Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)

The Sterile Insulated Dilators are surgical instruments available in 5, 10, 16, and 20mm sizes used during spine surgery to sequentially dilate the surgical site and deliver electrical stimulation to tissue and nerves to assist in locating nerves at risk during the procedure. The 5mm dilator can also be used as a navigated instrument with Medtronic Stealth™ Systems to help surgeons establish the desired surgical access trajectory.

The subject device differs from the predicate (Phantom XL) in base material (17-4 PH H900 vs. 304 stainless steel), distal shape (oval/rounded rectangle vs. triangle), electrode surface area (20-25 mm² vs. 7.5 mm²), body outer diameters (5, 10, 16, 20mm vs. 7, 8, 12, 13, 15, 18, 22mm), wall thickness, and geometry. Notably, the subject device is compatible with Medtronic Stealth™ Systems while the predicate is not. Both use unidirectional electrical stimulation for neuromonitoring and sequential dilation principles.

ISO 13485 (Design Controls, Nonconforming Product, Corrective/Preventative Action), IEC 60601-1 (electrical safety), ISO 11135:2014 (sterilization), ISO 11607-1 and ISO 11607-2 (packaging and sterile barrier), ISO 10993-1 (biocompatibility), and IEC 62366-1 (usability). Testing also referenced FDA Guidance on biological evaluation of medical devices.