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SatPads™ are registered as Class II medical devices with the Food & Drug Administration. In order to get that registration, clinical studies had to be conducted so a proposal could be put together for petition.
Clinical case studies were conducted to evaluate the performance of the fat saturation device. Healthy adult volunteers were imaged with and without the device and the scans were evaluated by a radiologist. Results indicated that the fat saturation technique was enhanced by the use of the fat saturation device. The device allowed the MR scanner to load more efficiently and reduce chemical shift artifacts. Each series demonstrated significantly improved homogeneity of the anatomical location examined, providing clearer, better-defined MR images relative to images without the fat saturation device.
Results of the studies demonstrate that the fat saturation device is safe and effective for enhancing MR fat saturation techniques. The fat saturation device provides better MR images when used in conjunction with fat saturation techniques than do the legally marketed medical devices to which substantial equivalency is claimed. Positioning devices improve MR by stabilizing body parts and reducing motion artifacts; however, they do not improve fat saturation. Radiographic grids improve x-ray images by reducing scatter radiation during roentgenography, whereas fat saturation devices improve MR images by nullifying fat during fat saturation pulsing parameters.
The polymeric materials that are used for the pad are commonly used for medical devices and are known to be safe for the intended use (i.e., skin contact). Based on permeation studies, skin contact with the liquid inside the pad is unlikely since the pads are nearly impervious to the perfluorocarbons. Additionally, due to product design, skin contact caused by a perforation of the pad will be limited. Furthermore, the perfluorocarbons used in the device are generally accepted as safe (i.e. nontoxic and nonirritating) due to their chemical and biological inertness and are not known to cause irritation of the skin after limited direct contact.