ARTOSCAN S

K981358 · Biosound Esaote, Inc. · LHN · Jul 13, 1998 · Radiology

Device Facts

• Record ID: K981358
• Device Name: ARTOSCAN S
• Applicant: Biosound Esaote, Inc.
• Product Code: LHN · Radiology
• Decision Date: Jul 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Artoscan S is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spinspin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

Device Story

Artoscan S is a dedicated extremity MRI system using a 0.18 T permanent Neodymium alloy magnet. It captures MR signals from limbs (hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist, hand) via solenoidal or DPA receiver coils. The system transforms these signals into cross-sectional images (transverse, sagittal, coronal, oblique) based on proton density and relaxation times (T1, T2). Operated by clinicians in a fixed installation, the device features a large gantry opening to reduce patient claustrophobia. Output images are displayed on a 17-inch monitor and used by physicians to visualize internal limb structures for diagnostic purposes. The system supports DICOM3 networking for printing and image transmission.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, technical specifications, and comparison of imaging parameters (e.g., pulse sequences, gradient strength, FOV) against predicate devices.

Technological Characteristics

0.18 T 'C'-shaped Neodymium alloy permanent magnet; 20 mT/m gradient strength; 0.5 msec rise time; solenoidal and DPA (quadrature) receiver coils; DICOM3 connectivity; Pentium 200 MHz CPU; 32 MB RAM; 2.6 GB hard disk; 640 MB optical disk; self-contained RF shielding.

Indications for Use

Indicated for diagnostic MRI of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist, and hand in patients requiring cross-sectional imaging of these anatomical regions.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Esaote Artoscan M (K963262)
• Hitachi AIRIS (K945155)
• Elscint PRIMA 1TG (K970990)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUL 1 3 1898

K981358

Safety and Effectiveness Summary Artoscan S Biosound Esaote

# Safety and Effectiveness Summary

The following safety and effectiveness summary has been prepared pursuant to The following surcey and commaries specified in 21CFR 807.92(a).

807.92(a)(1)

# Submitter Information

Submitter Information

| Colleen Hittle, Official Correspondent |
|----------------------------------------|
| 8000 Castleway Drive |
| Indianapolis, IN 46250 |

| Phone: | [phone] |
|------------|----------------|
| Facsimile: | [phone] |

| Contact Person: | Colleen Hittle |
|-----------------|----------------|
| Date: | March 25, 1998 |

807.92(a)(2)

FDA/CDRH/ODE/DMC

14 APR 98 09 57

Artoscan S Trade Name: Magnetic resonance diagnostic device Common Name: System, Nuclear Magnetic Resonance Imaging Classification Name(s):

90LNH Classification Number:

807.92(a)(3)

| Esaote | Artoscan M | K963262 |
|---------|------------|---------|
| Hitachi | AIRIS | K945155 |
| Elscint | PRIMA 1TG | K970990 |

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

Predicate Device(s)

{1}------------------------------------------------

#### Imaging System 1.

ERR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

,在

| Characteristic | ARTOSCAN S | AIRIS<br>K945155 | Comments |
|----------------|---------------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Clinical use | Knee, leg, ankle, foot,<br>hand, wrist, forearm,<br>elbow, shoulder, hip. | Whole body, central<br>nervous system and<br>orthopaedic regions. | Two new joints<br>(hip and<br>shoulder) have<br>been introduced<br>for examination. |
| Field of view | From 100 up to 300 mm,<br>step 10 mm (140 mm are<br>displayed). | From 50 up to 350 mm in<br>diameter. | A larger FOV<br>has been realized<br>to better cover<br>the anatomical<br>parts to be<br>imaged. |

#### 1. Magnetic System

| Characteristic | ARTOSCAN S | AIRIS<br>K945155 | Comments |
|---------------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------|
| Type of magnet | "C" shaped Neodymium<br>alloy permanent magnet. | "C" shaped Neomax™<br>(Neodymium alloy)<br>permanent magnet. | |
| Static field<br>strength | 0.18 T (perpendicular to<br>patient's body). | 0.3 T (perpendicular to<br>patient's body). | |
| Fringe field | 5 G line at 1.4 m<br>maximum from the centre<br>of the magnet. | 5 G line at 2.5 m<br>maximum from the centre<br>of the magnet. | |
| Gantry opening | 620 mm x 240 mm (w x h) | 1000 x 380 mm(w x h) | |
| Magnetic<br>system weight | 1700 kg | 10000 kg | |

