Ingenia 1.5T CX and Ingenia 3.0T CX R5.3

K162931 · Philips Medical Systems Nederland B.V. · LNH · Jan 6, 2017 · Radiology

Device Facts

• Record ID: K162931
• Device Name: Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: LNH · Radiology
• Decision Date: Jan 6, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities. Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the anatomy, and the MR scan technique applied. The image acquisition process can be synchronized with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent. In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the 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

Ingenia 1.5T CX and 3.0T CX R5.3 are MRI systems utilizing strong magnetic fields and radiofrequency pulses to generate cross-sectional images, spectra, and physical parameters of internal anatomy. Operated by trained clinicians in clinical settings, the system supports diagnostic imaging and interventional procedure guidance. Key features include 'ScanWise Implant' for managing MR Conditional implant safety by defining active field restrictions and '3D ASL' for non-contrast brain perfusion assessment. The system processes relaxation signals via reconstruction algorithms to produce visual outputs for physician interpretation. It incorporates dStream digital receive coil architecture and various enhanced sequences (e.g., LIPO, Black Blood, 4D TRAK XD, 3D NerveVIEW). The device assists in diagnosis and therapy planning by providing anatomical and functional data. Patient benefit includes non-invasive imaging and safer workflow management for patients with MR Conditional implants.

Clinical Evidence

No clinical study was required. Substantial equivalence was demonstrated through design features, indications for use, fundamental scientific technology, non-clinical performance testing (verification and validation), and safety/effectiveness analysis. Non-clinical testing included compliance with international consensus standards (IEC 60601 series, ISO 14971, NEMA MS series) and human factors engineering for the ScanWise Implant feature.

Technological Characteristics

1.5T/3.0T MRI system with 60 cm magnet. Components: magnet, transmit body coil, gradient coil, receive coils, patient support. Features: dStream digital receive coil architecture, ScanWise Implant (safety control), 3D ASL (perfusion). Connectivity: NEMA PS 3.1-3.20 (DICOM). Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-2-33, IEC 62304, ISO 14971, NEMA MS-1/4/8. Software: MR spectrometer (DDAS) platform, reconstruction algorithms, SAR/SED control, dB/dt control.

Indications for Use

Indicated for diagnostic imaging of the 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, INTERA AND PANORAMA 1.0T, RELEASE 2.5 (K063559)

Reference Devices

• Ingenia 1.5T and Ingenia 1.5T S R5.2 (K153324)
• ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T (aka Ingenia) (K110151)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2017

Philips Medical Systems Nederland B.v. Ruojuan Zhang Regulatory Affairs Engineer Veenpluis 4-6 Best, 5684 PC NL

Re: k162931

Trade/Device Name: Ingenia 1.5T Cx and Ingenia 3.0T Cx R5.3 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: October 17, 2016 Received: October 19, 2016

Dear Ruojuan Zhang:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D'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) K162931

Device Name Ingenia 1.5T CX and Ingenia 3.0T CX R5.3

#### Indications for Use (Describe)

This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities.

Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images.

Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.

In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities.

MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the 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> <b> \[X] </b> 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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Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is plain white, which makes the blue letters stand out. The image is a clear and simple representation of the Philips logo.

