ARTOSCAN M
Device Facts
| Record ID | K963262 |
|---|---|
| Device Name | ARTOSCAN M |
| Applicant | Biosound, Inc. |
| Product Code | LNH · Radiology |
| Decision Date | Mar 28, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
Indications for Use
The ARTOSCAN M is intended for diagnostic nuclear magnetic imaging of the knee, leg, ankle, foot, hand, wrist forearm and elbow. The device produces transverse, sagittal, coronal and oblique cross-sectional images displaying the internal structure of the anatomy being imaged.
Device Story
ARTOSCAN M is a dedicated extremity MRI system for imaging limbs (knee, leg, ankle, foot, hand, wrist, forearm, elbow). It utilizes a ferrite permanent magnet (0.18T) to generate cross-sectional images. The system features a modular design, integrated Faraday cage, and self-centering coils to minimize limb movement. Patients remain outside the gantry, reducing claustrophobia. It supports various pulse sequences (SE, GRE, IR, STIR, TSE, MT, FS) and includes kinematic devices for stress/dynamic examinations of knees and wrists. Operated by clinicians in fixed or mobile sites, the system provides image acquisition and processing via a Pentium-based console. Output images assist physicians in diagnosing musculoskeletal pathologies. Upgrades from the original ARTOSCAN are supported.
Clinical Evidence
Bench testing only. Imaging performance parameters were measured following NEMA standard methods. Safety parameters were measured following IEC 601-2-33 rules. Adaptive image filters underwent a validation protocol by clinical users with positive results.
Technological Characteristics
Ferrite permanent magnet (0.18T static field). Modular gantry with integrated Faraday cage. Solenoidal and quadrature coils with automatic clutch identification. Pentium 100 MHz CPU, 32 MB RAM, 2 GB HDD. Connectivity via Ethernet (DICOM, TCP/IP) and modem. Complies with EN 60601-1, IEC 601-2-33, and MDD 93/42/EEC. Software includes adaptive filtering and 3D reconstruction capabilities.
Indications for Use
Indicated for diagnostic nuclear magnetic imaging of the knee, leg (thigh excluded), ankle, foot, hand, wrist, forearm, and elbow in patients requiring cross-sectional anatomical 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 ARTOSCAN (K931022)
- MRI Device Corp. (K931008)
- Hitachi MRP-7000 (K911667)
- Medical Advances, Inc. (K934396)
- Siemans Magnetom (K935661)
- Hitachi NW 5000 (K911642)
- Philips Gyroscan (K940534)
- Resonex Kinematic MRI (K924154)
- Magna Lab (K940849)
- Hitachi Mobile NW 7000 (K920159)
Reference Devices
- Advanced Mammography System AURORA (K950837)
Submission Summary (Full Text)
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BIOSOUND ESAOTE
Biosound, Inc.
8000 Castleway Drive
Indianapolis, IN 46250
317 849.1793
800 428.4374
fax 317 841.8616
http://www.biosound.com/
MAR 28 1997
# Safety and Effectiveness Summary
The following safety and effectiveness summary has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR ¶807.92(a).
807.92(a)(1)
## Submitter Information
Wayne Nethercutt Director, Regulatory Affairs
7990 Castleway Drive
Indianapolis, IN 46250
Phone: (317) 849-1793
Facsimile: (317) 841-8616
Contact Person: Wayne Nethercutt
Date: 08-16-96
Our mission is to enhance the quality of life by providing diagnostic medical equipment and services of superior quality and value for the early detection and management of disease.
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807.92(a)(2)
Trade Name: ARTOSCAN M
Common Name: Magnetic Resonance Imaging Device
Classification Name(s): System, Nuclear Magnetic Resonance Imaging
Classification Number: 892.1000
807.92(a)(3)
## Predicate Device(s)
- Esaote ARTOSCAN K931022 MRI Device Corp. K931008
- Hitachi MRP-7000 K911667 Medical Advances, Inc. K934396
- Siemans Magnetom K935661 Hitachi NW 5000 K911642
- Philips Gyroscan K940534 Resonex Kinematic MRI K924154
- Magna Lab K940849 Hitachi Mobile NW 7000 K920159
Additional Substantial Equivalence information is provided in the attached Substantial Equivalence Comparison Table.
