ORTHO 8000

K963186 · Inner Vision Mri , Ltd. · LNH · Nov 12, 1996 · Radiology

Device Facts

• Record ID: K963186
• Device Name: ORTHO 8000
• Applicant: Inner Vision Mri , Ltd.
• Product Code: LNH · Radiology
• Decision Date: Nov 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Anatomical region : Extremities Nuclei excited : H-1 Diagnostic uses : 2D imaging, 3D imaging

Device Story

Ortho 8000 is a permanent magnet MRI system (0.17 Tesla) for extremity imaging. It uses RF coils (leg, arm, loop) to acquire H-1 proton signals via spin echo, gradient echo, and inversion recovery pulse sequences. Data is sampled in k-space and processed using 2D/3D Fourier transforms. The system is installed in fixed clinical sites and operated by trained personnel. Output consists of T1, T2, and T2* weighted images displayed on a monitor. Healthcare providers use these images to visualize anatomy and pathology (e.g., Du Puytrens contracture, localization for injections) to inform clinical diagnosis and treatment planning.

Clinical Evidence

Clinical evaluation performed at Middlesex Hospital, London (Feb-July 1996). Scans included investigation of Du Puytrens contracture, localization for steroid injections, and normal anatomy of extremities (fingers, hand, wrist, forearm, elbow, upper arm, toes, feet, ankles, lower leg, knee, upper thigh). Bench testing confirmed SNR >20:1 (leg/loop coils) and >40:1 (arm coil), non-uniformity <+/-20%, and geometric distortion <+/-5%.

Technological Characteristics

Permanent magnet (0.17T); 0.4 W/Kg max RF power; 6 T/s max dB/dt. RF coils: leg, arm, 12cm/18cm loop. Reconstruction: 2D/3D Fourier Transform. Connectivity: MOD/Tape storage, optional 3rd party DICOM. Power: 110/240V. Cooling: Air conditioning control +/- 1C. Software: 2x Pentium 100 MHz PCs, Dalanco Spry Model 500 DSP.

Indications for Use

Indicated for diagnostic imaging of human extremities (fingers, hand, wrist, forearm, elbow, upper arm, toes, feet, ankles, lower leg, knee, upper thigh) using H-1 proton imaging.

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

• Esaote Biomedica ArtoScan

Submission Summary (Full Text)

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# INNERVISION MRI

*Specialized MRI Systems for Medicine, Industry and Research* NOV 12 1996

## FDA 510K Summary

Submitter's Name: Dr Martyn Paley

Postal Address: PO Box 8232, London, W5 3WY

Telephone Number:
[phone] (Tel)
[phone] (Fax)

Contact Person: Dr Martyn Paley
Date Summary Prepared: 18th July 1996
K963186

INNERVISION MRI Ltd., PO Box 8232, London W5 3WY
Directors: Martyn Paley BSc PhD CPhys FInstP, John McGinley BA DPhil MInstP

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1. **DEVICE NAME**: Magnetic Resonance Diagnostic Device
Trade/Proprietary Name: Ortho 8000

2. **EQUIVALENT DEVICE**: Esaote Biomedica ArtoScan

3. **DEVICE DESCRIPTION**

A. **Device Characteristics**
Model Name: Ortho 8000
Isotope: Proton Imaging
Model Characteristics
Magnet Permanent
Static Field strength: 0.17 Tesla
Homogeneity: +/-20ppm over 16cm DSV
RF Coil Types
1. Leg coil
Transmit/receive coil for knee/foot/ankle/leg/elbow
15 cm Diameter x 8 cm Length
2. Arm Coil
Transmit/receive coil for hand/wrist/forearm
10 cm Diameter x 6 cm Length
3. 18 cm Loop Coil
Transmit/receive coil for general purpose use
4. 12 cm Loop
Transmit/receive coil for general purpose use
Data Acquisition Modes
Phase and frequency encoding to sample k-space
2D Multiple Slice
2D Multiple Slice, Multiple Echo
3D Multiple Slice
Pulse Sequences
Spin echo
Gradient (Field) echo
Inversion recovery
Dynamic imaging
These sequences can provide
T1 weighted, T2 weighted, T2* weighted images
Reconstruction Techniques
2D Fourier Transform

