OUTLOOK SYSTEM ENHANCEMENT PACKAGE

K974844 · Philips Medical Systems (Cleveland), Inc. · LNH · Mar 10, 1998 · Radiology

Device Facts

• Record ID: K974844
• Device Name: OUTLOOK SYSTEM ENHANCEMENT PACKAGE
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Mar 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Outlook 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

Outlook System Enhancement Package is an upgrade for existing MR imaging systems; modifies computer, magnet, gradient, RF, patient handling, and power distribution subsystems. Inputs: proton NMR signals from patient body; processed via enhanced acquisition/reconstruction techniques (Read Conjugate Symmetry, TrueRes, Keyhole) and imaging sequences (Inversion Recovery, Fast Spin Echo). Outputs: diagnostic MR images of head and whole body soft tissue. Used in clinical settings by trained physicians to assist in diagnosis. Enhancements include increased gradient performance, higher RF amplifier power (500W), and expanded receive coil options. System remains DICOM 3.0 compliant; operates via Windows NT-based GUI. Benefits include improved image acquisition speed and flexibility for clinical diagnostic workflows.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and bench testing of system enhancements.

Technological Characteristics

Magnetic Resonance Imaging system; iron C-arm magnet; active shielded gradient design; 500W RF amplifier; ± 100 kHz receive bandwidth. Connectivity: Ethernet, DICOM 3.0. Software: Windows NT-based GUI, multi-tasking scan/reconstruction. Power: line voltage monitoring. Patient handling: movable couch with laser positioning. Fiberglass enclosure.

Indications for Use

Indicated for patients requiring diagnostic imaging of head and whole-body soft tissue structures via NMR parameters (proton density, flow velocity, T1, T2). For use by trained physicians.

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

• Standard Outlook (K945827)
• Edge/Vista System Enhancement (K964626)

Submission Summary (Full Text)

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K97 4844

MAR 1 0 1998

### SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

#### General Information 1.

Classification:

Class II Magnetic Resonance (MR) Imaging System

Common/Usual Name:

Magnetic Resonance (MR) Imaging Option

Proprietary Name:

Outlook System Enhancement Package

Establishment Registration:

Manufacturer: Picker Nordstar, Inc. P.O. Box 33 FIN-00511 Helsinki, Finland [phone] Phone: [phone] Fax. FDA Facility Registration #9680194

United States Representative: Picker International, Inc. World Headquarters 595 Miner Road Highland Heights, Ohio 44143 FDA Owner Number: #1580240

Performance Standards:

No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act.

#### 2. Intended Uses

The system enhancement package does not change the existing indications for the standard Outlook system as defined below.

The Outlook 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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#### Device Description 3.

The Outlook System Enhancement Package includes changes in the computer subsystem, magnet subsystem, gradient subsystem, RF subsystem, patient handling subsystem, magnet enclosure and the power distribution subsystem. The package also includes additional imaging sequences and acquisition/reconstruction techniques. However, the basic features of the operating software are unchanged.

### Safety and Effectiveness 4.

Outlook systems with the System Enhancement Package are similar in technological characteristics and intended use to the standard Outlook system and the EDGE/VISTA System Enhancement Package. The following chart has been created to demonstrate their substantial equivalence.

