EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE

K964626 · Philips Medical Systems (Cleveland), Inc. · LNH · Feb 10, 1997 · Radiology

Device Facts

• Record ID: K964626
• Device Name: EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Picker International EDGE and VISTA systems are 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

The EDGE/VISTA System Enhancement Package is an upgrade for existing MRI systems. It incorporates water-cooled gradient subsystems, a 61 cm body coil, and increased SAR limits. The device uses magnetic resonance physics to acquire proton density, flow velocity, T1, and T2 signals. These inputs are processed by the system's computer subsystem to reconstruct images. Operated by trained technicians in clinical settings, the system provides images for physician interpretation to assist in diagnosis. The enhancement improves gradient performance and patient handling capacity. The output is displayed on a monitor for clinical review, aiding in the assessment of soft tissue structures.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness are supported by technical comparisons of gradient performance, RF absorption limits, acoustic noise levels, and system specifications against predicate devices.

Technological Characteristics

MRI system enhancement including water-cooled self-shielded gradient coils, 61 cm quadrature multi-conductor body coil, and increased SAR limits (3.2 W/kg). Connectivity via Ethernet (DICOM v3.0). Software operates on UNIX/X-Windows platform. Magnet enclosure is cylindrical fiberglass. Gradient performance levels: 16, 20, or 27 mT/m strength; 25, 40, or 72 mT/m/msec slew rates.

Indications for Use

Indicated for patients requiring MRI imaging of the head and whole body to visualize soft tissue structures for diagnostic purposes.

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

• EDGE/VISTA (K931544)
• High Performance Gradients Option (K954646)

Reference Devices

• K932693
• K941996
• K944469
• K952530
• K962117
• K963356
• K945397
• K945828

Submission Summary (Full Text)

{0}

FEB 10 1997

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

K964626

## 1. General Information

Classification: Class II
Magnetic Resonance (MR) Imaging System

Common/Usual Name: Magnetic Resonance Imaging Option

Proprietary Name: EDGE/VISTA System Enhancement Package

Establishment Registration: Picker International, Inc.
World Headquarters
595 Miner Road
Cleveland, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965

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

## 2. Intended Uses

The EDGE/VISTA System Enhancement Package does not change the existing indications for the EDGE/VISTA systems as defined below.

The Picker International EDGE and VISTA systems are 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.

## 3. Device Description

The EDGE/VISTA system enhancement package includes changes in the computer subsystem, the gradient subsystem, the RF subsystem, the magnet subsystem, the patient handling subsystem, and the magnet enclosure. The main features provided with this enhancement are a 61 cm body coil, three gradient performance levels, water cooled gradients, an increase in the SAR first controlled operating mode limit, and optional increased reconstruction rates.

PICKER INTERNATIONAL, INC.
(EDGE SE)
11/18/96
I - 1

{1}

# 4. Safety and Effectiveness

The EDGE/VISTA systems with the system enhancement package are similar in technological characteristics and intended use to EDGE/VISTA systems with standard or high performance gradients. The following chart has been created to demonstrate their substantial equivalence.

SUBSTANTIAL EQUIVALENCE CHART

| ITEM | EDGE/VISTA with System Enhancement Package | Predicate Devices EDGE/VISTA (K931544) & High Performance Gradients Option (K954646) |
| --- | --- | --- |
| Computer Subsystem | Similar display/database computer, monitor and Ethernet communications systems. Ethernet communications link complies with DICOM v3.0 to allow image transfer to other MR, CT, Nuclear, workstation systems and cameras. Optional packages available for increased image reconstruction rates. | Display/Database computer and scan reconstruction hardware connected together by a dedicated Ethernet communications system. Allows for simultaneous scanning and image reconstruction/ manipulation. Single monitor for system operation and image reviewing. Second Ethernet interface for communication with systems on the external network. (See K931544) |
| Image Storage
Short Term:
Archival: | Same
Same | Magnetic Disk
Optical Disk
(See K931544) |

PICKER INTERNATIONAL, INC.
(EDGE SE)
11/13/96
I - 2

{2}

| ITEM | EDGE/VISTA with System Enhancement Package | Predicate Devices EDGE/VISTA (K931544) & High Performance Gradients Option (K954646) |
| --- | --- | --- |
| Gradient Subsystem
Gradient Coils: | Water-cooled self-shielded gradient system for all performance levels. | Standard EDGE- Air-cooled self-shielded gradient system. (see K931544)

EDGE with High Performance Gradients - Water-cooled self shielded gradient system (see K954646) |
| Max. Gradient Strength | 16, 20 or 27 mT/m | 16 or 27 mT/m |
| Max. Slew Rate | 25, 40, 72 mT/m/msec | 25 or 72 mT/m |
| Gradient Amps: | 150 A RMS, 300 A peak, 400 V
or
270 A RMS, 440 A peak, 600 V | 135 A RMS, 220 A peak, 350 V
or
270 A RMS, 440 A peak, 600 V |
| RF Subsystem
DTR Spectrometer: | Same | Single Channel with fast sampling ADC and additional digital filtering. Three additional receive channels are available as an option. |
| RF Amplifiers: | Single frequency RF amplifiers with increased output power to give equivalent B_{1} field with larger body coil. | Single frequency RF amplifiers. (See K931544) |
| Body Coil | 61 cm quadrature multi-conductor transmit/receive coil. | 58 cm quadrature multi-conductor transmit/receive coil. (See K931544) |
| Head Coil | Same | Quadrature multi-conductor receive only. (See K931544) |

PICKER INTERNATIONAL, INC.
(EDGE SE)
11/13/96
I - 3

{3}

| ITEM | EDGE/VISTA with System Enhancement Package | Predicate Devices EDGE/VISTA (K931544) & High Performance Gradients Option (K954646) |
| --- | --- | --- |
| Receive Only Coil Connection | Same | All receive only coils plug into single couch RF connector. |
| Transmit/Receive Box | Same | Four receive channels in system. (See K931544) |
| Magnet Subsystem | Same | Active Shield Magnets offered at 1.5 T and 1.0 T. (See K931544) |
| Patient Handling | Computer controlled patient transport system with increased weight capacity. New method of patient illumination used to increase patient comfort. | Computer controlled patient transport system. (See K931544) |
| Magnet Facade | Cylindrical fiberglass enclosure. Hinge on front facade removed. | Cylindrical fiberglass enclosure. Hinged front facade. (See K931544) |
| Power Distribution Subsystem | Same | Isolation transformer, transient suppression circuitry, and power distribution center all contained in a single cabinet. (See K931544) |
| Operating Software | Same | UNIX - X Windows based operating software. Graphical User Interface - windows and multi-tasking capability provided.
SCAN, VIEW, FILM and UTILITIES operations all accessed from single console.
Able to switch between on-going tasks. (See K931544) |

PICKER INTERNATIONAL, INC.
(EDGE SE)
11/13/96
I - 4

{4}

| ITEM | EDGE/VISTA with System Enhancement Package | Predicate Devices EDGE/VISTA (K931544) & High Performance Gradients Option (K954646) |
| --- | --- | --- |
| Operational Features | Same | SCAN capabilities include: Pilot positioning on three different reference images. Preloaded anatomical protocol categories.
VIEW capabilities include: Multi planar reconstruction and curvilinear reformatting.
FILM capabilities include: ability to set film formats and load print queue directly from Display/Database computer. (See K931544) |
| Standard Imaging Sequences | Same | 2DFT: Field Echo, Spin Echo, Multiple Echo, Inversion Recovery and FAST.
3DFT: FAST |
| Acquisition and Reconstruction Techniques | Same | Main features include: Multi-angle oblique, presaturation, phase conjugate symmetry, TrueRes and TrueSlice. (See K931544) |

PICKER INTERNATIONAL, INC.
(EDGE SE)
11/13/96
I - 5

{5}

| ITEM | EDGE/VISTA with System Enhancement Package | Predicate Devices EDGE/VISTA (K931544) & High Performance Gradients Option (K954646) |
| --- | --- | --- |
| Optional Receive Only Coils | All coils for the EDGE/VISTA are compatible with the system enhancement package.
New coils/accessories described in this submission:
Quadrature Lower Extremity Coil
Coil Combiner | Large Joint Coil
Small Joint Coil
Volume Neck Coil
Quad Spine Coil and Positioner
General Purpose Flex Coil
Bilateral TMJ Coil (Linear and Phased Array versions)
Bilateral Breast Coil
C/T/L Phased Array
Pelvic Phased Array
Head-Neck Vascular Phased Array
Flexible Body Coil (Quadrature and Phased Array versions)
Quadrature Wrist Coil
Shoulder Phased Array
(See K931544, K932693, K941996, K944469, K952530, K962117, K963356) |

PICKER INTERNATIONAL, INC.
(EDGE SE)
11/13/96
I - 6

{6}

| ITEM | EDGE/VISTA with System Enhancement Package | Predicate Devices EDGE/VISTA (K931544) & High Performance Gradients Option (K954646) |
| --- | --- | --- |
| Software Options | Software options are the same except for the following additions:
Variable Fast Spin Echo: 2 and 32 echo sequences have been added. | Angiography
Cardiac Imaging
Variable Fast Spin Echo (4, 8, 16, 48 and 64 echo sequences with minimum TE’s of 16 to 32 msec)
Gradient-Recalled and Spin-Echo (GRaSE) Technique
Echo Planar Imaging
(See K931544, K945397, K945828, K954646) |
| Time Varying Magnetic Field | All gradient performance levels:
Normal Operating Mode: dB/dt ≤ 40 T/s
First Controlled Operating Mode: 40 T/s < dB/dt ≤ 60 T/s | Standard EDGE: dB/dt ≤ 20 T/s for all sequences.
(see K931544)
EDGE with high performance gradients:
Normal Operating Mode: dB/dt ≤ 40 T/s
First Controlled Operating Mode: 40 T/s < dB/dt ≤ 60 T/s
(see K954646) |

PICKER INTERNATIONAL, INC.
(EDGE SE)
11/13/96
I - 7

{7}

| ITEM | EDGE/VISTA with System Enhancement Package | Predicate Devices EDGE/VISTA (K931544) & High Performance Gradients Option (K954646) |
| --- | --- | --- |
| Radiofrequency Absorption | Normal Operating Mode: Limited to a maximum level of 1.2 W/kg.
First Level Controlled Operating Mode: Limited to a maximum value of 3.2 W/kg.
Change in method for acquiring the RF scale factor. | Normal Operating Mode: Limited to a maximum level of 1.2 W/kg.
First Level Controlled Operating Mode: Limited to a maximum value of 2.4 W/kg. (See K931544) |
| Acoustic Noise
Typical
Worst Case | 80.6 dBA (average)
93.3 dB (peak)
115.1 dBA (average)
123.8 dB (peak) | 90.7 dBA (average)
100.0 dB (peak)
118.7 dBA (average)
125.6 dB (peak)
(See K931544) |

PICKER INTERNATIONAL, INC.
(EDGE SE)
11/13/96
I - 8