### 510(k) Summary

## 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 17, 2016 | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| 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: | Ruojuan Zhang<br>Regulatory Affairs engineer<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Secondary Contact<br>Person | Henrie Daniels<br>Regulatory Affairs Engineer<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Device Name: | Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 | |
| Classification: | Classification Name: | Magnetic Resonance Diagnostic<br>Device (MRDD) |
| | Classification Regulation: | 21CFR §892.1000 |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Primary Product code: | 90LNH<br>90LNI |
| Primary Predicate<br>Device: | Trade Name: | ACHIEVA, INTERA AND<br>PANORAMA 1.0T, RELEASE 2.5 |
| | Manufacturer: | Philips Medical Systems Nederland<br>B.V. |
| | 510(k) Clearance: | K063559 (01/04/2007) |
| | Classification Regulation: | 21 CFR, Part 892.1000 |
| | Classification Name: | Magnetic Resonance Diagnostic<br>Device (MRDD) |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code: | 90LNH<br>90LNI |
| Reference Device: | Trade Name: | Ingenia 1.5T and Ingenia 1.5T S R5.2 |
| | Manufacturer: | Philips Medical Systems Nederland B.V. |
| | 510(k) Clearance: | K153324 (03/22/2016) |
| | Classification Regulation: | 21 CFR, Part 892.1000 |
| | Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code: | 90LNH<br>90LNI |
| Reference Device: | Trade Name: | ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T( aka Ingenia) |
| | Manufacturer: | Philips Medical Systems Nederland B.V. |
| | 510(k) Clearance: | K110151 (03/22/2011) |
| | Classification Regulation: | 21 CFR, Part 892.1000 |
| | Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code: | 90LNH<br>90LNI |
| Device description: | The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with<br>ScanWise Implant and 3D ASL features are provided with a 60 cm<br>magnet. The system and its control software are substantially<br>equivalent to the currently marketed and primary predicate device<br>Achieva R2.5 (K063559, 01/04/2007), enhanced by the digital<br>receive coil architecture as in the currently marketed and reference<br>device Ingenia R4 (K110151, 03/22/2011).<br><br>ScanWise Implant functionality enables MR technologists to<br>implement an improved and controlled workflow for MR<br>Conditional implants. The feature consists of an extension to the<br>Patient Registration User Interface where the information relevant<br>to MR Conditional device labeling can be assessed, controlled and<br>reviewed. The ScanWise Implant feature allows the user at the<br>examination level to define restrictions on the 'active fields'<br>generated by the MR system.<br><br>3D ASL functionality enables MR technologists to assess perfusion<br>in the brain without the usage of contrast agents. The feature | |

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consists of an extension to the available scan sequences and image reconstruction algorithms. The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features also consolidate separatelycleared novel functionalities, and minor changes since the clearance of the currently marketed and predicate device, Achieva R2.5 (K063559, 01/04/2007). Following minor changes are covered in this submission: Enhanced Patient Communication User Interface Module, 1. IEC/ISO compliant symbols. 2. New computing platform and peripherals for MR Spectrometer (DDAS). 3. MultiTransmit 4. dStream architecture implementation and commercialize system name as Ingenia CX 5. Planning on cine images. 6. SAR related parameters (SED). Pregnancy status related to Normal Mode. 7. SED limit 8. Parameter optimization for the reconstruction algorithms. 9. Partial NSA algorithm in reconstruction. 10. AutoVoice, using pre-recorded spoken instructions. 11. VCG, optimized electrode placement and enhanced algorithm. 12. ComforTone: mechanical resonance frequency dependent timing adjustments of sequences for lower acoustic noise. 13. Enhanced sequences: a. LIPO b. Black Blood Imaging c. 4D TRAK XD d. Zoom Diffusion Imaging e. 3D Vane XD 4D TRANCE f. g. 3D NerveVIEW h. Fast B1 Mapping and B1 Shading filter i. AutoSpair. TSE flow compensation enhancement 1. k. Optimized 3D TSE flip angle sweeps per anatomy ENCASE: 3D encoding 1. m. CardiacQuant: triggered T1 mapping sequence n. pCASL o. DTI enhancements QA Tool and fMRI stability p.

