Recreational Oxygen Concentrator - FDA or other requirements

A

abc01778

#1
Does anyone know if a machine that outputs low flow (<1 liter/min) and low concentration (<50%) oxygen needs to be registered or otherwise cleared by the FDA, or it can be marketed as a consumer product?

Any example you may be aware of?
 
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A

arios

#2
Re: Recreational Oxygen Concentrator

Hi Abc01778, Interesting post!

What is the intended use of your device? (if it can known)

Is there any predicate device? (I am probably asking what yo are asking already, but making the question with different terms can help narrow the search)

Although the below link relates to question regarding devices that may be ¨borderline¨ for the Europe, it could serve as a material for further discussion to your question.

http://www.donawa.com/medical-device/donawa/files/MDT Sept09 EU Borderline Products.pdf

My first guess is that your product is a medical device, but I will wait for further information from the covers and from you to get a better idea

Aberto
 
M

MIREGMGR

#3
What is a recreational oxygen concentrator used for?

If easing symptions of a physical / medical condition, of course it's a device.

If exercising, it might be a medical device.

??

Per the Act, a device is:
  • "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
Clause 3 of course is wide open to interpretation.

We do know, though, for instance, that an oxygen concentrator and gas separator for use in the blending of technical diving gases would not be a medical device. The preparation, concentration or pressurization of gases for breathing purposes, in and of itself, isn't inherently medical.

It depends on the product's use.
 
A

abc01778

#4
What is a recreational oxygen concentrator used for?

If easing symptions of a physical / medical condition, of course it's a device.

If exercising, it might be a medical device.

??

Per the Act, a device is:
  • "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
Clause 3 of course is wide open to interpretation.

We do know, though, for instance, that an oxygen concentrator and gas separator for use in the blending of technical diving gases would not be a medical device. The preparation, concentration or pressurization of gases for breathing purposes, in and of itself, isn't inherently medical.

It depends on the product's use.


This is from abc01778 who posted the original message:

The product will not be marketed for medical use but strictly as a consumer product, similar to the oxygen bar, but it is meant for personal and private use only.

There are similar products out there (below) that I don't believe any of which is FDA cleared:

[FONT=&quot]Tranquil Sounds Oxygen Bar[/FONT]

[FONT=&quot]O2-B® Personal Oxygen Bar[/FONT]

(I am not allowed to include links here but you can easily search them)

We are asking this question as we don't want to run afoul of the FDA, just in case.

Any opinion?

Many thanks for your help.
 
M

MIREGMGR

#5
As you presumably are aware, the fact that a similar product is being marketed without FDA involvement is interesting and perhaps suggests a direction of review, but is not regulatorily or legally definitive or excusatory regarding the question of whether FDA involvement is required.

I'd think for a "personal oxygen bar" product, the FDA might look at who the customers are for similar products. If they're normally healthy people who for one reason or another are convinced that some extra oxygen would be good for them, perhaps it's not a medical product. If on the other hand they tend to have some degree of emphysema/COPD, asthma or some other lung-effectiveness deficiency, or they moved to a high altitude and are having issues with chronic blood oxygen deficiency, or their blood O2 level is sometimes low for any other reason and their physician has recommended that they do something about it, I'd think it would be a medical device irrespective of how you describe it.
 
G

gar4guv

#6
i believe your product being classified as a medical device would hinge on whether you make any claims that it could be "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease"

if you do, then it might fall under this classification:

PART 868 -- ANESTHESIOLOGY DEVICES
Subpart F--Therapeutic Devices
Sec. 868.5440 Portable oxygen generator. (a)Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).
(b)Classification. Class II (performance standards).
 
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