DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA

K061429 · Esaote, S.p.A. · LNH · Jul 25, 2006 · Radiology

Device Facts

• Record ID: K061429
• Device Name: DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA
• Applicant: Esaote, S.p.A.
• Product Code: LNH · Radiology
• Decision Date: Jul 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Dynamic MRI Software Option for the C-scan, E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images when interpreted by a trained physician, vield information that may assist in diagnosis.

Device Story

Dynamic MRI Software Option is a software package for existing Esaote C-scan, E-scan XQ, and E-scan Opera MRI systems. It acquires dynamic MR image datasets and performs post-processing to display temporal variations in image contrast. The software calculates time-intensity data, interpolation curves, maximum slope, and asymptotic values. These outputs are presented to a trained physician to assist in clinical diagnosis. The device operates within the existing MRI system workflow; it does not alter the fundamental scientific technology of the host MRI systems. It provides diagnostic support by visualizing temporal changes in tissue enhancement.

Clinical Evidence

No clinical data provided; bench testing only. The submission relies on demonstrating substantial equivalence to predicate devices through comparison of technological characteristics and intended use.

Technological Characteristics

Software-only package for existing MRI systems. Operates on standard MRI hardware (magnet, RF, gradient systems). Utilizes existing Spin Echo T1 and Gradient Echo pulse sequences. Connectivity is integrated into the host MRI workstation. No changes to hardware materials or sterilization requirements.

Indications for Use

Indicated for use by trained physicians to acquire and post-process dynamic MR image datasets to display temporal variations in contrast over time, providing time-intensity curves to assist in the diagnostic process for patients undergoing MRI of limbs and joints.

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 C-scan (K040877)
• Esaote E-scan XQ (K032121)
• Esaote E-scan Opera (K060956)
• Siemens Medical Systems Perfusion Package for Magnetom Vision and Symphony MR Systems (K984224)
• GE Medical Systems Advantage Windows with FuncTool Option (K960265)

Submission Summary (Full Text)

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## 人心儿1429

510(k) Summary C-scan/E-scan XQ/E-scan Opera Esaote S.p.A.

# 510(k) Summary

JUL 25 2006

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

807.92(a)(1)

## Submitter Information

Carri Graham, Official Correspondent

11460 N. Meridian St., Suite 150

Carmel, IN 46032

| Phone: | [phone] x103 |
|-------------------------|--------------------------------------------------------------------|
| Facsimile: | [phone] |
| Contact Person: | Carri Graham |
| Date: | May 22, 2006 |
| 807.92(a)(2) | |
| Trade Name: | Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera |
| Common Name: | System, Nuclear Magnetic Resonance Imaging |
| Classification Name(s): | Magnetic Resonance Diagnostic Device |
| Classification Number: | 90LNH |
| 807.92(a)(3) | |

**Predicate Device(s)**

| Esaote | C-scan | K040877 |
|-------------------------|---------------------------------------------------------------|---------|
| Esaote | E-scan XQ | K032121 |
| Esaote | E-scan Opera | K060956 |
| Siemens Medical Systems | Perfusion Package for Magnetom Vision and Symphony MR Systems | K984224 |
| GE Medical Systems | Advantage Windows with FuncTool Option | K960265 |

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#### 807.92(a)(4)

## Device Description

The Dynamic MRJ Software Option is a software package intended to be used with the Esaote C-scan. E-scan XO and E-scan Opera MRI systems, cleared via K040877 K032121 and K060956, respectively, The software package allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired image datasets, showing changes in image contrast over time.

It provides time intensity data, calculates the interpolation curve of the data, its maximum slope and its asymptotic value. These data, when interpreted by a trained physician, vield information that may assist diagnosis.

C-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.

E-scan XO is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.

E-scan Opera is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and ioints. It is intended for imaging portions of the arm. including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.

The C-scan, E-scan XO and E-scan Opera MR images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

#### 807.92(a)(5)

## Intended Use(s)

The Dynamic MRI Software Option for the C-scan, E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images when interpreted by a trained physician, vield information that may assist in diagnosis.

