SureWave Elastography (Q7000225)

The SureWave Elastography device is an MRI accessory that generates shear wave vibrations in a patient's body during scanning using a transducer driven by a mobile tower and rotating axes. It produces images representing tissue stiffness (measured in kiloPascals) that can be used for diagnostic interpretation by trained physicians and is compatible with Siemens 1.5T and 3.0T MRI systems.

The proposed device uses shear wave vibrations via a tower, transducer, and flexible axes to generate tissue stiffness maps, whereas the predicate uses acoustic vibrations via an active driver, tubing, and passive driver. The SureWave inversion algorithm offers both 2D and 3D reconstruction solutions, compared to the predicate's 2D-only capability. Both devices apply MR acquisition sequences synchronized with external vibration sources and are compatible with MRI systems.

Not stated in this summary.

The SureWave Elastography demonstrates substantial equivalence through bench testing showing its stiffness measurements fall between predicate values and phantom manufacturer specifications, with accuracy comparable to or better than the predicate. Volunteer testing with 22 healthy adults showed SureWave 2D had excellent agreement with the predicate (slope 1.02, R²=0.99, 4% bias), with the expected 3D bias attributable to volumetric versus slice analysis. Repeatability testing confirmed all three methods were within 10% of their respective means, and electrical safety, electromagnetic compatibility, and biocompatibility data support safety equivalence.