FDA finalizes guidance for containment system used with power morcellators

The US Food and Drug Administration (FDA) has finalized guidance that lists non-clinical testing information the agency wants from sponsors of tissue containment systems used with gynecological and other types of laparoscopic power morcellators (LPMs). The guidance is meant to ensure containment systems are reasonably designed to catch cancerous tissue to prevent its spread.

The agency finalized the guidance less than a year after releasing the draft version for comment. FDA notes that LPMs may increase the risk of spreading cancer cells and can also spread benign uterine tissue that could require additional surgery due to abdominal pain and distension, as well as abscesses and infections. (RELATED: Draft guidance outlines FDA’s testing requirements for tissue containment systems, Regulatory Focus, 22 June 2022)

“While a tissue containment system cannot prevent all cases of tissue spread, as some cases may occur without morcellation or due to manipulation of the tissue before it is placed into the tissue containment system, it can provide an important mitigation for this risk,” said FDA. “Tissue containment systems should only be used with compatible LPMs that have received FDA marketing authorization.”

The final guidance largely mirrors the draft guidance and lists non-clinical performance testing FDA wants to see from sponsors to feel confident their products are designed to catch a reasonable amount of tissue during LPM surgeries.

The guidance notes that such devices are regulated as Class II devices that are subject to special controls, which include several non-clinical testing requirements. These requirements include system integrity testing as well as strength testing, as regulators are concerned the tissue containment systems could leak or lack sufficient tensile strength.

FDA also wants data on insufflation pressure control testing and clinical simulation studies.

“Insertion and withdrawal of laparoscopic instruments into the tissue containment system should not significantly impact the ability to maintain insufflation within the tissue containment system,” said FDA. “Inability to maintain the insufflation pressure could cause the power morcellator and/or other surgical instruments to contact and damage the tissue containment system.”

FDA notes that damage to the system could cause the contents of the tissue containment system to leak.

The agency also wants information that the system allows compatible laparoscopic devices to be inserted into the patient while maintaining gas in the abdominal cavity or pneumoperitoneum. Sponsors also need to prove that their products allow LPMs to operate with adequate space, that they don’t obstruct view of the tissue being extracted and that laparoscopic instruments can function without compromising the integrity of the containment system.

FDA wants sponsors to submit data from clinical simulation studies that demonstrate the structural integrity and impermeability of the devices. The agency says clinical simulation study designs should provide details on the scope of the study, include surgeons with varying levels of expertise and ensure the simulation closely mimics real-world clinical use.

Besides the types of testing required to show the devices meet the class II special controls requirements set out by FDA, the agency also wants to see certain other testing such as those to evaluate the thickness and material composition of the devices and material permeability testing.

“If the device material, following manufacturing and additional processing, including sterilization, is not adequately robust to ensure that the tissue containment system is impermeable to tissues, cells, and fluids, cancerous and non-cancerous blood cells, tissue cells, and fluids can leak from the tissue containment system into the abdomen,” the agency warned.

Final guidance

FDA finalizes guidance for containment system used with power morcellators

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