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3D Fourier Transform

Type of Installation

Fixed Site

Slice Selection Methods

Selective excitation in the presence of a field gradient
Phase encoding for 3D

Display Matrix

256 x 256
1 - 4 Simultaneous Images

Acquisition Matrix

64 - 256 in steps of 1 for the phase encoding direction
256 in the frequency encoding direction

Image Acquisition Time

2D - Repeat Time x Number of Excitations x Number of Phase Encoding Steps
3D - Repeat Time x Number of Excitations x Number of Phase Encoding Steps x Number of Slice Encoding Steps

Image Pre and Post Processing

Magnitude Value
Pixel Value
Horizontal/Vertical Line Profiles
Spatial Filtering - Hamming Filter in Frequency and Phase Directions

Number of Slices, Range and Increment

2D - 1-16 in steps of 1
3D - 16 slice only

Slice Orientation

Transverse (Axial)
Sagittal
Coronal
Oblique
3 Orthogonal Plane Scouts

Interslice Spacing, minimum, maximum and increment

0 mm, 10mm, Increment 1 mm

## B Safety Parameters

| Static Field Strength | 0.17 Tesla |
| --- | --- |
| Rate of change of magnetic field, maximum | < 6 Tesla/Second |
| Radiofrequency Power Deposition, maximum | < 0.4 W/Kg |

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Acoustic Noise
80 dBA

## C. Imaging Performance

### Specification Volume

75mm length x 75 mm diameter Cylinder

#### a. Signal to Noise Ratio (SNR)

1. Leg Coil
SNR &gt; 20:1 Transverse, Sagittal, Coronal, Oblique

2. Arm Coil
SNR &gt; 40:1 Transverse, Sagittal, Coronal

3. 18 cm Loop Coil
SNR &gt; 20:1 Transverse, Sagittal, Coronal

4. 12 cm Loop Coil
SNR &gt; 30:1 Transverse, Sagittal, Coronal

#### b. Uniformity

1. Leg Coil
Non-Uniformity &lt; +/-20% Transverse, Sagittal, Coronal

2. Arm Coil
Non-Uniformity &lt; +/-20% Transverse, Sagittal, Coronal

3. 18 cm Loop Coil
Non-Uniformity &lt; +/-20% Transverse, Sagittal, Coronal

4. 12 cm Loop Coil
Non-Uniformity &lt; +/-20% Transverse, Sagittal*, Coronal

#### c. Geometric Distortion

Geometric Distortion &lt; +/- 5% Transverse, Sagittal, Coronal

#### d.1 Slice Profile

Arm coil
&gt;80% of material within Full Width Half Maximum. See detailed plots. Transverse, Sagittal, Coronal

#### d.2 Slice Thickness

Arm coil

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2-10 mm in 1mm increments - Transverse, Sagittal, Coronal

d.3 Slice Spacing

Arm coil

0 - 10 mm in 1mm increments - Transverse, Sagittal, Coronal

Simultaneous Slices

16 maximum

e Spatial Resolution

Leg Coil

Maximum theoretical pixel resolution = 80/256 mm = 0.31 mm.

1mm test rods resolved in all 4 quadrants Transverse, Sagittal, Coronal.

Note : Performance parameters measured using the phantom and techniques described in Section 8B below.

## 4. INTENDED USE

Anatomical region : Extremities

Nuclei excited : H-1

Diagnostic uses : 2D imaging, 3D imaging

## 5. TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE

See Appendix A

## 6. CLINICAL DATA

Testing of the system was performed at the Middlesex Hospital, London, England during the period February - July 1996. Clinical scans performed included investigation of Du Puytrens contracture of the hand localisation of the calcaneus for steroid injections and scans of the normal anatomy of the toes, feet, ankles, lower leg, knee and upper thigh, fingers, hand, wrist, forearm, elbow and upper arm.

## 7. CONCLUSIONS FROM TESTING

The measurement methods used are based on calibration using a well characterised physical object and provide direct evidence of the performance characteristics of the scanner.

The signal to noise ratio values were consistently above the target specification values for each of the coils with the parameters measured above.

Non-uniformity was &lt; +/- 20% for all coil and sequence combinations tested.

Geometric distortion was &lt; +/- 5% for all coil and sequence combinations tested.

Slice thickness, spacing and gap were all within the quoted specifications using the frequency encoding method. This method relies on accurate calibration of the Field of View using MR imaging. The size of the test object is very accurately known and the measurement method provides a scale with 256 pixels. It is believed that this method gives more reliable results than the slice ramp technique which was also used to confirm the measurements. This is because the method has a much higher signal to noise ratio.

