Who is the manufacturer of M2 WRIST 2 MRI SYSTEM?

Aspect Imaging, Ltd. filed the 510(k) submission for M2 WRIST 2 MRI SYSTEM (K130692).

What is the FDA product code for M2 WRIST 2 MRI SYSTEM?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for M2 WRIST 2 MRI SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like M2 WRIST 2 MRI SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

M2 WRIST 2 MRI SYSTEM

K130692 · Aspect Imaging, Ltd. · LNH · Jan 14, 2014 · Radiology

Device Facts

Record ID	K130692
Device Name	M2 WRIST 2 MRI SYSTEM
Applicant	Aspect Imaging, Ltd.
Product Code	LNH · Radiology
Decision Date	Jan 14, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended 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.

Device Story

M2 Wrist 2 MRI System is a 1 Tesla compact permanent magnet MRI device for wrist imaging. System inputs include RF signals from wrist anatomy; transforms signals via pulse sequences (2D/3D Spin-Echo, Spoiled Gradient Echo, Fast Spin Echo) into transverse, sagittal, and coronal images. Operated by trained personnel in fixed installations; no RF-shielded room required due to self-shielded magnet. Output is MR images displayed on a workstation for physician interpretation to assist in clinical diagnosis. Benefits include high-performance imaging in a compact, low-noise, low-field footprint.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical/mechanical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software validation, and NEMA performance standards (MS-1, MS-3, MS-4, MS-5, MS-8, MS-10, MS-11, MS-12) for image quality, SNR, geometric distortion, acoustic noise, slice thickness, and SAR.

Technological Characteristics

1 Tesla permanent magnet MRI; horizontal field. Components: magnet subsystem, wrist coil (Ultralloy 304 housing), electronics cabinet, computer, isolation transformer. Connectivity: DICOM export. Software: Windows 7 Professional, proprietary MRI software. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA MS series. Cooling: built-in fans.

Indications for Use

Indicated for patients with arm length > 320mm requiring magnetic resonance imaging of the wrist for diagnostic purposes. To be interpreted by a trained physician.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

M2 Wrist MRI System (K120701)

Related Devices

K120701 — M2 WRIST MRI SYSTEM · Aspect Imaging, Ltd. · Feb 7, 2013
K160185 — Wrist 3 · Aspect Imaging, Ltd. · Mar 1, 2016
K073131 — MICROMRI WRIST COIL · Micromri, Inc. · Jan 18, 2008
K991434 — QUADRATURE WRIST COIL, MODEL 445PH-64 · Medical Advances, Inc. · Jul 6, 1999
K173469 — 16ch T/R Hand Wrist Coil · Quality Electrodynamics, LLC · Jan 9, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {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 | <75db | same | | Cooling | Built-in cooling fans for magnet and gradient subsystem | same | | Wrist RF Coil | | | | Central Frequency | 45 MHz | same | | Solenoid (9 turns) | yes | same | | B 1 Direction | yes | same | | Coil Housing Material | Ultralloy 910-5 GLU | Ultralloy 304 | | Balance Matching Circuit | yes | yes | | Tuning Capacitor | yes | yes | | Maximum RF peak handling | 500 W | same | | Topology | Transmit/Receive Coil | same | | | | | | Electrical | Solenoid Central Frequency: 45 MHz typical No decoupling circuits | same | | Dimensions of Magnet sub- system | Height = 114 cm Width = 79 cm Length = 79 cm Weight = Approx. 930 kg | Height = 125 cm Width = 87 cm Length = 82 cm Weight = Approx. 1050 kG | | Wrist Coil Dimensions & Positions | The maximum hand size that can be scanned is: Width: 108 mm Length: 210 mm Height: 50 mm | The maximum hand size that can be scanned is: Width: 108 mm Length: 220 mm Height: 50 mm | | Electronics Cabinet | | | | RF Power Amplifier | Tomco | same | | Control Unit | Aspect | same | | Gradient Amplifier | Copley | same | | Power Distribution Unit | Aspect | same | | Spectrometer | Tecmag-Apollo | Tecmag-Redstone | | Dimensions of Electronics Cabinet | Height: 130 cm Width: 60 cm Length: 80 cm Weight: Approx. 205 kg | same | | Isolation Transformer | | | | Input | 200-240 VAC 50/60 Hz | same | | Output | 200-240 VAC 9A, 2.16 kVA | same | | Operator Emergency Stop Switch | yes | same | | Main Circuit Breaker LED for Power Indication | yes | same | | Proprietary Software | | | | Software | Windows 7 Professional & Wrist MRI Software | same | | Conventional MRI | 2D Spin-Echo | 2D Spin-Echo 2D Spoiled | | | | 3D Spoiled Gradient Echo | | | | 2D Fast Spin Echo | | | | 3D Fast Spin Echo | | | | Fat Suppression | | Software Features | Perform MRI Scan Sequence parameter variability Multi-Slice 2D Viewer DICOM Export | same | | Wrist MRI Software | Version 1.1 | Version R.1.2.0.6 | | TNMR Software | Version 2.11.2 | Version 2.11.22 | | Processor | Computer Intel Xeon W3520 (2.66GHz,4.8GT/s,8 MB) Memory runs at 1066MHz | same | | Resource DVD | Precision T3500 Diagnostics and Drivers | same | | Memory | 4GB (4x1GB)1066MHz DDR3 ECC-UDIMM | same | | Hard Drive | 2x320GB (7200RPM) Serial ATA II with NCQ and 16MB DataBurst Cache | same | | Raid Controller | C1 All SATA Hard Drives, NON-RAID for 2 Hard Drive | same | | Optical Drive | 16X DVD+/-RW Drive; Power DVD 8.1 Software and Media included | same | | Graphics | 768 MB Quadro NVIDIA FX1800 - 2 DP, 1 DVI (1 DP- DVI, 1 DVI-VGA adapter) | same | | Operating System | English Windows 7 Professional with SP1 | same | {2}------------------------------------------------ . . . {3}------------------------------------------------ {4}------------------------------------------------ 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. - 7. Performance Data Non- Clinical: 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 - 7. 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. {5}------------------------------------------------ K130692 Page 6 of 6 ### Substantial Equivalence: 8. 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. {6}------------------------------------------------ #### 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. {7}------------------------------------------------ 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 {8}------------------------------------------------ ## 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