ECG MONITOR MODEL DS-3130/3140

{0} K96 1174 JUN 21 1996 # Attachment 1 ## 510(k) Summary of Safety and Effectiveness {1} 1.0 SUBMITTER INFORMATION: 1.1 Submitter: Hitachi Medical Systems America 1963 Case Parkway Twinsburg, OH 44087 PH: 216 425 1313 FX: 216 425 1410 1.2 Contact: James Jochen Rogers 1.3 Date: March 21, 1996 2.0 DEVICE NAME 2.1 Classification Panel: Radiology 2.2 Classification Number: 892.1000 Magnetic Resonance Diagnostic Device 2.3 Product Number: 90LNH 2.4 Product Nomenclature: System, Nuclear Magnetic Resonance Imaging 2.5 Trade/Proprietary Name: ECG Monitor Model DS-3130/3140 2.6 Predicate Device: Hitachi AIRIS with ECG Monitor Hitachi STRATIS with ECG Monitor. 3.0 DEVICE DESCRIPTION: 3.1 FUNCTION The Fukuda Denshi ECG Monitor Model DS-3130/3140 is being added to increase the clinical utility of the AIRIS and STRATIS in the stationary configuration. The new ECG Monitor is UL-listed, and is being added to meet UL/ETL listing requirements for the AIRIS and STRATIS. The Model DS-3140 ECG Monitor has a stripchart recorder, the Model DS-3130 does not. As with the previous version of the ECG Monitor, the Model DS-3130/3140 supports ECG, peripheral pulse and respiratory gating; respiratory gating is not supported on the AIRIS. The Fukuda Denshi ECG Monitor Model DS-3130/3140 is only intended for distribution in the US as an accessory to the Hitachi MRI systems. 3.2 SCIENTIFIC CONCEPTS Magnetic Resonance (MR) is based on the fact that certain atomic 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. {2} 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 T1 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 consideration can be 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 pulse powers from several watts to greater than 10 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 submillisecond to several milliseconds. ## 3.3 PHYSICAL AND PERFORMANCE CHARACTERISTICS MR is currently of great interest because it is capable of producing high quality anatomical images without the associated risks of ionizing radiation. In addition, the biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In x-ray imaging, differences in x-ray attenuation, largely based on differences in electro density are responsible for the contrast observed in x-ray images. In MR imaging, differences in proton density, blood flow, and relaxation times T1 and T2 all may contribute to image contrast. In addition, by varying the duration and spacing of the RF pulses, images may be produced in which the contrast is primarily dependent on T1 relaxation, T2 relaxation, proton density, or a combination of all three. ## 4.0 DEVICE INTENDED USE: The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial 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 flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. - Anatomical Region: Head, Body, Spine, Extremities - Nucleus excited: Proton - Diagnostic uses: - 2D T1- / T2-weighted imaging - T1, T2, proton density measurements - MR Angiography - image processing {3} - Imaging capabilities: 2D, 3D Spin Echo (SE) 2D Fast Spin Echo (FSE) 2D Inversion Recovery (IR) 2D, 3D Gradient Echo (GE) 2D, 3D Gradient Echo with Rephasing (GR) 2D, 3D Steady state acquisition with rewinded GE (SARGE) 2D Dual Slice acquisition (DS) MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition) ## 5.0 DEVICE TECHNOLOGICAL CHARACTERISTICS: Identical to the Predicate Device.