NORMA 10

{0}------------------------------------------------ JUN 18 1999 : KQ9/243 # ATTACHMENT 1 # 510(k) Summary of Safety and Effectiveness {1}------------------------------------------------ # ODIN Technologies Ltd. P.O. Box 248, Yokneam Elit 20698, Israel. Tel. 972-4-9591010, Fax. 972-4-9591011 # 510(k) Summary of Safety and Effectiveness The Following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a). ### 807.92(a)(1) - Submitter Details: | Submitter name: | Adi Ickowicz – Regulatory Affairs / Quality Assurance<br>Director | |-----------------|-------------------------------------------------------------------| | Address: | P.O. Box 248, Yokneam Elit 20698, Israel | | Phone: | +972-4-959-1010 | | Fax: | +972-4-959-1011 | | E-mail: | adi@odin.co.il | | Contact Person: | Adi Ickowicz – Regulatory Affairs / Quality Assurance<br>Director | | Date: | March 15, 1999 | {2}------------------------------------------------ ## 807.92(a)(2) - Device Details: | Trade Name and Common Name: | NORMA 10 - Magnetic Resonance<br>Diagnostic Device | |-----------------------------|-----------------------------------------------------------------------------------------------| | Classification: | 21 CRF 892.1000 Magnetic Resonance<br>Diagnostic Device. | | Class: | II<br>MRDD were reclassified by FDA from<br>Class III to Class II effective July 28,<br>1998. | | Product Code: | LNH - Magnetic Resonance Imaging<br>System | ## 807.92(a)(3) - Predicate Devices: | Medical Device<br>Name | Applicant<br>Name | 510(k) Number | Classification | |------------------------|-------------------|---------------|-----------------| | Ortho 8000 | Inner Vision | K963186 | Class II device | | MRP-5000 | Hitachi | K911642 | Class II device | Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table. {3}------------------------------------------------ ### 807.92(a)(4) - Device Description: #### Device Functions: The NORMA 10 utilizes a permanent magnet to acquire 2D single-slice, multi slice, and 3d volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, gradient echo, fast spin echo, and steady state free precession acquisitions. The NORMA 10 is a fixed system. #### Scientific Concepts: Magnetic Resonance (MR) is based on the fact that certain anatomic nuclei have electromagnetic properties, which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nucleus used in current imaging experiments in magnetic resonance. When placed in a magnetic field, there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of Radiofrequency (RF) excitation of wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is removed, the proton relaxes and returns to its original orientation. The rate of relaxation is exponential, and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by two exponential relaxation times called TI and T2, which can be measured. These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emissions on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by appropriately applying magnetic field gradients in x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under {4}------------------------------------------------ consideration can he constructed by using image processing techniques similar to those used in CT. For magnetic fields up to 1.5T, the RF frequencies commonly used range up to 65MHz. The RF fields have pulsed power from several watts to greater than 2 kilowatts, and repeat at rates from once every few seconds to greater than fifty per second. The time-varying magnetic gradient fields have a typical duration of sub-millisecond to several milliseconds. #### Physical and Performance Characteristics: ODIN Technologies Ltd., has developed an open MRI system based on an innovatively designed permanent magnet of 0.12 Tesla. The system is compact, displaceable, inexpensive and widely open. The magnetic probe consists of two lateral permanent-magnet poles that can be adjusted laterally and longitudinally, mounted on a C-arm gantry. The anatomic region to be scanned is positioned between the poles. Except for the anatomic region been scanned, the patient is positioned outside of the gantry, thus enhancing patient comfort and reducing the possibility of a claustrophobic reaction. ### 807.92(a)(5) — Device Intended Use: The NORMA 10 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the NORMA 10 reflect the special distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*. {5}------------------------------------------------ When interpreted by trained physicians, these images provide information that can be useful in determining a diagnosis. - Anatomical regions: extremities and selected sections of the . head. - H-1 Nuclei excited: . - Diagnostic uses: T1, T2, T2* and density weighted . imaging. # 807.92(a)(6) - Substantial Equivalence Comparison Table: | Model | Odin | Hitachi | Innervision | |-------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | parameter | NORMA 10 | MRP-5000 | Ortho 8000 | | Clinical application | Extremities and<br>selected sections of<br>the head | Whole body | Extremities | | Magnet type | Permanent | Permanent | Permanent | | Field strength | 0.12T | 0.2T | 0.17T | | 5 gauss fringe field<br>(radial/axial, m) | 1.5 | <2.1 | 0.3 | | Shimming | Passive, active | Passive | Passive, active | | Gradient subsystem | | | | | - Strength mT/m | 25 | 8 | 15 | | - Rise time to 10mT/m | <1 | <1 | <1 | | msec | | | | | Model | Odin | Hitachi | Innervision | | parameter | NORMA 10 | MRP-5000 | Ortho 8000 | | Computer system | | | | | - CPU: | Pentium 586 | Motorola 32 bit | IBM PC | | - Memory size [MB] | 64 | 4 | 32 | | array processor | 4xDSP C44 TI | Hitachi | TI | | - Memory size [MB] | 4000 | 68 | Not specified | | storage