AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE

K984280 · Hitachi Medical Systems America, Inc. · LNH · Feb 8, 1999 · Radiology

Device Facts

• Record ID: K984280
• Device Name: AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

By providing in-suite scan control and viewing of MR images, the AIRIS II with the Interventional MR Package aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user. 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 (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

AIRIS II MRI system enhanced with Interventional MR Package; provides real-time MR guidance for minimally invasive, diagnostic, and therapeutic procedures. Inputs: proton magnetic resonance signals. Processing: spatial localization via RF excitation and magnetic field gradients; image reconstruction via T1, T2, and proton density measurements. Outputs: transverse, coronal, sagittal, oblique, and curved cross-sectional images. Used in clinical settings by physicians; includes in-suite image display, scanner control, physician kneelers, gantry illumination, and surgical drapes for sterile field. Facilitates procedure performance by allowing real-time visualization of anatomy and instrumentation. Benefits: non-invasive imaging without ionizing radiation; enables precise guidance for interventional procedures.

Clinical Evidence

Bench testing only. No clinical data provided. The device relies on the established safety and effectiveness of the predicate AIRIS II system, with additional hardware evaluated for compatibility with the MR environment.

Technological Characteristics

Magnetic resonance imaging system; proton excitation; 1.5T field strength capability. Hardware includes QD Interventional Body Coil (IBC), in-suite display, and scanner controls. Connectivity: ACR/NEMA/DICOM 3 compliant. Software: Adaptive image post-processing. No changes to base system software required for hardware integration.

Indications for Use

Indicated for patients requiring diagnostic imaging of head, body, spine, and extremities. Aids in minimally invasive, diagnostic, and therapeutic procedures via real-time MR guidance. Requires use of MRI-compatible instrumentation. Contraindications: None stated, but requires trained physician interpretation.

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 (K974212)
• Siemens Magnetom OPEN (K955389)
• Siemens Magnetom VISION and IMPACT (K962927)

Submission Summary (Full Text)

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1

Federal de 1999

:

# Attachment 1 510(k) Summary of Safety and Effectiveness

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#### SUBMITTER INFORMATION: 1.0

| 1.1 | Submitter: | Hitachi Medical Systems America |
|-----|------------|---------------------------------|
| | | 1959 Summit Commerce Park |
| | | Twinsburg, OH 44087 |
| | | PH: 330 425-1313 |
| | | FX: 330 425-1410 |

- James Jochen Rogers 1.2 Contact:
- February 2, 1999 1.3 Date:

#### 2.0 DEVICE NAME:

- Radiology 2.1 Classification Panel:
- 2.2 Classification Number: 892.1000 Magnetic Resonance Diagnostic Device
- System, Nuclear Magnetic Resonance Imaging 2.3 Product Nomenclature:
- 2.4 Product Code(s): 90LNH 90MOS (Magnetic Resonance Specialty Coil)
- 2.5 Trade/Proprietary Name: AIRIS II
- 2.6 PREDICATE DEVICE(s):

Hitachi AIRIS II (K974212) Siemens Magnetom OPEN (K955389) Siemens Magnetom VISION and IMPACT (K962927)

#### DEVICE DESCRIPTION: 3.0

#### FUNCTION 3.1

Identical to the AIRIS II 510(k) K974212.

The AIRIS II MRI Magnetic Resonance Diagnostic Device is being enhanced by optional hardware to aid in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body, and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user. Additional hardware includes QD Interventional Body Coil (IBC), in-suite image display and scanner control, physician kneelers, directed gantry illumination, and surgical drapes to provide a sterile field. The Latchable Joint/Large Extremity Coil, P/N MR-JCL-52, currently in commercial distribution supports imaging of the head and neck during interventional procedures of those anatomies.

AIRIS II software did not need to be revised in order to support full functionality of this additional hardware. MR Fluoroscopy was not made as an explicit marketing claim of the AIRIS II 510(k) K974212, however, the capabilities were available at the time of the submission (Cf. K974212, Attachment F, Functional Specification, 2D/3D SG and 2D/3D SG (RSSG) images acquisition sequences).