807.92(a)(4)
## Device Description
ARTOSCAN M is an MRI system designed specifically to image the extremities: leg (thigh excluded), knee, ankle and foot, forearm, elbow, wrist and hand. A number of modifications have been designed to enhance the functioning of the ARTOSCAN system previously cleared under K931022. The modifications will collectively be referred to as the ARTOSCAN M. Once the modifications described herein are cleared, the ARTOSCAN M will be marketed in place of the original ARTOSCAN device. The difference in the name is very subtle and consists of adding an M after the ARTOSCAN name. Existing ARTOSCAN units (original configuration) can be upgraded to the ARTOSCAN M if the user so desires.
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No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act. The equipment complies with EN 60601 - 1, EN 60601-1-1, IEC 601-2-33, EN 60601-1-2. The equipment is certified according to MDD 93/42/EEC (CE mark). ESAOTE meets the quality standard requirements of, UNI EN ISO 9001 (CISQ CSQ 9120.ESOI) and UNI CEI EN 46001 (CISQ CSQ NffiD 9124.ES03). All phases regarding design, prototyping, manufacturing, quality tests, etc. related to ARTOSCAN M and ARTOSCAN upgrades are performed according to the above mentioned requirements. Safety parameters are measured following the IEC 601-2-33 rules. Imaging performance parameters are measured following the proper NEMA standard methods.
## Summary of ARTOSCAN M Features:
- A modular structure allows a great flexibility in location.
- A compact magnet, specifically designed for the NM imaging of limbs, provides the power and field uniformity required for quality imaging with a negligible fringe field.
- An Integrated Faraday Cage eliminates any need for external shielding.
- A unique coupling between gantry and coils provides an accurate Self-Centering Mechanism. The self-centering coils optimize imaging and restrict involuntary limb movements.
- For examination of knees and wrists under dynamic and stress conditions, special Cinematic Devices are provided.
- The ARTOSCAN M user interface is simple and very complete. For routine limb studies, pre-defined imaging protocols guide the user in optimizing scan parameters and minimize operator training. The ARTOSCAN software provides all standard image acquisition and processing functions in a user-friendly format.
- The patient is outside of the gantry, except for limb being examined, thus enhancing patient comfort and eliminating any claustrophobic reaction.
## 807.92(a)(5)
### Intended Use(s)
The ARTOSCAN M is intended for diagnostic nuclear magnetic imaging of the knee, leg, ankle, foot, hand, wrist forearm and elbow. The device produces transverse, sagittal, coronal and oblique cross-sectional images displaying the internal structure of the anatomy being imaged.
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# Substantial Equivalence Comparison Table
## Imaging System
| Characteristics | ARTOSCAN | ARTOSCAN M | Comments |
| --- | --- | --- | --- |
| Clinical use | Knee, leg, ankle, foot hand wrist, forearm, elbow | Knee, leg, ankle, foot, hand wrist, forearm, elbow | Unchanged |
| Data acquisition modes | Spin warp 2D/3D
Spin warp 2D/3D
Half Scan
Half Echo | Two further acquisition modes are now included: the Half Scan mode allows to speed up the acquisition time while the Half Echo mode permits to shorten the echo time and improve the image contrast. Both techniques are universally known by the literature and used on commercial MRI scanners. See for instance the Hitachi MRP-7000 (K911667) | |
| Pulse sequences | Multiplanar Ortho-Scout
Spin Echo (SE) | Multiplanar Ortho-Scout T1-weighted Spin Echo T2-weighted Spin Echo (SET2) | The set of available sequences has been enlarged to cover what is now usually offered on standard MRI systems and is required by physicians to improve their clinical activity. |
| | Multiple Spin-Echo (ME)
