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 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.

AI/ML Overview

The provided text describes a medical device, the ARTOSCAN M, and its modifications from the original ARTOSCAN system. It details the device's features, intended use, and a comparison table with the predicate device (ARTOSCAN). However, it does NOT include specific acceptance criteria or a study proving the device meets said criteria.

The document is a "Safety and Effectiveness Summary" submitted for 510(k) clearance, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance.

Therefore, I cannot provide the requested information from the provided text. The document acts as a comparison between two device versions, highlighting improvements and equivalence, rather than a performance study with defined acceptance criteria and results.

Summary

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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.

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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

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

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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 60601-1-1, 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)

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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

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Characteristics	ARTOSCAN	ARTOSCAN M	Comments
		Turbo T2-weighted SE (TSE)Turbo ME (TME)	TSE and TME are based on theHalf Fourier technique, thereforeare quicker than the standard SEand ME sequences. The HalfFourier technique and thecontribution of different echoes areoptimized to obtain proton densityand T2weighted images. Thecontrast provided by thosesequences is equivalent to thecontrast provided by standardproton density and T2weightedsequences. See SiemensMagnetom Open (K935661)
		Turbo GRE (TGRE)standard GRE	This is an optimized version of the
		Turbo GRE3D (TGRE3D)	The TGRE3D sequence is anoptimized version of the GRE3D.See Philips Gyroscan T I O-NTwhere the technique is mentionedas Kspace shutter (K940534)
		Magnetization TransferContrast(MT GRE, MT GRE3D)	The MT allows to change thecontrast provided by any sequence.In particular, with regard toarticular applications, it allows toincrease the contrast fat/muscleand cartilage/synovia. MT isavailable on other commercial MRscanners, typically for angiographicapplications, like for instancePhilips Gyroscan TIO-T(K940534).
		Fat Suppression (FS)	The FS sequence uses the 3 pointsDixon technique. It is available onAdvanced Mammography SystemAURORA (K950837)
Characteristics	ARTOSCAN	ARTOSCAN M	Comments
Patient comfort	The patient iscompletely out of themagnet, except theexamined portion,eliminatingclaustrophobia andother related reactionsduring the examination	The patient is completely out ofthe magnet, except the examinedportion, eliminatingclaustrophobia and other relatedreactions during the examination
Networkcapability(optional)	Ethernet local network	* Ethernet thin wire localconnection through DICOAFprotocol* Ethernet thin wire localconnection through TCPIIPprotocol* Remote connection throughmodem	With the present release, theDICOM protocol is available(at the moment DICOM isthe most accreditedcommunication standard)and both local and remoteconnections are provided.
Additional console(optional)	n.a.	Includes all the image processingfunctions available on the mainsystem. Configuration:CPU.- Pentium 100 MhzMain memory: 32 MR3-1/4 " Hard disk: 2 GB
Type of installation	Fixed site("Permanentlyinstalled" according toIEC 601-1)	Fixed site ("Permanentlyinstalled" according to IEC 601-1)Mobile	ARTOSCAN andARTOSCAN M may beinstalled also as mobilesystems. See for instanceHITACHI Mobile NW-7000(K920159)

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Safety and Effectiveness Summary
ARTOSCAN M
Biosound, Inc.

