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Hello,
I'm working with a company developing test plans for a catheter introducer sheath (intended for introduction of devices into the vasculature) for a planned 510(k) submission. I have a few questions on test requirements and recent experience with FDA expectations.
- A potential predicate device 510(k) Summary includes flex fatigue and torque testing "per ISO 10555-1: 2013" however I don't see these tests in this standard. I'm familiar with FDA PTA and PTCA guidance for these tests - are there other guidance or standards to consult?
- ISO 10555-1 section 4.4 says, "If the catheter is lubricated, the lubricant shall not be visible as drops of fluid on the external surface." Does anyone have insight on what risk is behind this requirement? Does it apply to hydrophilic or hydrophobic coating? If the inner lumen of the catheter is coated and the catheter passes particle and biocomp and other testing what do visible drops indicate?
- Finally - particle testing. Has anyone had recent experience with FDA expectations for this? Is acute particulate testing required or can a fluid sample be collected in a beaker and then particles counted? Based on previous experience with PTCA catheters and coronary stents I believe that this is a complicated test that can be difficult to validate and it may be worthy of outsourcing to a lab with a validated test method. But I don't want to recommend this path unless it's warranted.
I greatly appreciate any and all insights.