Ingenia 1.5T and Ingenia 1.5T S R5.2

K153324 · Philips Medical Systems Nederlands B.V. · LNH · Mar 22, 2016 · Radiology

Device Facts

• Record ID: K153324
• Device Name: Ingenia 1.5T and Ingenia 1.5T S R5.2
• Applicant: Philips Medical Systems Nederlands B.V.
• Product Code: LNH · Radiology
• Decision Date: Mar 22, 2016
• 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. For some studies the use of contrast agents can be essential. Their application is subject to local medico-legal regulations and to their appropriateness to assist the diagnosis and therapy planning as judged by a trained physician. 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/1.5T S R5.2 is a 70cm bore MRI system. Inputs: proton/nuclei spin signals in magnetic field. Operation: system excites nuclei with RF pulses; detects relaxation signals; reconstructs cross-sectional/spectroscopic images. Features: ScanWise Implant workflow for MR Conditional implants; AutoVoice; ComforTone for noise reduction; cardiac/respiratory gating; various advanced sequences (DTI, pCASL, CardiacQuant). Used in clinical settings by physicians/technicians. Output: images/spectra for diagnostic/therapy planning. Benefits: improved workflow control for implants; enhanced image quality/patient comfort; guidance for interventional procedures.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, verification/validation of technical requirements, and human factors engineering for the ScanWise Implant feature.

Technological Characteristics

70cm magnet; transmit body coil; gradient/receive coils. Connectivity: networked. Standards: IEC60601-1, IEC60601-1-2, IEC60601-1-6/62366, IEC60601-1-8, IEC60601-2-33, IEC62304, NEMA MS-1/4/8, ISO 14971. Software: reconstruction algorithms, SAR/dB/dt control, sequence optimization.

Indications for Use

Indicated for diagnostic imaging of internal structures of head, body, and extremities in patients requiring MR examination; includes guidance for interventional and minimally invasive procedures. Contraindications include patients with non-MR safe/conditional implants unless evaluated by clinical user.

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)

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

March 22, 2016

Philips Medical Systems, Nederlands B.V. % Mr. Henrie Daniels Regulatory Affairs Engineer Veenpluis 4-6 Best, 5684 PC THE NETHERLANDS

Re: K153324

Trade/Device Name: Ingenia 1.5T and Ingenia 1.5T S R5.2 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI Dated: February 16, 2016 Received: February 18, 2016

Dear Mr. Daniels:

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 device-related 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/Resourcesfor You/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 yours.

Michael D.'Hara

For

Robert 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) K153324

#### Device Name

Ingenia 1.5T and Ingenia 1.5T S R5.2

#### 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. For some studies the use of contrast agents can be essential. Their application is subject to local medico-legal regulations and to their appropriateness to assist the diagnosis and therapy planning as judged by a trained physician.

