(77 days)
90LNH, 90MOS
Not Found
No
The summary focuses on hardware enhancements (RF coils) and mentions standard image processing techniques, with no indication of AI/ML being incorporated.
No
The device is described as an "imaging device" and a "Magnetic Resonance Diagnostic Device" intended for obtaining "physiological and clinical information" to assist in "diagnosis determination," without any mention of actively treating or curing a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination." Additionally, the "Device Description" section refers to the device as an "AIRIS MRI Magnetic Resonance Diagnostic Device."
No
The device description explicitly details hardware components (RF Coils) being added to an existing MR system. While software is mentioned as not needing revision, the core of the submission is about hardware enhancements to a physical imaging device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an "imaging device" that provides "physiological and clinical information, obtained non-invasively and without the use of ionizing radiation." It produces images of internal structures.
- Mechanism: The device works by utilizing Magnetic Resonance (MR) properties of protons to create images. This is an imaging modality, not a diagnostic test performed on biological samples in vitro (outside the body).
- IVD Definition: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue, taken from the human body, to provide information for diagnosis, monitoring, or screening. This device does not perform such tests on biological samples.
- Device Description: The description focuses on the hardware (MR system, RF coils) and its function in acquiring images.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, assays, or any other components typically associated with IVD devices.
The device is a diagnostic imaging device, which is a different category of medical device than an IVD.
N/A
Intended Use / 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.
Product codes
90LNH, 90MOS
Device Description
The AIRIS MRI Magnetic Resonance Diagnostic Device is being enhanced by two additional RF Coils (QD HP [High Performance] Wrist Coil, and Shaped Shoulder Coil) to increase the clinical utility of the AIRIS in the stationary configuration.
The QD HP [High Performance] Wrist Coil P/N MR-QWC-51 is a new addition to the complement of coils intended for use with AIRIS. The coil utilizes a proprietary multiple receiver quadrature coil design for improved S/N Ratio.
The Shaped Shoulder coil P/N MR-SC-51 is identical to the Latchable Large Extremity coil, which was documented in a Memo-to-File document as identical to the original Large Extremity Coil for AIRIS, with the exception that the coil geometry has been curved for easier coil positioning over the anatomy of interest. Safety and effectiveness of the coil are unchanged from the original, and this coil will replace the original coil.
AIRIS software did not need to be revised in order to support full functionality of these coils.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Head, Body, Spine, Extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hitachi AIRIS
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY | | 1998
Attachment 1 510(k) Summary of Safety and Effectiveness
: 上一篇:
1
SUBMITTER INFORMATION: 1.0
- Hitachi Medical Systems America 1.1 Submitter: 1959 Summit Commerce Park Twinsburg, OH 44087 PH: 330 425-1313 FX: 330 425-1410
- James Jochen Rogers 1.2 Contact:
- February 17, 1998 1.3 Date:
2.0 DEVICE NAME:
- Radiology Classification Panel: 2.1
- 892.1000 Magnetic Resonance Diagnostic Device 2.2 Classification Number:
- System, Nuclear Magnetic Resonance Imaging 2.3 Product Nomenclature:
- 90LNH Product Code(s): 2.4
- 90MOS (Magnetic Resonance Specialty Coil)
- 2.5 Trade/Proprietary Name: AIRIS
- PREDICATE DEVICE(s): 2.6
Hitachi AIRIS
3.0 DEVICE DESCRIPTION:
FUNCTION 3.1
The AIRIS MRI Magnetic Resonance Diagnostic Device is being enhanced by two additional RF Coils (QD HP [High Performance] Wrist Coil, and Shaped Shoulder Coil) to increase the clinical utility of the AIRIS in the stationary configuration.
The QD HP [High Performance] Wrist Coil P/N MR-QWC-51 is a new addition to the complement of coils intended for use with AIRIS. The coil utilizes a proprietary multiple receiver quadrature coil design for improved S/N Ratio.
The Shaped Shoulder coil P/N MR-SC-51 is identical to the Latchable Large Extremity coil, which was documented in a Memo-to-File document as identical to the original Large Extremity Coil for AIRIS, with the exception that the coil geometry has been curved for easier coil positioning over the anatomy of interest. Safety and effectiveness of the coil are unchanged from the original, and this coil will replace the original coil.
AIRIS software did not need to be revised in order to support full functionality of these 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
2
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.
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.
| ● 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 Spin Echo (SE); also with rephase |
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
3
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
DEVICE TECHNOLOGICAL CHARACTERISTICS: 5.0
Identical to the Predicate Device.
4
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 caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1998
James Jochen Rogers Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44087
Re:
QD HP Wrist and Shaped Shoulder Coils for Airis Magnetic Resonance Imaging System Dated: February 17, 1998 Received: February 23, 1998 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 (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 equivalient determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 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 (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/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Device Name: Additional RF Coils for AIRIS (QD HP Wrist, Shaped Shoulder)
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 crosssectional 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-lattion 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.
- Head, Body, Spine, Extremities Anatomical Region:
- Nucleus excited: Proton
- Diagnostic uses:
- 2D T1- / T2-weighted imaging T1, T2, proton density measurements MR Angiography image processing
- 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
(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
Over-the-Counter Use _ (Division Sign-Off)
Division of Reproductive Abdominal, ENT, and Radiological Devi 510(k) Number
(Optional Format 1-2-96)