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)
 
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Pads38

Trusted Information Resource
#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.
 

SteveK

Trusted Information Resource
#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
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
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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