(91 days)
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.
The AIRIS Magnetic Resonance Diagnostic Device is being enhanced by the AIRIS II System-level upgrade to increase the clinical utility of the AIRIS in the stationary configuration. The AIRIS II is provided in a stand-alone configuration, and as an upgrade path to existing AIRIS installations.
AIRIS II System-level upgrade enhancements include a new Back End user interface featuring a workstation-based User Console, implementing a graphical user interface operating system and task card-style operations (OpenWindows™). A new Front End provides real-time system control, data acquisition and reconstruction, implements all image acquisition sequences available on current AIRIS, and provides two additional types of image acquisition sequences: TRSG (time-reversed steady-state acquisition with rewinded gradient echo) and RSSG (rf spoiled steady-state acquisition with rewinded gradient echo). Other enhancements include increased gradient strength, a patient physiological gating package, and phased-array RF coils.
This document is a 510(k) summary for the AIRIS II, a Magnetic Resonance Diagnostic Device. It claims substantial equivalence to the Hitachi AIRIS with Version 4.0 Operating System Software. The document describes the device's function, scientific concepts, physical and performance characteristics, intended use, and technological characteristics.
There is no information provided in the given text regarding acceptance criteria, a study proving device conformance, reported device performance, sample sizes, data provenance, ground truth establishment, expert involvement, adjudication methods, or MRMC studies.
The document states that the DEVICE TECHNOLOGICAL CHARACTERISTICS are "Identical to the Predicate Device." This implies that the current submission relies on the predicate device's existing substantial equivalence for its technological characteristics, rather than presenting a new study for the AIRIS II's performance.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document is primarily focused on describing the enhancements of the AIRIS II over the AIRIS, its intended use, and its equivalence to a predicate device for regulatory purposes.
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Attachment A 510(k) Summary of Safety and Effectiveness
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SUBMITTER INFORMATION: 1.0
- Hitachi Medical Systems America 1.1 Submitter: 1963 Case Parkway Twinsburg, OH 44087 PH: 216 425-1313 FX: 216 425-1410
- James Jochen Rogers 1.2 Contact:
- November 3, 1997 1.3 Date:
DEVICE NAME: 2.0
- Radiology Classification Panel: 2.1
- Classification Number: 892.1000 Magnetic Resonance Diagnostic Device 2.2
- System, Nuclear Magnetic Resonance Imaging Product Nomenclature: 2.3
- 90LNH Product Code(s): 2.4
- 90MOS (Magnetic Resonance Specialty Coil)
- AIRIS II 2.5 Trade/Proprietary Name:
PREDICATE DEVICE(s): 2.6
Hitachi AIRIS Hitachi AIRIS with Version 4.0 Operating System Software
DEVICE DESCRIPTION: 3.0
FUNCTION 3.1
The AIRIS Magnetic Resonance Diagnostic Device is being enhanced by the AIRIS II System-level upgrade to increase the clinical utility of the AIRIS in the stationary configuration. The AIRIS II is provided in a stand-alone configuration, and as an upgrade path to existing AIRIS installations.
AIRIS II System-level upgrade enhancements include a new Back End user interface featuring a workstation-based User Console, implementing a graphical user interface operating system and task card-style operations (OpenWindows™). A new Front End provides real-time system control, data acquisition and reconstruction, implements all image acquisition sequences available on current AIRIS, and provides two additional types of image acquisition sequences: TRSG (time-reversed steady-state acquisition with rewinded gradient echo) and RSSG (rf spoiled steady-state acquisition with rewinded gradient echo). Other enhancements include increased gradient strength, a patient physiological gating package, and phased-array RF coils.
SCIENTIFIC CONCEPTS 3.2
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, 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
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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 timevarving magnetic gradient fields have a typical duration of sub-millisecond 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 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, obligue, 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, 3D Fast Spin Echo (FSE) | |
| 2D Inversion Recovery (IR) | |
| 2D, 3D Fast Inversion Recovery (FIR) | |
| 2D, 3D Gradient Echo (GE) | |
| 2D, 3D Steady state acquisition with rewinded GE (SARGE) |
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2D, 3D RF-spoiled SARGE (RSSG) 2D, 3D Time-reversed SARGE (TRSG) MR Angiography 2D, 3D TOF 2D, 3D TOF RSSG ECG, Peripheral Gating
DEVICE TECHNOLOGICAL CHARACTERISTICS: 5.0
Identical to the Predicate Device.
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three wavy lines representing its body and wings. The eagle is facing to the left.
Food and Drug Administration 9200 Corcorate Boulevard Rockville MD 20850
FEB - 9 1998
James Jochen Rogers Manager Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44087-2371
K974212 AIRIS II (MRI System) Dated: November 3, 1997 Received: November 10, 1997 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 interstate commence prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 and prohibitions against misbranding and adulteration.
Re:
If your device is classified (see above) into either 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
h.J.Liau Yu
Lillian Yin, Ph.D.
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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197 4212 510(k) Number (if known): Device Name: AIRIS II
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:
- Diagnostic uses:
Proton 2D T1- / T2-weighted imaging T1, T2, proton density measurements MR Angiography image processing
- Imaging capabilities:
2D. 3D Spin Echo (SE) 2D, 3D Fast Spin Echo (FSE) 2D Inversion Recovery (IR) 2D, 3D Fast Inversion Recovery (FIR) 2D,3D Gradient Echo (GE) 2D, 3D Steady state acquisition with rewinded GE (SARGE) 2D, 3D RF-spoiled SARGE (RSSG) 2D, 3D Time-reversed SARGE (TRSG) MR Angiography 2D, 3D TOF 2D, 3D TOF RSSG ECG, Peripheral Gating
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vahid le. Nygam
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801-109
OR
Over-the-Counter Use _
(Optional Format 1-2-96)
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.