MODIFICATION TO E-SCAN XQ MRI SYSTEM

K041145 · Esaote, S.p.A. · MOS · May 14, 2004 · Radiology

Device Facts

• Record ID: K041145
• Device Name: MODIFICATION TO E-SCAN XQ MRI SYSTEM
• Applicant: Esaote, S.p.A.
• Product Code: MOS · Radiology
• Decision Date: May 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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

Device Story

E-scan XQ is a magnetic resonance imaging (MRI) system used in clinical settings by trained medical experts. The system utilizes a DPA (Dual Phased Array) Shoulder Coil, which combines two coils to improve image homogeneity and signal-to-noise ratio (SNR). The primary coil is worn by the patient; a secondary coil with 3 turns is positioned to provide spatially complementary sensitivity. The device captures proton density and relaxation data (T1, T2) to generate transversal, sagittal, coronal, and oblique images. These images are interpreted by clinicians to provide diagnostic information regarding the patient's musculoskeletal anatomy. The system benefits patients by providing non-invasive diagnostic imaging of limbs and joints.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and technological comparison of the DPA Shoulder Coil design to previously cleared DPA receiving coils.

Technological Characteristics

Magnetic resonance diagnostic device. System includes DPA (Dual Phased Array) receiving coils designed for morphological adaptation to the examined area (shoulder, knee, hand, foot/ankle). Sensing principle: proton magnetic resonance. Connectivity: standalone MR system. Software: embedded control system for image acquisition and processing.

Indications for Use

Indicated for MR imaging of upper limbs (hand, wrist, forearm, elbow, upper arm, shoulder) and lower limbs (foot, ankle, calf, knee, thigh, hip) in patients requiring diagnostic imaging of joints and limbs.

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

• E-Scan (K990968)
• E-Scan (K001894)
• Hip Coil (K012728)
• E - Scan XQ (K020164)
• E-Scan XQ (K032121)

Submission Summary (Full Text)

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510(k) Summary E-scan XQ Biosound Esaote

MAY 1 4 2004

K041145
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# 510(k) Summary

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<br>8000 Castleway Drive<br>Indianapolis, IN 46250<br>[phone]<br>Phone:<br>[phone]<br>Facsimile: | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|---------|--|--|
| Carri Graham<br>Contact Person: | | | | |
| Date: | April 30, 2004 | | | |
| 807.92(a)(2) | | | | |
| Trade Name: | E-Scan XQ | | | |
| Common Name: | Magnetic resonance diagnostic device | | | |
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging | | | |
| Classification Number: | 90LNI-I | | | |
| 807.92(a)(3) | Predicate Device(s) | | | |
| Esaote | E-Scan | K990968 | | |
| Esaote | E-Scan | K001894 | | |
| Esaote | Hip Coil | K012728 | | |
| Esaote | E - Scan XQ | K020164 | | |
| Esaote | E-Scan XQ | K032121 | | |

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510(k) Summary E-scan XQ Biosound Esaote

K041145
Pengelup

01.92(a)(4)

#### Device Description

The DPA Shoulder Coil is to be used with the E-scan XQ magnetic resonance imaging system. It is a receiving THE DF A Shoulder Con is to be asou with and is the result of the combination of two different coils. The first is con designed to be "wom" by are patient and lonected in a series with 4 tuning capacitors positioned under the the printary con and is composed of - cans ocists of 3 turns designed to improve the image homogenery and having spatially complementary sensitivity with respect to the primary coil. The coil allows for imaging of both the left and right shoulder, due to the symmetrical mechanical connection between its base and the magnet.

807.92(a)(5)

#### Intended Use(s)

E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique L-scall AQ is a maginent resumbled for imaging the upper limb, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging the lower limb, including the foot, ankle, calf, knee, thigh and hip.

E-scan XQ 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 magine resolutios proportion (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a I II, Spin Telandien and ( of MR equipment, the images can provide diagnostically useful information.

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## 807.92(a)(6)

# Technological Characteristics

## Comparison to the cleared device E-scan XQ K032121

| Characteristics | E-scan XQ<br>K032121 | Modified<br>E-scan XQ | Comments |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DPA receiving<br>coils | 2 Knee coil: 22.5 x<br>21.0 x 18.3 cm (h x w x d) external; 14.3 x<br>16.0 x 18.3 cm (h x w x d) internal<br>3 Hand coil: 17.8 x<br>17.5 x 20 cm (h x w x<br>d) external; 11.9 x 7.2<br>x 20 cm (h x w x d)<br>internal<br>4 Foot/Ankle coil: 22.0<br>x 19.2 x 28.5 cm (h x<br>w x d) external; 14.6 x<br>10.0 x 28.5 cm (h x w<br>x d) internal | 2 Knee coil: 22.5 x<br>21.0 x 18.3 cm (h x w x d) external; 14.3 x<br>16.0 x 18.3 cm (h x w x d) internal<br>3 Hand coil: 17.8 x<br>17.5 x 20 cm (h x w x<br>d) external; 11.9 x 7.2<br>x 20 cm (h x w x d)<br>internal<br>4 Foot/Ankle coil: 22.0<br>x 19.2 x 28.5 cm (h x<br>w x d) external; 14.6 x<br>10.0 x 28.5 cm (h x w<br>x d) internal<br>7 Shoulder coil: 25.5 x<br>18.5 cm (larger<br>opening)<br>13.3 x 13.3 cm<br>(smaller opening) | The technological<br>characteristics of the<br>DPA 7 Shoulder coil<br>are similar to the<br>characterisitics of the<br>predicate device DPA<br>receiving coils.<br>The coil is designed to<br>be morphologically<br>adapted to the<br>examined area for<br>increasing the Signal-<br>to-Noise Ratio.<br>See section "DPA<br>Shoulder Coil<br>Description". |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

MAY 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Esaote S.p.A. % Ms. Carri Graham Official Correspondent The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K041145

Trade/Device Name: E-scan XQ MRI System Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II Product Code: 90 MOS Dated: April 30, 2004 Received: May 3, 2004

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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 clectronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050

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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 Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogden

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

Enclosure

Page 2

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### Indications for Use

510(k) Number (if known): ΚοΨ 114)

Device Name: E-scan XQ MR System

Indications for Use:

E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and L-scan AQ is a inaginene resources of the limbs and joints. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and maging portions of the apper will the lower limb, including the foot, ankle, calf, knee, thigh and hip.

E-scan XQ 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.

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

David h. Lyonn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

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