#### 3.2 SCIENTIFIC CONCEPTS

Magnetic Resonance (MR) is based on the fact that certain atomic nuclei have electromagnetic properties which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nucleus used in current imaging experiments in magnetic resonance. When placed in a magnetic field,

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there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of radiofrequency (RF) excitation of wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is removed, the proton relaxes and returns to its original orientation. 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 which can be measured.

These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emissions on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by appropriately applying magnetic field gradients in x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under consideration can be constructed by using image processing techniques similar to those used in CT.

For magnetic fields up to 1.5T, the RF frequencies commonly used range up to 65MHz. The RF fields have pulse powers from several watts to greater than 10 kilowatts, and repeat at rates from once every few seconds to greater than fifty per second. The timevarying magnetic gradient fields have a typical duration of sub-millisecond to several milliseconds.

#### PHYSICAL AND PERFORMANCE CHARACTERISTICS 3.3

MR is currently of great interest because it is capable of producing high quality anatomical images without the associated risks of ionizing radiation. In addition, the biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In x-ray imaging, differences in x-ray attenuation, largely based on differences in electro density are responsible for the contrast observed in x-ray images. In MR imaging, differences in proton density, blood flow, and relaxation times T1 and T2 all may contribute to image contrast. In addition, by varying the duration and spacing of the RF pulses, images may be produced in which the contrast is primarily dependent on T1 relaxation, T2 relaxation, proton density, or a combination of all three.

#### DEVICE INTENDED USE: 4.0

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 (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: Head, Body, Spine, Extremities
- . Nucleus excited: Proton
- Diagnostic uses: 2D T1- / T2-weighted imaging T1, T2, proton density measurements MR Angiography image processing

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- Imaging capabilities:
- 2D Spin Echo (SE); also with rephase
- 2D Gradient Field Echo (GE); also with rephase (2D GR)
- 2D Steady state acquisition with rewinded GE (SARGE);
- also with RF spoiling, rephasing
- 2D Inversion Recovery (IR)
- 2D Fast Spin Echo (FSE); also with rephase
- 2D Fast Inversion Recovery (FIR)
- 2D Dual Slice acquisition (SEDS)
- 3D Spin Echo (SE)
- 3D Gradient Field Echo (GE)
- 3D Steady state acquisition with rewinded GE (SARGE); also with RF spoiling, rephasing
- MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)
- MR Fluoroscopy
- RF Coil Uniformity
- Adaptive Image post-processing
- ACR/NEMA/DICOM 3 compliant
- Aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body, and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.

#### DEVICE TECHNOLOGICAL CHARACTERISTICS: 5.0

Identical to the Predicate Device.

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Image /page/4/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

8 1999 EEB

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

James Jochen Rogers Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44087

Re: K984280

> Interventional MR Package for Airis II Dated: November 3, 1998 Received: November 30, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Rogers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requiration (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel C. Schultz, M.D.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): _ K 9 8 42 80

## Device Name: Interventional MR Package for AIRIS II

### Indications for Use:

By providing in-suite scan control and viewing of MR images, the AIRIS II with the Interventional MR Package aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.

The MR system is an imaging device, and is intended to provide the plysician 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: | Head, Body, Spine, Extremities |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ● Nucleus excited: | Proton |
| ● Diagnostic uses: | 2D T1-/T2-weighted imaging<br>T1, T2, proton density measurements<br>MR Angiography<br>image processing |
| ● Imaging capabilities: | 2D Spin Echo (SE); also with rephase<br>2D Gradient Field Echo (GE); also with rephase (2D GR)<br>2D Steady state acquisition with rewinded GE (SARGE); also with RF spoiling, rephasing<br>2D Inversion Recovery (IR)<br>2D Fast Spin Echo (FSE); also with rephase<br>2D Fast Inversion Recovery (FIR)<br>2D Dual Slice acquisition (SEDS)<br>3D Spin Echo (SE)<br>3D Gradient Field Echo (GE)<br>3D Steady state acquisition with rewinded GE (SARGE); also with RF spoiling, rephasing<br>MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)<br>MR Fluoroscopy<br>RF Coil Uniformity<br>Adaptive Image post-processing<br>ACR/NEMA/DICOM 3 compliant<br>Aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use __ (Per 21 CFR 801-109 OR

Over-the-Counter Use _

(Optional Format 1-2-96)

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