| Item | Outlook System Enhancement<br>Package | Predicate Devices<br>Standard Outlook (K945827)<br>Edge/Vista System<br>Enhancement (K964626) |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer subsystem | Same display/database computer<br>system with some additional<br>options.<br><br>Ethernet communication system<br><br>Scan/reconstruction hardware:<br>• single processor for<br>reconstruction<br>• additional hard disk for buffering<br>image raw data<br><br>DICOM 3.0 compliant | Display/database computer system:<br>• workstation<br>• single monitor<br>• movable keyboard and mouse<br>• magnetic disk storage<br>• optical disk storage<br>• CD-ROM<br><br>Ethernet communication system<br><br>Scan/reconstruction hardware:<br>• 16 parallel processors for<br>reconstruction<br>(See K945827)<br><br>DICOM 3.0 compliant. (See<br>K964626) |
| Magnet subsystem | • Iron C-arm magnet<br>• Ramp up time: 6 minutes<br>• Increased stability of magnetic<br>field | • Iron C-arm magnet<br>• Ramp up time: 10 minutes<br>(See K945827) |
| Item | Outlook System Enhancement<br>Package | Predicate Devices<br>Standard Outlook (K945827)<br>Edge/Vista System<br>Enhancement (K964626) |
| Gradient subsystem | Increased gradient performance<br>with an active shielded design. | Gradient performance level of 12<br>mT/m and 20 T/m/s with a<br>shielded design. (See K945827) |
| RF subsystem<br>• RF amplifier max<br>average power | • 500 W | • 250 W |
| • Receive bandwidth | • ± 100 kHz | • ± 50 kHz<br>(See K945827) |
| Patient Handling<br>subsystem | • Modified couch movable in two<br>directions | • Couch movable in two directions |
| | • Laser positioning | • Laser positioning<br>(See K945827) |
| Magnet Enclosure | Fiberglass enclosure re-designed to<br>accommodate patient handling<br>subsystem. | Fiberglass enclosure.<br>(See K945827) |
| Power Distribution<br>subsystem | Same with the addition of line<br>voltage monitoring circuitry. | Isolation transformer, transient<br>suppression circuitry, power<br>distribution center all contained in<br>a single cabinet. (See K945827) |
| Operating software | Same. | Windows NT based Graphical<br>User Interface and scan /<br>reconstruction software with<br>multi-tasking capability.<br>(See K945827) |
| Imaging Sequences | Same with enhancements to<br>Inversion Recovery and Fast Spin<br>Echo sequences. | Standard: Field Echo, Spin Echo,<br>Inversion Recovery, Dual Echo,<br>and CBASS. |
| | | Optional: Fast Spin Echo and<br>Angiography. (See K945827) |
| Item | Outlook System Enhancement<br>Package | Predicate Devices<br>Standard Outlook (K945827)<br>Edge/Vista System<br>Enhancement (K964626) |
| Acquisition and<br>Reconstruction<br>Techniques | Same with addition of:<br>• Read Conjugate Symmetry<br>• TrueRes<br>• Keyhole | Main features include:<br>• Presaturation<br>• MAST<br>• Optimized Data Acquisition<br>• Phase Conjugate Symmetry<br>• No Phase Wrap-Around<br>• No Slice Wrap-Around<br>• Dynamic Imaging<br>• Cardiac gating<br>• Optimized Bandwidth<br>• Turbo Multislice<br>(See K945827) |
| Receive Only Coils | • Head<br>• Brain<br>• Vascular Head and Neck<br>• Neck<br>• Body/Spine<br>• Flexible Spine<br>• Multipurpose<br>• Extremity<br>• Small Joints | • Head<br>• Vascular Head and Neck<br>• Neck<br>• Body<br>• Spine<br>• Flexible Spine<br>• Multipurpose<br>• Extremity<br>(See K945827) |
| Static Magnetic<br>Field | Same. | 0.23 T (See K945827) |
| Time Varying<br>Magnetic Field | Same. | Normal operating mode:<br>$dB/dt \le 40$ T/s<br><br>First level controlled operating<br>mode:<br>$dB/dt \le 60$ T/s<br>(See K964626) |
| Radiofrequency<br>Absorption | Same. | Normal operating mode: Limited<br>to a maximum level of 1.2 W/kg.<br><br>First level controlled operating<br>mode: Limited to a maximum<br>level of 3.2 W/kg. (See K964626) |
| Acoustic Noise | Same. | A-weighted average value < 85<br>dBA. (See K945827) |

# SUBSTANTIAL EQUIVALENCE CHART

PICKER INTERNATIONAL, INC.

(OUTLOOK SE) 12/23/97

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PICKER INTERNATIONAL, INC.

(OUTLOOK SE) 12/23/97 I - 4

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 1998

Duane C. Praschan Manager, MR Regulatory Affairs and Clinical Testing Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143

Re: K974844

Outlook System Enhancement Package Dated: December 22, 1997 Received: December 24, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Praschan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 probibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 predication 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 and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): K47 4844

Device Name: Outlook System Enhancement Package

Indications for Use:

The system enhancement package does not change the existing indications for the standard Outlook system as defined below.

The Outlook 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Segarra

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K974844

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use (Optional Format 1-2-96)