Draft guidance outlines FDA’s testing requirements for tissue containment systems

Regulatory NewsRegulatory News | 22 June 2022 |  By 

A new draft guidance from the US Food and Drug Administration (FDA) lists potential non-clinical testing requirements for tissue containment systems used in power morcellation surgeries. The objective is to prevent potentially cancerous tissue from getting out of the containment systems and spreading the disease to other parts of the body.
 
On 17 June, FDA published a draft guidance titled Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures. The systems are used to capture benign tissue that is not suspected to contain malignancies during gynecological and other types of laparoscopic power morcellator procedures. They may help prevent potentially cancerous cells from spreading to other parts of the body if they work properly.
 
FDA notes that laparoscopic power morcellators (LPMs) are associated with a risk of spreading potentially cancerous tissue from the uterus during gynecological surgeries to treat benign fibroids.
 
“Tissue containment systems used during laparoscopic power morcellation are intended to isolate and contain tissue that is considered benign, which may prevent the peritoneal spread of cancerous tissue in cases of an occult cancer,” the agency said. “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.”
 
The non-clinical testing requirements outlined by FDA in the draft guidance are meant to demonstrate several qualities, including that the tissue containment system is impermeable so as to prevent tissue, cells and fluids from leaking out, and 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.
 
The guidance also recommends sponsors conduct clinical simulation studies to ensure that their containment systems are durable enough to withstand stresses during surgery.
 
“The clinical simulation study is important to evaluate the ability of the tissue containment system to maintain its structural integrity and impermeability when users perform power morcellation of resected tissue,” FDA said. “Inability to use the tissue containment system appropriately could cause damage to the tissue containment system while operating the power morcellator and other surgical instruments. Any damage to the tissue containment system may cause leakage of bag contents.”
 
While not required as part of the special controls, FDA also recommends sponsors conduct additional tests to ensure material composition, mechanical strength and puncture testing.
 
The agency also notes that in addition to non-clinical performance testing required by the special controls, differences in technological characteristics between the sponsor’s new device and the predicate device in a 510(k) application may require additional testing to demonstrate substantial equivalence. In such cases, the guidance recommends sponsors talk to FDA through the Q-Submission process early on to figure out what additional testing the agency would like to see.
 
Stakeholders can comment on the draft guidance on www.regulations.gov under docket no. FDA-2022-D-0737 until 22 August.

 

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