(78 days)
Not Found
Not Found
No
The document describes a new coil for an existing MR system and mentions standard image processing techniques, but there is no mention of AI, ML, or related concepts.
No
The device is described as an "imaging device" intended to provide "physiological and clinical information" and for use in "diagnosis determination," clearly indicating its diagnostic, not therapeutic, purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MR system's images can "provide information that can be useful in diagnosis determination," indicating its role in the diagnostic process.
No
The device description explicitly details a physical component, the "QD C-Spine Coil," which is a hardware accessory for an existing MR system. While image processing is mentioned, the core device being described and cleared is a hardware coil.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MR system is an "imaging device" that provides "physiological and clinical information" through "non-invasive" imaging. It produces images of internal structures.
- Device Description: The device description focuses on the technical aspects of the MR system and a specific coil (QD C-Spine Coil) used for imaging the cervical spine and surrounding areas.
- Mechanism: The mechanism described is based on magnetic resonance properties of protons (hydrogen nuclei) and image processing techniques to construct images. This is a physical imaging process, not a diagnostic test performed on biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests in vitro (outside the body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This MR system operates by imaging the body directly.
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.
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
2D T1- / T2-weighted imaging Diagnostic uses:
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
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Head, Body, Spine, Extremities, cervical spine anatomy, upper thoracic and lower cranial structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K971016
JUN - 6 1997
Attachment 1 510(k) Summary of Safety and Effectiveness
1
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
- Contact: James Jochen Rogers 1.2
- 1.3 Date: March 13, 1997
2.0 DEVICE NAME:
- Magnetic Resonance Diagnostic Device 2.1
- 2.2 System, Nuclear Magnetic Resonance Imaging Classification Name:
- 2.3 Classification Number: 90LNH
- 2.4 Classification Panel: Radiology
- 892.1000 Magnetic Resonance Diagnostic Device 2.5 Radiology Device:
- MRP-7000 with QD C-Spine Coil (P/N MR-QCSC-42) 2.6 Trade/Proprietary Name: AIRIS with QD C-Spine Coil (P/N MR-QCSC-52)
- Hitachi MRP-7000 with Neck/Joint Coil 2.7 Predicate Device: Hitachi AIRIS with Neck/Extremity Coil
3.0 DEVICE DESCRIPTION:
FUNCTION 3.1
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
2
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.
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 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.
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.
3
- · Anatomical Region: Head, Body, Spine, Extremities
- Proton Nucleus excited:
- 2D T1- / T2-weighted imaging Diagnostic uses:
- T1, T2, proton density measurements MR Angiography image processing
● Imaging capabilities:
ﺮ ﺗﺮﺗﺒﻪ ﺍ
- 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
DEVICE TECHNOLOGICAL CHARACTERISTICS: 5.0
Identical to the Predicate Devices.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
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
JUN - 6 1997
OD C-Spine Coil for MRP-7000 and AIRIS Dated: March 13, 1997 Received: March 20, 1997. Regualtory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Rogers:
44
We have reviewed your Section 5100k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the includions for use stated in the enclosure) to devices marketed in interstate commerce 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, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.
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 and in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantialion 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 does not affect any obligation you might have under sections 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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) 594-4591 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 (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 yours,
William Ym
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
5
QD C- Spine Coil (AIRIS, MRP-7000) Device Name:
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-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
- 2D T1- / T2-weighted imaging Diagnostic uses:
- T1. T2. proton density measurements
- MR Angiography image processing
- 2D T1- / T2-weighted imaging Diagnostic uses:
- 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
- 2D, 3D Spin Echo (SE) 2D Inversion Recovery (IR)
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)