CDRH Draft Guidance Offers Further Info on 510(k)s for PTA, Specialty Catheters

Regulatory NewsRegulatory News | 10 January 2020 |  By 

The US Food and Drug Administration (FDA) on Friday released new draft guidance to help clarify the agency’s premarket submission recommendations for percutaneous transluminal angioplasty (PTA) catheters and specialty catheters to promote consistency across submissions. 
The 27-page draft provides anatomy-specific testing recommendations and expands on FDA’s current thinking for testing these class II PTA balloon catheters and specialty catheters intended to treat lesions in the peripheral vasculature, which are veins and arteries not in the chest or abdomen.
And since the draft covers 510(k) submissions, it discusses side-by-side comparisons with predicate devices, how to determine the biocompatibility of all patient-contacting materials present in the device, how to ensure sterility (since these devices come in contact with blood), how to assess the risk of febrile reaction due to gram-negative bacterial endotoxins and/or chemicals that can leach from a device and shelf-life testing.
The bulk of the draft deals with non-clinical performance testing, which is recommended for PTA and specialty catheters in order to fully characterize the devices and ensure they can perform as intended. Sections discuss non-clinical performance testing and the applicable ISO standards, as well as offer recommendations on dimensional verification, simulated use, balloon rated burst pressure, balloon fatigue, inflation and deflation time, torque strength, coating integrity and particulate evaluation.
“Clinical evidence is generally unnecessary for most PTA balloon and specialty catheters; however, such testing may be requested in situations such as the following: indications for use dissimilar from legally marketed devices of the same type (e.g., treatment of specific diseases or lesion types); new technology (i.e., technology different from that used in legally marketed devices of the same type); and cases where engineering and/or animal testing raise issues that warrant further evaluation with clinical evidence,” the draft adds.
FDA also discusses changes or modifications that would likely require a new 510(k), including a change in specific lesion characteristics or claims in improvement of outcomes in other technologies. But minor changes in packaging or changes that increase a device’s shelf-life (and are not expected to impact device safety and performance) will likely not require a new 510(k).
The new draft comes as in October, FDA also issued final guidance on labeling considerations for intravascular catheters, wires and delivery systems with lubricious coatings.
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy