Biocompatibility Test requirements for 510k - Orthopaedic Implant Screws

[mpfizer]

we are an Orthopaedic Implant manufacturing company and manufacture different kinds of plates , screws , nails .We are planning to apply for 510k .Our consultant is saying that for each and every product we need a biocompatibility test done . Now screws are made form 8mm or 6mm dia bars in various lengths ie, from 5mm to 100mm and diameters also vary from 2.7mm to 8mm so he wants a test done for each length and dia . Similar for different type of plates which are made from sheets thickness from 2mm to 6mm. Is this really required ?? or can we just test one size of screw and one type of plate since the raw material is the same ss / ti. We would be having a total of 400 products like this and it would not be economically feasible to do testing on all products . What is the solution .

Thanks

Michelle

 

[MIREGMGR]

1. It's permissible in some circumstances to obtain a 510(k) on a family or bundled basis, when the entire family shares key characteristics, usually including material and manufacturing processes. In such a case, you might obtain biocompatibility data for the largest and smallest family members, or perhaps just a single one.

You should be familiar with http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089731.htm and ISO 10993-1:2009.

2. If the materials being used are the subject of a Recognized Consensus Standard, it's much more straightforward to establish implant suitability. Per ISO 10993-1:2009 Section 4.1, this may allow provision of a rationale as to why no biocompatibility testing is required.

If your consultant's advice is fairly characterized, it sounds as if perhaps he or she isn't doing a good job for you.

 

[planB]

Adding to the previous poster:

With a portfolio of 400 products, you definitely may want to aim at grouping your products into families based on similarities in

(1) materials
(2) manufacturing processes
(3) intended use (i.e. nature and duration of body contact according to ISO 10993-1:2009)

For each family, you may want to define a worst-case representative in terms of (1), (2) and (3). For these worst-case representatives you then have to perform your material characterization and any biological test you may consider necessary to mitigate biological risks.

Alternatively, you may also want to consider pooling your families. While this may drastically bring down the numbers of test runs you have to perform, you will also loose information. You would have to assess whether pooling of test items is an option in your case.

HTH,

Gerhard