Why a 510k can includes multiple medical devices with difference indication for use

[Emma2010]

Hi everyone,
I have a quick question regarding the grouping of a 510k for medical devices.
There are a lot of active medical devices (like muscle stimulators) that are cleared under one 510k with very different indications for use.
Does that means once they are under the same code, medical devices can be submitted in one 510k?
It will be greatly appreciated if you can provide any of your comments! Thanks a bunch!
B&R
Emma

 

[SeanN]

Hi everyone,
I have a quick question regarding the grouping of a 510k for medical devices.
There are a lot of active medical devices (like muscle stimulators) that are cleared under one 510k with very different indications for use.
Does that means once they are under the same code, medical devices can be submitted in one 510k?
It will be greatly appreciated if you can provide any of your comments! Thanks a bunch!
B&R
Emma

I am not aware of this situation (i.e., a 510k submission for multiple devices), but IMHO, in certain situations, if the devices are considered as a system or if they are intended to be used together, the FDA may allow a single 510(k) submission covering the entire system. Awaiting comments from MD experts.

 

[Parul Chansoria]

Hi @Emma2010 - first I will address - can many medical devices be submitted under one 510k. Following is the answer to that question.

A company can submit multiple products in one submission in the following cases:
1. As @SeanN mentioned it could be for a system where accessories and the capital equipment are a part of one submission.
2. A wearable product with several single use disposables or consumable accessories
3. Several products which are essentially the same with same indications for use, but there is variation only in length, permeability, etc. like for a suture.
4. Hardware or software products which are same in terms of the technological characteristics and indications for use but again variation in terms of report generated or certain features.
5. A kit where several things work together to achieve the same intended use.

Finally, there has to be a way where you can group the products together in a product family. Whenever you can do that, and it is generally justified to do one single submission for multiple products, and yes that is accepted and allowed by the FDA. However, the justification should be robust from a regulatory perspective.

Now, if there are products with different indications for use, and they are meant to be grouped in one 510k then they may be products that go along with each other to achieve one final indications for use.

If you share specific case that you are trying to decipher then I can give more specific inputs as well.

Best,
Parul

 

[Ed Panek]

My experience along with comments from Parul above, is that FDA will allow multiple devices is

1) there are no new questions about safety and efficacy
2) The combination does not create a new product category the FDA does not have established controls over.

 

[Parul Chansoria]

Hi @Emma2010 - first I will address - can many medical devices be submitted under one 510k. Following is the answer to that question.

A company can submit multiple products in one submission in the following cases:
1. As @SeanN mentioned it could be for a system where accessories and the capital equipment are a part of one submission.
2. A wearable product with several single use disposables or consumable accessories
3. Several products which are essentially the same with same indications for use, but there is variation only in length, permeability, etc. like for a suture.
4. Hardware or software products which are same in terms of the technological characteristics and indications for use but again variation in terms of report generated or certain features.
5. A kit where several things work together to achieve the same intended use.

Finally, there has to be a way where you can group the products together in a product family. Whenever you can do that, and it is generally justified to do one single submission for multiple products, and yes that is accepted and allowed by the FDA. However, the justification should be robust from a regulatory perspective.

Now, if there are products with different indications for use, and they are meant to be grouped in one 510k then they may be products that go along with each other to achieve one final indications for use.

If you share specific case that you are trying to decipher then I can give more specific inputs as well.

Best,
Parul

@Emma2010 In case you wish to explore what are the common mistakes that people make during 510(K) submission, you must check out our blog - 13 Common Mistakes to Avoid in the 510(k) Submission

 

[EmiliaBedelia]

Note also that "Indications for Use" and "Intended Use" are 2 different concepts. They are related but not the same. Here is a good guidance on this topic: General/Specific Intended Use - Guidance for Industry

The Intended Use is more general and basically just describes the function of the device.
The Indications for Use are the medical conditions that the device can be used to treat/cure. This is where the risk level of the device can very quickly change - the indications will affect the patient population, use environment, and potential hazards/harms for the patient.

A device can have one intended use with many indications for use. Devices that share an intended use/function can often be combined. In your example, the intended use is stimulation of muscle tissue. The indications for use could include clinical use on the legs by a healthcare provider in a physical therapy setting, but it could also include home use by lay users for menstrual cramps. The devices could be identical in every way - but if you are going to market it for those specific indications, then you need to show that it is safe and effective for the specific patient population/use.

The product code is not fully relevant to the question of whether devices can be submitted together.
The product code can sometimes be determined by the intended use, but sometimes it is based on the indications. The technical characteristics of the devices (and the nature of the change, if it's a modification to an existing device) will determine whether it makes sense to evaluate them together.

 

[Gelnas Kot]

Hi everyone,
I have a quick question regarding the grouping of a 510k for medical devices.
There are a lot of active medical devices (like muscle stimulators) that are cleared under one 510k with very different indications for use.
Does that means once they are under the same code, medical devices can be submitted in one 510k?
It will be greatly appreciated if you can provide any of your comments! Thanks a bunch!
B&R
Emma

In general, devices with similar intended use and technological characteristics can be grouped together under one 510(k) submission. However, it's essential to ensure that each device within the group shares substantial equivalence to a predicate device and meets all regulatory requirements.

For devices like muscle stimulators with different indications for use, careful consideration is needed to determine if they can be appropriately grouped under the same 510(k). Factors such as intended use, technological differences, and regulatory classification will influence this decision.

I would recommend consulting with regulatory experts or reaching out to the relevant regulatory authority for specific guidance on your particular case.

 

[Emma2010]

In general, devices with similar intended use and technological characteristics can be grouped together under one 510(k) submission. However, it's essential to ensure that each device within the group shares substantial equivalence to a predicate device and meets all regulatory requirements.

For devices like muscle stimulators with different indications for use, careful consideration is needed to determine if they can be appropriately grouped under the same 510(k). Factors such as intended use, technological differences, and regulatory classification will influence this decision.

I would recommend consulting with regulatory experts or reaching out to the relevant regulatory authority for specific guidance on your particular case.

Thanks Gelnas for your helpful information!