Dive Brief:

• FDA on Friday released a draft guidance document with recommendations that focus in large part on bench testing and coating standards to be met in 510(k) applications for Class II peripheral (PTA) balloons and specialty catheters.
• Devices covered under the guidance range from standard angioplasty balloon catheters to those with unique design characteristics such as cutting and scoring, and balloon catheters intended for specific indications such as in-stent restenosis and post-dilatation of stents.
• The agency said it was providing the advice, which supplements other documents that address specific content requirements for the premarket process, to encourage consistency across submissions.

Dive Insight:

While the guidance goes into the most specific detail on testing requirements, FDA covers several categories of information it expects manufacturers to include in their premarketing submissions. For example, medical devices reviewed under the 510(k) process must be compared to a similar predicate device to support its substantial equivalence. In the new guidance, FDA suggests organizing the information in a side-by-side format for comparison of device characteristics.

Among other recommendations, FDA advises identifying all components, accessories and packaging, and providing a clear description of the device’s intended use in the patient’s anatomy. A photograph of the device and engineering drawings with all dimensions and components labeled should be included in the submission, along with technical and performance specifications and materials used.

A section on biocompatibility recommends determining whether a new device is identical in composition and processing methods to a catheter with a history of successful use. If so, previous testing experience may be referenced; if not, a biocompatibility risk assessment is advised. The documents direct manufacturers to previous guidance documents that address the topics of sterility, pyrogenicity and device modifications. Shelf-life, packaging and labeling requirements are also covered.

FDA recommends non-clinical performance testing for PTA balloon and specialty catheters. The guidance document offers a number of recommendations for testing to augment consensus standards. Tests covered include dimensional verification, simulated use, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull test, flexibility and kink test, torque strength, radiopacity, coating integrity and particulate evaluation.

Coating characteristics receive particular attention in the document. FDA said coating integrity testing should be conducted if a device has any coating along the length of the catheter or on the balloon. Noting that coatings are intended to improve device performance, FDA said degradation could negatively impact patient safety, causing embolization risk for example. Assessment of baseline coating integrity, simulated use integrity, functional testing and particulate evaluations for coated devices are covered in the guidance.

The document notes that clinical performance testing is generally unnecessary for most PTA balloon and specialty catheters.

FDA is seeking comments on the draft guidance within 60 days of publication of the draft guidance in the Federal Register.