General

・・

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Imaging System

Characteristics	ARTOSCAN	ARTOSCAN M	Comments
Scan parameters:	TR:SE: 50 - 5000 ms.IR: 200 - 5000 msGRE: 40 - 5000 ms	TRSET 1 50 - 5000 ms., step 10 msSET2: 200 - 5000 ms., step 10 msNE: 200 - 5000 ms., step 10 msGRE: 40 - 5000 ms., step 10 msGRE3D: 40 - 5000 ms., step 10 msIR: 260 - 5000 ms., step 10 msSTIR: 90 - 5000 ms., step 10 msSETIHE: 50 - 5000 ms., step 10 msSETIHF- 50 - 5000 ms., step 10 msTSE: 200 - 5000 ms., step 10 msTGRE: 30 - 5000 ms., step 5 msTGRE3D: 30 - 5000 ms., step 5 msMTGRE: 50 - 5000 ms., step 10 msMTGRE3D: 50 - 5000 ms., step 10 msFS: 70 - 5000 ms., step 10 msSTIR-GRE: 40 - 5000 ms., step 10 ms	Parameters have beenoptimized.
TE	SE: 18, 21, 26, 40, 80,120,150 msGRE: 10 ms	TESETI: 18 -34 ms., step 2 msSET2: 80 - 120 ms., step 10 msNffi: I st echo 40 ms, 2nd echo 80 and 100 msGRE: 12 - 24 ms., step 2 msGRE3D: 14 - 24 ms., step 2 msIR: 18 - 34 ms., step 2 msSTIR: 18 - 34 ms., step 2 msSET UM: 12 - 24 ms., step 2 msSET I HF: 18 - 34 ms., step 2 msTSE: 80 - 120 ms., step 10 msIst echo 34 ms; 2nd echo 90 MsTGRE: 8 - 24 ms., step 1 msTGRE3D:8 - 24 ms., step I msMT-GRE: 12 - 24 ms., step 2 msMT-GRE3D: 14 - 24 ms., step 2 ms

・ .

