(307 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the M2 Wrist 2 MRI System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not list specific numerical acceptance criteria with corresponding device performance metrics for diagnostic accuracy. Instead, it focuses on demonstrating that the revised device (M2 Wrist 2 MRI System) is substantially equivalent to its predicate device (M2 Wrist MRI System) and meets various safety and performance standards relevant to MRI systems.
The acceptance criteria are implicitly derived from the performance standards met, which ensure the device functions as intended and produces images of sufficient quality for diagnostic use by a trained physician. The "reported device performance" is a statement of compliance with these standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Electrical & Mechanical Safety (IEC 60601-1) | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| Electromagnetic Compatibility (IEC 60601-1-2) | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| Software Validation | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| MR Image Quality Testing | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| SNR (NEMA MS-1-2008) | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| 2D Geometric Distortion (NEMA MS 3-2008) | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| Acoustic Noise (NEMA MIS 4 (2006)) | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| Slice Thickness (NEMA MS 5-2010) | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| SAR (NEMA MS 8 (2006) & NEMA MS 10-2006) | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| Gradient-Induced Electric Fields (NEMA MS 11 -2006) | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| Geometric Distortion for Special Applications (NEMA MS 12-2006) | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| Basic Safety & Essential Performance of MR (IEC 60601-2-33) | M2 Wrist 2 MRI System functioned as intended and met requirements. |
| High Contrast Spatial Resolution Testing | M2 Wrist 2 MRI System functioned as intended and met requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of clinical images or diagnostic performance. The performance data presented are "Non-Clinical" and consist of engineering tests and evaluations against industry standards. Therefore:
- Sample Size for Test Set: Not applicable/not explicitly stated in the context an imaging-based performance test with patient data. The tests performed are on the device itself (e.g., phantom images, electrical measurements) rather than on a dataset of patient images with ground truth.
- Data Provenance: Not applicable, as the tests are non-clinical engineering and performance evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the non-clinical performance data presented. No "experts" were used to establish ground truth for a test set of images; rather, the device's technical specifications and image quality were assessed against predefined objective standards using test equipment.
4. Adjudication Method for the Test Set
Not applicable, as no human-read test set requiring adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The summary explicitly states: "7. Clinical Performance Data: Not applicable". The submission focuses on non-clinical performance and substantial equivalence to a predicate device based on technical characteristics.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an MRI system, not an AI algorithm. Its performance is inherent in its ability to produce diagnostic images for interpretation by a human physician, not to provide an automated diagnosis.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests consisted of the technical specifications and requirements defined by the various IEC and NEMA standards (e.g., specific SNR values, geometric distortion limits, acoustic noise levels). The device's performance was compared against these objective, established standards using measurement tools and phantoms.
8. The Sample Size for the Training Set
Not applicable. The M2 Wrist 2 MRI System is a medical imaging device, not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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K130692
Page 1 of 6
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
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- 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 | $1.05 (+/- 2%)$ Teslavertical field | $1.05 (+/- 2%)$ Teslahorizontal field |
| Bore OpeningSize (H x W) | 76 x 200 mm | same |
| Field of View | 115 x 80 x 50 mm | 110 x 80 x 50 mm |
| Gradient SystemType | Special purposegradient system | same |
| Gradient Strength | 190 mT/m | same |
| Slew Rate | 400 T/m/sec | same |
| Rise Time | 475 $\mu$ sec | same |
| Gradient AmplifierGain Scale | $\pm$ 10 A output per $\pm$ 1 V input | same |
| Acoustic Noise | <75db | same |
| Cooling | Built-in cooling fansfor magnet andgradient subsystem | same |
| Wrist RF Coil | ||
