INFINION 0.6T MR IMAGING SYSTEM

K013858 · Philips Medical Systems (Cleveland), Inc. · LNH · Jan 22, 2002 · Radiology

Device Facts

• Record ID: K013858
• Device Name: INFINION 0.6T MR IMAGING SYSTEM
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Jan 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Infinion 0.6T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Device Story

Infinion 0.6T MR Imaging System is a superconducting MRI system; utilizes magnetic resonance to generate images of head and whole body soft tissue. Inputs: proton distribution, flow velocity, T1, and T2 relaxation parameters. Operation: system applies magnetic fields and RF pulses; signals processed to reconstruct images. Output: diagnostic images displayed on workstation. Used in clinical settings by trained physicians. Features include motorized patient couch, laser positioning, and various phased-array RF coils. Enhancements over predicate include higher field strength (0.6T vs 0.23T), increased gradient strength/slew rates, and additional imaging sequences (e.g., EXPRESS, CBASS, DWISE). Physician interprets images to aid clinical diagnosis; provides anatomical information for patient management.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, bench testing, and comparison of imaging capabilities to the predicate device.

Technological Characteristics

0.6T superconducting magnet; water-cooled gradient system; max gradient strength 20 mT/m; max slew rate 40 T/m/s; 9 kW RF amplifier; phased-array RF coils (head, neck, extremity, body/spine); DICOM-compliant network communications; Windows 2000-based software; motorized patient couch (220 kg capacity); laser positioning; complies with IEC 60601-2-33 for time-varying magnetic fields and RF absorption.

Indications for Use

Indicated for use as an NMR device to produce images of the head and whole body based on proton density, flow velocity, T1, and T2 relaxation times to assist trained physicians in diagnosis.

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

• Philips Proview 0.23T System (K974844)

Submission Summary (Full Text)

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# Kol 3858

### SUMMARY OF SAFETY AND EFFECTIVENESS JAN 2 2 2002

(As required by 21 CFR 807.92)

**JAN 2 2 2002**

#### General Information 1.

| Classification: | Class II<br>Magnetic Resonance Imaging (MRI) System |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) System |
| Proprietary Name: | Infinion 0.6T MR Imaging System |
| Establishment Registration: | Manufacturer:<br>Philips Medical Systems MR Technologies Finland, Inc.<br>P.O. Box 185<br>FIN-00511 Vantaa, Finland<br>Phone: [phone]<br>Fax: [phone]<br>FDA Facility Registraton #9680194<br><br>United States Representative:<br>Philips Medical Systems (Cleveland), Inc.<br>595 Miner Road<br>Highland Heights, Ohio 44143<br>Contact: Duane C. Praschan<br>Phone: [phone]<br>FDA Owner Number: #1580240<br>FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have been issued<br>under section 514 of the Food, Drug and Cosmetic Act |

#### 2. Intended Uses

The Infinion 0.6T MR Imaging System does not change the existing indications as defined below.

The Infinion 0.6T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

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K013858
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#### 3. Device Description

This submission describes the hardware and software changes for the Philips' 0.6T Open Magnetic Resonance Imaging system, the Infinion 0.6T.The package also includes additional imagin sequences and acquisition/construction techniques. However, the basic features are unchanged.

#### 4. Safety and Effectiveness

The functionality included in Philips' Infinion 0.6T MR Imaging System is similar in technological characteristics and intended use to the Proview 0.23T MR. The following table has been created to demonstrate their substantial equivalence.

