Dive Brief:

• The Food and Drug Administration is seeking feedback on draft guidance intended to help manufacturers of tissue containment systems comply with special controls related to non-clinical performance data.
• The systems mitigate the risks of laparoscopic power morcellators, devices that treat conditions such as uterine fibroids but can significantly worsen long-term survival by spreading unsuspected cancerous tissue. The FDA established special controls for the systems as part of De Novo reviews of devices from Advanced Surgical Concepts in 2016 and 2017.
• To help other manufacturers comply with the special controls, the agency has drafted guidance describing non-clinical performance tests and other studies it expects applicants to run before seeking 510(k) clearance for the devices.

Dive Insight:

The FDA issued a safety communication for laparoscopic uterine power morcellation devices used in hysterectomy and myomectomy in 2014, noting that the devices may spread uterine sarcomas and other cancerous tissue beyond the uterus. In light of the risk, the FDA recommended against the use of the devices in most women undergoing hysterectomy or myomectomy for uterine fibroids.

In the years after the notice, Advanced Surgical Concepts sought De Novo classifications for two devices intended to address the problem. The FDA classified PneumoLiner, a hysterectomy and myomectomy tissue containment system, as a Class II device and established special controls in 2016. The next year, the FDA classified a general laparoscopic power morcellation containment system, Advanced Surgical Concepts’ ContainOR, as a Class II device and again established special controls.    

The availability of tissue containment systems led the FDA to update its 2014 safety communication in 2020, telling physicians they should only perform laparoscopic power morcellation for myomectomy or hysterectomy with a containment system that confines the tissue that is cut up for removal.

In the draft guidance, which is open for comment for 60 days, the FDA covers the non-clinical performance data that manufacturers of gynecologic and general tissue containment systems need to provide to meet the special controls created through the De Novo classifications. The special controls require the testing of attributes such as the impermeability of the device to tissue, cells and fluids.

The draft lists recommended test methods for all five of the special controls.

To show the impermeability of the systems, the agency is advising manufacturers to carry out material permeability testing and run integrity tests on the final finished tissue containment system. The draft features recommendations for each test, explaining, for example, that material permeability testing should use an appropriate marker, such as a viral or bacteriophage marker, that is less than or equal to the size of cancer cells.