Updating class I device IFU with instructions to use class II cleared device

#1
Daer all,

I have a case where a manufacturer of medical forceps [class I]
Is looking to add into its IFU a section stating that his forceps can be used also for pushing/withdrawing a fiberoptic camera [Nasopharyngoscope = class II] into the nasal cavity, when the M.D. is taking care that no harm shall be made to the patient (using the Nasopharyngoscope display).
Since the upgraded IFU is now containing a new intended use of using the Nasopharyngoscope
Does it lead to a conclusion that the forceps are also class II, is it possible?
 
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shimonv

Trusted Information Resource
#2
Hi Nissim,
From what you wrote it seems that the forceps is an accessory to a class II device. An accessory can have its own classification.
I suggest you run through the product codes / classification rules as if it's a new device and see if it remains class I.

Cheers,
Shimon
 

Ronen E

Problem Solver
Staff member
Moderator
#3
“Class II” indicates it’s not an EU classification (unless a mistake).
In the FDA system, most accessories “inherit” the parent device’s classification. The exception are relatively few product codes that were created for specific items (accessories).
I would look for a manual tool that is intended for placing an active/diagnostic device into a body cavity through a body orrifice (non-surgically). If there’s no product code that fits, the forceps will probably need to inherit the device’s classification.

By the way, the FDA’s definition for “accessory” is not all that clear or useful :(
 
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