Regulatory Open Forum

Hello RAPS community,

I would like to ask for your opinion on a device classification. We
have a device that is an accessory to a class II ventilator. Our
accessory is a berating circuit that is attached to the ventilator.
The said ventilator has a breathing circuit as part of it's 510K
clearance. The berating circuit does not contact the patient and is
not sterile. Off the shelf medical devices are attached to the
breathing circuit for the patient contact but the breathing circuit is
a gas path device. It is also reused for several times for the same
patient and cleaned in between uses. We can use the ventilator with
the existing breathing circuit as a predicate via the 510K pathway.

I am wondering is there is a chance to classify the breathing circuit
as a class I device?
I don't think so because this is a gas path device but thought I ask
for others opinions.

Thank you in advance!

Original Message------

Hello RAPS community,

I would like to ask for your opinion on a device classification. We
have a device that is an accessory to a class II ventilator. Our
accessory is a berating circuit that is attached to the ventilator.
The said ventilator has a breathing circuit as part of it's 510K
clearance. The berating circuit does not contact the patient and is
not sterile. Off the shelf medical devices are attached to the
breathing circuit for the patient contact but the breathing circuit is
a gas path device. It is also reused for several times for the same
patient and cleaned in between uses. We can use the ventilator with
the existing breathing circuit as a predicate via the 510K pathway.

I am wondering is there is a chance to classify the breathing circuit
as a class I device?
I don't think so because this is a gas path device but thought I ask
for others opinions.

Thank you in advance!

Thank you John and Elizabeth for your suggestions. I looked at §868.5240   Anesthesia breathing circuit before posting my message. Our berating circuit is not for anesthesia, it will be used in the ICU for up to one week. I am wondering if the intended use will be considered different. The device is also designed so when the airway pressure increases (e.g. exhalation phase), flow entrainment decreases and vice versa. Do you think a device with such function can be still classified under §868.5240?

------------------------------
Virginia Anastassova RAC
RA Manager, Senior QA Specialist
Starfish Medical
Victoria BC
Canada
------------------------------

Original Message:
Sent: 13-Mar-2017 14:20
From: John Beasley
Subject: Device classification

Brings back memories from my "Isothermal" days ...

For the USA, see the following:

§868.5240   Anesthesia breathing circuit (Class I)

unless, of course, it has a heated wire function, then see

§868.5450   Respiratory gas humidifier (Class II)

This is just a very quick look.  It should get you started on researching further - this only applies to USA!

John

Hi-

I have experience working in the respiratory field and agree with John, re: reviewing §868.5240   Anesthesia breathing circuit (Class I) (non-heated) and §868.5450   Respiratory gas humidifier (Class II) (heated) for applicability to your product.

Re: predicate devices - you can certainly use a ventilator submission which includes a similar breathing tube (assuming you determine the 510K pathway is appropriate), but there are definitely 510K clearances for standalone breathing tubes (without the ventilator) which might make things a bit easier for you.

Hope this helps!


------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
------------------------------

Original Message:
Sent: 13-Mar-2017 12:45
From: Virginia Anastassova
Subject: Device classification

Hello RAPS community,

I would like to ask for your opinion on a device classification. We
have a device that is an accessory to a class II ventilator. Our
accessory is a berating circuit that is attached to the ventilator.
The said ventilator has a breathing circuit as part of it's 510K
clearance. The berating circuit does not contact the patient and is
not sterile. Off the shelf medical devices are attached to the
breathing circuit for the patient contact but the breathing circuit is
a gas path device. It is also reused for several times for the same
patient and cleaned in between uses. We can use the ventilator with
the existing breathing circuit as a predicate via the 510K pathway.

I am wondering is there is a chance to classify the breathing circuit
as a class I device?
I don't think so because this is a gas path device but thought I ask
for others opinions.

Thank you in advance!