Medical Device FDA Product Classification help needed

My company is designing a medical device and is in the process of trying to determine FDA classification. I am confused as to which class this product falls, as there is no existing product classification that completely categorizes this product.

The product is a breast shield which is to be attached to powered breast pumps. The breast shield is just a plastic piece which itself has no electrical component. FDA classifies powered breast pumps in Class II and manual breast pumps in Class I.

My questions are:

1) Which class does this product fall into? Would it fall into class II because the device it will be used with (powered breast pump) is in Class II? Or does it fall into Class I because it by itself does not have an electrical component?

2) Would it be worth the time and money to submit a 513g in this case to determine classification? Is there a case for arguing that it should be a class I device?

3) If it is classified as Class II, can we use existing powered breast pumps as a predicate for 510k to prove substantial equivalence? The existing powered breast pumps contain the machine itself as well as their own breast shields. The breast shields are very similar to our product. Is it permissible to use only part of a device (in this case just the breast shield, not the powered machine component) to justify substantial equivalence for our product? In other words, can I compare our breast shield to the breast shield used in existing breast pumps if they are indeed very similar, even though we are not making the machine itself?

Thanks so much for your help!! Any feedback would be greatly appreciated.

Hello Lei,

lei622 said:

1) Which class does this product fall into? Would it fall into class II because the device it will be used with (powered breast pump) is in Class II? Or does it fall into Class I because it by itself does not have an electrical component?

Click to expand...

Another product code that's worth checking is OHH, Breast Pump Kit, class 2, exempt from 510(k) submission (Just have seen that powered breast pump manufacturers also offer such kits that include shields)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm?db=PCD&id=OHH

This product code refers to the "Convenience Kits Interim Regulatory Guidance" http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm. You can see there an explanation why the kit is exempted from 510(k) clearance.

Yana