Devices

Power Morcellation Tissue Containment Guidance

FDA has published a guidance, Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures, with recommendations it says may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems. The document says tissue containment systems are used to enable the isolation and containment of tissue during a power morcellation procedure performed following a laparoscopic procedure to excise benign tissue that is not suspected to contain malignancy. The devices are Class II and subject to 510(k) requirements.

In an online statement, CDRH says the guidance is intended to:

provide information to industry about the recommendations on non-clinical test methods, test parameters, and test acceptance criteria to support premarket submissions for gynecologic and general use of laparoscopic power morcellation tissue containment systems;
support manufacturers in complying with special controls related to non-clinical performance data for laparoscopic power morcellation tissue containment systems for gynecologic and general use; and
ensure the non-clinical test methods can help mitigate safety issues related to damage of the tissue containment system and subsequent leakage of cancer cells.

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