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FDA Classifies Magnetic Surgical Instrument Systems as Class II

September 23, 2016

The FDA issued a final order on Sept. 21 that classified magnetic surgical instrument systems as Class II devices with special controls.

Firms that intend to market this type of device must submit a premarket notification and comply with the special controls listed in the final order.

A magnetic surgical instrument system is used in laparoscopic surgical procedures and consists of several components, including surgical instruments and a magnetic controller.

Companies marketing a magnetic surgical instrument system must adhere to the following special controls:

  • In vivo performance data must demonstrate that the device has the ability to grasp, hold, retract, mobilize, or manipulate soft tissue and organs;
  • Non-clinical performance data must demonstrate that the system performs as intended. Performance characteristics must be tested for magnetic field strength testing characterization; ability of the internal surgical instrument to be coupled, de-coupled and re-coupled with the external magnet;
  • The patient-contacting components must be biocompatible and sterile;
  • Methods and instructions for reprocessing reusable components must be validated;
  • Performance data must support shelf life by demonstrating continued sterility;
  • Training must be developed and validated by human factors testing; and
  • Labeling must include: magnetic field safe zones; instructions for proper device use; a screening checklist to ensure that all patients and operating staff are screened from bringing ferromagnetic implants, devices, or objects near the external magnet; and reprocessing instructions for reusable components.