Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3

K163116 · Philips Medical Systems Nederland B.V. · LNH · Jan 6, 2017 · Radiology

Device Facts

• Record ID: K163116
• Device Name: Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T 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 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

Magnetic resonance imaging system (1.5T/3.0T) for head, body, extremities; inputs include proton spin signals; transforms signals via reconstruction algorithms into cross-sectional/spectroscopic images; used in clinical settings by trained physicians/technologists; assists diagnosis/therapy planning; includes ScanWise Implant feature for managing MR Conditional implant restrictions; includes 3D ASL for contrast-free brain perfusion assessment; includes various sequence enhancements (e.g., ComforTone for acoustic noise reduction, AutoVoice, VCG optimization).

Clinical Evidence

No clinical data; substantial equivalence demonstrated via bench testing, verification, and validation of design features, safety mechanisms, and software performance against consensus standards.

Technological Characteristics

1.5T/3.0T MRI system; 70 cm magnet; components include transmit body coil, gradient coil, receive coils. Connectivity: DICOM. Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-2-33, IEC 62304, NEMA MS-1/4/8, ISO 14971. Software: R5.3 release; includes reconstruction algorithms, safety control modules for SAR/B1+rms/dB/dt.

Indications for Use

Indicated for diagnostic imaging of head, body, or extremities using MR; includes MR fluoroscopy for interventional/minimally invasive procedures. Applicable to patients requiring MR diagnostic imaging or interventional guidance. Contraindications include use of non-MR Safe/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 R4 1.5T and Achieva R4 3.0T (aka Ingenia) (K110151)

Reference Devices

• Ingenia 1.5T and Ingenia 1.5T S R5.2 (K153324)

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 Veenpluis 4-6 Best, 5684PC NL

Re: k163116

Trade/Device Name: Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: November 3, 2016 Received: November 7, 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) K163116

Device Name Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T 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> <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

## 510(k) Summary of Safety and Effectiveness

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

| Date Prepared: | November 3, 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, Ingenia 1.5T S and Ingenia 3.0T R5.3 | |
| Classification: | Classification Name: | Magnetic Resonance Diagnostic 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 R4 1.5T and Achieva R4<br>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 |
| | Product Code: | 90LNH<br>90LNI |
| | Device Class: | Class II |
| Reference Device: | Trade Name: | Ingenia 1.5T and Ingenia 1.5T S R5.2 |
| | Manufacturer: | Philips Medical Systems Nederland<br>B.V. |
| | 510(k) Clearance: | K153324 (03/22/2016) |
| | 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 |
| Device description: | | The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T<br>R5.3 with ScanWise Implant and 3D ASL features are provided<br>with a 70 cm magnet. The system and its control software are<br>substantially equivalent to the currently marketed and primary<br>predicate device Ingenia R4 (K110151, 03/22/2011), combined with<br>the ScanWise Implant feature and other minor changes as in the<br>currently marketed and reference device Ingenia 1.5T and Ingenia<br>1.5T S R5.2 (K153324, 03/22/2016). |
| | | 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. |
| | | 3D ASL functionality enables MR technologists to assess perfusion<br>in the brain without the usage of contrast agents. The feature<br>consists of an extension to the available scan sequences and image<br>reconstruction algorithms. |
| | | The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T<br>R5.3 with ScanWise Implant and 3D ASL features also consolidate<br>separately-cleared novel functionalities, and minor hardware and<br>software changes since the clearance of the currently marketed and<br>primary predicate device, Ingenia R4 (K110151, 03/22/2011). |
| | Following minor hardware and software changes are covered in this submission: | |
| | 1. Enhanced Patient Communication User Interface Module, IEC/ISO compliant symbols. | |
| | 2. New computing platform and peripherals for MR Spectrometer (DDAS). | |
| | 3. Planning on cine images. | |
| | 4. SAR related parameters (SED). Pregnancy status related to Normal Mode. | |
| | 5. SED limit | |
| | 6. Parameter optimization for the reconstruction algorithms. | |
| | 7. Partial NSA algorithm in reconstruction.…