FS:30 ms

STIR-GRE: 12 - 24 ms., step 2 ms

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Characteristics	ARTOSCAN	ARTOSCAN M	Comments
	TIIR: 100 - 800 ms	TIIR: 200 - 800 ms., step 10 msSTIR: 50 - 200 ms., step 5 msSTIR-GRE: 50 - 200 ms., step 5Ms
	FAGRE: IO'- 90'	FAGRE: 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 coilsLowerjoint: 16x18 cm0Lower joint (that can beopened): 14 cm 0Ankle (that can beopened): 12x 16 cm 0Upperjoint: 10 cm 0	Solenoidal coilsLarge knees: 14.5x 19 cm 0Knee/Ankle: 13. x 14.5 cm 0Upperjoint: 12 cm 0examination.Quadrature coils (optional)Han Wrist: 8x 11.5x14.5 cmAnklelFoot .- 9.5x5x23 cm 0Knee: 12.9x4.5x5.5 cm 0	Solenoidal coils have beenchanged a little bit in sizeand design to better fit theanatomic regions underNo coils that can be openedare present in the actualversion because of theeasiness in positioning thestandard coils.
		Image Processing / Display System
Characteristics	ARTOSCAN	ARTOSCAN M	Comments
Central processingunit	CPU: 486 33 MHz256 KB cache memoryMain memory: 16 MB;5-1/4" Hard disk: 650 MBControl processor: 12.5MIPS - 0.5 NM on boardDigital Signal Processor:25 Mflops -0.7 MB on board	CPU: Pentium 100 MHzMain memory: 32 MB;512 KB cache memory3-1/4" Hard disk: 2 GBControl processor: 16.7 MIPS0.5 NM on boardDigital Signal Processor: 33Mflops* 5 MB on board (standardconfiguration)* 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 reconstructiontime (256x256)	1.5 sec./imgsimultaneous display ispossible (+ 1.3 sec. todisplay a 512x512image or + 0.4 sec. todisplay a 256x256image)	2D1.4 sec./imgsimultaneous display is possible(+ I sec. to display a 512x512image or + 0.3 sec. to display a256x256 image)3D≈3 min. for reconstructing a192x160x96 volume, reslicingthree scout images and saving thevolume (256x256x96 bit/voxel)≈30 sec. with the 3D Turbooption enabled	Improved. In the presentrelease, 3D raw data may besaved and permanentlystored to be resliced later,even from a differentconsole.
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 intwo variants (internally named Aand B) may be appliedautomatically by the system,according to the acquisitionparameters characterizing theimage to be filteredThe other way they may beapplied off-line by the user whendesired. In this case, the originalimages are always at the user'sdisposal for possiblecomparisons.	The present filters are part ofthe most recent filteringpackages to improve theimage quality. Theyunderwent a validationprotocol carried out byclinical users, that endedwith positive results.
Characteristics	ARTOSCAN	ARTOSCAN M	Comments
Type of magnet	Ferrite permanentmagnet	Ferrite permanent magnet	Unchanged
Static field strength	0.18T (transversal)	0.18T (transversal)	Unchanged
Stray field	5G line at 65 cmmaximum from themagnet	5G line at 65 cm maximumfrom the magnet	Unchanged
Gradients strength	10 mT/m	10 mT/m	Unchanged
Gantry opening	160 x 340 mm	160 x 336 mm
Magnetic systemweight	900 Kg	1000 Kg
Characteristics	ARTOSCAN	ARTOSCAN M	Comments
Size	2 m2 footprint	2 m2 footprint	The modularity conceptintroduced withARTOSCAN M allows agreater flexibility in siting. Ifdesired by the user, also anARTOSCAN system may beseparated in modules soallowing the same flexibilitythan the "M" version.
RF shielding	Self contained RF shielding (up to 50dB@V/m)* External shielding(up to IO 0 dBu Vlm)(optional)	Self contained RF shielding (upto 80 dBuV/m)* Shielding cloth cover (up to 90dBuV/m) (optional)* External shielding (up to 110dBuV/m) (optional)	A different technical solutionhas allowed to achieve betterresults in the standardconfiguration.A shielding cloth cover hasbeen added as anintermediate solutionbetween the standardconfiguration and anexternal shielding for thosesites that are a little bit noisythan the usual ones. Thesame solution had beenalready adopted byHITACHI in the NW-5000(5 1 0(k) accession number:K911642),
Patient positioning	Automatically, by thecoil and a propermechanical gantrystructure. The coil ispushed into the gantrymanually.	Automatically, by the coil and aproper mechanical gantrystructure. The coil is pushed intothe gantry manually,	Unchanged
Limb fastening	All coils are especiallydesigned to fasten in aproper position theexamined area. As forthe knee, in particular,a special lockingdevice is provided tofasten the foot and theleg to allow the controlof both kneeextension/flexionmovements and intra-and extra-rotations.	All coils are especially designedto keep the examined limb in theproper position.Special locking devices areprovided for kinematic exams ofleg and wrist (optional).	A special device for the wristhas been added to studythose pathologies that maybenefit a kinematicexamination (e.g. carpalinstability). See for instanceResonex - Kinematic MRImoviemaker (K924154)
Characteristics	ARTOSCAN	ARTOSCAN M	Comments
Patient comfort	The patient iscompletely out of themagnet, except theexamined portion,eliminatingclaustrophobia andother related reactionsduring the examination	The patient is completely out ofthe magnet, except the examinedportion, eliminatingclaustrophobia and other relatedreactions during the examination
Networkcapability(optional)	Ethernet local network	* Ethernet thin wire localconnection through DICOAFprotocol* Ethernet thin wire localconnection through TCPIIPprotocol* Remote connection throughmodem	With the present release, theDICOM protocol is available(at the moment DICOM isthe most accreditedcommunication standard)and both local and remoteconnections are provided.
Additional console(optional)	n.a.	Includes all the image processingfunctions available on the mainsystem. Configuration:CPU.- Pentium I 00 MHzMain memory: 32 MR3-1/4 " Hard disk: 2 GB
Type of installation	Fixed site("Permanentlyinstalled" according toIEC 601-1)	Fixed site ("Permanentlyinstalled" according to IEC 601-1)Mobile	ARTOSCAN andARTOSCAN M may beinstalled also as mobilesystems. See for instanceHITACHI 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.

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Magnetic / Gradients System

ﺗﻌﻀﺎﯾﯽ

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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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General

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.