(75 days)
Not Found
No
The summary focuses on hardware enhancements (RF coils) and explicitly states that the software did not need revision. There is no mention of AI, ML, or related concepts in the intended use, device description, or other sections.
No
The device is described as a diagnostic device that produces images to provide information useful for diagnosis, not for therapeutic purposes.
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: Images may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis." Furthermore, the "Device Description" identifies the device as "The TREX MRI 0.15T Elliptical MRI Magnetic Resonance Diagnostic Device." These statements clearly indicate its diagnostic purpose.
No
The device description explicitly details the addition of three physical RF coils, which are hardware components of the MRI system.
Based on the provided information, the TREX MRI system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- TREX MRI Function: The TREX MRI system produces images of the internal anatomy of the body by utilizing magnetic resonance. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states that the system produces cross-sectional images of general body anatomy for diagnostic purposes, interpreted by a trained physician. This is consistent with imaging devices, not IVDs.
Therefore, the TREX MRI system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The TREX MRI system produces cross-sectional images:
diaqnosis
- · Anatomical Region: General body anatomy, including head, spine, forso, and extremities
- 1H nuclei (Proton) Nucleus excited: .
- Images correspond to the distribution of 1H nuclei exhibiting Diagnostic uses: . 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) lmages may be interpreted by a trained physician to yield Clinical use: . information that can be useful in the determination of a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
90LNH, 90MOS
Device Description
Identical to the IMiG-MRI 510(k) K963953. As a result of newly created business arrangements, the original IMiG-MRI system will now be renamed as TREX MRI. With the exception of the device modifications identified in this 510(k) submission, and the renaming of the product, the TREX MRI is identical to the original IMiG-MRI system.
The TREX MRI 0.15T Elliptical MRI Magnetic Resonance Diagnostic Device is being enhanced by three additional RF Coils (Head Coil [quadrature], C-Spine Coil [quadrature], and Knee Coil [linear]) to increase the clinical utility of the TREX MRI in the stationary configuration.
The new quadrature Head Coil (Field Effects P/N 96530-01) will have a smaller diameter of 19 cm. The reduction in diameter will allow for improved coil fill factor, increasing SNR, while maintaining optimal coil uniformity. This new coil will replace the original Head Coil.
The new C-Spine Coil Field Effects P/N 96529-01) is substantially re-designed from the original coil, optimized for Cervical Spine imaging, and reducing the potential for patient anxiety and claustrophobia. This new coil utilizes a proprietary multiple receiver coil design, and will replace the original C-Spine/Knee Special Purpose Coil.
The new Knee Coil (Field Effects P/N 96629-01) utilizes a proprietary solenoid receiver coil design optimized for knee and extremity anatomies, improving coil fill factor, and increased S/N Ratio.
TREX MRI software did not need to be revised in order to support full functionality of these coils.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
General body anatomy, including head, spine, torso, and extremities
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.
IMiG-MRI K963953
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
Attachment 1 510(k) Summary of Safety and Effectiveness
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1
SUBMITTER INFORMATION: 1.0
- 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: Mgr., Imaging Science and Applications
- June 10, 1998 1.3 Date:
- Regulatory Counsel: 1.4 Jonathan S. Kahan, Attorney at Law Hoaan & Hartson 555 Thirteenth St. NW Washington, DC 20004-1109 PH: 202 637-5794 FX: 202 637-5910
DEVICE NAME: 2.0
- Radiology Classification Panel: 2.1
- 892.1000 Maanetic Resonance Diagnostic Device Classification Number: 2.2
- System, Nuclear Magnetic Resonance Imaging 2.3 Product Nomenclature:
- Product Code(s): 90LNH 2.4
- 90MOS (Maanetic Resonance Specialty Coil)
- 2.5 Trade/Proprietary Name: TREX MRI
- IMiG-MRI 2.6 Predicate Device:
DEVICE DESCRIPTION: 3.0
3.1 FUNCTION
Identical to the IMiG-MRI 510(k) K963953. As a result of newly created business arrangements, the original IMiG-MRI system will now be renamed as TREX MRI. With the exception of the device modifications identified in this 510(k) submission, and the renaming of the product, the TREX MRI is identical to the original IMiG-MRI system.
The TREX MRI 0.15T Elliptical MRI Magnetic Resonance Diagnostic Device is being enhanced by three additional RF Coils (Head Coil [quadrature], C-Spine Coil [quadrature], and Knee Coil [linear]) to increase the clinical utility of the TREX MRI in the stationary configuration.
The new quadrature Head Coil (Field Effects P/N 96530-01) will have a smaller diameter of 19 cm. The reduction in diameter will allow for improved coil fill factor, increasing SNR, while maintaining optimal coil uniformity. This new coil will replace the original Head Coil.
2
The new C-Spine Coil Field Effects P/N 96529-01) is substantially re-designed from the original coil, optimized for Cervical Spine imaging, and reducing the potential for patient anxiety and claustrophobia. This new coil utilizes a proprietary multiple receiver coil design, and will replace the original C-Spine/Knee Special Purpose Coil.
The new Knee Coil (Field Effects P/N 96629-01) utilizes a proprietary solenoid receiver coil design optimized for knee and extremity anatomies, improving coil fill factor, and increased S/N Ratio.
TREX MRI software did not need to be revised in order to support full functionality of these coils.
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 |
3.3 Performance Parameter Summary
| Receiver Coil | Head | Body |
|---|---|---|
| Specification Volume | 15cm dsv | 30cm dsv |
| SNR | > 34.2 | > 33.1 |
| Uniformity |