Need help on Device Description in the Acceptance Checklist for Traditional 510(k)

[gerhardr]

Hi All,
I am new to this forum and new to medical devices and I have some questions. I am trying to put together a 510(k) submission for a simple OTC medical device. It is a Micro-current Electro-stimulator combined with an infrared LED panel (product codes NUH and ILY)
In the Acceptance Checklist published by the FDA ( I would post a link but I am not allowed to)

Link - http://www.fda.gov/downloads/Medica...dance/GuidanceDocuments/UCM315014.pdf#page=17
it states in section 10a:
10. a.
If there are requirements regarding the device description, such as
special controls, in a device-specific regulation that are applicable
to the device, the submission includes device description
information to establish that the submitter has followed the
device-specific requirement.

Can someone help me figure out whether my device(s) require this type of description, or more generally, what does this paragraph mean, anyway.

It goes on from there, but let's start with this.

Thank you in advance

Gerhard

 

[Ronen E]

Re: Need help on Device Description in the Acceptance Checklist for Traditional 510(k

Hi All,
I am new to this forum and new to medical devices and I have some questions. I am trying to put together a 510(k) submission for a simple OTC medical device. It is a Micro-current Electro-stimulator combined with an infrared LED panel (product codes NUH and ILY)
In the Acceptance Checklist published by the FDA ( I would post a link but I am not allowed to)

Link - http://www.fda.gov/downloads/Medica...dance/GuidanceDocuments/UCM315014.pdf#page=17
it states in section 10a:
10. a.
If there are requirements regarding the device description, such as
special controls, in a device-specific regulation that are applicable
to the device, the submission includes device description
information to establish that the submitter has followed the
device-specific requirement.

Can someone help me figure out whether my device(s) require this type of description, or more generally, what does this paragraph mean, anyway.

It goes on from there, but let's start with this.

Thank you in advance

Gerhard

Hello and welcome to medical devices and to the Cove

ProCode NUH deosn't have any associated special controls.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NUH

ProCode ILY has a guidance document associated with it: Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=4607

That guidance document can be found here:

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/ucm080418.pdf

Please note that it's pretty old.

The section "DEVICE DESCRIPTIVE INFORMATION" may help you in your quest.

Note: The submitter is responsible for the identification of proper ProCodes. If your device comes under codes other than NUH and/or ILY, there may be other applicable requirements.

Cheers,
Ronen.

 

[gerhardr]

Re: Need help on Device Description in the Acceptance Checklist for Traditional 510(k

Hi Ronen,

thank you! I read the article in the link you gave, but frankly, it did not make things any clearer. for now, I am just going to assume it is a N/A and go forward.

I'm sure I will have more questions.

regards,

Gerhard