| Parameter | Infinion 0.6T MR Imaging System | Predicate Device - Philips<br>Proview 0.23T System (K974844) |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer Subsystem | | |
| Display/database system: | Same. | Single display for system operation and<br>image reviewing, workstation tower,<br>moveable keyboard and mouse, CD-ROM.<br>Allows for simultaneous scanning and image<br>reconstruction/manipulation. Image storage<br>via magneo-optical disk. |
| Network communications: | DICOM Query/Retrieve, DICOM<br>Modality WL Management. | Display/Database computer and scan<br>reconstruction hardware connected together<br>by fast Ethernet communications system.<br>DICOM compliant for transfer of images to<br>other systems. |
| Gradient Subsystem | | |
| Gradient Coils: | Same. | Water-cooled self-shielded gradient system. |
| Max. Gradient Strength: | 20 mT/m | 16 mT/m (XY), 18 mT/m (Z) |
| Max. Slew Rate: | 40 T/m/s | 25 mT/m/msec (XY), 40 mT/m/msec (Z). |
| RF Subsystem | | |
| RF Amplifiers: | Max power 9 kW. | 5 kW solid state. |
| RF transmitter coils: | Same but with tuning adjusted to proton<br>resonance at 0.6T field strength instead<br>of 0.23 T, and with water cooling. | Upper and lower, planar coils, integrated in<br>the magnet. |
| Parameter | Infinion 0.6T MR Imaging System | Predicate Device - Philips<br>Proview 0.23T System (K974844) |
| Receive only RF coils: | Head (phased array two-channel)<br>Head and Neck (phased array four-<br>channel).<br>Neck (phased array two-channel)<br>Extremity (phased array two-channel)<br>Body & Spine, different sizes (phased<br>array two-channel)<br>Multipurpose, different sizes (linear<br>single-channel) | Head (phased array two-channel).<br>Brain (phased array two-channel).<br>Head and Neck (phased array four-channel,<br>formerly Vascular Head and Neck).<br>Neck (phased array two-channel).<br>Extremity (phased array two-channel).<br>Body and Spine, different sizes (phased array<br>two-channel)<br>Flexible Spine (phased array two-channel).<br>Flexible Multipurpose, different sizes (linear<br>single-channel).<br>Small Extremity (phased array two-channel,<br>earlier name Small Joints).<br>Large Neck (phased array two-channel). |
| Receive only coil connection: | All receive only coils plug into the RF<br>connectors in both ends of the patient<br>couch. | All receive only coils plug into the RF<br>connector on the front of the magnet façade. |
| Magnet Subsystem | | |
| Magnet Type: | 0.6 T superconducting | 0.23 T iron-core electromagnetic. |
| Patient Handling | | |
| Patient couch: | Motorized movement in three<br>orthogonal dimensions. Optional<br>trolley which can be used for<br>transporting the couch upper part<br>together with the coil and patient.<br>Couch weight capacity is 220 kg.<br>Remote control of the couch in<br>horizontal direction. | Computer and couch controlled patient<br>transport system with 200 kg weight capacity.<br>Optional couch with vertical movement. |
| Patient positioning: | Same laser positioning marker.<br>Additional automated stepping<br>capabilities. | Laser positioning marker for accurate<br>placement of patient at isocenter. |
| Patient communication: | Same. | Two-way intercom system and hand-held<br>audio alarm. |
| Magnet Enclosure | | |
| Magnet Façade: | Same. | Fiberglass enclosure. |
| Controls: | LCD display above bore capable of<br>displaying system status. Two keypads<br>on either side of bore for system<br>controls. | LED display capable of display system<br>status. Control panel in upper front pole. |
| Power Distribution Subsystem | | |
| Subsystem components: | Same. | Isolation transformer, transient suppression<br>circuitry, and power distribution center all<br>contained in a single cabinet. |
| Operating Software | | |
| Base Software: | Same. | Windows 2000 based Graphical User<br>Interface and scan / reconstruction software<br>with multi-tasking capability. |
| | Infinion 0.6T MR Imaging System | Predicate Device – Philips<br>Proview 0.23T System (K974844) |
| Parameter | | |
| Imaging sequences<br>Main features include: | Field Echo, Spin Echo, Dual Echo,<br>Dual Spin Echo, Inversion Recovery,<br>Dual Inversion Recovery, Fast Spin<br>Echo, EXPRESS, CBASS, MRCP,<br>MRA, STIR, FLAIR, TSHIRT, RF-<br>FAST, CE-FAST, DWISE. | Field Echo, Spin Echo, Dual Echo, Inversion<br>Recovery, Fast Spin Echo, CBASS, MRCP,<br>MRA, STIR. |
| Acquisition and reconstruction<br>techniques<br>Main features include: | Same and additionally MAO, MAST,<br>presaturation, chemical fat saturation,<br>phase conjugate symmetry, read<br>conjugate symmetry, true res, true slice,<br>elliptic encoding, RAM, CODA, MTC,<br>dynamic examination curve, contrast<br>dynamic imaging, reconstruction filters,<br>respiratory gating, multiplanar<br>reconstruction, maximum intensity<br>projection, phase correction, fat/water<br>suppression, ADC map. | Presaturation, MAST, ODA, PCS, no phase<br>wrap-around, no slice wrap around, dynamic<br>imaging, cardiac gating, optimized<br>bandwidth, turbo multislice. |
| Time Varying Magnetic Field<br>Normal Operating Mode: | According to 60601-2-33 FDISscript<br>2001-11-02. | dB/dt ≤ 20 T/s |
| First Level Controlled<br>Operating Mode: | According to 60601-2-33 FDISscript<br>2001-11-02. | Not applicable. |
| Radiofrequency Absorption<br>Normal Operating Mode: | Same. | Limited to a maximum level of 1.2 W/kg. |
| First Level Controlled<br>Operating Mode: | Same. | Limited to a maximum value of 3.2 W/kg. |
| Acoustic Noise<br>Typical: | 87 dBA (average)<br>102 dB (peak) | <85 dBA (average, normal clinical<br>sequences) |
| Worst Case: | 91 dBA (average)<br>104 dB (peak) | 84 dBA (average)<br>98 (peak) |
| Intended Use and<br>Indications for Use | Same. | The Proview System is indicated for use as a<br>NMR device that produces images that: (1)<br>correspond to the distribution of protons<br>exhibiting NMR, (2) depend upon the NMR<br>parameters (proton density, flow velocity,<br>spin-lattice relaxation time (T1), and spin-<br>spin relaxation time (T2)) and (3) display the<br>soft tissue structure of the head and whole<br>body. When interpreted by a trained<br>physician, these images yield information<br>that can be useful in the determination of a<br>diagnosis. |

