Magnetic Surgical System

The Levita Magnetic Surgical System is a minimally invasive surgical device comprising a disposable magnetic grasper and a reusable external magnetic controller. It grasps and retracts soft tissues and organs (gallbladder, liver, diaphragm, prostate, colon) during laparoscopic and open procedures to improve visualization. The device is indicated for patients with BMI 20–60 kg/m², including a new 12.5 cm grasper tip for diaphragm retraction in bariatric and hiatal hernia surgery.

The modified magnetic grasper incorporates minor changes to materials and manufacturing processes, with shelf life extended from 6 months to 12 months. A new 12.5 cm detachable grasper tip (previously 6.5 cm) enables reach to deeper anatomical structures. The magnetic controller and overall functional mechanism remain unchanged from the predicate device.

IEC 62366-1 (human factors); ISO 10993-1 (biocompatibility); AAMI TIR35, ISO 11137-1, and ISO 11137-2 (sterilization); ASTM F2096 and ASTM F88 (packaging); ISO 14971:2019 (risk management). Real-time shelf-life testing and mechanical performance testing were also conducted.

The expanded indications (grasping diaphragm and peripillar tissue in bariatric/hiatal hernia procedures) do not create new safety or effectiveness questions because they represent the same fundamental tissue-grasping and retraction function already cleared for the predicate device. A prospective 30-subject clinical study in Chile demonstrated zero serious adverse events and 100% technical success with no conversions or device malfunctions. The 12.5 cm tip and extended shelf life are minor technological refinements with no new or different risks identified through formal ISO 14971 risk assessment. Bench testing, biocompatibility, and sterilization validation all met acceptance criteria, confirming the device performs as intended and is therefore substantially equivalent to the predicate.