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In conclusion, the InnerVision MRI extremity scanner meets the performance specifications claimed.

## 8. OTHER INFORMATION REQUIRED BY FDA

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# Appendix A

## Equivalency Information

This information has been obtained from a recent report by ECRI.

IMRI/FDANICHE/1/1/001

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Appendix A

Comparison of Esaote Artoscan and InnerVision Niche

| Model | Esatote/Lunar Artoscan | Innervision/Vision Ortho 8000 |
| --- | --- | --- |
| Clinical application | Extremities | Extremities |
| Magnet type | Permanent | Permanent |
| Field Strength | 0.18T | 0.17T |
| 5 Gauss Fringe Field m | 0.6/0.28 | 0.3/0.3 |
| Shimming | Passive | Passive/Active |
| Gradient Subsystem mT/m Risetime to 10mT/m msec | 10/0.5 | 15/0.5 |
| Computer System | PC DX2, 66 | 2 x PC Pentium 100 MHz |
| Memory Size (MB) | 32 | 16+16 |
| Array Processor | DSP 25 Mflops | DSP Dalanco Spry Model 500 |
| Storage Media | MOD | MOD, Tape |
| No. Images Stored | 5,000 | 5,000 |
| Imaging Modes | | |
| Single | Yes | Yes |
| MultiSlice | Yes | Yes |
| Volume Study | Yes | Optional |
| Other | 3 Plane Scout View | 3 Plane Scout View |
| Reconstruction time | | |
| Single Slice (sec) | 1.5 | 5 |
| Multi Slice (sec) | 1.5 | 5 |
| Volume Study | 1.5 | 20/slice average |
| Cardiac Gating | NA | NA |
| Respiratory Gating | NA | NA |
| Angiography | NA | NA |
| Spectroscopy | NA | NA |
| Pulse Sequences | SE, Multiple SE, GE, IR, STIR, 3D, TSE, TME, HSE | SE, Multiple SE, GE, IR, STIR, 3D |
| Repetition Time (msec) | 50-5000SE, 40-5000 GE, 260-5000 IR, 100-4000 STIR | 50-5000SE, 35-5000 GE, 100-5000 IR |
| Echo Time (msec) | 18-120 SE, 12-34 GE, 18-34 IR, 12-120 TSE | 20-100 SE, 5 GE, 20 IR |
| Inversion Time (msec) | 50-800 | 25-999 |
| Slice Thickness mm | 2-10 0.5 incr 2D, 0.8 - 10 0.1 incr 3D | 2 - 10 1 incr 2D, 1-10 1 incr 3D |
| FOV mm | 100 - 200 | 80 - 200 |
| Displayed FOV | 110 max Increments of 10 | 200 max increments of 1 |
| FOV offsets | NA | NA |
| Scan Orientations | Transverse, coronal, sagittal, oblique, compound oblique | Transverse, coronal, sagittal, oblique |
| Measuring Matrix | 128x128 to 256x256 2D 128x128x8 to 256x256x128 3D | 64x256 to 256x256 2D 64x256x16 to 256x256x16 3D incr 1 in phase |
| Display Matrix | 254x238, 510x478 | 256x256, 512x512 |
| Pixel Intensity | 0-4095 | 0.255 |
| Spatial Resolution | 0.4 mm | 0.5 |
| Coils | Knee 2 Sizes, Extremity | Arm Coil, Leg Coil, 12 cm Loop, 18 cm Loop |
| Bore Diameter W x H cm | 16 x 33.6 | 20 x 75 |
| Bore Features | Self centring mechanism, internal RF shield, Leg-locking device | Self centring mechanism |
| Cooling System | Not required | Air Conditioning Control +/- 1C |
| Cryogens | NA | NA |
| Magnet Weight | 1000 | 500 |
| HxWxD cm | 120x73x52 | 118x51x52 |
| Dicom 3.0 | Optional | From 3rd Party |
| Power Requirements | | |
| Line Voltage | 110 | 110/240 |
| kVA | 1.3 | <3 |
| AC BTU | 4500 | <10,000 |
| Sitting Requirement ft2 | <100 | <100 |
| RF shielding | Integral | Modular screened room |