Oxygen Generator - Classification

sriramsl

Involved In Discussions
#1
Dear all

We have a device that Generates Oxygen from Chemicals, through chemical reaction. When a mechanical trigger is twisted by hand, two chemicals come in to contact and then it generates Oxygen, the Oxygen generated builds pressure in the chamber and this pressure is controlled through pressure regulators and using a flow meter, the Oxygen is delivered to the patient. There are no electrical parts. This is purely a mechanical device. The energy for delivery of oxygen is generated by generation of pressure through production of oxygen from chemical reaction. The operation is not through energy generated by the body or Gravity. Hence I have concluded that the device is an Active Medical Device .
Question 1 - Is my conclusion that device is Active device correct?
Question 2 - Should Oxygen has to be considered as a "substance", will Rule 12 of Annex VIII of MDR apply?

Thank you for your support
 
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Raisin picker

Quite Involved in Discussions
#2
Hi,
Reading MDCG 2021-24, it seems that your device is an active device. See the example with heating pads on page 11. And according to the examples on page 44/45, rule 12 should apply (IIb).

The whole classification, however, relys on your intended use. MDCG 2021-24 has the example "Oxygen concentrator used to deliver oxygen enriched air directly to the patient", which might be close to what you describe. If the oxygen is used for some other purpose (can't think of an example right now that fits medical device definition), everything might be different.
 

sriramsl

Involved In Discussions
#3
Hi,
Reading MDCG 2021-24, it seems that your device is an active device. See the example with heating pads on page 11. And according to the examples on page 44/45, rule 12 should apply (IIb).

The whole classification, however, relys on your intended use. MDCG 2021-24 has the example "Oxygen concentrator used to deliver oxygen enriched air directly to the patient", which might be close to what you describe. If the oxygen is used for some other purpose (can't think of an example right now that fits medical device definition), everything might be different.
Thank you Raisin Picker for your clarification - Yes MDCG 2021-24 clearly points out both -
1- the heating pad example of converting chemical energy in to heat energy - in our case the chemical energy in to gas production which in turn is turned into penumatic pressure....
2. Yes the example of Oxygne Concentrator gives Rule 12 applicability, but am surprised it is under Class IIb, not Class IIa - may be because the pressure that is built up is considered as potentially hazardous

Thanks again Raisin - Really helpful

Were you by any chance with Picker International, which got dismantled and sold to Philips?

Regards
Sriram
 

Raisin picker

Quite Involved in Discussions
#4
I think the oxygene concentrator is providing a substance that some living beings consider as essential ;-) So too high or too low a pressure (or O2 concentration) can both be harmful, even deadly. That's why I mentioned the intended use. If you don't supply the oxygen to the lungs for respiration, you might get away with IIa.

And no, my name is just a variation of nitpicker. I have no direct or indirect connection to Philips (or any other major company out there).
 
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