This guidance document provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems (“tissue containment systems”). Tissue containment systems are used to enable isolation and containment of tissue during a power morcellation procedure performed following a laparoscopic procedure for the excision of benign tissue that is not suspected to contain malignancy. These devices are class II (special controls) and subject to premarket notification (510(k)) requirements. Throughout this guidance, the terms “FDA,” “the Agency,” “we,” and “us” refer to the Food and Drug Administration and the terms “you” and “yours” refer to medical device manufacturers.
For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. 1 For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”
Background
Laparoscopic power morcellators (LPMs) have been associated with the spread of tissue. There is a risk of spreading unsuspected cancerous tissue beyond the uterus when LPMs are used during gynecologic surgeries intended to treat benign fibroids. Unsuspected cancerous tissue may also be spread in the abdomen during use of a LPM during general surgical procedures. This may have a negative impact on survival. In addition, there is a risk of spreading benign uterine tissue beyond the uterus that may result in additional surgery due to symptoms such as abdominal pain and distension which are related to adhesions resulting in response to the devitalized tissue. Benign tissue may also be spread in the abdomen during use of a LPM during surgical procedures, which can lead to abscess or infection. 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. 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. Tissue containment systems should only be used with compatible LPMs that have received FDA marketing authorization. For more information, refer to the FDA guidance document “Product Labeling for Laparoscopic Power Morcellators.”
A laparoscopic power morcellation containment system, for gynecologic or general use, is a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign tissue that is not suspected to contain malignancy. FDA classified both laparoscopic power morcellation containment systems for gynecologic and general uses into class II (special controls), subject to 510(k) requirements, under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA determined the special controls that are necessary, in conjunction with the general controls of the FD&C Act, to provide reasonable assurance of safety and effectiveness for these devices. The special controls for laparoscopic power morcellation containment systems for gynecologic and general use are codified in 21 CFR 884.4050(b) and 21 CFR 878.4825(b), respectively.
This guidance recommends non-clinical test methods that may help manufacturers meet the nonclinical performance data requirements identified in the special controls codified in 21 CFR 884.4050(b)(4) (for gynecologic use) and 21 CFR 878.4825(b)(4) (for general use), and also includes other non-clinical testing recommendations to support a 510(k) submission/substantial equivalence determination. The recommendations in this guidance are based on FDA’s experience evaluating the safety and effectiveness of tissue containment systems. However, manufacturers may use alternative approaches and provide different documentation so long as their approach and documentation satisfy premarket submission requirements in applicable statutory provisions and regulations.
For more information about the specific content requirements of and recommendations for a 510(k) submission, refer to 21 CFR 807.87 and FDA’s guidance document, “Format for Traditional and Abbreviated 510(k)s.”
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