ALTAIRE

K050602 · Hitachi Medical Systems America, Inc. · LNH · Apr 7, 2005 · Radiology

Device Facts

• Record ID: K050602
• Device Name: ALTAIRE
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: LNH · Radiology
• Decision Date: Apr 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Altaire MR system is an imaging device, and is intended to provide the use of 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.

Device Story

Altaire is a 0.7 Tesla superconducting open-bore MRI system. It utilizes magnetic resonance principles: static magnetic field aligns hydrogen nuclei; RF excitation pulses reorient magnetization vectors; subsequent relaxation (T1/T2) emits RF signals. System applies magnetic field gradients in x, y, and z directions to encode spatial localization. Echoes are processed into 3D anatomical images. Operated by trained clinicians in clinical settings. Output provides visual diagnostic information regarding internal structures, blood flow, and tissue characteristics. Benefits include high-quality anatomical imaging without ionizing radiation exposure.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

0.7 Tesla superconducting magnet; open-bore design. Imaging based on proton density, T1, T2 relaxation, and flow. Software-controlled image reconstruction. Connectivity and specific materials not detailed beyond standard MRI components.

Indications for Use

Indicated for patients requiring non-invasive diagnostic imaging of the head, body, spine, and extremities. Used for proton density, T1, T2 weighted imaging, diffusion-weighted imaging, and MR angiography. No specific contraindications listed.

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 Altaire MRI System (K023390)
• Hitachi Altaire MRI System (K002420)

Submission Summary (Full Text)

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K050602

2005 APR 7

# Section 2

# 510(k) Summary of Safety and Effectiveness

.

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## Submitter Information 1.0

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

- 1.2 Contact: Douglas J. Thistlethwaite
- Date: 1.3 March 7, 2005

### Device Name 2.0

- System, Nuclear Magnetic Resonance Imaging Classification Name: 2.1
- Classification Number: 90LNH 2.2
- ALTAIRE Magnetic Resonance Imaging System Trade/Proprietary Name: 2.3
- Hitachi Altaire MRI System (K023390, K002420) Predicate Device(s): 2.4

#### Device Intended Use 3.0

The MR system is an imaging device and is intended to provide the physician with The MAX system is and clinical information, obtained non-invasively and without the use of physionegledi and childer informations transverse, coronal, sagittal, oblique, and fomzing radiation: The Price of Stort Fisplay 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.

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### Device Description 4.0

#### Function 4.1

The ALTAIRE is a Magnetic Resonance Imaging System that utilizes a 0.7 Tesla The ALTANSE is a Magnetic resormance were in the design was based on the AIRIS II superconducting magiler in an open gail. 3 access. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Open MIC of stem. Thing 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 Magicul resolutios magains (12215) them to act as small spinning bar magnets. The most electionaglicit propertios that base a which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a magnetic resolulios imaging. Thathe magnetic field, referred to as a net magnetization nector. The introduction with and the may of radiofrequency (RF) excitation of a wavelength vector. The magnetic field strength and to the atomic nuclei under consideration can specific to the magnetization vector. When the RF excitation is removed, Cause a re-offenation of the negisterial vector. The rate of relaxation is exponential and the prototts roux and rotal the proton and its adjacent molecular environment. This revalies with the onaracter cad by two exponential relaxation times, called T1 and T2.

A RF emission or echo that can be measured accompanies these relaxation events. The A NI cimsolon of cent are a representation of the relaxation events in a three cimissional matrix. Spatial localization is encoded into the echoes by varying the RF dimensional mattin. Dpropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial changing the arrooman and characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.

# 4.3 Physical and Performance Characteristics

MRI 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 different from those report, and T1 and T2 relaxation times can all contribute to image proton delisity, brood now, and squence characteristics, the resulting images can emphasize Tt, T2, proton density, or the molecular diffusion of water or other proton containing molecules.

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# Device Technological Characteristics 5.0

The technological characteristics of this device are similar to the primary predicate I he technological characteristics of the inclusion of software enhancements. The control and device. The primary unrerence to the base elements of the operating system software are identical to the predicate device.

## Conclusions 6.0

It is the opinion of Hitachi Medical Systems America, Inc. that Altaire MRI system is it is the opinion of Irmatin the listed predicate device. The intended use is identical to the listed predicate device.

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APR 7 2005 Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Public Health Service

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

Re: K050602 Trade/Device Name: Altaire MRDD, w/V5.0

Operating System Software Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 7, 2005 Received: March 9, 2005

Dear Mr. Thistlewaite:

We have reviewed your Section 510(k) premarket notification of intent to market the device is a vace estad in We have reviewed your Section 510(ts) promanted included (for the indications for use stated in above and nave determined the devices is devices marketed in interstate commerce prior to the enclosure) to regally marketed produced Dovice Amendments, or to devices that have been May 28, 1976, the enaculient cate of the Federal Food, Drug, and Cosmetic Act (Act) that reclassimed in accordance with the provisions of any is one of therefore, make the do not require approval of a prematic approvisions of the Act. The general controls provisions of the Act device, subject to the general controls provided on and 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 (Premarker If your device is classified (35c above) interest . Existing major regulations affecting your Approval), It may be subject to such adeitions, Title 21, Parts 800 to 898. In addition, FDA device can oc nound in the cour nts 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 mail FDA s Issualled of a sabsamian syther requirements of the Act or any F DA has made a delemination mar your do view Federal agencies. You must comply with all the Federal statues and regulations administer of Scalisting (21 CFR Part 807); abeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set forth (ZT CFR Part 801), good manufacturing practice to 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)
10 legal This letter will allow you to begin maketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale not this ne premarket notification. The FDA miding of substantial equilted of 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
r the may be If you desire specific advice for your device on our labeling regaration (1) - 1 the regulation number at 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, formation on your responsibilities under the Act from the 807.97). You may obtain other getterar intonnation of Four respensions of its toll-free number (800)
Division of Small Manufacturers, International deve DIVISION of Binan Mail........................................................................................................................................................ 056-2041 Or (3.gov/cdrh/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 (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Altaire MRDD, w/V5.0 Operating System Software

Indications for Use:

Indications for USe:
The Altaire MR system is an imaging device, and is intended to provide the use of ignit The Altaire MK system is an maging device, and to anvasively and without the use of ionizing physiological and clinical information, coronal, sagitty, bolique, and curred crossradiation. The MK system produces thansverse of the head, body, or extremities. The sectional images that display the methor of the spatial as protons (hydropen nuclei)
images produced by the MR system reflect the spatial ad starting are images produced by the MK System ichect the spains that determines the image appearance are
exhibiting magnetic resonance. The NMR properties that determine time (T2), and f exhibiting magnetic resoluation time (T1), spin-spin relaxation time (T2), and flow. profon density, spin-latite relaxation time (11), spill open open information that can be useful in diagnosis determination.

Head, Body, Spine, Extremities Anatomical Region: Nucleus excited: Proton T1, T2, proton density weighted imaging Diagnostic uses: Diffusion weighted imaging MR Angiography Image processing

X Prescription Use

AND/OR

Over-the-Counter 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)

Nancy Brogdon

(Division Sigh-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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