Description
This guidance document provides the FDA’s recommendations on non-clinical performance testing to support premarket submissions for gynecologic and general laparoscopic power morcellation containment systems and may also help manufacturers comply with the special controls related to non-clinical performance data for these devices. This guidance applies to the tissue containment systems used during a power morcellation procedure for gynecologic use and for general use and provides recommendations on (1) test methods, (2) test parameters, and (3) test acceptance criteria. The recommendations are intended to promote consistency and facilitate efficient review of gynecologic and general laparoscopic power morcellation containment systems submissions. The recommendations are being made to ensure that the non-clinical test methods can effectively identify safety issues related to damage of the tissue containment system and subsequent leakage of any tumor cells and other contents.
Scope & Applicability
Product Classes
4Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
The device under consideration for non-clinical performance assessment.
Prescription device consisting of an instrument port and tissue containment method; Classified into class II (special controls) for gynecologic and general uses.
Guidance for non-clinical performance assessment of these devices
Stakeholders
2Entities preparing and maintaining a QMS; entities intended to prepare and maintain a QMS
Intended users to be included in the simulation study
Regulatory Context
Attributes
5Regulatory status of the containment system
Parameter to be reported from tensile testing.
Comparison of burst pressure to radial forces during surgery
Performance characteristic requiring demonstration of device resistance to tissue, cells, and fluids.
Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
Identified Hazards
Hazards
3Risk associated with power morcellation procedures
Environmental factors affecting biological products
Risk associated with loss of insufflation pressure
Related CFR Sections (2)
- 21CFR878.4825§ 878.4825 General laparoscopic power morcellation containment system.
(a) Identification. A general laparoscopic power morcellation containment system 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 proceRead full regulation →
- 21CFR884.4050§ 884.4050 Gynecologic laparoscopic power morcellation containment system.
(a) Identification. A gynecologic laparoscopic power morcellation containment system 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 pRead full regulation →