(65 days)
Not Found
No
The document mentions "image processing software" but does not explicitly state or imply the use of AI or ML technologies. The description focuses on renaming and minor modifications to an existing MRI system.
No
The device is described as a diagnostic imaging system, designed to produce images for interpretation by a physician to aid in diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic uses: Images correspond to the distribution of 1H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters..." and "Clinical use: lmages may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis". Additionally, the "Device Description" section refers to it as "The Field Effects MRI 0.15T Elliptical MRI Magnetic Resonance Diagnostic Device".
No
The device description explicitly states it is an "MRI Magnetic Resonance Diagnostic Device" which is being "enhanced by image processing software". This indicates the device is a hardware system (MRI scanner) with accompanying software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Field Effects MRI system produces cross-sectional images of the human body using magnetic resonance. It excites 1H nuclei and the images correspond to the distribution of these nuclei.
- Clinical Use: The clinical use is described as images being interpreted by a trained physician to yield information useful in determining a diagnosis. This is a direct imaging modality, not a test performed on a sample outside the body.
The device is a medical imaging system used for diagnostic purposes, but it operates in vivo (within the living body) rather than in vitro (in glass, referring to laboratory tests on samples).
N/A
Intended Use / Indications for Use
The Field Effects MRI system produces cross-sectional images:
• Anatomical Region: General body anatomy, including head, spine, torso, and extremities
• Nucleus excited: 1H nuclei (Proton)
• Diagnostic uses: Images correspond to the distribution of 1H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including - spin-lattice relaxation time (T1) - spin-spin relaxation time (T2) - density of nuclei (ρ) - flow velocity - chemical shift (δ)
• Clinical use: Images may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis.
• RF Coils: Head - quadrature Cervical Spine - quadrature Lumbar Spine, Thoracic Spine, and Abdomen - quadrature Knee - linear
• Image Acquisition Spin Echo Gradient Echo (GE,RGE) Fast Spin Echo (FSE) Fast Dual Echo (FDE) 3D Fast Gradient Echo (3DGE, 3DRGE) Inversion Recovery with Fast Spin Echo (FSE STIR, FSE FLAIR)
Product codes (comma separated list FDA assigned to the subject device)
90LNH
Device Description
Identical to the IMiG-MRI 510(k) K963953. The original IMiG-MRI system was renamed as TREX MRI in 510(k) submission K982157. As a result of changing business arrangements, the TREX MRI is now renamed as the Field Effects MRI System. In addition, following successful FDA determination of substantial equivalence of this 510(k) submission for the Image Processing software, Field Effects will cease commercialization efforts and support for the Field Effects MRI System. Service Support will be available through SMIS (refer to ttem 9, Address of Manufacturing Facilities for SMIS contact information). With the exception of the device modifications identified in this 510(k) submission, and the renaming of the product, the Field Effects MRI System is identical to the original IMiG-MRI system (and to the TREX.MRI).
The Field Effects MRI 0.15T Elliptical MRI Magnetic Resonance Diagnostic Device is being enhanced by image processing software to increase the clinical utility of the Field Effects MRI System in the stationary configuration.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
General body anatomy, including head, spine, torso, and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Not Found
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.
IMiG-MRI, K963953, Hitachi MRP-5000 with Version 5.0 Operating System Software, K943799
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
JAN 7 1999
:
Attachment 1 510(k) Summary of Safety and Effectiveness
1
1.0 SUBMITTER INFORMATION:
- Field Effects, a division of Intermagnetics General Corporation 1.1 Submitter: 300 Vesper Executive Park Tynasborough, MA 01879 PH: 978 649-8590 FX: 978 649-8520 Email: GHURST@IGC.com
- Grea Hurst, Ph.D. 1.2 Contact: Mar., Imaging Science and Applications
- 1.3 Date: October 30, 1998
- 1.4 Regulatory Counsel: Jonathan S. Kahan, Attorney at Law Hoaan & Hartson 555 Thirteenth St. NW Washington, DC 20004-1109 PH: 202 637-5794 FX: 202 637-5910
2.0 DEVICE NAME:
- 2.1 Classification Panel: Radiology
-
- 1000 Maanetic Resonance Diagnostic Device 2.2 Classification Number:
- 2.3 Product Nomenclature: System, Nuclear Magnetic Resonance Imaging
- 2.4 Product Code(s): 90LNH
- 2.5 Trade/Proprietary Name: Field Effects MRI
- 2.6 Predicate Device(s): IMiG-MRI, K963953 Hitachi MRP-5000 with Version 5.0 Operating System Software, K943799
3.0 DEVICE DESCRIPTION:
3.1 FUNCTION
Identical to the IMiG-MRI 510(k) K963953. The original IMiG-MRI system was renamed as TREX MRI in 510(k) submission K982157. As a result of changing business arrangements, the TREX MRI is now renamed as the Field Effects MRI System. In addition, following successful FDA determination of substantial equivalence of this 510(k) submission for the Image Processing software, Field Effects will cease commercialization efforts and support for the Field Effects MRI System. Service Support will be available through SMIS (refer to ttem 9, Address of Manufacturing Facilities for SMIS contact information). With the exception of the device modifications identified in this 510(k) submission, and the renaming of the product, the Field Effects MRI System is identical to the original IMiG-MRI system (and to the TREX.MRI).