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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: | March 16, 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: | Henrie Daniels<br>Regulatory Affairs Engineer<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Secondary Contact<br>Person | Ruojuan Zhang<br>Regulatory Affairs engineer<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Device Name: | Ingenia 1.5T and Ingenia 1.5T S R5.2 | |
| 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 R4 1.5T and ACHIEVA<br>R4 3.0T (aka Ingenia) |
| | Manufacturer: | Philips Medical Systems Nederland<br>B.V. |
| | 510(k) Clearance: | K110151 (March 22, 2011) |
| | 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 |
| | 90LNI | |
| Device description: | The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with<br>ScanWise Implant feature is provided with a 70 cm magnet.<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 <i>at the<br/>examination level</i> to define restrictions on the 'active fields'<br>generated by the MR system.<br><br>The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with<br>ScanWise Implant feature also consolidates separately-cleared novel<br>functionalities, and minor hardware and software changes since the<br>clearance of the currently marketed and predicate device, Ingenia<br>R4 (K110151, 03/22/2011).<br><br>Following minor hardware and software changes are covered in this<br>submission:<br>1. (Hardware) Enhanced Patient Communication User Interface<br>Module, IEC/ISO compliant symbols.<br>2. (Hardware) New computing platform and peripherals for MR<br>Spectrometer (DDAS).<br>3. (Software) User Interface layout modifications for scan<br>preparation, sequence planning (geometries and parameters), and<br>data processing and viewing.<br>4. (Software) Planning on cine images.<br>5. (Software) SAR related parameters (SED). Pregnancy status<br>related to Normal Mode.<br>6. (Software) Parameter optimization for the reconstruction<br>algorithms.<br>7. (Software) Partial NSA algorithm in reconstruction.<br>8. (Software) AutoVoice, using pre-recorded spoken instructions.<br>9. (Software) VCG, optimized electrode placement and enhanced<br>algorithm.<br>10. (Software) ComforTone: mechanical resonance frequency<br>dependent timing adjustments of sequences for lower acoustic<br>noise.<br>11. Enhanced sequences:<br>a. AutoSpair.<br>b. TSE flow compensation enhancement.<br>c. Optimized 3D TSE flip angle sweeps per anatomy. | |
| | | d. ENCASE: 3D encoding. |
| | | e. CardiacQuant: triggered T1 mapping sequence. |
| | | f. pCASL. |
| | | g. DTI enhancements. |
| Indications for 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. For some studies the use of contrast agents can be essential. Their application is subject to local medico-legal regulations and to their appropriateness to assist the diagnosis and therapy planning as judged by a trained physician. | |
| | 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. | |
| Fundamental<br>Scientific Technology: | The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature is based on the principle that certain atomic nuclei present in the human body will emit a weak relaxation signal when placed in a strong magnetic field and excited by a radio signal at the precession frequency | |
| Summary of Non-Clinical Performance<br>Data: | The emitted relaxation signals are analyzed by the system and a computed image reconstruction is displayed on a video screen.<br>The principal technological components (magnet, transmit body coil, gradient coil, receive coils and patient support) of the proposed <b>Ingenia 1.5T and Ingenia 1.5T S R5.2</b> with ScanWise Implant feature is identical to those used in the currently marketed and predicate device, Ingenia R4( K110151, 03/22/2011).<br>ScanWise Implant uses existing safety mechanisms to protect the patient against excessive RF exposures. This includes Whole Body and Head SAR, local SAR controls, and display of B1+rms. No modifications relative to the implementation of safety mechanisms relative to the predicate device was required.<br>ScanWise Implant extends existing software safety provisions to prevent peripheral nerve stimulation. In previous products, dB/dt was evaluated (at the compliance volume defined in IEC60601-2-33) and displayed for informational purposes. In this software, dB/dt is controlled not to exceed a user-specified value.<br>Based on the information provided above, the proposed <b>Ingenia 1.5T and Ingenia 1.5T S R5.2</b> with ScanWise Implant feature does not raise different questions of safety and effectiveness compared to the marketed and predicate device, Ingenia R4(K110151,03/22/2011).<br>The proposed <b>Ingenia 1.5T and Ingenia 1.5T S R5.2</b> with ScanWise Implant feature comply with the following international and FDA-recognized consensus standards:<br>IEC60601-1 Edition 3 Amendment 1 IEC60601-1-2 Edition 3 IEC60601-1-6 Edition 3 / IEC62366 IEC60601-1-8 Edition 2 IEC60601-2-33 Edition 3 Amendment 1 IEC 62304 NEMA MS-1 2008 NEMA MS-4 2008 NEMA MS-8 2008 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" | |
| | Non-Clinical verification and or validation tests have been performed<br>with regards to the intended use, the technical claims, the requirement<br>specifications and the risk management results. | |
| | Specifically for ScanWise Implant, Human Factors Engineering<br>testing was performed in line with FDA's guidance document entitled<br>"Applying Human Factors and Usability Engineering to Optimize<br>Medical Device Design - June 22, 2011".…