Can we take a part from 510k cleared medical device and use it in class I device?

[Nissim Shaked]

We are planning to take part of an already 510k cleared device (its energy converting part=motor)
to drive a new class I (510k exempt) device?
The new device shall undergo risk analysis, design input and V&V full testing for making 100%
sure it is safe for use and perform its intended use properly.

Do we mis any regulatory requirement which restrict us to do such a combination?

 

[Watchcat]

There is no regulatory requirement that prohibits you from doing this. The regulatory requirements and restrictions kick in when you put a medical on the US market.

Perhaps what you meant to ask is whether you can reasonably claim that the "new" device is a Class I device, and, if so, that the "new" device is also 510(k) exempt. That depends on whether or not it is substantially equivalent to a predicate device. The answer to this question has nothing to do with where the motor came from. It might or might not have something to do with the regulatory status of the device in which the motor will be placed.

To answer this question, I strongly recommend that your company hire a regulatory specialist who is knowledgeable in FDA regulation of medical devices, or secure the services of a regulatory consultant who is knowledgeable in the FDA regulation of medical devices.

This is not a good fit for me, but there are several consultants in this forum with this expertise.

 

[Nissim Shaked]

There is no regulatory requirement that prohibits you from doing this. The regulatory requirements and restrictions kick in when you put a medical on the US market.

Perhaps what you meant to ask is whether you can reasonably claim that the "new" device is a Class I device, and, if so, that the "new" device is also 510(k) exempt. That depends on whether or not it is substantially equivalent to a predicate device. The answer to this question has nothing to do with where the motor came from. It might or might not have something to do with the regulatory status of the device in which the motor will be placed.

To answer this question, I strongly recommend that your company hire a regulatory specialist who is knowledgeable in FDA regulation of medical devices, or secure the services of a regulatory consultant who is knowledgeable in the FDA regulation of medical devices.

This is not a good fit for me, but there are several consultants in this forum with this expertise.

Thank you for the information

 

[duinyk]

I had a similar question.
If you intend to bring a class II 510k exempt to the market, could you use or classify the device with two 510k exempt codes from two different regulation numbers?

 

[Parul Chansoria]

Yes, this is possible, however, you will have to check whether or not the new device is 510(k) exempt as per the FDA regulations. A risk analysis, appropriate test and compatibility test need to be conducted to prove safety and effectiveness.

 

[Nissim Shaked]

Yes, this is possible, however, you will have to check whether or not the new device is 510(k) exempt as per the FDA regulations. A risk analysis, appropriate test and compatibility test need to be conducted to prove safety and effectiveness.

Thank you for sharing such information.

 

[Ronen E]

whether you can reasonably claim that the "new" device is a Class I device, and, if so, that the "new" device is also 510(k) exempt. That depends on whether or not it is substantially equivalent to a predicate device.

Strictly speaking, this is not how it works. The "substantially equivalent" and "predicate device" terminology belongs to devices that are NOT 510(k)-exempt. In the case of exempt (or potentially exempt) devices, one needs to look for an equivalent device that is on the USA market and that is Listed under a ProCode that is 510(k)-exempt. It's not a predicate device per-se, but it's a precedent that allows - if indeed it's equivalent and the rationalization is solid enough - to classify the new device in the same 510(k)-exempt code. There is no Substantially Equivalent determination made in such cases, and typically no one will officially check the classification rationalization as long as nothing goes wrong with the new device on the USA market, but the manufacturer should be prepared to defend it, if and when required, which might happen in an FDA routine on-site inspection at some point.

The new device shall undergo risk analysis, design input and V&V full testing for making 100% sure it is safe for use and perform its intended use properly.

The requirements that normally apply to a 510(k)-exempt device are the General Controls, part of which is 21 CFR 820. This scope doesn't include "risk analysis" in the broadly used sense of the term (there are some risk analysis requirements but they are quite specific and minimal). Design Input, Design Verification and Design Validation are included in Part 820, but are N/A to most class I devices. There is no requirement in FDA regulations to ensure that a new device is "safe for use and perform its intended use properly", unless it's a class III device, though it's not a bad idea to do that (whatever you take it to mean) for the sake of your own success.

Yes, this is possible, however, you will have to check whether or not the new device is 510(k) exempt as per the FDA regulations.

It's unclear whether you were replying to @Nissim Shaked or to @duinyk. Could you please clarify?

A risk analysis, appropriate test and compatibility test need to be conducted to prove safety and effectiveness.

As above, from a regulatory perspective this is not required unless the device is in class III, and definitely not if it's 510(k)-exempt.