e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector

The e²Coil Imaging System is a prostate MRI coil designed for use with Siemens 3.0T MRI scanners. It consists of a disposable endorectal probe inserted into the rectum for high-resolution imaging of the prostate and surrounding pelvic tissue, plus a reusable interface device that connects the probe to the MRI system. The device is intended for use by trained healthcare professionals only.

The subject device has two coils (loops) with four channels in the disposable probe, compared to the predicate's single coil with one channel. The e²Coil includes an intermediate cable assembly and adds a fuse as an additional level of electrical protection. Both devices share the same soft tip, thin-wall balloon, semi-flexible shaft, depth stopper, and flexible syringe connector tubing components. The e²Coil is compatible with Tim 4G connector systems, whereas the predicate was designed for Tim Trio platforms.

Testing conducted per IEC 60601-1 for electrical safety and electromagnetic compatibility, IEC 60601-2-33 for MR safety, ISO 10993-1:2018 for biocompatibility, IEC 62464-1 for signal uniformity, and NEMA MS 1 and MS 3 for SNR and uniformity testing. Mechanical testing per IEC 60601-1 standards included push, impact, drop, and moulding stress relief tests.

The devices share identical indications for use (high-resolution prostate MRI imaging), identical mechanical components in the disposable probe (same balloon, shaft, stopper, tubing), and same principles of operation as MR receive coils. The increase from one to two coils with four channels represents an enhancement rather than a fundamental change in technology. The addition of the fuse and intermediate cable actually improves safety without introducing new hazards. Performance testing demonstrated equivalent or superior signal characteristics, and biocompatibility is maintained since the probe materials are identical to the predicate.