The recent guidance released by the FDA has a clear objective: to streamline the evaluation process for peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters. These catheters are classified by the FDA as per CFR 21 as follows:
(a) Continuous Flush Catheter: Product Code 870.1210 (KRA)
(b) Percutaneous Catheter: Product Code 870.1250 (DQY)
(c) Peripheral Transluminal Angioplasty Catheter: Product Code 870.1250 (LIT)
(d) Percutaneous Cutting/Scoring Catheter: Product Code 870.1250 (PNO)
The evaluation for these catheters involves a comprehensive assessment of their safety and performance through non-clinical testing. These tests are designed to evaluate the design, materials, functionality, and potential risks associated with the use of each catheter type.
The non-clinical test recommendations for these catheters encompass several key areas of evaluation. Firstly, the mechanical properties of the catheters should be thoroughly assessed. This includes evaluating properties such as flexibility, tensile strength, and fatigue resistance to ensure that the catheters can withstand normal usage conditions without failure.
Secondly, biocompatibility testing is crucial for these catheters. It involves assessing their potential for causing irritation, inflammation, or adverse reactions when in contact with biological tissues. This is particularly important for percutaneous catheters, which come into direct contact with the body during procedures.
Furthermore, testing the fluid flow characteristics of the catheters is essential. This includes evaluating parameters such as flow rate, pressure, and resistance to ensure proper functionality during clinical applications.
In the case of the Peripheral Transluminal Angioplasty Catheter and Percutaneous Cutting/Scoring Catheter, additional evaluations specific to their intended use should be considered. For example, the angioplasty catheter may require testing of its ability to dilate narrowed blood vessels effectively. The cutting/scoring catheter may require evaluations of its cutting efficiency and potential tissue damage.
Other important test recommendations include assessing the catheters' resistance to kinking, occlusion, or collapse, as these issues can affect their performance. Sterility testing should also be conducted to ensure the catheters' sterility before use.
- ● Peripheral Percutaneous Transluminal Angioplasty and Specialty Catheters-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
- ● Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions