Guidance on Selecting Appropriate FDA Product Code for Non-Invasive Neonatal Bubble CPAP Device

[Goutham prasad]

Hello all,


We are currently in the process of preparing a 510(k) submission for a non-invasive Bubble CPAP device intended for neonatal use.

During our predicate search using the FDA 510(k) database with keywords like "non-invasive" and "Bubble CPAP", we identified product code BZD. We also found devices under BZD (868.5905) that deliver CPAP therapy specifically for neonates, and selected one such device as our predicate.

However, there is a technological difference:

• Our device uses an internal blower to generate airflow.
• The predicate device uses an external wall gas source (hospital line).

To address this, we included a reference device under product code CBK (868.5895) "Ventilator, Continuous, Facility Use" – to demonstrate the blower functionality and use of ambient air.

In response, the FDA advised us to classify our device under CBK, considering our design as more advanced. However, we have concerns:

• Most devices listed under CBK (868.5895) are full-fledged ventilators, both invasive and non-invasive, typically used for life-support ventilation. Our device, by contrast, is a non-invasive system limited to providing CPAP only.
• We also reviewed product code MNT (868.5895) - "Ventilator, Continuous, Minimal Ventilatory Support, Facility Use" – and found that it includes non-invasive BiPAP systems for adult patients, which appear functionally closer to our system than full-featured ventilators in CBK.

Given this, we are seeking guidance on the following:

1. How should we determine the most appropriate product code when our device offers non-invasive CPAP and does not provide full ventilatory support?
2. Are there official FDA definitions or criteria distinguishing CBK, MNT, BZD, etc., and their intended clinical use scopes?
3. What is the best approach to justify a product code selection if the FDA recommends one that seems overly broad or mismatched with our device’s intended function and risk profile?

Any input, shared experiences, or reference materials from similar 510(k) submission would be greatly appreciated.


Thank you,

 

[yodon]

Consider a pre-sub! But you don't ask for direction, you present your approach and your rationale to get feedback on feasibility.

...if the FDA recommends...

They won't / they don't. They will only give a thumbs up or down on what you present.

 

[EmiliaBedelia]

If there is any official direction from FDA on product codes, it would be in a device specific guidance document. The official definitions are in the CFR as well as the Product Classification database. For FDA purposes, the product code is a pretty wide bucket - it basically just narrows down which group is reviewing and what submission type it should be. The "broadness" of the product code doesn't really matter (ie, it doesn't make a difference to YOUR device if there are other devices in the same code that are not similar to yours). If the predicate device that's most technologically and indication-ally similar to your device is in that procode, that's all you need to worry about.

Personally I think the only reason FDA recommended you use CBK is because you brought it up... I don't know anything about this device type, but it seems to me like you have a predicate problem, not a procode problem.
You selected a predicate in one product code and then explained how your device is actually more technologically similar to a device in a different product code. Are there any other predicates that use the same technology as your device that are in the desired product code?

See the snip below from "The 510(k) Program: EvaluatingSubstantial Equivalence in PremarketNotifications [510(k)]" - it seems like your device has technological differences from the predicate AND it raises new questions of S&E, which means that it is not a suitable predicate device. A reference device is not a predicate, so you can't claim equivalence to the technological features of the reference device if you aren't equivalent to the primary predicate.

The best way to justify your product code choice is to defend your predicate selection by demonstrating that the technological differences between your desired predicate and your device do not raise new questions of S&E. The guidance above will help you with the predicate/reference device. Remember that the goal of a 510k is to demonstrate substantial equivalence to a predicate device. Your goal is not to demonstrate equivalence to a product code.

I second the recommendation above - this is a really good topic for a presub.

 

[Goutham prasad]

Consider a pre-sub! But you don't ask for direction, you present your approach and your rationale to get feedback on feasibility.


They won't / they don't. They will only give a thumbs up or down on what you present.

Thank you !

 

[Goutham prasad]

@EmiliaBedelia​

Thank you for your response.
To clarify your question: there are no devices using the same technology as ours under the desired product code. The only similar device falls under a different product code (CBK), but its intended use differs significantly. While our device is specifically for CPAP therapy in treating RDS, the CBK device supports both invasive and non-invasive ventilation for a broader patient population, including adults.
Given this difference in intended use, we’re unsure if it would qualify as a suitable predicate.

 

[EmiliaBedelia]

That is not a difference in intended use. That is a difference in indications for use. These are related but not exactly the same.

Again I don't know anything about this specific type of device but it sounds like your device and the predicate do have the same intended use, and your proposed indications are less broad than the predicate. That wouldn't preclude it from being a predicate.

Differences in indications can be ok, as long as you can show that your device is not LESS safe and effective. If the predicate device was originally cleared for a range of specific indications, limiting that scope is generally less of an issue than expanding the cleared indications. The guidance on specific vs. general indications may also be good to consider - it has some additional details about how FDA assesses risk between different indications based on patient population, body location, disease state, etc.

General/Specific Intended Use - Guidance for Industry

Helps manufacturers understand principles used by FDA to determine whether the addition of an indication for use could trigger the need for a PMA.

www.fda.gov

Ultimately, all your predicates are Class II 510k devices. Is a different predicate going to change anything about your V&V strategy or your risk files or the testing that you intend to submit? If not... I don't want to say that the predicate doesn't matter at all, but it kind of doesn't. I personally would go with the one that FDA recommended and then argue your device is lower risk than that one based on the limited scope, but I'm just a stranger on the internet so do with that what you will.

 

[Goutham prasad]

That is not a difference in intended use. That is a difference in indications for use. These are related but not exactly the same.
View attachment 31174

Again I don't know anything about this specific type of device but it sounds like your device and the predicate do have the same intended use, and your proposed indications are less broad than the predicate. That wouldn't preclude it from being a predicate.

Differences in indications can be ok, as long as you can show that your device is not LESS safe and effective. If the predicate device was originally cleared for a range of specific indications, limiting that scope is generally less of an issue than expanding the cleared indications. The guidance on specific vs. general indications may also be good to consider - it has some additional details about how FDA assesses risk between different indications based on patient population, body location, disease state, etc.

General/Specific Intended Use - Guidance for Industry

Helps manufacturers understand principles used by FDA to determine whether the addition of an indication for use could trigger the need for a PMA.

www.fda.gov

Ultimately, all your predicates are Class II 510k devices. Is a different predicate going to change anything about your V&V strategy or your risk files or the testing that you intend to submit? If not... I don't want to say that the predicate doesn't matter at all, but it kind of doesn't. I personally would go with the one that FDA recommended and then argue your device is lower risk than that one based on the limited scope, but I'm just a stranger on the internet so do with that what you will.

Thank you , this discussion has been really helpful.
We now have a much clearer understanding of how to approach the product code and predicate selection, and the distinction between predicates and reference devices.
Appreciate the guidance and shared experiences!