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#### 807.92(a)(6)

## Technological Characteristics

The addition of the Dynamic MRI Software Option, reflected in this 510(k), does not alter the fundamental scientific technology of the C-scan system, cleared via K040877, E-scan XQ system, cleared via K032121 and E-scan Opera system, cleared via K060956.

| Characteristic | Dynamic MRI<br>Software Option<br>for C-scan, E-scan<br>XQ and E-scan<br>Opera | C-scan<br>K040877 | E-scan XQ<br>K032121 | E-scan Opera<br>K990968 | Comments |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse sequences | Spin Echo T1<br>(SETI)<br>Gradient Echo (GE) | Spin Echo T1<br>(SETI)<br>Gradient Echo (GE) | Spin Echo T1<br>(SETI)<br>Gradient Echo (GE) | Spin Echo T1<br>(SETI)<br>Gradient Echo (GE) | Unchanged |
| Sequence<br>parameters | Spin Echo 16<br>TR from 40 ms to<br>5000 ms, step 20 ms<br>TE fixed at 16 ms<br>minimum FOV 100<br>mm<br>minimum slice<br>thickness 2 mm | SETI<br>TR from 40 ms to<br>5000 ms, step 20 ms<br>TE from 18 ms to 34<br>ms, step 2 ms<br>minimum FOV 100<br>mm<br>minimum slice<br>thickness 2 mm | SET 1<br>TR from 50 ms to<br>5000 ms, step 10 ms<br>TE from 18 ms to 34<br>ms, step 2 ms<br>minimum FOV 100<br>mm<br>minimum slice<br>thickness 2 mm | SETI<br>TR from 50 ms to<br>5000 ms, step 10 ms<br>TE from 18 ms to 34<br>ms, step 2 ms<br>minimum FOV 100<br>mm<br>minimum slice<br>thickness 2 mm | They are a<br>particular<br>version of the<br>Spin Echo T1<br>and Gradient<br>Echo standard<br>sequences for<br>obtaining high<br>acquisition<br>speed and<br>contrast<br>resolution. |
| | Gradient Echo 6<br>TR from 40 ms to<br>5000 ms, step 20 ms<br>TE fixed at 6 ms<br>FA from 10° to 90°,<br>step 5°<br>minimum FOV 100<br>mm<br>minimum slice<br>thickness 2 mm | GE<br>TR from 40 ms to<br>5000 ms, step 20 ms<br>TE from 8 ms to 24<br>ms, step 2 ms<br>FA from 10° to 90°,<br>step 5°<br>minimum FOV 100<br>mm<br>minimum slice<br>thickness 2 mm | GE 10<br>TR from 35 ms to<br>5000 ms, step 5 ms<br>TE fixed at 10 ms<br>FA from 10° to 90°,<br>step 5°<br>minimum FOV 130<br>mm<br>minimum slice<br>thickness 2 mm | GE 10<br>TR from 35 ms to<br>5000 ms, step 5 ms<br>TE fixed at 10 ms<br>FA from 10° to 90°,<br>step 5°<br>minimum FOV 130<br>mm<br>minimum slice<br>thickness 2 mm | |

## Substantial Equivalence Comparison Tables

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| Characteristic | Dynamic MRI Software Option for C-scan, E-<br>scan XQ and E-scan Opera | Perfusion package for Magnetom Vision and<br>Symphony MR systems - K984224 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | LNH | LNH |
| Indications for use | The Dynamic MRI Software Option for the C-scan,<br>E-scan XQ and E-scan Opera MRI Systems allows<br>the acquisition of MR dynamic image datasets and<br>the post processing display of temporal variations<br>in the acquired datasets, showing changes in<br>contrast over time. Its purpose is to provide time<br>intensity curves that support the diagnostic process.<br>These images when interpreted by a trained<br>physician, yield information that may assist in<br>diagnosis. | The Perfusion Package for the Magnetom Vision<br>and Symphony MR Systems is a software<br>package which allows the display of temporal<br>variations in dynamic MR Datasets, showing<br>changes in contrast over time. Its purpose is to<br>provide either time intensity curves or the<br>creation of parametric images for parameters like<br>time to peak that support the diagnostic process.<br>These images when interpreted by a trained<br>physician, yield information that may assist in<br>diagnosis. One clinical application where this<br>could be useful is the diagnosis of lesions by<br>temporal analysis of tumor enhancement. |
| Device<br>Description | The Dynamic MRI Software Option is intended to<br>acquire MR dynamic image datasets and uses a<br>post processing procedure for display of temporal<br>variations in the acquired datasets for the C-scan,<br>E-scan XQ and E-scan Opera MRI Systems. | The Perfusion Package is a post processing<br>option for the Magnetom Vision and Symphony<br>MR Systems |
| Technological<br>Characteristics | The magnet, RF system and gradient system of C-<br>scan, E-scan XQ and E-scan Opera MRI Systems<br>configured with the Dynamic MRI Software<br>Option is substantially equivalent to the standard<br>C-scan, E-scan XQ and E-scan Opera Systems. | The magnet, RF system and gradient system of<br>the Magnetom Vision and Symphony configured<br>with the Perfusion Package is substantially<br>equivalent to the standard Magnetom Vision and<br>Symphony Systems. |
| Input data | Dynamic MR datasets<br>Single or multi-slice datasets | Dynamic MR datasets |
| Features | Display of temporal variations in dynamic MR<br>datasets, showing changes in image contrast over<br>time | Display of temporal variations in dynamic MR<br>datasets, showing changes in image contrast over<br>time |
| Image Processing | Time intensity data and time intensity interpolation<br>curve, its maximum slope and its asymptotic value | Time intensity curves<br>Parametric images for parameters like time to<br>peak |

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| Characteristic | Dynamic MRI Software Option for<br>C-scan, E-scan XQ and E-scan Opera | FuncTool Option<br>K960265 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | LNH | LLZ |
| Indications for use | The Dynamic MRI Software Option for the<br>C-scan, E-scan XQ and E-scan Opera MRI<br>Systems allows the acquisition of MR<br>dynamic image datasets and the post<br>processing display of temporal variations in<br>the acquired datasets, showing changes in<br>contrast over time. Its purpose is to provide<br>time intensity curves that support the<br>diagnostic process. These images when<br>interpreted by a trained physician, yield<br>information that may assist in diagnosis. | The FuncTool option to the Advantages Windows<br>workstation is a software module that provides<br>supplemental information to those images extracted<br>from CT and MR temporal datasets. |
| Device<br>Description | The Dynamic MRI Software Option is<br>intended to acquire MR dynamic image<br>datasets and uses a post processing procedure<br>for display of temporal variations in the<br>acquired datasets for the C-scan, E-scan XQ<br>and E-scan Opera MRI Systems. | FuncTool is a functional imaging software package,<br>which allows to display the temporal variation in<br>dynamic CT and MR datasets. Single or multi-slice<br>datasets, with equally spaced time interval are used for<br>input. The purpose is to provide Time Intensity Curves<br>and parametric images that provide clinical information<br>for diagnosis purposes. This software is used during<br>post-processing of MR and CT images on GE's CT and<br>MR Systems. |
| Input data | Dynamic MR datasets<br>Single or multi-slice datasets with equally or<br>differently spaced time interval | Dynamic CT and MR datasets<br>Single or multi-slice datasets, with equally spaced time<br>interval |
| Features | Display of temporal variations in dynamic<br>MR datasets, showing changes in image<br>contrast over time | Display of temporal variations in dynamic CT and MR<br>datasets, showing changes in image contrast over time |
| Image Processing | Time intensity data and time intensity<br>interpolation curve, its maximum slope and<br>its asymptotic value | Time intensity curves and parametric images |

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## JUL 25 2006

Esaote, S.p.A. % Ms. Carri Graham Consultant Anson Group, LLC 11460 N Meridian St., Ste 150 CARMEL IN 46032

Re: K061429

Trade/Device Name: Dynamic MRI Software for C-scan, XQ and E-scan Opera Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 22, 2006 Received: May 23, 2006

#### Dear Ms. Graham:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Eederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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noting Public G

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Conipliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): Kol /429

Device Name: Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera

Indications for Use:

The Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Mendoza

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number