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Accessory or a Component

M

monoj mon

Quite Involved in Discussions
#1
#1
There is a filter to be connected to a suction system for the obvious reason, to protect the suction system from microbial contamination. The vacuum system works without the filter too. So, if we consider "protecting the system from contamination" as "Augmenting its performance" according to the screenshot from this guidance, can we consider it as an accessory!
1619173285797.png
If it is an accessory then in normal cases it shall be classified together with the parent device! But I couldn't find it in the following definition. Or it is just a component as the user shall keep replacing it frequently!
1619173407275.png

Whether it is an accessory or just a component, can it be sold in the US just by following registration listing option without its parent device which is also a 510k exempt class II device!
 
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I

indubioush

Quite Involved in Discussions
#2
#2
Accessory: A finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.

Is your filter a finished device? I'm guessing probably not.
 
M

monoj mon

Quite Involved in Discussions
#3
#3
indubioush said:
Accessory: A finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.

Is your filter a finished device? I'm guessing probably not.
Click to expand...
It is actually a finished device. It consist of a filtration part within a housing and user facilities can use it directly by fitting it into their suction system in order to protect it from contamination by microorganisms.
 
somashekar

somashekar

Staff member
Super Moderator
#4
#4
monoj mon said:
It is actually a finished device. It consist of a filtration part within a housing and user facilities can use it directly by fitting it into their suction system in order to protect it from contamination by microorganisms.
Click to expand...
Yes, it is a finished part (not a device as used in the term medical device)
In your case it is a component. A replaceable component.
 
somashekar

somashekar

Staff member
Super Moderator
#7
#7
monoj mon said:
I think it still be considered as device even though it is still a part/accessory! But, the point to consider here is whether or not the filter of concern can be included in the second point or not!
View attachment 27784
Click to expand...
It would fail to be classified as a device in the second point. I am unsure if it will qualify as a device within the first point. This is someting to be investigated. My strong guess is that such filter is not recognized in the USP. It can be therefore just delivered to customer whenever there is a requirement!
 
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