ECHELON SHOULDER COIL

K062556 · Hitachi Medical Systems America, Inc. · MOS · Oct 5, 2006 · Radiology

Device Facts

• Record ID: K062556
• Device Name: ECHELON SHOULDER COIL
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: MOS · Radiology
• Decision Date: Oct 5, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MR-RSC-150 Shoulder coil is a receive-only multiple array coil used for MRI imaging of the human shoulder, its surrounding structures and other large joints.

Device Story

Receive-only RF phased array coil; 5 elements; contours to shoulder. Used in open MRI systems to detect MR signals (hydrogen nuclei relaxation echoes). Signals processed by MRI system to reconstruct 3D images (transverse, coronal, sagittal, oblique, curved). Used by trained physicians for diagnostic imaging. Benefits include non-invasive visualization of internal structures without ionizing radiation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Receive-only RF phased array coil; 5 elements; contoured form factor; compatible with open MRI systems.

Indications for Use

Indicated for MRI imaging of the human shoulder, surrounding structures, and other large 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

• Shoulder coil cleared with AIRIS II MRI System (K992650)

Submission Summary (Full Text)

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Kob 255.6

OCT - 5 2006

# Section 2

### 510(k) Summary of Safety and Effectiveness

.

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## Submitter Information

| Submitter: | Hitachi Medical Systems America, Inc.<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44080-2371<br>ph: [phone]<br>fax: [phone] |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |
| Date: | August 25, 2006 |
| Device Name | |
| Classification Name: | Coil, magnetic resonance, specialty |
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | Echelon™ MR-RSC-150 Shoulder Coil |
| Predicate Device(s): | Shoulder coil cleared with AIRIS II MRI<br>System (Cf. K992650) |

### Device Intended Use

The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The shoulder coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the body. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The indications for use are as follows:

The MR-RSC-150 Shoulder coil is a receive-only multiple array coil used for MRI imaging of the human shoulder, its surrounding structures and other large joints.

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## Device Description

#### Function

The Echelon Shoulder Coil is a receive only RF phased array coil, used for obtaining diagnostic images of the abdominal region, in an open Magnetic Resonance Imaging (MRI) system.

#### Scientific Concepts

Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by two exponential relaxation times, called T1 and T2.

A RF emission or echo that can be measured accompanies these relaxation events. The receive coil detects these emissions which are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.

### Physical and Performance Characteristics

The Shoulder coil is a receive-only coil designed to contour to the outline of the shoulder. The coil consists of 5 elements. The signal output of each element is independently processed by the MRI system to enhance performance.

### Device Technological Characteristics

The technological characteristics of this device are similar to the predicate device.

### Conclusions

It is the opinion of Hitachi Medical Systems America that the Echelon™ Shoulder Coil is substantially equivalent to the Shoulder coil cleared in AIRIS II MRI System (Cf. K992650). The technological characteristics and intended use are identical to the Predicate Device.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

OCT - 5 2006

Mr. Doug Thistlewaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087

Re: K062556

Trade/Device Name: Echelon Shoulder Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 25, 2006 Received: August 31, 2006

Dear Mr. Thistlewaite:

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 Cometic Act (Act) that do not require approval of a premarket approval application (PMA). Your oven. 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 affections your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition FFA may publish further announcements concerning your device in the Federal Register.

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Protecting and Promoting Public Health

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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 Compliance 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. Brogdon

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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510(k) Number KOK 2556 (if known): Echelon Shoulder Coil Device Name:

Indications for Use:

The MR-RSC-150 Shoulder coil is a receive-only multiple array coil used for MRI imaging of the human shoulder, its surrounding structures and other large joints.

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

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Syverson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 51((k) Number_