The FDA today announced that it reclassified Levita Magnetics’ magnetic surgical system, cleared for gallbladder removal surgeries, as a Class II device.
The system is designed to retract and maneuver the gallbladder using magnetic fields, which the San Mateo, Calif.-based company said “reduces the number of incisions” necessary for the procedure and prevents damage to the abdominal wall.
The company put in a request seeking a class change for the device in February last year, according to an FDA release. The Agency said it reviewed the request and determined that the device can be classified into class II with the establishment of special controls.
The federal watchdog issued an order classifying the device in Class II on June 13, according to the release, and laid out its special controls for magnetic surgical instrument systems.
The FDA identified 6 risks associated with such devices, including tissue damage, the need for extended or additional surgery, abdominal wall injuries, electromagnetic field incompatibility or interference, adverse tissue reactions and infections.
Controls to mitigate such risks include in vivo performance testing, human factors testing and analysis, biocompatibility evaluation, non-clinical performance testing, training, labeling and sterilization and reprocessing validations.
Earlier this month, Levita Magnetics said it won FDA de novo clearance for its magnetic surgical system with indications for gallbladder removal surgery, and launched the system in the U.S.
The company said that the FDA created a new category to accommodate the unique magnetic surgery platform, and said the platform also recently won CE Mark approval in the European Union.