The new article addresses specific matters related to the non-clinical performance testing, and regulatory requirements associated thereto.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the non-clinical performance assessment of tissue containment systems used during power morcellation procedures. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding and are not intended to introduce new rules or impose new requirements. The authority also mentions that an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance.
The guidance describes, inter alia, the main aspects related to non-clinical performance testing and provides the appropriate recommendations based on the requirements set forth by regulations 21 CFR 884.4050(b)(4) and 21 CFR 878.4825(b)(4), as well as the matters related to 510(k) submissions. The document also contains references to the FDA guidance on Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.
Demonstrating Compliance with Special Controls: Key Points
First of all, the document describes the testing to be conducted to demonstrate compliance with special controls. As explained by the FDA, the applicant should ensure that non-clinical performance testing information is included in the 510(k) submission. The document further outlines the test methods to be used to meet the requirements of the particular special controls, and also describes each of the testing methods in detail.
- Material Permeability Testing. According to the guidance, the material permeability testing is intended to demonstrate impermeability to tissue, cells, and fluids of the tissue containment system material and does not address the final finished device testing (the aspects related to a final finished device are to be addressed in the course of separate testing).
- Final Finished Tissue Containment System Testing. The said test methods are intended to evaluate the mechanical strength and integrity of the final finished tissue containment system. For such testing, the samples used should represent the final finished version of the device to ensure the accuracy and reliability of the results. In the course of testing, it should be demonstrated that the device operates as intended within the whole intended shelf-life period. In case the device exists in different sizes, all the size versions should be subject to testing. The scope of the aforementioned testing includes:
- Final Finished Tissue Containment System Integrity Testing;
- Final Finished Tissue Containment System Strength Testing;
- Insufflation Pressure Control Testing; and
- Clinical Simulation Study.
Additional Testing Recommendations
The guidance also provides additional testing recommendations to be considered by medical device manufacturers/study sponsors. In particular, the document describes non-obligatory testing to be performed to demonstrate substantial equivalence of the tissue containment system in question. The authority outlines the scope of testing to be performed, and information to be included in the premarket submission. The FDA also encourages study sponsors to consider evaluating the design specifications for both individual device components and the final finished device. It is also recommended to conduct comparative testing using a predicate device with similarities in device design and material composition (e.g., homogeneous versus composite materials) to [the device in question].
The scope of additional testing includes:
- Thickness/Material Composition, which includes the assessment of the matters related to the materials and their characteristics to be conducted to ensure that the product meets the respective requirements and specifications. Apart from that, the said testing could be helpful to identify the defects and irregularities that could adversely impact the characteristics of the medical device subject to review. The recommendations related to thickness/material composition testing provided by the FDA include, inter alia, the following ones:
- The authority expects the applicant to provide detailed information regarding the specific methods used in the course of testing, together with the description of corresponding manufacturing processes that could impact the characteristics of the device.
- The scope of information to be provided should include measurements of thickness for the different layers (e.g., as averages with standard deviations), and if applicable, the entire system.
- The applicant is also expected to provide information regarding the homogeneity of the system.
- When assessing the material specimens, it is important to evaluate specimens from multiple locations to ensure the reliability of testing results.
- Mechanical Strength. The authority also recommends conducting the test addressing the aspected related to the mechanical strength of the materials used for the tissue containment system. The FDA additionally emphasizes the importance of assessing mechanical strength for critical components of the device (e.g., straps, tethers, and opening rings). When providing information about the testing conducted, the applicant should duly justify the way the particular elements to be tested were determined. The aspects to be considered in this respect include, inter alia, the following ones:
- When establishing the acceptance criteria, [the sponsor] should consider the forces applied to the tissue containment system during clinical use and include a safety factor by comparing the clinical forces to force-to-failure. The sponsor is also expected to justify the acceptance criteria applied.
- The applicant should also provide information about the test endpoint and the way it was determined.
In summary, the present FDA guidance provides a detailed description of various test methods to be used in the course of non-clinical performance assessment of tissue containment systems used during power morcellation. The document highlights the key points to be considered by study sponsors when determining the particular test methods to be used and also outlines other specific aspects impacting the accuracy and reliability of the results.
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