HHF1 MAGNETIC RESONANCE IMAGING SYSTEM

K052172 · Hitachi Medical Systems America, Inc. · LNH · Sep 27, 2005 · Radiology

Device Facts

• Record ID: K052172
• Device Name: HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: LNH · Radiology
• Decision Date: Sep 27, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The HHF I MR system is an imaging device, and is intended to provide the use of ion non-invasively and without the use of ionizing physiological and cinical information, obtained notital, oblique, and curved crossradiation. The MR system produces transverse, coronal, sand had as assessmities. The radiation. The MK system produces thansverse, contine thead, body, or extremities. The sectional images that display the methal structure of any 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

HHF1 is a 1.5 Tesla superconducting magnetic resonance imaging (MRI) system; utilizes open gantry design. Inputs: proton (hydrogen nuclei) signals within static magnetic field; RF excitation pulses applied to induce resonance. Transformation: spatial localization encoded via gradient magnetic fields; RF echoes measured and processed into 3D matrix; image reconstruction via algorithms similar to computed tomography. Outputs: transverse, coronal, sagittal, oblique, and curved cross-sectional anatomical images. Used in clinical settings by trained physicians. Output provides diagnostic information regarding internal structures; assists in clinical decision-making; enables non-invasive visualization without ionizing radiation.

Clinical Evidence

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

Technological Characteristics

1.5 Tesla superconducting magnet; open gantry design. Imaging based on proton (hydrogen) magnetic resonance. Produces T1, T2, proton density, diffusion-weighted, and MR angiography images. System includes control and image processing hardware. Software is identical to the predicate device.

Indications for Use

Indicated for non-invasive imaging of the head, body, spine, and extremities to provide physiological and clinical information. Uses proton density, T1, T2, and flow characteristics for diagnosis. Includes diffusion-weighted imaging and MR angiography.

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 (K050602)

Submission Summary (Full Text)

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K052172

SEP 2 7 2005

## 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 |

- 8/1/05 1.3 Date:
#### Device Name 2.0

| 2.1 Classification Name: | System, Nuclear Magnetic Resonance Imaging |
|-----------------------------|--------------------------------------------|
| 2.2 Classification Number: | 90LNH |
| 2.3 Trade/Proprietary Name: | HHF1 Magnetic Resonance Imaging System |
| 2.4 Predicate Device(s): | Hitachi Altaire MRI System (K050602) |

#### Device Intended Use 3.0

The MR system is an imaging device and is intended to provide the physician with The Mrs system is an maging do rise anbrained non-invasively and without the use of physiological and chilical information, obtailed is as thansverse, coronal, sagittal, oblique, and fonizing radiation. The NH system produces anternal structure of the head, body, or curved cross-scenonal images that =2.p.g 1R system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that protons (first of nage appearance are proton density, spin-lattice relaxation time (TI), spindetermine the miage appearance are promic eented by a trained physician, these images provide information that can be useful in diagnosis determination.

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#### Device Description 4.0

### 4.1 Function

The HHF1 is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla The First I is a Magnetic Resolunce antinging and based on the Altaire superconducting magnet in an open ganaly coorgined to enhance clinical utility as compared to Open MRT system. The imaging properties of the imaging properties of the 1.5T magnet.

### 4.2 Scientific Concepts

Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have Magnetic resolutice magniz (1112) is an to act as small spinning bar magnets. The most electionaglicit propertios that bases it the primary nuclei currently used in ubiquitous of these nacier is nydrogen, which a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization nector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength vecific to 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-onemation of the magnetiation vor. The rate of relaxation is exponential and the prototts than and retaril to their originand its adjacent molecular environment. This revalles will the character of the provential 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 elimensional matrix. Spatial localization is encoded into the echoes by varying the RF unnensional mattin. Spatial locallents in the x, y, and z directions, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial changing the direction and strenger of sean 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 loifferent from those responsible for x-ray image contrast. In MR imaging, difference in different noin those responsible for in ag ming and contribute to image proton delisity, blood now, and 11 anse characteristics, the resulting images can emphasize TI, 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 tcembological enaracteribles of the 1.5 Tesla superconducting magnet. The control and image processing hardware and the base elements of the system software are identical to the predicate device.

#### Conclusions 6.0

It is the opinion of Hitachi Medical Systems America, Inc. that HHF1 MRI system is it is the opinion of Intellisted predicate device. The intended use is identical to the listed predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.

### SEP 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052172 Trade/Device Name: HHF1 MRDD, w/V1.0 Operating System Software Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 1, 2005 Received: August 9, 2005

### Dear Mr. Thistlewaite:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have teviewed your becaled by equivalent (for the indications for use stated in above and nave determined the ac redicate devices marketed in interstate commerce prior to the enclosure) to regally mancede production in the Medical Device Amendments, or to devices that have been May 20, 1770, the chaoinent acte 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 do not require approval of a promance approvisions of the Act. The general controls provisions of the Act device, subject to the general contons provisions 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 If your device is olassilied (500 such additional controls. Existing major regulations affecting your Apploval), it thay be subject to basil adains 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 I Toase or devisou that 1 Driver that your device complies with other requirements of the Act or any FDA has made a decemination that your as a ministered by other Federal agencies. You must comply with all the I cut at statues and regulations administed 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) (21 Crici Cric Part 820); and if applicable, the electronic 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) I his letter will anow you to ocgin manceling your device of your device to a legally premarket notification. The PDA Intentig of substantial 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 If you desire spective advice for your device on our labeling org 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 childer, "Wisonaining on your responsibilities under the Act from the 180 807.97). You may obtain other general information your of your of its toll-free number [phone] or [phone] or at its Internet address http://www.fda.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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### 长05 2172 510(k) Number (if known): HHF1 MRDD, w/V1.0 Operating System Software Device Name:

Indications for Use:

Indications for USC.
The HHF I MR system is an imaging device, and is intended to provide the use of ion I he HHF I MK system is an maging de nee, and is non-invasively and without the use of ionizing physiological and cinical information, obtained notital, oblique, and curved crossradiation. The MR system produces transverse, coronal, sand had as assessmities. The radiation. The MK system produces thansverse, contine thead, body, or extremities. The sectional images that display the methal structure of any of protons (hydrogen nuclei)
images produced by the MR system reflect the spatial distribution of protons arc mages produced by the MR System reneve the spance that determine the image appearance are
exhibiting magnetic resonance. The NMR properties that determine time (T2), and flo exhibiting magnetic resoliatics. The Nink properates spin relaxation time (T2), and flow.
proton density, spin-lattice relaxation time (T1), spin-spin relaxation that segment proton density, spin-latice relaxation inne (11), spill spill spin relation that can be useful in diagnosis determination.

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

| Prescription Use | X |
|------------------|---|
|------------------|---|

Part 21 CFR 801 Subpart D)

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 C. Bergdon

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