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# PHILIPS

| Indications for Use: | This system is a Magnetic Resonance Medical Electrical Systems<br>indicated for use as a diagnostic device.<br>The system can produce cross-sectional images, spectroscopic<br>images and/or spectra in any orientation of the internal structure of<br>the head, body or extremities.<br>Magnetic Resonance images represent the spatial distribution of<br>protons or other nuclei with spin. Image appearance is determined<br>by many different physical properties of the tissue and the anatomy,<br>and the MR scan technique applied. The image acquisition process<br>can be synchronized with the patient's breathing or cardiac cycle.<br>The systems can use combinations of images to produce physical<br>parameters, and related derived images.<br>Images, spectra, and measurements of physical parameters, when<br>interpreted by a trained physician, provide information that may<br>assist the diagnosis and therapy planning. The accuracy of<br>determined physical parameters depends on system and scan<br>parameters, and must be controlled and validated by the clinical<br>user. The use of contrast agents for diagnostic imaging applications<br>should be performed consistent with the approved labeling for the<br>contrast agent.<br>In addition the Philips MR systems provide imaging capabilities,<br>such as MR fluoroscopy, to guide and evaluate interventional and<br>minimally invasive procedures in the head, body and extremities.<br>MR Interventional procedures, performed inside or adjacent to the<br>Philips MR system, must be performed with MR Conditional or MR<br>Safe instrumentation as selected and evaluated by the clinical user<br>for use with the specific MR system configuration in the hospital.<br>The appropriateness and use of information from a Philips MR<br>system for a specific interventional procedure and specific MR<br>system configuration must be validated by the clinical user. |
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| Fundamental<br>Scientific Technology: | The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with<br>ScanWise Implant and 3D ASL features are based on the principle<br>that certain atomic nuclei present in the human body will emit a<br>weak relaxation signal when placed in a strong magnetic field and<br>excited by a radio signal at the precession frequency.<br><br>The emitted relaxation signals are analyzed by the system and a<br>computed image reconstruction is displayed on a video screen.<br>The principal technological components (magnet, transmit body<br>coil, gradient coil, receive coils and patient support) of the proposed<br>Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise<br>Implant and 3D ASL features are identical to those used in the |
| | currently marketed and primary predicate device Achieva R2.5<br>(K063559, 01/04/2007) and reference device Ingenia R4(k110151,<br>03/22/2011) |
| | ScanWise Implant uses existing safety mechanisms to protect the<br>patient against excessive RF exposures. This includes Whole Body<br>and Head SAR, local SAR and B1+rms controls and Gradient Slew<br>Rate. No modifications relative to the implementation of safety<br>mechanisms relative to the predicate device was required.<br>ScanWise Implant extends existing software safety provisions to<br>prevent peripheral nerve stimulation. In previous products, dB/dt<br>was evaluated (at the compliance volume defined in IEC60601-2-<br>33) and displayed for informational purposes. In this software,<br>dB/dt is controlled not to exceed a user-specified value. |
| | 3D ASL is an extension to the previously cleared pCASL<br>functionality (K153324). 3D ASL allows the user to perform ASL<br>perfusion studies according to international recommendation which<br>includes 3D acquisition |
| | Based on the information provided above, the proposed Ingenia<br>1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and<br>3D ASL features are considered substantially equivalent to the<br>currently marketed and primary predicate device Achieva<br>R2.5(K063559, 01/04/2007) in terms of fundamental scientific<br>technology. |
| Summary of Non-<br>Clinical Performance<br>Data: | The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with<br>ScanWise Implant and 3D ASL features comply with the following<br>international and FDA-recognized consensus standards:<br>• IEC60601-1 Edition 3 Amendment 1<br>• IEC60601-1-2 Edition 3<br>• IEC60601-1-6 Edition 3 / IEC62366<br>• IEC60601-1-8 Edition 2<br>• IEC60601-2-33 Edition 3 Amendment 1<br>• IEC 62304<br>• NEMA MS-1 2008<br>• NEMA MS-4 2008<br>• NEMA MS-8 2008<br>• NEMA PS 3.1-PS 3.20 - [DICOM]<br>• ISO 14971 Application of risk management to medical |
| | • devices (2007) |
| | Device specific guidance document, entitled “Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 14, 1998”<br>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.<br>Specifically for ScanWise Implant, Human Factors Engineering testing was performed in line with FDA's guidance document entitled "Applying Human Factors and Usability Engineering to Optimize Medical Device Design - June 22, 2011".<br>The verification and or validation test results, combined with sample clinical images demonstrate that the proposed <b>Ingenia 1.5T CX</b> and <b>Ingenia 3.0T CX R5.3</b> with ScanWise Implant and 3D ASL features: Complies with the aforementioned international and FDA-recognized consensus standards and Device specific guidance document, entitled “Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 14, 1998” Meets the acceptance criteria and is adequate for its intended use. Therefore, the proposed <b>Ingenia 1.5T CX</b> and <b>Ingenia 3.0T CX R5.3</b> with ScanWise Implant and 3D ASL features are substantially equivalent to the currently marketed and primary predicate device Achieva R2.5 (K063559, 01/04/2007) in terms of safety and effectiveness. |
| Summary of Clinical Data: | The proposed <b>Ingenia 1.5T CX</b> and <b>Ingenia 3.0T CX R5.3</b> with ScanWise Implant and 3D ASL features did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness.…