#### Radiofrequency System 1.

| Characteristic | ARTOSCAN S | AIRIS<br>K945155 | Comments |
|------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Solenoidal<br>receiver coils | Shoulder/Knee Coil<br>17.5x7.6x14.7 cm<br>Hip Coil<br>20 x 23 x 14 cm<br>(internal dimensions: w x d x h) | Large joint Coil (shoulder, knee)<br>18.4x23 cm wxh<br>Flexible body Coil (hip and other regions)<br>20x150 cm wxd | The technology of the solenoidal (or linear) coils is unchanged compared to the technology used for the ARTOSCAN M coils. Coils with different shapes |

{2}------------------------------------------------

| Characteristic | ARTOSCAN S | AIRIS<br>K945155 | Comments |
|----------------|------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | | | have been<br>developed to<br>adapt to the<br>geometrical<br>characteristics of<br>the gantry and to<br>the new limbs to<br>examine. |
| RF power | up to 600 W peak pulse | up to 5000 W peak pulse | |

#### Patient Positioning 1.

、

| Characteristic | ARTOSCAN S | AIRIS K945155 | Comments |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Patient comfort | The large magnet opening<br>and the device design, that<br>allows the patient to be<br>almost completely out of<br>the magnet, except the<br>examined portion, virtually<br>eliminate claustrophobia<br>and other related reactions<br>during the examination. | The large magnet opening<br>virtually eliminates the<br>anxiety and claustrophobia<br>often experienced by<br>patients in the narrow bore<br>of conventional MR imag-<br>ing systems. | |
| Patient<br>positioning | An adjustable couch is<br>used to position the<br>patient's limb inside the<br>gantry.<br>The couch is pushed into<br>the gantry manually. | An adjustable motorized<br>table is used to position the<br>patient inside the gantry. | The same<br>positioning<br>philosophy as<br>ARTOSCAN M,<br>suitable for the<br>new gantry<br>shape, has been<br>used for<br>ARTOSCAN S. |

:

{3}------------------------------------------------

#### Installation Area Conditions 1.

: 上一篇:

,

| Characteristic | ARTOSCAN S | AIRIS<br>K945155 | Comments |
|----------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------|
| Area necessary | 3.7 m x 3.7 m | 4 m x 5 m (gantry and<br>patient table)<br>4 m x 2.5 m (operator<br>console, MRI unit and<br>other components) | |
| RF shielding | Self contained RF<br>shielding (up to 30<br>dBμV/m).<br>External shielding (up to<br>100 dBμV/m). | The scan room must be RF<br>shielded to 60 dB. RF<br>noise inside the scan room<br>should meet 0.5-30 MHz,<br>0 dBμV/m or less. | |

#### 2. Magnetic System

| Characteristic | ARTOSCAN S | PRIMA 1TG<br>K970990 | Comments |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gradient<br>strength | 20 mT/m | whole-body set<br>21 mT/m | With higher<br>gradient strength<br>it is possible to<br>minimize at the<br>same time FOV<br>and slice<br>thickness, also<br>for sequences<br>with very short<br>TE, improving<br>the spatial<br>resolution. |
| | | | |
| Rise time | 0.5 msec from 0 to 20 mT<br>or from -20 to 0 mT | 0.5 msec to full amplitude<br>supplementary set<br>30 mT/m<br>0.41 msec to full amplitude | |
| | | | |
| Characteristic | ARTOSCAN S | ARTOSCAN M<br>K963262 | Comments |
| Data<br>acquisition<br>modes | Spin warp 2D/3D<br>Half Scan<br>Half Echo | Spin warp 2D/3D<br>Half Scan<br>Half Echo | Unchanged |
| Pulse sequences | Multiplanar Ortho-Scout<br>T1-weighted Spin Echo<br>(SET1)<br>T2-weighted Spin Echo<br>(SET2)<br>Multiple Spin-Echo<br>(MEDE)<br>Gradient Echo (GE)<br>Inversion Recovery (IR)<br>Short TI Inversion<br>Recovery (STIR)<br>Half Echo T1-weighted<br>Spin Echo (SET1HE)<br>Half Fourier T1-weighted<br>Spin Echo (SET1HF)<br>Turbo T2-weighted Spin-<br>Echo (TSE)<br>Turbo Multiple Spin-Echo<br>(TME)<br>Turbo Gradient Echo<br>(TGE)<br>3D Gradient Echo (GE3D)<br>Turbo 3D T1-weighted<br>Gradient Echo (T3D_T1)<br>Turbo 3D T2-weighted<br>Gradient Echo (T3D_T2)<br>Short TI Inversion<br>Recovery Gradient Echo<br>(GEFS)<br>Magnetization Transfer<br>(GEMT)<br>3D Magnetization Transfer<br>(GE3DMT) | Multiplanar Ortho-Scout<br>T1-weighted Spin Echo<br>(SET1)<br>T2-weighted Spin Echo<br>(SET2)<br>Multiple Spin-Echo<br>(MEDE)<br>Gradient Echo (GE)<br>Inversion Recovery (IR)<br>Short TI Inversion<br>Recovery (STIR)<br>Half Echo T1-weighted<br>Spin Echo (SET1HE)<br>Half Fourier T1-weighted<br>Spin Echo (SET1HF)<br>Turbo T2-weighted Spin-<br>Echo (TSE)<br>Turbo Multiple Spin-Echo<br>(TME)<br>Turbo Gradient Echo<br>(TGE)<br>3D Gradient Echo (GE3D)<br>Turbo 3D T1-weighted<br>Gradient Echo (T3D_T1)<br>Turbo 3D T2-weighted<br>Gradient Echo (T3D_T2)<br>Short TI Inversion<br>Recovery Gradient Echo<br>(GEFS)<br>Magnetization Transfer<br>(GEMT)<br>3D Magnetization Transfer<br>(GE3DMT) | Unchanged |
| Slice thickness | 2D FT: from 2 mm to 10<br>mm, step 0.5 mm<br>3D FT: from 0.6 mm to 10<br>mm, step 0.1 mm | 2D FT: from 2 mm to 10<br>mm, step 0.5 mm<br>3D FT: from 0.6 mm to 10<br>mm, step 0.1 mm | Unchanged |
| Interslice<br>spacing | Not necessary: contiguous<br>slicing is available | Not necessary: contiguous<br>slicing is available | Unchanged |
| Characteristic | ARTOSCAN S | ARTOSCAN M K963262 | Comments |
| Slice orientation | Transverse<br>Sagittal<br>Coronal<br>Oblique<br>Multislice packages | Transverse<br>Sagittal<br>Coronal<br>Oblique<br>Multislice packages | Unchanged |
| Acquisition matrix | 2D FT: from 192x128 up to 256x256; phase encoding step 8<br>3D FT: from 192x128 up to 256x256; slice encoding from 8 to 128, step 8; phase encoding step 8 | 2D FT: from 192x128 up to 256x256; phase encoding step 8<br>3D FT: from 192x128 up to 256x256; slice encoding from 8 to 128, step 8; phase encoding step 8 | Unchanged |
| Spatial resolution | Up to 0.4 mm. | Up to 0.4 mm. | Unchanged |