Gradient Echo (GRE)
Inversion Recovery (IR) | Multiple Spin-Echo (ME)
Gradient Echo (GRE - GRE3D)
Inversion Recovery (IR) | |
| | | Short T1 Inversion Recovery (STIR) | The STIR sequence is an FR sequence, where the minimum T1 is 50 ms, providing fat-suppressed T1-weighted images |
| | | Half Echo T1-weighted SE (SETIHE) | SE sequence using the Half Echo technique aimed at obtaining strongly T1-weighted images |
| | | Half Fourier T1-weighted SE (SET1HF) | SE sequence using the Half Fourier technique aimed at reducing the acquisition time |
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# Imaging System
| Characteristics | ARTOSCAN | ARTOSCAN M | Comments |
| --- | --- | --- | --- |
| | | 7'urbo T2-weighted SE (TSE)
Turbo ME (TME) | TSE and TME are based on the Half Fourier technique, therefore are quicker than the standard SE and ME sequences. The Half Fourier technique and the contribution of different echoes are optimized to obtain proton density and T2-weighted images. The contrast provided by those sequences is equivalent to the contrast provided by standard proton density and T2-weighted sequences. See Siemens Magnetom Open (K935661) |
| | | Turbo GRE (TGRE)
standard GRE | This is an optimized version of the |
| | | Turbo GRE3D (TGRE3D) | The TGRE3D sequence is an optimized version of the GRE3D. See Philips Gyroscan T I O-NT where the technique is mentioned as Kspace shutter (K940534) |
| | | Magnetization Transfer Contrast
(MT GRE, MT GRE3D) | The MT allows to change the contrast provided by any sequence. In particular, with regard to articular applications, it allows to increase the contrast fat/muscle and cartilage/synovia. MT is available on other commercial MR scanners, typically for angiographic applications, like for instance Philips Gyroscan TIO-T(K940534). |
| | | Fat Suppression (FS) | The FS sequence uses the 3 points Dixon technique. It is available on Advanced Mammography System AURORA (K950837) |
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Safety and Effectiveness Summary
ARTOSCAN M
Biosound, Inc.
# General
| Characteristics | ARTOSCAN | ARTOSCAN M | Comments |
| --- | --- | --- | --- |
| Patient comfort | The patient is completely out of the magnet, except the examined portion, eliminating claustrophobia and other related reactions during the examination | The patient is completely out of the magnet, except the examined portion, eliminating claustrophobia and other related reactions during the examination | |
| Network capability(optional) | Ethernet local network | * Ethernet thin wire local connection through DICOAF protocol
* Ethernet thin wire local connection through TCP/IP protocol
* Remote connection through modem | With the present release, the DICOM protocol is available (at the moment DICOM is the most accredited communication standard) and both local and remote connections are provided. |
| Additional console (optional) | n.a. | Includes all the image processing functions available on the main system. Configuration: CPU.- Pentium I 00 Mhz
Main memory: 32 MR
3-1/4 " Hard disk: 2 GB | |
| Type of installation | Fixed site ("Permanently installed" according to IEC 601-1) | Fixed site ("Permanently installed" according to IEC 601-1)
Mobile | ARTOSCAN and ARTOSCAN M may be installed also as mobile systems. See for instance HITACHI Mobile NW-7000 (K920159) |
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# Imaging System
| Characteristics | ARTOSCAN | ARTOSCAN M | Comments |
| --- | --- | --- | --- |
| Scan parameters: | TR:
SE: 50 - 5000 ms.
IR: 200 -5000 ms
GRE: 40 - 5000 ms | TR
SET 1 50 - 5000 ms., step 10 ms
SET2: 200 - 5000 ms., step 10 ms
NE: 200 - 5000 ms., step 10 ms
GRE: 40 - 5000 ms., step 10 ms
GRE3D: 40 - 5000 ms., step 10 ms
IR: 260 - 5000 ms., step 10 ms
STIR: 90 - 5000 ms., step 10 ms
SETIHE: 50 - 5000 ms., step 10 ms
SETIHF- 50 - 5000 ms., step 10 ms
TSE: 200 - 5000 ms., step 10 ms
200 - 5000 ms., step 10 ms
