MagDI System (MAG-02, DS-01)

The MagDI System is a sterile, single-use magnetic compression anastomosis device consisting of two magnets used to create side-to-side duodeno-ileal anastomoses (bowel connections) during minimally invasive and laparoscopic surgery. After 7–21 days, the magnets compress tissue between them, causing necrosis; the device then naturally detaches and is expelled. It is intended for adult patients over 21 years old.

The subject device (MAG-02, 50mm length) is a planned variant of the predicate device (MAG-01, 39mm length). The sole change is increased magnet length while maintaining similar compression strength. Both devices use the same fundamental magnetic compression anastomosis technology, intended use, and indications for use. The longer magnet provides surgeons flexibility to choose device length based on individual patient morphology and clinical characteristics.

ISO 10993-1 (biocompatibility), ISO 11137-1, ISO 11137-2, and ISO 11137-3 (sterilization validation with sterility assurance level of 10^-6), and ISO 15223 (labeling symbols). The device demonstrated magnet field strength safety, adequate separation forces over use life, and successful connection/disconnection to the delivery system.

The subject device is substantially equivalent because it maintains identical intended use and indications for use as the predicate (K242086), employs the same fundamental magnetic compression anastomosis technology without fundamental changes, and the sole modification—increased magnet length—does not raise new safety or effectiveness questions. Clinical testing in obese patients demonstrated successful anastomosis creation with a safety profile as least as safe as the predicate, with no cases of internal hernia, bowel obstruction, anastomotic complications, or deaths. The device will be incorporated into the same post-market surveillance study as the predicate.