| Multi-slice | 128 slices max (for each echo) | 128 slices max (for each echo) | Unchanged |
| Multi-echo | 2 echoes max | 2 echoes max | Unchanged |
| Scan parameters | TR<br>SET1: 50 ~ 5000 ms, step 10 ms<br>SET2: 200 ~ 5000 ms, step 10 ms<br>MEDE: 200 ~ 5000 ms, step 10 ms<br>GE: 60 ~ 5000 ms., step 10 ms<br>IR: 260 ~ 5000 ms, step 10 ms<br>STIR: 100 ~ 5000 ms, step 10 ms<br>SET1HE: 50 ~ 5000 ms, step 10 ms<br>SET1HF: 50 ~ 5000 ms, step 10 ms<br>TSE: 200 ~ 5000 ms, step 10 ms<br>TME: 200 ~ 5000 ms., step 10 ms<br>TGE: 30 ~ 5000 ms, step 5 ms<br>GE3D: 40 ~ 5000 ms, step 10 ms<br>T3D_T1: 25 ~ 5000 ms, step 5 ms | TR<br>SET1: 50 ~ 5000 ms, step 10 ms<br>SET2: 200 ~ 5000 ms, step 10 ms<br>MEDE: 200 ~ 5000 ms, step 10 ms<br>GE: 60 ~ 5000 ms., step 10 ms<br>IR: 260 ~ 5000 ms, step 10 ms<br>STIR: 100 ~ 5000 ms, step 10 ms<br>SET1HE: 50 ~ 5000 ms, step 10 ms<br>SET1HF: 50 ~ 5000 ms, step 10 ms<br>TSE: 200 ~ 5000 ms, step 10 ms<br>TME: 200 ~ 5000 ms., step 10 ms<br>TGE: 30 ~ 5000 ms, step 5 ms<br>GE3D: 40 ~ 5000 ms, step 10 ms<br>T3D_T1: 25 ~ 5000 ms, step 5 ms | Unchanged |
| Characteristic | ARTOSCAN S | ARTOSCAN M<br>K963262 | Comments |
| | T3D_T2 : 35 ~ 5000 ms,<br>step 1 ms | T3D_T2 : 35 ~ 5000 ms,<br>step 1 ms | |
| | GEFS: 70 ~ 5000 ms., step<br>10 ms | GEFS: 70 ~ 5000 ms., step<br>10 ms | |
| | GEMT: 40 ~ 5000 ms,<br>step 5 ms | GEMT: 40 ~ 5000 ms,<br>step 5 ms | |
| | GE3DMT: 45 ~ 5000 ms,<br>step 5 ms | GE3DMT: 45 ~ 5000 ms,<br>step 5 ms | |
| TE | SET1: 16~34 ms, step 2 ms | SET1: 18 ~ 34 ms, step 2 ms | The sequences<br>are substantially<br>unchanged. For<br>some sequences<br>we used shorter<br>TE, to obtain a<br>more T1-<br>weighted<br>contrast. That is<br>possible thanks<br>the higher<br>gradient strength. |
| | SET2: 80~ 120 ms, step<br>10 ms | SET2: 80~ 120 ms, step<br>10 ms | |
| | MEDE: 1st echo 38 ms;<br>2nd echo 90 ms | MEDE: 1st echo 38 ms;<br>2nd echo 90 ms | |
| | GE: 12 ~ 24 ms, step 2 ms | GE: 12 ~ 24 ms, step 2 ms | |
| | IR: 16 ~ 34 ms, step 2 ms | IR: 18~34 ms, step 2 ms | |
| | STIR: 16 ~ 34 ms, step 2<br>ms | STIR: 18 ~ 34 ms, step 2<br>ms | |
| | SET1HE: 10 ~ 24 ms, step<br>2 ms | SET1HE: 12 ~ 24 ms, step<br>2 ms | |
| | SET1HF: 16 ~ 34 ms, step<br>2 ms | SET1HF: 18 ~ 34 ms, step<br>2 ms | |
| | TSE: 80 ~ 120 ms, step 10<br>ms | TSE: 80 ~ 120 ms, step 10<br>ms | |
| | TME: 1st echo 38 ms; 2nd<br>echo 90 ms | TME: 1st echo 38 ms; 2nd<br>echo 90 ms | |
| | TGE: 8 ~ 24 ms, step 1 ms | TGE: 8 ~ 24 ms, step 1 ms | |
| | GE3D: 8 ~ 24 ms, step 1<br>ms | GE3D: 14~24 ms, step 2<br>ms | |
| | T3D_T1: 8~24 ms, step<br>1 ms | T3D_T1: 8~24 ms, step<br>1 ms | |
| | T3D_T2 : fixed at 16 ms | T3D_T2 : fixed at 16 ms | |
| | GEFS: 8 ~ 24 ms, step 1<br>ms | GEFS: 12 ~ 24 ms, step 2<br>ms | |
| | GEMT: 8 ~ 24 ms, step 1<br>ms | GEMT: 8 ~ 24 ms, step 1<br>ms | |
| | GE3D MT: 8 ~ 24 ms, step<br>1 ms | GE3D MT: 8 ~ 24 ms, step<br>1 ms | Unchanged |
| TI | IR: 200 ~ 800 ms, step 10<br>ms | IR: 200 ~ 800 ms, step 10<br>ms | |
| | STIR: 50~200 ms, step 5<br>ms | STIR: 50~200 ms, step 5<br>ms | |
| Characteristic | ARTOSCAN S | ARTOSCAN M<br>K963262 | Comments |
| | GEFS : 20 ~ 200 ms, step<br>5 ms | GEFS : 20 ~ 200 ms, step<br>5 ms…