TGRE: 30 - 5000 ms., step 5 ms
TGRE3D: 30 - 5000 ms., step 5 ms
MTGRE: 50 - 5000 ms., step 10 ms
MTGRE3D: 50 - 5000 ms., step 10 ms
FS: 70 - 5000 ms., step 10 ms
STIR-GRE: 40 - 5000 ms., step 10 ms | Parameters have been optimized. |
| | T'E
SE: 18, 21, 26, 40, 80, 120,150 ms
GRE: 10 ms | TE
SET1: 18 -34 ms., step 2 ms
SET2: 80 - 120 ms., step 10 ms
Nffi: 1 st echo 40 ms; 2nd echo 80 and 100 ms
GRE: 12 - 24 ms., step 2 ms
GRE3D: 14 - 24 ms., step 2 ms
IR: 18 - 34 ms., step 2 ms
STIR: 18 - 34 ms., step 2 ms
SET UM: 12 - 24 ms., step 2 ms
SET I HF: 18 - 34 ms., step 2 ms
TSE:80 - 120 ms., step 10 ms
1st echo 34 ms; 2nd echo 90 Ms
TGRE: 8 - 24 ms., step 1 ms
TGRE3D:8 - 24 ms., step 1 ms
MT-GRE:12 - 24 ms., step 2 ms
MT-GRE3D: 14 - 24 ms., step 2 ms
FS:30 ms
STIR-GRE: 12 - 24 ms., step 2 ms | |
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# Imaging System
| Characteristics | ARTOSCAN | ARTOSCAN M | Comments |
| --- | --- | --- | --- |
| | TI
IR: 100 - 800 ms | TI
IR: 200 - 800 ms., step 10 ms
STIR: 50 - 200 ms., step 5 ms
STIR-GRE: 50 - 200 ms., step 5 Ms | |
| | FA
GRE: IO'- 90' | FA
GRE: IO' - 120', step 5'
GRE3D: IO' - 120', step 5'
MT GRE: IO'- 120', step 5'
M'CGRE3D: IO' - 120', step 5-
TGRE: 10' - 90', step 5'
TGRE3D: IO'- 90', step 5'
STIR-GRE: 10' - 120', step 5' | |
| Receiver coils | Solenoidal coils
Lowerjoint: 16x18 cm 0
Lower joint (that can be opened): 14 cm 0
Ankle (that can be opened): 12x 16 cm 0
Upperjoint: 10 cm 0 | Solenoidal coils
Large knees: 14.5x 19 cm 0
Knee/Ankle: 13.1x 14.5 cm 0
Upperjoint: 12 cm 0
examination.
*Oudature coils (optional)*
Han Wrist: 8x 11.5x14.5 cm
Ankle/Foot.- 9.5x15x23 cm 0
Knee: 12.9x14.5x15.5 cm 0 | Solenoidal coils have been changed a little bit in size and design to better fit the anatomic regions under
No coils that can be opened are present in the actual version because of the easiness in positioning the standard coils.
*Quadrature coils, usually present on most of commercial NMI scanners, have been included to further increase the S/N ratio and the image quality on the whole.*
See for instance MRI Devices Corp. - QD wrist and hand coil (K931008) and Medical Advances, Inc. - QD Lower extremity coil (K934396)
All the new coils may be automatically identified through a clutch system, so avoiding possible mistakes in the setup session. |
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Image Processing / Display System
| Characteristics | ARTOSCAN | ARTOSCAN M | Comments |
| --- | --- | --- | --- |
| Central processing unit | CPU: 486 33 MHz
256 KB cache memory
Main memory: 16 MB;
5-1/4" Hard disk: 650 MB
Control processor: 12.5
MIPS - 0.5 NM on board
Digital Signal Processor: 25 Mflops -
0.7 MB on board | CPU: Pentium 100 MHz
Main memory: 32 MB;
512 KB cache memory
3-1/4" Hard disk: 2 GB
Control processor: 16.7 MIPS
0.5 NM on board
Digital Signal Processor: 33 Mflops
* 5 MB on board (standard configuration)
* 65 MB on board (optional) | Improved |
| Optical disk | 5-1/4" R/W 650 MB (optional) | 5-1/4" R/W 1.3 GB (optional) | Improved |
| Monitor | 15" B/W 640x480 | 15" B/W 640x4g0 | Unchanged |
| Gray scale | 4096 gray levels (O..4095) | 4096 gray levels (O..4095) | Unchanged |
| Image reconstruction time (256x256) | 1.5 sec./img
simultaneous display is possible (+ 1.3 sec. to display a 512x512 image or + 0.4 sec. to display a 256x256 image) | 2D
1.4 sec./img
simultaneous display is possible (+ 1 sec. to display a 512x512 image or + 0.3 sec. to display a 256x256 image)
3D
≈3 min. for reconstructing a 192x160x96 volume, reslicing three scout images and saving the volume (256x256x96 bit/voxel)
≈30 sec. with the 3D Turbo option enabled | Improved. In the present release, 3D raw data may be saved and permanently stored to be resliced later, even from a different console. |
| Display matrix | 510x478,254x239 | 510x478,254x238 | Uchanged |
| Image filtering | Edge enhancement (Off-line)
Noise cleaning (Off-line) | Adaptive filters (optional).
