MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)

K971016 · Hitachi Medical Systems America, Inc. · MOS · Jun 6, 1997 · Radiology

Device Facts

• Record ID: K971016
• Device Name: MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jun 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for 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 (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

QD C-Spine Coil is an accessory for Hitachi MRP-7000 and AIRIS MR systems; designed to improve signal-to-noise ratio (S/N) for cervical spine imaging; may also image upper thoracic and lower cranial structures. Device uses multiple receiver quadrature coil design to capture RF emissions (echoes) from hydrogen nuclei; spatial localization achieved via magnetic field gradients. System operated by trained professionals in clinical settings; output consists of cross-sectional images (transverse, coronal, sagittal, oblique, curved). Physician interprets images to assist in diagnosis. Benefits include high-quality anatomical imaging without ionizing radiation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Multiple receiver quadrature RF coil design. Operates within MR systems using magnetic fields up to 1.5T and RF frequencies up to 65MHz. Supports various pulse sequences including SE, FSE, IR, FIR, GE, and SARGE. Connectivity is integrated with the host MR system. Software includes adaptive image post-processing.

Indications for Use

Indicated for patients requiring diagnostic imaging of the head, body, spine, and extremities. Used to obtain physiological and clinical information via proton density, T1, T2, and flow-based MR imaging. Contraindications not specified.

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 MRP-7000 with Neck/Joint Coil
• Hitachi AIRIS with Neck/Extremity Coil

Submission Summary (Full Text)

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K971016
JUN - 6 1997

# Attachment 1

## 510(k) Summary of Safety and Effectiveness

Page 9

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Page 10

# 1.0 SUBMITTER INFORMATION:

1.1 Submitter: Hitachi Medical Systems America
1963 Case Parkway
Twinsburg, OH 44087
PH: 216 425-1313
FX: 216 425-1410

1.2 Contact: James Jochen Rogers
1.3 Date: March 13, 1997

# 2.0 DEVICE NAME:

2.1 Magnetic Resonance Diagnostic Device
2.2 Classification Name: System, Nuclear Magnetic Resonance Imaging
2.3 Classification Number: 90LNH
2.4 Classification Panel: Radiology
2.5 Radiology Device: 892.1000 Magnetic Resonance Diagnostic Device
2.6 Trade/Proprietary Name: MRP-7000 with QD C-Spine Coil (P/N MR-QCSC-42)
AIRIS with QD C-Spine Coil (P/N MR-QCSC-52)
2.7 Predicate Device: Hitachi MRP-7000 with Neck/Joint Coil
Hitachi AIRIS with Neck/Extremity Coil

# 3.0 DEVICE DESCRIPTION:

## 3.1 FUNCTION

The QD C-Spine Coil is being added to increase the clinical utility of the MRP-7000 in the stationary and mobile configurations. The new coil is intended to provide high quality imaging of cervical spine anatomy; dependent upon patient anatomy, the coil sensitivity may additionally effectively image upper thoracic and lower cranial structures. The QD C-Spine utilizes a proprietary multiple receiver quadrature coil design for improved S/N Ratio.

The QD C-Spine Coil is being added to increase the clinical utility of the AIRIS in the stationary configuration. The new coil is intended to provide high quality imaging of cervical spine anatomy, dependent upon patient anatomy, the coil sensitivity may additionally effectively image upper thoracic and lower cranial structures. The QD C-Spine utilizes a proprietary multiple receiver quadrature coil design for improved S/N Ratio.

## 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

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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 time-varying magnetic gradient fields have a typical duration of submillisecond to several milliseconds.

## 3.3 PHYSICAL AND PERFORMANCE CHARACTERISTICS

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 electron 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.

## 4.0 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 (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.

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- 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
- Imaging capabilities:
- 2D, 3D Spin Echo (SE)
- 2D Inversion Recovery (IR)
- 2D, 3D Fast Spin Echo (FSE)
- 2D, 3D Fast Inversion Recovery (FIR)
- 2D,3D Gradient Field Echo (GE); also with rephasing (GR)
- 2D, 3D Steady state acquisition with rewinded GE (SARGE)
- 2D Dual Slice acquisition (DS)
- MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)
- RF Coil Uniformity
- Adaptive Image post-processing

## 5.0 DEVICE TECHNOLOGICAL CHARACTERISTICS:

Identical to the Predicate Devices.

Page 12

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN - 6 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

James Jochen Rogers
Manager, Regulatory Affairs
Hitachi Medical Systems America
1963 Case Parkway
Twinsburg, Ohio 44087

Re: K971016
QD C-Spine Coil for MRP-7000 and AIRIS
Dated: March 13, 1997
Received: March 20, 1997
Regulatory class: II
21 CFR 892.1000/Procode: 90 MOS

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
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): _________________________

Device Name: QD C- Spine Coil (AIRIS, MRP-7000)

Indications for 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 (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
- Imaging capabilities:
- 2D, 3D Spin Echo (SE)
- 2D Inversion Recovery (IR)
- 2D, 3D Fast Spin Echo (FSE)
- 2D, 3D Fast Inversion Recovery (FIR)
- 2D, 3D Gradient Field Echo (GE); also with rephasing (GR)
- 2D, 3D Steady state acquisition with rewinded GE (SARGE)
- 2D Dual Slice acquisition (DS)
- MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)
- RF Coil Uniformity
- Adaptive Image post-processing

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☐
(Per 21 CFR 801-109)

OR

Over-the-Counter Use ☐

(Optional Format 1-2-96)