Classification for Nasal Aspirator (non powered)

marmotte

Involved In Discussions
#1
Dear all,

I am advising a friend who's marketing a nasal aspirator. This is a "basic" one, where the user sucks on a small tube hoping not to swallow the patient's nasal material :cool:

I found a post already related to this issue - MDD-wise a nasal aspirator seems to be a medical device.http://www.elsmar.com/Forums/showthread.php?t=36554&highlight=nasal+aspirator

I am interested though at this stage at the US/FDA definition.
I am not sure what regulation actually covers it.
Under the ENT rule - which is the first to come to mind - there is nothing appropriate.It seems like only powered devices are even classified!
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=874

880.6740 Vacuum-powered body fluid suction apparatus is my next bet...but
WTF classII? Hospital panel ? Special control --- Sounds to me like the “vacuum” means “vacuum from a powered source”.

Any other idea?
I think there may be a case to justify that it is NOT EVEN a medical device, as it does not intend to treat the disease, but alleviate the discomfort of some of the symptoms (i.e. runny nose)
 
#2
I can not immediately answer your question, but I was myself searching for an applicable ProCode and found that a complete listing of ProCodes is available, as a spreadsheet, for download. A new one is produced each week here:-

http://www.fda.gov/MedicalDevices/D...nce/Overview/ClassifyYourDevice/ucm051668.htm

Once you have that you can use the 'Filter' controls of your spreadsheet to reduce and sort to allow you to "zoom in" on any possible codes.
 
#3
If it is one of these nasal sprays that just form a barrier like Prevalin; which contains inactive ingredients such as bentonite, xanthan gum etc (which are not absorbed into the body from the nose) – then it is a medical device. Under the MDD it should be a Class I device under rule 5.

Steve
 

Ronen E

Problem Solver
Staff member
Super Moderator
#6
Seems like there's no existing ProCode that suits.
Doubtfully it is a Medical Device - what disease is it intended to mitigate (if any)?
If it's a Medical Device you could make a 513(g) submission, under which the FDA will classify it for you (a fee applies).

Cheers,
Ronen.
 
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marmotte

Involved In Discussions
#7
Thx Ronen.

I agree that indeed it does not treat any disease . Just the uncomfort created by some of the symptoms.
Theree are plethora of competing devices. On amazon, some even claim to be "FDA approved" :lol:...
But i can't find anyhting on any FDADB, including MAUDE and product registrations....
 

Ronen E

Problem Solver
Staff member
Super Moderator
#8
Thx Ronen.

I agree that indeed it does not treat any disease . Just the uncomfort created by some of the symptoms.
Theree are plethora of competing devices. On amazon, some even claim to be "FDA approved" :lol:...
But i can't find anyhting on any FDADB, including MAUDE and product registrations....
Just to clarify, "mitigate a disease" doesn't equal "treat a disease". It can include your description - "treat the uncomfort created by symptoms". Since "mitigate a disease" appears in the FDA Medical Device definition, claiming downright treatment is not necessary to render a product a Medical Device.

The important question is whether the symptoms you referred to can be attributed to a disease, or they're just the "normal", healthy manifests of the subject's physiology. What really matters in that context is labeling contents, which includes advertising materials.
 

QA-Man

Involved In Discussions
#10
Try these (separated by semi-colon)

PRODUCT CODE; Device; Reg; Class
BZE; heater, breathing system w/wo controller (not humi ... ; 868.527; 2
OGG; humidifier nebulizer kit ; 868.545; 2
KFZ; humidifier, non-direct patient interface (home-use ... ; 868.546; 1
BTT; humidifier, respiratory gas, (direct patient inter ... ; 868.545; 2
KCO; inhaler, nasal ; 874.522; 1
CAF; nebulizer (direct patient interface) ; 868.563; 2
CCQ; nebulizer, medicinal, non-ventilatory (atomizer) ; 868.564; 1
JPW; pump, nebulizer, electrically powered ; 874.522; 1
EPN; pump, nebulizer, manual ; 874.522; 1
CAD; vaporizer, anesthesia, non-heated ; 868.588; 2
 
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