October 05, 2012, Accutek Engineering Team
By: Maciej Jakucki
Great question! The first step is to actually check with the FDA.
How do I do that?
Well, the FDA has developed specific guidance documents for medical devices which are organized by class. If you can classify your device, then it is easy to find the guidance document. For example, in the spinal industry, two common guidance documents include Class II Special Controls Guidance Document: Intervertebral Body Fusion Device and Guidance for Industry and FDA Staff: Spinal System 510(k)s.
The Spinal System Guidance Document outlines the requirements for submitting your 510(k), and also provides a wealth of specific testing information. Let’s say you have a device that is a Vertebral Body Replacement (VBR) or an Interbody Vertebral Fusion Device (IBFD). The guidance document not only outlines the specific testing requirements (such as ASTM F2077-11), but also some acceptance criteria, recommended sample size, and worst case scenario evaluations.
For example, static and dynamic compression, static and dynamic torsion, and expulsion are all recommended for VBRs. Additionally, if your device is an IBFD, the testing requirements may differ dependent on whether it is cervical or lumbar. It is always a good idea to double check your testing matrix with the FDA guidance documents to make sure you are doing the required testing.
One of the most important criteria for testing your device is making sure that you are testing your worst case scenario. Your product line is only as strong as its weakest link. The guidance documents also provide worst case evaluation recommendations. For example, testing the worst case scenario for VBRs usually results in the tallest implants with the smallest cross sectional areas.
Finally, after you have familiarized yourself with the guidance documents and test specifications, either you or your regulatory consultant should contact the FDA directly. If necessary, the FDA has a document available on how to schedule a pre-submission meeting .It’s always a good idea to get the conversation with the FDA started early, before you invest heavily in testing, to ensure your testing program covers no more or less than what you need for the 510(k) submittal.
So now that you’re armed with what tests to perform and the worst case scenario, how many parts are needed for testing? Well, the guidance document addresses that, as does Accutek’s recent blog on sample size. A sample size of n = 6 is typically recommended for each test, which is relatively standard across the medical industry.
For additional insight into what the FDA is looking for, register now for Accutek’s Lunch & Learn on October 25, 2012 near the NASS Annual Conference in Dallas. Speakers include a former FDA Orthopedic Device Branch Manager and an attorney specializing in litigation involving medical devices.
While our event is independent of the official program of the NASS Annual Meeting, it is conveniently located near the conference in downtown Dallas.