media | magnetic disk,<br>floppy disk | magnetic disk,<br>optical disk | optical disk, tape,<br>CD-R, floppy disk | | number of images stored | 5000 | 2000 magnetic disk<br>4300 optical disk | 5000 | | Imaging modes: | | | | | - single | Yes | Yes | Yes | | - multislice | Yes | Yes | Yes | | - volume study | Yes | Yes | Optional | | - other | FSE, Multislice | Multislab,<br>multiangle, FS, dual<br>slice, MRA, cardiac<br>gated,<br>multislice/multiple<br>angle | Dynamic scan | | Reconstruction time: | | | | | - single slice, sec | <3/slice | <4/slice | <3/slice | | - multislice, sec | <3/slice | <4/slice | <3/slice | | - volume sec | <20/slice, ave. | <4/slice | <20/slice, ave. | | model | Odin | Hitachi | Innervision | | parameter | NORMA 10 | MRP-5000 | Ortho 8000 | | Cardiac gating<br>(ECG/peripheral) | No | Yes/yes | NA | | Respiratory gating | No | No | NA | | Angiography | Optional | Optional | NA | | Spectroscopy | No | No | NA | | Imaging; | | | | | - pulse sequence | Spin Echo, Fast<br>Spin Echo,<br>Gradient Echo, 2D<br>3D | SE, multiple SE,<br>GE, IR, STIR,<br>FSE,dual slice,<br>MRA | SE, FE, IR,<br>multiecho, dynamic | | - repetition time, msec | 50-5000 increments<br>of 1 | 50-4000 | 50-5000 increments<br>of 1 | | - echo time, msec | 5-150 | 10-150 | 7-100 increments of<br>1 | | - inversion time, msec | N/A | 100-800 | 15-5000 incr. of 1 | | - slice thickness, mm | 4-10 | 3,4,5,6,7,8,10,12.5,<br>15,17.5,20,30,50<br>(2D) 1-5 (3D) | 3-10 incr. of 1 | | - FOV, cm | 5-18 | 12-40 | 8-16 increments of<br>0.1 | | model | Odin | Hitachi | Innervision | | parameter | NORMA 10 | MRP-5000 | Ortho 8000 | | - scan orientation | Transverse,<br>coronal, sagittal,<br>oblique | Transverse,<br>coronal, sagittal,<br>dual axis, oblique | Orthogonal, oblique | | - measuring matrix | 64x64 to 256x256<br>steps of 1 in phase<br>encoding | 128x256, 160x256<br>192x256, 256x256,<br>half scan, rectang. | 64x256 to 256x256<br>steps of 1 in phase<br>encoding | | - display matrix | 1024x768 | 512x512 | Up to 512x512 | | - pixel intensity | 0-4095 | -2000 to +4000 | 0-255 | | Surface coils: | | | | | - spine | No | Yes | NA | | - knee | Yes | Yes | Yes | | - neck | No | Yes | NA | | - TMJ | No | Bilateral | NA | | - extremity | Yes | Oval Solenoid | Yes | | - head | Yes | Solenoid quad. | NA | | - breast | No | Optional bilateral | NA | | - shoulder | No | Yes | NA | | - others | No | Flexible | Small dynamic<br>(12cm) large<br>dynamic (18cm) | | Bore diameter or WxH, cm | 24.5x39 | 100x48 rectangle | 20x75 | | model | Odin | Hitachi | Innervision | | parameter | NORMA 10 | MRP-5000 | Ortho 8000 | | Bore features | Open access to<br>patient | Wide bore short<br>depth, intercom,<br>soft sound<br>gradients | Open access to<br>patient, quiet<br>gradient system<br>built in CD sound<br>sys. | | Cooling system type | Water cooling<br>(Gradients only) | None, room<br>air-conditioning | Thermal insulation | | Cryogen use | NA | NA | NA | | Magnet weight, kg | 380 | 12200 | 500 | | HxWxD, cm | 135x86x80 | 175x228x157 | 118x51x52 | | Dicom 3.0 interface | No | Optional | From 3rd party | | Power requirements: | | | | | - line voltage, V | 3x208 (3 phase) | 200-240 single<br>phase | 110/240 | | - Kva | 16 | 6 | <3 | | - A/C, BTU/hr | <10000 | <10000 | 10000 | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ## Clinical Data: Testing of the system was performed at the Odin premises, during the period of October 1998 through February 1999. The scans were performed on normal anatomy including extremities and selected sections of the head. {10}------------------------------------------------ # Conclusions from Testing: Safety and magnetic resonance performance tests were performed on the NORMA 10 in accordance with the NEMA standards. The results obtained from the safety tests including acoustic noise, Specific Absorption Rate (SAR) and Time-Varying Gradient Fields (dB/dt) were found to be below the levels of significant risk as described in the FDA Guidance for the Submission Of Premarket Notification for Magnetic Resonance Diagnostic Device, dated November 14, 1998. The performance results obtained including Signal-to-Noise Ratio (SNR), Geometric Distortion, Image Uniformity, Slice Thickness, Characterization of Special Purpose Coils and spatial resolution meets the performance specifications claimed. {11}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service DEPARTMENT OF HEALTH Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 8 1999 Adi Ickowicz Odin Technologies, Ltd. P.O. Box 248 Yokneam, Elet 20698 ISRAEL RE: K991243 Norma 10 MR Diagnostic Device Dated: April 10, 1999 Received: April 12, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH Dear Mr. Ickowicz: 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 III (Special Controls) or dass 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. Failure to comply with the GMP regult 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 {12}------------------------------------------------ 510(k) Number (if known): Device Name: NORMA 10 Indication For Use: The NORMA 10 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the NORMA 10 reflect the spatial distribution of protons (Hydrogen Nucle) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis. - Anatomical regions: extremities and selected sections of the head. ● - Nuclei excited: H-1 . - T1, T2, T2* and density weighted imaging. Diagnostic uses: . (PLEASE DO NOT WRITE BELOW THE LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH. Office of Device Evaluation (ODE) Ovid A. Seymore (Division Sign-Off) (Division Sign-Off) Division of Reproductive, Abdominal, E. and Radiological D 510(k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)