510(k) Submission for a huge, changing complex Medical Device System

W

wangyang

#1
Hi:

We have a system under design, and going to submit 510(k) for it.This system have mainly three part, the cloud, the apps and the devices. The devices are some home-used devices such as the blood pressure monitor and the oximeter, the apps can receive and transmit signal through blueteeth with devices,(for example, apps can control the start of the device and make some analysis of the test result from the devices), The cloud is a web-based software which can receive and store the user information and test result from the apps, when user enter their account information, they can log-into the cloud and review the test result graphcially.

Since this is a very complex system, all of the three parts may change, so if i submit 510(k) for the whole system, i must apply new 510(k) for every significant change( i am sure there will be many significant change, since the connected device will be added-on per the market requirment, some important functions of the apps and cloud will be changed quickly), so i am going to submit 510(k) for each parts instead of for the whole system, that is, submit seperate 510(k) for the devices, the apps and the cloud. If any part of the other system is changed, the other part will remain uneffected. It is terrible if i must submit 510(k) for the whole system each time of significant design modification.

Now the question is, since the three parts are not standalone, so will my strategy be successful to submit 510(k) for each part?

In fact, all of the three part is connected by the pre-defined communication ptocotol, we also have designed a equipment which can transmit and receive the data between the three parts. In this communication protocol, we defined the basic data format as well as the product-specific data requirement. In the 510(k) submission for the cloud and the apps, i will provide the software transmit accuracy test using the equipment i mentioned above as part of the software validation. In the 510(k) submission for the device, except for the above software validation, i will also provide the electrical safety, EMC test and blueteeth test(these tests and its test result is not closely related to the software it is not intended to test the software performance.), as well as the performance test (by the device and the simulated equipment which can receive and transmit the signal).

I know many of you here are expert about FDA regulation, could you please give me some suggestions about it? Any input will be appreciated.

Thanks.

Wangyang.

By the way, maybe it is a common practice but not falimiar to me: Can i submit 510(k) for the accessory of a medical device? In my case, if the apps and the cloud can be treated as an accessory? ( the device are not standalone one and some of its functions will be controlled by the apps).

If an acessory can be connected to several products, then these products must have some common features for connection, (just like the communication protocol), is it possible for me to mention in the indication for use form that "this accessory is intended to be used together with device of "the common features" instead of the name of the connected device?
 
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G

Gert Sorensen

#3
It sounds like quite a challenge to keep your system compliant. If I were you I would go straight to the FDA, and preferably set up a meeting with them to explain your challenge is this manner, and gain some input as to what strategy you should pursue. They are quite interested in helping us, so don't be afraid to contact them.

Their contact information is:

1-800-638-2041
301-796-7100
Fax:301-847-8149
[email protected]
CDRH-Center for Devices and Radiological Health
Food and Drug Administration

10903 New Hampshire Avenue

WO66-5429

Silver Spring, MD 20993
 
D

drewsky1

#4
Are there any FDA regulations that require and indication for use to be on an accessory label? We have connectors and adapters that can be used with our devices that are packaged and sold separately. There is no IFU for these accessories and they have been on the market for years. Often the labels state what the accessory can be used with but the IFU for the device it can be used with does not address the accessory. We have come across these labels and I cannot find any FDA regulation that addresses this. The product is not registered in the EU. I appreciate your expertise.
 

Ronen E

Problem Solver
Moderator
#5
Are there any FDA regulations that require and indication for use to be on an accessory label? We have connectors and adapters that can be used with our devices that are packaged and sold separately. There is no IFU for these accessories and they have been on the market for years. Often the labels state what the accessory can be used with but the IFU for the device it can be used with does not address the accessory. We have come across these labels and I cannot find any FDA regulation that addresses this. The product is not registered in the EU. I appreciate your expertise.
Hi,

Except for a limited number of cases, accessories are regulated just like devices (they inherit the device's procode). Make sure that whatever you refer to as an "Accessory" really is one by regulatory terms. Whatever is relevant under the procode would typically apply, on top of the General Controls' Misbranding & Labeling requirements.

http://www.fda.gov/MedicalDevices/D...rview/GeneralandSpecialControls/ucm055910.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/default.htm

Cheers,
Ronen.
 
R

robertjbeck

#6
Did you pursue this with FDA or determine how to approach this interesting question? If you have any additional information, it would be quite helpful to the users of this forum.



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Last edited by a moderator:
M

mogluk

#7
initially if you will submit a full usable device as a single 510k. If all 3 pieces are necessary for functioning then you should submit together. If the Cloud portion is not required for initial use/function then that might be left out and submitted later as a separate accessory.
 
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