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Perfusion System - HLM Components with Vendor Neutrality

Highground

Involved In Discussions
#1
Would I include the components of a HLM as generic or list them as different systems that can be customized and configured to a central monitoring systems if the components don't have 510K clearance as individual systems? Or will they need individual 510k clearance first before it can be a part of the Perfusion System? Plus the Perfusion system can be use by other manufactures centrifugal pumps with the system...vendor neutrality.

e.g. Ventilation system is a monitoring system that will monitor and adjust to settings and is an accessory to the Perfusion system? :confused:

I did a look up roller blood pumps, ventilation, and blood gas monitors and Perfusion Systems. They all seem to have their own 510k clearances.

Any discussion on the subject would be appreciated.
 
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shimonv

Trusted Information Resource
#2
Hi there,
Your post is almost cryptic and it makes it difficult for people to understand and contribute from their knowledge.

From what I could gather, if the HLM (Hear Lung Machine) components are independent medical devices, each with a specific function - you must 510(k) them separately. In order to achieve vendor neutrality you need to present them as different systems that can be customized and configured to a central monitoring system. Of course, you will need to provide V&V records to prove it.

Hope it helps.

-Shimon
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Would I include the components of a HLM as generic or list them as different systems that can be customized and configured to a central monitoring systems if the components don't have 510K clearance as individual systems? Or will they need individual 510k clearance first before it can be a part of the Perfusion System? Plus the Perfusion system can be use by other manufactures centrifugal pumps with the system...vendor neutrality.

e.g. Ventilation system is a monitoring system that will monitor and adjust to settings and is an accessory to the Perfusion system? :confused:

I did a look up roller blood pumps, ventilation, and blood gas monitors and Perfusion Systems. They all seem to have their own 510k clearances.

Any discussion on the subject would be appreciated.
Hi,

If you intend to distribute a perfusion system in the USA, including elements / accessories / peripherals / the like that aren't 510(k) cleared and aren't 510(k) exempt, you'll have to include all of them in your 510(k) scope and treat them as components of your own device (the system).

If you only intend to supply a control unit that is supposed to work with other, interchangeable units, you'll have to support your claims of safety and effectiveness with each and every listed configuration. In that case I don't recommend including devices / units that aren't 510(k) exempt and don't have one.

Cheers,
Ronen.
 

Highground

Involved In Discussions
#4
This is exactly what I needed to know. Sorry it seemed cryptic, didn't mean for it to be that way.
I thank you both! I was struggling with this all week. reading the FDA guidance was confusing. I pulled up a few of the summary's from different makers, but I couldn't make out if their components were independent of the HLM system or not. I may have a few more questions soon.

:thanx:
 

Ronen E

Problem Solver
Staff member
Moderator
#5
You're welcome.

The first and most important thing to do is define the regulatory scope of your product / device / system. This is something only you can do, since we don't have access to the specifics. Once this is done, there might be a lot of guidance to go through, but from my experience FDA guidance is quite instructive in most cases. Don't worry, it'll all fall into place at some point. And you can always come back with more questions.

510(k) summaries are not the ideal reference for strategic regulatory issues because they only contain the bare minimum that's required for informing the public. Applicants will normally only put in there what the FDA makes them divulge. Those summaries become useful later on, when you go to the nuts and bolts of putting your 510(k) submission together (and even then it's usually barely enough!). Your strategy should be derived from a good general understanding of the regulatory system and from a broad knowledge of relevant guidance documents.

Cheers,
Ronen.
 

Highground

Involved In Discussions
#6
I will certainly know more specifics once I start this new position next week. My previous 510k was working with a team for a needle safety device. It seems like that project was simple compared to this new endeavor.
 

Highground

Involved In Discussions
#7
You're welcome.

The first and most important thing to do is define the regulatory scope of your product / device / system. This is something only you can do, since we don't have access to the specifics. Once this is done, there might be a lot of guidance to go through, but from my experience FDA guidance is quite instructive in most cases. Don't worry, it'll all fall into place at some point. And you can always come back with more questions.

510(k) summaries are not the ideal reference for strategic regulatory issues because they only contain the bare minimum that's required for informing the public. Applicants will normally only put in there what the FDA makes them divulge. Those summaries become useful later on, when you go to the nuts and bolts of putting your 510(k) submission together (and even then it's usually barely enough!). Your strategy should be derived from a good general understanding of the regulatory system and from a broad knowledge of relevant guidance documents.

Cheers,
Ronen.
Thank you Ronen. You were correct...things are falling into place. They are not as far as I was lead to believe...thank goodness! Only at mid-point with the devices. So one device at a time will be put forward for clearance. :D
 
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