The Field Effects MRI 0.15T Elliptical MRI Magnetic Resonance Diagnostic Device is being enhanced by image processing software to increase the clinical utility of the Field Effects MRI System in the stationary configuration.
2
3.2 Safety Parameter Summary
| Maximum static magnetic field | 0.15 Tesla |
|---|---|
| Maximum rate of magnetic field | |
| change | 18.4 Tesla/sec |
| Maximum RF power deposition | 0.05W/kg |
| Acoustic noise levels | 114dB peak; 95dB A-weighted RMS |
Performance Parameter Summary 3.3
ldentical to the Predicate Device.
3.4 General Safety and Effectiveness Summary
Safe and effective use of the machine is assured by the associated labeling. This labeling includes: advertising brochures, Site Planning Guide, and Instructions for Use (comprised of Clinical Users Guide, User Safety Guide, User Training Guide, User Applications Guide, and User QA & Maintenance Guide).
DEVICE INTENDED USE: 4.0
The Field Effects MRI system produces cross-sectional images:
- · Anatomical Region: General body anatomy, including head, spine, torso, and extremities
- 1H nuclei (Proton) . Nucleus excited:
- Diagnostic uses: Images correspond to the distribution of 1H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including spin-lattice relaxation time (T1) spin-spin relaxation time (T2) density of nuclei (p) flow velocity chemical shift (δ)
- · Clinical use: lmages may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis
5.0 DEVICE TECHNOLOGICAL CHARACTERISTICS:
Identical to the Predicate Device.
3
Image /page/3/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
10000 7 JAN
Ian L. Pykett, Ph.D., F.Inst.P. Vice President. Technology Development Intermagnetics General Corporation 450 Old Niskavuna Road P.O. Box 461 Latham, NY 12110-0461
Re:
Field Effects MRI Magnetic Resonance Diagnostic Device Dated: October 30, 1998 Received: November 3, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Dr. Pykett:
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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Fallure 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/dsma/dsmamain.html".
Sincerely yours,
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
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Image Processing Software for Field Effects MRI
Indications for Use:
The Field Effects MRI system produces cross-sectional images:
| • | Anatomical Region: | General body anatomy, including head, spine, torso, and extremities |
|---|---|---|
| • | Nucleus excited: | 1H nuclei (Proton) |
| • | Diagnostic uses: | Images correspond to the distribution of 1H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including |
- spin-lattice relaxation time (T1)
- spin-spin relaxation time (T2)
- density of nuclei (ρ)
- flow velocity
- chemical shift (δ) |
| • | Clinical use: | Images may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis. |
| • | RF Coils: | Head - quadrature
Cervical Spine - quadrature
Lumbar Spine, Thoracic Spine, and Abdomen - quadrature
Knee - linear |
| • | Image Acquisition | Spin Echo
Gradient Echo (GE,RGE)
Fast Spin Echo (FSE)
Fast Dual Echo (FDE)
3D Fast Gradient Echo (3DGE, 3DRGE)
Inversion Recovery with Fast Spin Echo (FSE STIR, FSE FLAIR) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| (Division Sign-Off) | (Division Sign-Off) | ||
| (Division Sign-Off) |
| Prescription Use (Per 21 CFR 801-109 | ✓ |
|---|---|
| -------------------------------------- | --- |
| Division of Reproductive, Abdominal, ENT Over-The-Counter Use ______ | |
|---|---|
| and Radiological Devices | |
| 510(k) Number | K983902 |
| (Optional Format 1-2-96) | |
|---|---|
| -- | -------------------------- |