when compared to the primary predicate <i>Achieva, Ingenia, Ingenia CX,<br/>Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583,<br/>05/16/2022)</i> . | |
| | Philips Magnetic Resonance (MR) systems are Medical Electrical<br>Systems indicated for use as a diagnostic device. | |
| | This MR system enables trained physicians to obtain cross-sectional<br>images, spectroscopic images and/or spectra of the internal structure<br>of the head, body or extremities, in any orientation, representing the<br>spatial distribution of protons or other nuclei with spin. | |
| | Image appearance is determined by many different physical properties<br>of the tissue and the anatomy, the MR scan technique applied, and<br>presence of contrast agents. | |
| | The use of contrast agents for diagnostic imaging applications should<br>be performed consistent with the approved labeling for the contrast<br>agent. | |
| | The trained clinical user can adjust the MR scan parameters to<br>customize image appearance, accelerate image acquisition, and<br>synchronize with the patient's breathing or cardiac cycle. The systems<br>can use combinations of images to produce physical parameters, and<br>related derived images. Images, spectra, and measurements of<br>physical parameters, when interpreted by a trained physician, provide<br>information that may assist diagnosis and therapy planning. The<br>accuracy of determined physical parameters depends on system and<br>scan parameters and must be controlled and validated by the clinical<br>user. | |
| | In addition, the Philips MR systems provide imaging capabilities, such<br>as MR fluoroscopy, to guide and evaluate interventional and minimally<br>invasive procedures in the head, body and extremities. MR<br>Interventional procedures, performed inside or adjacent to the Philips<br>MR system, must be performed with MR Conditional or MR Safe<br>instrumentation as selected and evaluated by the clinical user for use<br>with the specific MR system configuration in the hospital. The<br>appropriateness and use of information from a Philips MR system for a<br>specific interventional procedure and specific MR system configuration<br>must be validated by the clinical user. | |
| Design Features/<br>Fundamental<br>Scientific<br>Technology: | The proposed MR 5300 and MR 7700 R11 MR Systems are based on<br>the principle that certain atomic nuclei present in the human body will<br>emit a weak relaxation signal when placed in a strong magnetic field<br>and excited by a radio signal at the precession frequency. The emitted<br>relaxation signals are analyzed by the system and a computed image<br>reconstruction is displayed on a video screen. | |
| | The principal technological components (magnet, transmit body coil,<br>gradient coil, gradient amplifier, RF amplifier and patient support) of the<br>proposed MR 5300 and MR 7700 R11 MR Systems are identical to<br>those used in the legally marketed primary predicate, Achieva,<br>Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR<br>Systems R11 (K213583, 05/16/2022) and the secondary predicate<br>devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 | |
| | with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300<br>(K212673, 11/19/2021). | |
| | The software R11 used on the proposed MR 5300 and MR 7700 R11<br>MR Systems is previously cleared on the legally marketed primary<br>predicate, Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia<br>Ambition MR Systems R11 (K213583, 05/16/2022). | |
| Summary of Non-<br>Clinical<br>Performance Data: | The proposed MR 5300 and MR 7700 R11 MR Systems are in<br>compliance with the following international and FDA-recognized<br>consensus standards:<br>• IEC60601-1 Edition 3<br>• IEC60601-1-2 Edition 4<br>• IEC60601-1-6 Edition 3<br>• IEC62366-1 Edition 1<br>• IEC60601-1-8 Edition 2<br>• IEC60601-2-33 Edition 3<br>• IEC 62304 Edition 1<br>• NEMA MS-1 2008<br>• NEMA MS-4 2010<br>• NEMA MS-8 2008<br>• NEMA PS 3.1-PS 3.20<br>• ISO 14971 Edition 2<br>• Device specific guidance document, entitled "Guidance for the<br>Submission Of Premarket Notifications for Magnetic Resonance<br>Diagnostic Devices" (issued November 18, 2016 – document<br>number 340)<br>• Guidance for Industry and FDA Staff – Guidance for the<br>Content of Premarket Submissions for Software Contained in<br>Medical Devices (issued May 11, 2005 – document number<br>337)<br>• Guidance for Industry and FDA Staff – Content of Premarket<br>Submissions for Management of Cybersecurity in Medical<br>Devices (issued October 2, 2014 – document number 1825)<br>• Guidance for Industry and FDA Staff – Applying Human Factors<br>and Usability Engineering to Medical Devices (issued February<br>3, 2016 – document number 1757)<br>• Guidance for Industry and FDA Staff – Use of International<br>Standard ISO 10993-1, “Biological evaluation of medical<br>devices - Part 1: Evaluation and testing within a risk<br>management process" (issued June 16, 2016 – document<br>number 1811)<br>• Guidance for Industry and FDA Staff – Information to Support a<br>Claim of Electromagnetic Compatibility (EMC) of Electrically-<br>Powered Medical Devices (issued July 11, 2016 – document<br>number 1400057)<br>• Guidance for Industry and FDA Staff – Design Considerations<br>and Premarket Submission Recommendations for Interoperable<br>Medical Devices (issued September 6, 2017 – document<br>number 1500015) | |
| | |…