FDA Issues Recommendations on 510(k) Applications for Guidewires

The FDA released draft guidance with recommendations for 510(k) submissions of guidewires intended for use in coronary, peripheral and neurovasculature procedures, including recommendations for biocompatibility tests.

The guidance provides an example table with suggested information to include in a side-by-side comparison with a similar legally marketed predicate device, such as tip material, shelf life, indications for use, device length, wire diameter and wire material.

Because guidewires contain materials that come in contact with patients and could produce a harmful effect, the FDA recommends that all patient-contacting materials in the device undergo a biocompatibility determination.

Previous testing experience or documentation of guidewires with a history of success may be included when appropriate if the device’s composition and processing methods are identical.

A biocompatibility risk assessment should be conducted if the manufacturer cannot identify a legally marketed predicate device with a similar intended use and location/duration of contact that uses the same materials. The assessment should explain the relationship between the identified biocompatibility risks, the information available for mitigating them and any remaining knowledge gaps, the agency said.

For determining the types of biocompatibility assessments to use, the FDA recommends referring to its guidance, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

When finalized, the guidance will supersede the agency’s January 1995 Coronary and Cerebrovascular Guidewire Guidance.

Read the draft guidance here: www.fdanews.com/06-14-18-Guidewires.pdf. — James Miessler