AIRIS ELITE RAPID BODY COIL

K050307 · Hitachi Medical Systems America, Inc. · MOS · Feb 28, 2005 · Radiology

Device Facts

• Record ID: K050307
• Device Name: AIRIS ELITE RAPID BODY COIL
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: MOS · Radiology
• Decision Date: Feb 28, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

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 body coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and curved cross-sectional 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: Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.

Device Story

AIRIS Elite Rapid Body Coil is a receive-only RF phased array coil for open MRI systems; used for abdominal imaging. Device consists of rigid upper section and base positioned around patient abdomen; contains four coil elements (two-turn solenoid, anterior saddle, posterior saddle, anti-turn loop) in plastic housing. Coil detects RF emissions from hydrogen nuclei relaxation; signals processed by MRI system to reconstruct 3D images. Operated by MRI technicians/radiologists in clinical settings. Output images interpreted by physicians for diagnostic purposes; aids in visualization of internal structures without ionizing radiation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing.

Technological Characteristics

Receive-only RF phased array coil; four-channel design; rigid plastic housing; electrical pin connection; components include two-turn solenoid, anterior saddle, posterior saddle, and anti-turn loop. Operates within open MRI system environment.

Indications for Use

Indicated for MRI and MRA of musculoskeletal, soft tissue, and vascular structures in the chest to pelvic region.

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

• AIRIS Elite (K032232)

Submission Summary (Full Text)

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K050307

# 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: | February 4, 2005 |

### Device Name

| Classification Name: | Coil, magnetic resonance, specialty |
|-------------------------|-------------------------------------|
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | AIRIS Elite Rapid Body Coil |
| Predicate Device(s): | AIRIS Elite (K032232) |

## 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 body coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and curved cross-sectional 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:

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.

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### Device Description

#### Function

The AIRIS Elite Body Coil (hereby referred to as body 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 Magnetic 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 maquetic 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 specific to the magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and the prototte rear. Caracter of the proton and its adjacent molecular environment. This revarres with arocess 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 echnes 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 body coil consists two mechanical sections: a rigid removable upper section and a base, which is positioned above and below the patient abdomen respectively. The upper section can be connected to the base by the electrical pins. There is a latch on the upper section. The coil consists of four coil elements: a two-turn solenoid, an anterior saddle, a posterior saddle and an anti-turn loop. All the elements are enclosed in a rigid plastic housing. The signal output of each element is independently processed by the system to enhance performance.

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## Device Technological Characteristics

The technological characteristics of this device are similar to the predicate device. The device has four channels vs. two in the predicate device. Each channel output is independently processed.

### Conclusions

It is the opinion of Hitachi Medical Systems Amcrica that the AIRIS Elite RAPID Body Coil is substantially equivalent to the body coil cleared with the AIRIS Elite MRI System. The technological characteristics and intended use are identical to the Predicate Device.

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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

FEB 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Douglas Thistlewaite Manager of Regulatory Affairs Hitachi Medical Systems America 1959 Summit Commerce Park TWINSBURG OH 44087-2371

Re: K050307

Trade/Device Name: AIRIS Elite Rapid Body Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: February 4, 2005 Received: February 8, 2005

Dear Mr. Thistlewaite:

We have reviewed your Section 510(k) premarket notification of intent to maket the device referenced in We have reviewed your Section 510(K) premants interests (for the indications for use stated in
above and have determined the device is substantially equivalse commerce prior above and have determined the devices marketed in interstate commerce prior to the enclosure) to legally marketed predical Device Amendments, or to devices that have been
May 28, 1976, the enactment date of the Medical Execut Development Casemane Ast (A May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provinsions of the A.). You may, therefore, market the do not require approval of a prematics approval approval controls provisions of the Act
device, subject to the general controls provisions of the Act. The Act device, subject to the general controls of the real "The game"
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 (Prematket If your device is classified (see above) incols. Existing major regulations affecting your Approval), it may be subject to such additional controls. "Little 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Pa device can be found in the Code of I concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mat I DA S Issualice of a substance of the Act or any of the Act or any
FDA has made a determination that your device complies with semply with all FDA has made a determination mar your device comples. You must complex You must comply with all the Federal statutes and regulations administered by their reson and listing (21 CFR Part 807); labeling Act 's requirements, including, out not minited to registration as a to the internations of the visions (2) CFR Part 801); good filandiaciumig practice realertedic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product radia (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)
10 legal This letter will allow you to begin harketing your avression of your device to a legally premarket notification. The FDA Inding of substantial equice 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 If you desire specific advice for your device on our labering regardants ( the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "visorianting of tresponsibilities under the Act from the 807.97). You may obtain other gelleral information on your respections
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) Division of Binan Mas-6597 or at its Internet address http://www.fda.gov/cdrh/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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _AIRIS Elite Rapid Body Coil

Indications for Use:

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Magnetic resonance imaging (MRT) and magnetic resolulies within the anatomic regions from the chest to the pelvic region.

Over-the-Counter Use X AND/OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Legare

KD50307

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