In case the user chooses the on-line option, a specific filter in two variants (internally named A and B) may be applied automatically by the system, according to the acquisition parameters characterizing the image to be filtered
The other way they may be applied off-line by the user when desired. In this case, the original images are always at the user's disposal for possible comparisons. | The present filters are part of the most recent filtering packages to improve the image quality. They underwent a validation protocol carried out by clinical users, that ended with positive results. |
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# Magnetic / Gradients System
| Characteristics | ARTOSCAN | ARTOSCAN M | Comments |
| --- | --- | --- | --- |
| Type of magnet | Ferrite permanent magnet | Ferrite permanent magnet | Unchanged |
| Static field strength | 0.18T (transversal) | 0.18T (transversal) | Unchanged |
| Stray field | 5G line at 65 cm maximum from the magnet | 5G line at 65 cm maximum from the magnet | Unchanged |
| Gradients strength | 10 mT/m | 10 mT/m | Unchanged |
| Gantry opening | 160 x 340 mm | 160 x 336 mm | |
| Magnetic system weight | 900 Kg | 1000 Kg | |
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General
| Characteristics | ARTOSCAN | ARTOSCAN M | Comments |
| --- | --- | --- | --- |
| Size | 2 m2 footprint | 2 m2 footprint | The modularity concept introduced with ARTOSCAN M allows a greater flexibility in siting. If desired by the user, also an ARTOSCAN system may be separated in modules so allowing the same flexibility than the "M" version. |
| RF shielding | Self contained RF
Shielding (up to 50 dB@V/m)
* External shielding (up to 100 dBu V/m) (optional) | Self contained RF
Shielding cloth cover (up to 90 dBuV/m) (optional)
* External shielding (up to 110 dBuV/m) (optional) | A different technical solution has allowed to achieve better results in the standard configuration.
A shielding cloth cover has been added as an intermediate solution between the standard configuration and an external shielding for those sites that are a little bit noisy than the usual ones. The same solution had been already adopted by HITACHI in the NW-5000 (5 1 0(k) accession number: K911642), |
| Patient positioning | Automatically, by the coil and a proper mechanical gantry structure. The coil is pushed into the gantry manually. | Automatically, by the coil and a proper mechanical gantry structure. The coil is pushed into the gantry manually, | Unchanged |
| Limb fastening | All coils are especially designed to fasten in a proper position the examined area. As for the knee, in particular, a special locking device is provided to fasten the foot and the leg to allow the control of both knee extension/flexion movements and intra- and extra-rotations. | All coils are especially designed to keep the examined limb in the proper position.
Special locking devices are provided for kinematic exams of leg and wrist (optional). | A special device for the wrist has been added to study those pathologies that may benefit a kinematic examination (e.g. carpal instability). See for instance Resonex - Kinematic MRI moviemaker (K924154) |
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General
| Characteristics | ARTOSCAN | ARTOSCAN M | Comments |
| --- | --- | --- | --- |
| Patient comfort | The patient is completely out of the magnet, except the examined portion, eliminating claustrophobia and other related reactions during the examination | The patient is completely out of the magnet, except the examined portion, eliminating claustrophobia and other related reactions during the examination | |
| Network capability(optional) | Ethernet local network | * Ethernet thin wire local connection through DICOAF protocol
* Ethernet thin wire local connection through TCPIP protocol
* Remote connection through modem | With the present release, the DICOM protocol is available (at the moment DICOM is the most accredited communication standard) and both local and remote connections are provided. |
| Additional console (optional) | n.a. | Includes all the image processing functions available on the main system. Configuration: CPU - Pentium I 00 Mhz
Main memory: 32 MR
3-1/4 " Hard disk: 2 GB | |
| Type of installation | Fixed site ("Permanently installed" according to IEC 601-1) | Fixed site ("Permanently installed" according to IEC 601-1)
Mobile | ARTOSCAN and ARTOSCAN M may be installed also as mobile systems. See for instance HITACHI Mobile NW-7000 (K920159) |
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