| Central Frequency | 45 MHz | same |
| Solenoid (9 turns) | yes | same |
| B 1 Direction | yes | same |
| Coil HousingMaterial | Ultralloy 910-5 GLU | Ultralloy 304 |
| Balance MatchingCircuit | yes | yes |
| Tuning Capacitor | yes | yes |
| Maximum RFpeak handling | 500 W | same |
| Topology | Transmit/ReceiveCoil | same |
| Electrical | SolenoidCentral Frequency:45 MHz typicalNo decouplingcircuits | same |
| Dimensions ofMagnet sub-system | Height = 114 cmWidth = 79 cmLength = 79 cmWeight = Approx. 930 kg | Height = 125 cmWidth = 87 cmLength = 82 cmWeight = Approx. 1050 kG |
| Wrist CoilDimensions &Positions | The maximum handsize that can bescanned is:Width: 108 mmLength: 210 mmHeight: 50 mm | The maximum hand sizethat can be scanned is:Width: 108 mmLength: 220 mmHeight: 50 mm |
| Electronics Cabinet | ||
| RF PowerAmplifier | Tomco | same |
| Control Unit | Aspect | same |
| Gradient Amplifier | Copley | same |
| Power DistributionUnit | Aspect | same |
| Spectrometer | Tecmag-Apollo | Tecmag-Redstone |
| Dimensions ofElectronicsCabinet | Height: 130 cmWidth: 60 cmLength: 80 cmWeight: Approx. 205 kg | same |
| Isolation Transformer | ||
| Input | 200-240 VAC 50/60Hz | same |
| Output | 200-240 VAC 9A,2.16 kVA | same |
| OperatorEmergency StopSwitch | yes | same |
| Main CircuitBreaker LED forPower Indication | yes | same |
| Proprietary Software | ||
| Software | Windows 7Professional & WristMRI Software | same |
| Conventional MRI | 2D Spin-Echo | 2D Spin-Echo2D Spoiled |
| 3D SpoiledGradient Echo | ||
| 2D Fast Spin Echo | ||
| 3D Fast Spin Echo | ||
| Fat Suppression | ||
| Software Features | Perform MRI ScanSequence parametervariabilityMulti-Slice 2DViewerDICOM Export | same |
| Wrist MRISoftware | Version 1.1 | Version R.1.2.0.6 |
| TNMR Software | Version 2.11.2 | Version 2.11.22 |
| Processor | ComputerIntel Xeon W3520(2.66GHz,4.8GT/s,8MB) Memory runs at1066MHz | same |
| Resource DVD | Precision T3500Diagnostics and Drivers | same |
| Memory | 4GB(4x1GB)1066MHzDDR3 ECC-UDIMM | same |
| Hard Drive | 2x320GB (7200RPM)Serial ATA II withNCQ and 16MBDataBurst Cache | same |
| Raid Controller | C1 All SATA HardDrives, NON-RAID for 2Hard Drive | same |
| Optical Drive | 16X DVD+/-RW Drive;Power DVD 8.1Software and Mediaincluded | same |
| Graphics | 768 MB QuadroNVIDIA FX1800 - 2DP, 1 DVI (1 DP-DVI, 1 DVI-VGAadapter) | same |
| Operating System | English Windows 7Professional with SP1 | same |
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.
. .
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Though there are some minor differences in the characteristics of the two systems, these differences do not raise new questions of safety or efficacy. Furthermore, the M2 Wrist 2 MRI System has passed all the required tests and standards for MRI devices, as did the predicate M2 Wrist MRI System.
-
- Performance Data Non-
Clinical:
- Performance Data Non-
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
-
- Clinical Performance Not applicable Data: 8. Conclusions: Conclusions Drawn from Non-Clinical and Clinical Tests The performance tests demonstrate that M2 Wrist 2 MRI System may be safely
and effectively used in acquiring wrist MR images. The software validation and performance tests demonstrate that the M2 Wrist 2 MRI System meets its design and performance specifications and is substantially equivalent to the cleared M2 Wrist MRI System.
- Clinical Performance Not applicable Data: 8. Conclusions: Conclusions Drawn from Non-Clinical and Clinical Tests The performance tests demonstrate that M2 Wrist 2 MRI System may be safely
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K130692
Page 6 of 6
Substantial Equivalence:
In summary, the indications for use of the M2 Wrist 2 MRI System are the same and thus substantially equivalent to the M2 Wrist MRI System. Furthermore, the basic technological characteristics of the M2 Wrist 2 MR1 System are similar to the predicate M2 Wrist MRI System. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the M2 Wrist 2 MRI System is substantially equivalent it's predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three wavy lines representing the branches of government.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
January 14, 2014
Aspect Imaging Ltd. % Mr. George Hattub Senior Staff Consultant MedicSence, USA 291 Hillside Avenue SOMERSET MA 02726
Re: KI30692
Trade/Device Name: M2 Wrist 2 MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 1, 2013 Received: December 13, 2013
Dear Mr. Hattub:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Hattub
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/McdicalDevices/Safetw/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Andra D. O'Hara
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130692
Device Name: M2 Wrist 2 MRI System
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.
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)
Page 1 of 1
§ 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.