### Substantial Equivalence Chart

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 2 2 2002

Mr. Duane Praschan Manager, Regulatory Affairs Philips Medical Systems 595 Miner Road HIGHLAND HEIGHTS OH 44143 Re: K013858

Trade/Device Name: Infinion 0.6T MR Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: November 16, 2001 Received: November 21, 2001

Dear Mr. Praschan:

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.

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); 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): Ko 1 3 8 58

Infinion 0.6T MR Imaging System Device Name:

### Indications for Use:

The Infinion 0.6T MR Imaging System does not change the existing indications as defined below.

The Infinion 0.6T MR Imaging System is indicated for use as a NMR device that produces i he mininon 0.0 I Wirk maging by seen lution of protons exhibiting NMR, (2) depend upon the Inlages that. (1) correspond to the distributiv, spin-lattice relaxation time (T1), and spin-spin North paraticiels (procent dealer) from volt tightig ; in the head and whole body. When iclaxation thire (12)) and (2) also images yield information that can be useful in the determination of a diagnosis.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| Prescription Use | | OR | | Over-The-Counter Use |
|----------------------|-----------------------------------------------|----|--|--------------------------|
| (Per 21 CFR 801.109) | <div style="text-align: left;"><i>✓</i></div> | | | (Optional Format 1-2-96) |

*Jansylf Brydon*
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | <i>K013858</i> |
|---------------|----------------|
|---------------|----------------|