SBS - The best value in QMS software

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)
 
Elsmar Forum Sponsor
#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.
 
S

SteveK

#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.
 
Last edited:

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.
 
Q

QA-Man

#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
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
C MDR Classification Rule 10 EU Medical Device Regulations 7
C MDR software classification EU Medical Device Regulations 12
K Classification Rationale for class 1 EU Medical Device Regulations 3
K Question on MDR classification EU Medical Device Regulations 4
L Programmer accessories classification EU Medical Device Regulations 0
R ELISA reader - IVDR classification EU Medical Device Regulations 9
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 3
D Classification of product for clinical trials EU Medical Device Regulations 14
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Surgical Instrument Tray Classification EU Medical Device Regulations 7
S Classification of a product according to MDR EU Medical Device Regulations 3
L Classification under MDR EU Medical Device Regulations 1
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
K Biological indicator system classification under MDR EU Medical Device Regulations 2
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
nadhar2 Classification of Action Items Misc. Quality Assurance and Business Systems Related Topics 3
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
M Classification of Clean Rooms Other Medical Device Related Standards 9
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 3
DuncanGibbons Classification of aerospace parts depending on their risk and criticality etc. Federal Aviation Administration (FAA) Standards and Requirements 3
M Barrier cream classification EU Medical Device Regulations 2
N Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 11
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
D Classification of Syringe (nozzle) of needle free injection system. EU Medical Device Regulations 8
S CE Mark - Classification Confusion EU Medical Device Regulations 12
S Medical Device Product Classification in South Korea Other Medical Device Regulations World-Wide 1
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
D MDR 2017/745 Classification Guide EU Medical Device Regulations 8
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
M Informational EU MDR Classification Rule 11 – what??? Medical Device and FDA Regulations and Standards News 9
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
A Fire hazard classification - Clause in IEC 60601 about gauze and electricity ISO 14971 - Medical Device Risk Management 0
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
A Device Classification - India CDCSO - How to classify the device? Other Medical Device Related Standards 1
B ASTM F2924-14 /ASTM F3001 - Room temperature classification criteria Other US Medical Device Regulations 0
M Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019) Medical Device and FDA Regulations and Standards News 2
E Wristwatch Skin-proximal glucose sensor - Classification under MDR EU Medical Device Regulations 4
K MEDDEV 2.4/1 rev. 9 Classification EU Medical Device Regulations 1
M Informational USFDA – Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph Medical Device and FDA Regulations and Standards News 0
N Medical Device Re-Classification EU Medical Device Regulations 2
B Class IIB Device - IEC 62304 Software Classification IEC 62304 - Medical Device Software Life Cycle Processes 13
C Suppliers re-classification from Critical to Significant or from Significant to Non-critical Supply Chain Security Management Systems 0
J Medical Device re-classification and marketing ISO 13485:2016 - Medical Device Quality Management Systems 13
M APQC PCF (Process Classification Framework) and ISO 9001 - Processes Based Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom