(307 days)
Not Found
No
The summary describes a standard MRI system and its components, focusing on hardware specifications and image acquisition. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is used for diagnostic imaging to provide information for diagnosis, not for treating a disease or condition.
Yes
The device is indicated for use as a magnetic resonance imaging device to produce images that, when interpreted by a trained physician, provide information useful in determining a diagnosis. This clearly defines its role in the diagnostic process.
No
The device description explicitly lists multiple hardware components (Magnet Sub-system, Wrist Coil, Electronics Cabinet, Computer, Isolation Transformer) in addition to the software.
Based on the provided information, the M2 Wrist 2 MRI System 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. They are used to examine these samples outside of the body ("in vitro").
- M2 Wrist 2 MRI System Function: The description clearly states that the M2 Wrist 2 MRI System is a magnetic resonance imaging device used to produce images of the internal structure of the wrist. This is an in vivo imaging technique, meaning it is performed on the living body.
- Intended Use: The intended use is to provide images that can be useful in determining a diagnosis, but this is based on the interpretation of images of the body itself, not on the analysis of samples taken from the body.
Therefore, the M2 Wrist 2 MRI System falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The M2 Wrist 2 MRI System is indicated for use as a magnetic resonance imaging device for producing transverse, sagittal and coronal images of the internal structure of the wrist (in patients with an arm length > 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.
Product codes
LNH
Device Description
The M2 Wrist 2 MRI System is a 1 Tesla, compact, high-performance solution, based on a permanent magnet. Due to its remarkable structure, the external magnetic field is very low, thus offering unique safety advantage. The system has very low Eddy currents and exhibits very low gradient-related acoustic noise. The magnet is self-shielded and thus no RF shielded room is required. The type of installation is fixed. The M2 Wrist 2 MRI System's main components are: . Magnet Sub-system Wrist Coil . Electronics Cabinet . Aspect Imaging Proprietary Software . Computer . . Isolation Transformer
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
wrist
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Standards: The following performance tests were performed on the M2 Wrist 2 MRI System or its components:
- Electrical & Mechanical Safety (IEC 60601 -1) .
- Electromagnetic Compatibility (IEC 60601-1-2) .
- Software Validation .
- MR Image Quality Testing .
- NEMA MS- 1-2008 Determination of Signal-to-Noise Ratio (SNR) in . Diagnostic Magnetic Resonance Imaging
- NEMA MS 3-2008 Determination of Two-Dimensional Geometric . Distortion in Diagnostic Magnetic Resonance Images (Image Uniformity Test)
- . NEMA MIS 4 (2006) Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
- NEMA MS 5-2010 Determination of Slice Thickness in Diagnostic . Magnetic Resonance Imaging
- NEMA MS 8 (2006) Characterization of the Specific Absorption Rate . (SAR) for MRI Systems
- NEMA MS 10-2006 Determination of Local Specific Absorption Rate . (SAR) in Diagnostic Magnetic Resonance Imaging
- NEMA MS 11 -2006 Determination of Gradient-Induced Electric Fields in . Diagnostic Magnetic Resonance Imaging
- NEMA MS 12-2006 Quantification and Mapping of Geometric Distortion . for Special Applications
- IEC 60601-2-33 Medical electrical equipment Part 2-33: Particular . requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic (2007 (Second Edition) + Al 1:2005 ± A2:2007)
- High Contrast Spatial Resolution Testing .
In all instances, the M2 Wrist 2 MRI System functioned as intended and/or met the requirements of the standard
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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.
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K130692
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510(k) Summary of Safety & Effectiveness
JAN 1 4 2014
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
- George J. Hattub Submitter 1. (a) Address: MedicSense, USA . 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com 1. (b) Manufacturer Aspect Imaging, Ltd. Address: 27 Shaked Street Industrial Area Hevel Modi'in Shoham, Israel 60850 Mfg. Phone: Tel.: +972 73 2239000 Contact Uri Hoffer Person: December 1, 2013 Date: Magnetic Resonance Imaging System have been classified as Class 2 LNH, 2. Device & Classification: Regulation Number 21 CFR 892.1000 Magnetic resonance diagnostic device M2 Wrist 2 MRI System Name: Predicate M2 Wrist MRI System K120701 3. Device: The M2 Wrist 2 MRI System is a 1 Tesla, compact, high-performance solution, 4. Description: based on a permanent magnet. Due to its remarkable structure, the external magnetic field is very low, thus offering unique safety advantage. The system has very low Eddy currents and exhibits very low gradient-related acoustic noise. The magnet is self-shielded and thus no RF shielded room is required. The type of installation is fixed. The M2 Wrist 2 MRI System's main components are: . Magnet Sub-system Wrist Coil . Electronics Cabinet . Aspect Imaging Proprietary Software . Computer . . Isolation Transformer
Specific Technical Description: see below in Section 6
1
- The M2 Wrist 2 MRI System is indicated for use as a magnetic resonance ട. Intended Use: imaging device for producing transverse, sagittal and coronal images of the internal structure of the wrist (in patients with an arm length > 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.
6. Technology: Technology and Comparison of Characteristics
With respect to technology and intended use, the M2 Wrist 2 MRI System is substantially equivalent to its predicate device which is the M2 Wrist MRI System. The primary differences are the addition of plastic panels, modified wrist coil, a change in the spectrometer, additional pulse sequences and added MRI viewing features. Based upon the validation results, Aspect Imaging believes these changes do not raise additional safety of efficacy concerns.
| Characteristic /
Feature | Predicate Device
(System) | Modified Device
(System) |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Magnet Subsystem | | |
| Field Strength | $1.05 (+/- 2%)$ Tesla
vertical field | $1.05 (+/- 2%)$ Tesla
horizontal field |
| Bore Opening
Size (H x W) | 76 x 200 mm | same |
| Field of View | 115 x 80 x 50 mm | 110 x 80 x 50 mm |
| Gradient System
Type | Special purpose
gradient system | same |
| Gradient Strength | 190 mT/m | same |
| Slew Rate | 400 T/m/sec | same |
| Rise Time | 475 $\mu$ sec | same |
| Gradient Amplifier
Gain Scale | $\pm$ 10 A output per $\pm$ 1 V input | same |
| Acoustic Noise | 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael D. O'Hara
(Division Sign-Off) Division of Radiological Health/OIR K130692 510(k)
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