HITACHI ALTAIRE

K022390 · Hitachi Medical Systems America, Inc. · LNH · Oct 11, 2002 · Radiology

Device Facts

• Record ID: K022390
• Device Name: HITACHI ALTAIRE
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: LNH · Radiology
• Decision Date: Oct 11, 2002
• 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 MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (TI), spinspin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Device Story

ALTAIRE is a 0.7 Tesla superconducting MRI system with an open gantry design. It utilizes hydrogen nuclei magnetic resonance properties to generate anatomical images. Input consists of RF excitation pulses and magnetic field gradients (x, y, z) to encode spatial localization of proton relaxation events (T1, T2, proton density, flow). The system reconstructs these signals into 2D/3D cross-sectional images (transverse, coronal, sagittal, oblique, curved). Operated by trained clinicians in a clinical setting, the output images are interpreted by physicians to assist in diagnosis. The device builds upon the AIRIS II platform, incorporating software enhancements to improve clinical utility. It provides high-quality anatomical visualization without ionizing radiation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

0.7 Tesla superconducting magnet; open gantry design. Employs RF excitation and magnetic field gradients for spatial encoding. Produces T1, T2, proton density, diffusion-weighted, and MR angiography images. Software-enhanced operating system (V4.5).

Indications for Use

Indicated for diagnostic imaging of head, body, spine, and extremities using proton density, T1, T2, diffusion-weighted imaging, and MR angiography. Intended for use by trained physicians for non-invasive physiological and clinical information.

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

• Hitachi AIRIS II MRI System (K001334)
• GE Signa OpenSpeed MRI System (K992746)

Submission Summary (Full Text)

{0}------------------------------------------------

KO2390

# 1.0 Submitter Information

# 1.1 Submitter: Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44080-2371 ph: [phone] fax: [phone]

- 1.2 Contact: Douglas J. Thistlethwaite
- 1.3 Date: July 19, 2002

### 2.0 Device Name

### Classification Name: 2.1 System, Nuclear Magnetic Resonance Imaging

- Classification Number: 2.2 90LNH
- Trade/Proprietary Name: 2.3 ALTAIRE Magnetic Resonance Imaging System
- Predicate Device(s): 2.4 Hitachi AIRIS II MRI System (K001334) GE Signa OpenSpeed MRI System (K992746)

# 3.0 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 MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (TI), spinspin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

{1}------------------------------------------------

# 4.0 Device Description

# 4.1 Function

The ALTAIRE is a Magnetic Resonance Imaging System that utilizes a 0.7 Tesla superconducting magnet in an open gantry design. The design was based on the AIRIS II Open MRI system. The ALTAIRE has been designed to enhance clinical utility as compared to the AIRIS II by taking advantage of the imaging properties of the 0.7T magnet.

# 4.2 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 emissions 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.

# 4.3 Physical and Performance Characteristics

MRI is currently of great interest because it is capable of producing high quality anatomical images without the associated risks of ionizing radiation. The biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In MR imaging, difference in proton density, blood flow, and TI and T2 relaxation times can all contribute to image contrast. By varying the pulse sequence characteristics, the resulting images can emphasize T1, T2, proton density, or the molecular diffusion of water or other proton containing molecules.

{2}------------------------------------------------

# 5.0 Device Technological Characteristics

The technological characteristics of this device are similar to the primary predicate device. The primary difference is the inclusion of software enhancements. The control and image processing hardware and the base elements of the operating system software are identical to the primary predicate device.

## 6.0 Conclusions

It is the opinion of Hitachi Medical Systems America that ALTAIRE MRI system is substantially equivalent to the listed predicate device. The intended use is identical to the listed predicate device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is facing left and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper portion of the circle.

.
.
.
.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Mr. Doug Thistlewaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087-2371

. Re: K022390

Trade/Device Name: Hitachi ALTAIRE™ Magnetic Resonance Imaging Device Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device . . Regulatory Class: II

Product Code: 90 LNH Dated: July 19, 2002 Received: July 23, 2002

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 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 adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your 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:

| 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" (21 CFR Part 807.97). Other general information on 1 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. Brogdon

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

Enclosure

{5}------------------------------------------------

762 2390

# 510(k) Number (if kr Altaire MRDD, w/V4.5 Operating System Software Device Name:

Indications for Use:

The Altaire 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 MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Anatomical Region: Nucleus excited: Diagnostic uses:

Head, Body, Spine, Extremities Proton T1, T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Image processing

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-the-Counter Use

David A. Gyson

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