Predicate Devices

K931022, K911667, K935661, K940534, K940849

Reference Devices

K931008, K934396, K911642, K924154, K920159

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard MRI system with image processing functions, but there is no mention of AI, ML, or related concepts.

Therapeutic

No
The device is intended for diagnostic imaging, not for treating conditions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states that "The ARTOSCAN M is intended for diagnostic nuclear magnetic imaging." This explicitly indicates its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "MRI system" and describes hardware modifications, indicating it is a physical medical device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the ARTOSCAN M is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states "diagnostic nuclear magnetic imaging of the knee, leg, ankle, foot, hand, wrist forearm and elbow." This describes an imaging system used to visualize internal structures of the body.
Device Description: The description confirms it's an "MRI system designed specifically to image the extremities." MRI is an imaging modality, not a diagnostic test performed on biological samples in vitro (outside the body).
IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The ARTOSCAN M does not process biological specimens.

The ARTOSCAN M is a medical imaging device used for diagnostic purposes, but it falls under the category of in vivo (within the living body) diagnostic imaging, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

892.1000

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Nuclear Magnetic Imaging

Anatomical Site

knee, leg, ankle, foot, hand, wrist forearm and elbow

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K931022, K911667, K935661, K940534, K940849

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K931008, K934396, K911642, K924154, K920159

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.

Summary

0

Image /page/0/Picture/0 description: The image shows the words "BIOSOUND ESAOTE" in a stylized font. The word "BIOSOUND" is in bold, black letters, while the word "ESAOTE" is outlined in black. The letters in "ESAOTE" are also more angular and geometric than the letters in "BIOSOUND".

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 MAR 2 8 1997

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

ﻣﻤﺴﺎ

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.

1

807.92(a)(2)

Trade Name: ARTOSCAN M

Common Name: Magnetic Resonance Imaging Device

Classification Name(s): System, Nuclear Magnetic Resonance Imaging

892.1000 Classification Number:

807.92(a)(3)

Predicate Device(s)

Esaote ARTOSCAN K931022 ●
Hitachi MRP-7000 K911667
Siemans Magnetom K935661
Philips Gyroscan K940534 .
Magna Lab K940849 .

MRI Device Corp. K931008 Medical Advances, Inc. K934396 Hitachi NW 5000 K911642 Resonex Kinematic MRI K924154 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.

2

No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act. The equipment complies with EN 60601-1-1, 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.

3

Substantial Equivalence Comparison Table

Imaging System

Comments ARTOSCAN M ARTOSCAN Characteristics Unchanged Knee, leg, ankle, foot, hand Clinical use Knee, leg, ankle, foot wrist, forearm, elbow hand wrist, forearm, elbow Spin warp 2D/3D Two further acquisition Spin warp 2D/3D Data acquisition modes are now included: the Half Scan modes Half Echo 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) Multiplanar Ortho-Scout The set of available sequences Pulse sequences Multiplanar Orthohas been enlarged to cover Scout T I -weighted Spin Echo

、・

T2-weighted Spin Echo what is now usually offered Spin Echo (SE) on standard MRI systems and (SET2) Multiple Spin-Echo (ME) Multiple Spin-Echo (ME) is required by physicians to improve their clinical activity. Gradient Echo (GRE) Gradient Echo (GRE -GRE3D) Inversion Recovery (IR) Inversion Recovery (IR) Short TI Inversion Recovery The STIR sequence is an FR (STIR) sequence, where the minimum TI is 50 ms. providing fat-suppressed TIweighted images Half Echo TI -weighted SE SE sequence using the Half (SETIHE) Echo technique aimed at obtaining strongly TIweighted images Half Fourier TI -weighted SE SE sequence using the Half Fourier technique aimed at (SETTHF) reducing the acquisition time

4

Characteristics	ARTOSCAN	ARTOSCAN M	Comments
		Turbo 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 T2weighted images. The
contrast provided by those
sequences is equivalent to the
contrast provided by standard
proton density and T2weighted
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)
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 TCPIIP
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 100 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-

Mobile | ARTOSCAN and
ARTOSCAN M may be
installed also as mobile
systems. See for instance
HITACHI Mobile NW-7000
(K920159) |

5

Safety and Effectiveness Summary
ARTOSCAN M
Biosound, Inc.

.

General

:

·

・・

.

6

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
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.
TE	SE: 18, 21, 26, 40, 80,
120,150 ms
GRE: 10 ms	TE
SETI: 18 -34 ms., step 2 ms
SET2: 80 - 120 ms., step 10 ms
Nffi: I 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
Ist echo 34 ms; 2nd echo 90 Ms
TGRE: 8 - 24 ms., step 1 ms
TGRE3D:8 - 24 ms., step I 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

7

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: 10'- 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. x 14.5 cm 0
Upperjoint: 12 cm 0
examination.
Quadrature coils (optional)
Han Wrist: 8x 11.5x14.5 cm
AnklelFoot .- 9.5x5x23 cm 0
Knee: 12.9x4.5x5.5 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.
		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 640x480 | Unchanged | |
| Gray scale | 4096 gray levels
(0..4095) | 4096 gray levels (0..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
(+ I 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. | |
| 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 | | |
| 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 IO 0 dBu Vlm)
(optional) | Self contained RF shielding (up
to 80 dBuV/m)
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) | |
| 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 TCPIIP
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-

Mobile | ARTOSCAN and
ARTOSCAN M may be
installed also as mobile
systems. See for instance
HITACHI Mobile NW-7000
(K920159) | |

Imaging System

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.

8

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9

ﺗ

9

Magnetic / Gradients System

ﺗﻌﻀﺎﯾﯽ

ﺴﻴﺴﻴﺔ

... . ... ... ................................................................................................................................................................

10

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10

General

ﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

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11

General

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/