Catalog of Regulatory Science Tools to Help Assess New Medical Devices
This regulatory science tool presents a lab method designed to assess the mechanical strength and leakage integrity of tissue containment systems (TCS) and its component materials, aimed to complement testing protocols outlined in the "Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures" guidance document. Please see appendix.
Technical Description
This tool provides protocols to evaluate the mechanical strength and leakage integrity of tissue containment systems (TCS) and its component materials.
In the appendix section of the tool, protocols for conducting the following preclinical tests are provided for TCS materials.
Table 1: Summary of preclinical test methods for TCSs
| Evaluation Type | Preclinical Testing | Outcome/Metric | Rationale |
|---|---|---|---|
| Mechanical Strength Evaluation |
|
| To evaluate strength of the containment system when subjected to tensile, radial, and puncture forces. |
| Leakage Integrity (or Material Impermeability) Evaluation |
|
| To understand the ability of the TCS material to remain impermeable under clinically relevant forces. |
Intended Purpose
The test methods in this tool are intended to evaluate the mechanical strength and leakage integrity of TCSs and its materials. These tests are designed to complement testing recommendations in the “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures” guidance document issued in May 2023, specifically the special controls outlined in 21 CFR 884.4050(b)(4) [Product Code PMU] and 21 CFR 878.4825(b)(4) [Product Code PZQ].
Testing
The adequacy of all the test methods listed in Table 1 were evaluated using 7 different tissue containment systems.
See the following publications for details:
- Herman, A., Duraiswamy, N., Nandy, P., Myers, M. R., Price, V., Gibeily, G., & Hariharan, P. (2020). In Vitro Leakage Testing of Tissue Containment Bags When Subjected to Power Morcellation Forces. Journal of minimally invasive gynecology, 27(3), 655–664. https://doi.org/10.1016/j.jmig.2019.05.006
- Herman, A., Duraiswamy, N., Nandy, P., Price, V., Gibeily, G., & Hariharan, P. (2023). Mechanical and leakage integrity testing considerations for evaluating the performance of tissue containment systems. Scientific reports, 13(1), 5104. https://doi.org/10.1038/s41598-023-31847-7
Limitations
- These protocols are not applicable to testing of the TCS bag as a whole but only to assess the materials used to manufacture TCS. Additional test methods are needed to evaluate the mechanical and leakage integrity of the full TCS bag.
- Additional simulated use methods may be needed to evaluate all aspects of device performance.
Supporting Documentation
- Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures Final Guidance
- ASTM F1670
- ISO 16603
- ASTM F1671
- ASTM D882
- ASTM D412
- ASTM D2240
- Herman, A., Duraiswamy, N., Nandy, P., Myers, M. R., Price, V., Gibeily, G., & Hariharan, P. (2020). In Vitro Leakage Testing of Tissue Containment Bags When Subjected to Power Morcellation Forces. Journal of minimally invasive gynecology, 27(3), 655–664. https://doi.org/10.1016/j.jmig.2019.05.006
- Herman, A., Duraiswamy, N., Nandy, P., Price, V., Gibeily, G., & Hariharan, P. (2023). Mechanical and leakage integrity testing considerations for evaluating the performance of tissue containment systems. Scientific reports, 13(1), 5104. https://doi.org/10.1038/s41598-023-31847-7
Contact
Tool Reference
- In addition to citing relevant publications please reference the use of this tool using RST24PM01.01