Proper FDA Classification for a DICOM Viewer

[sorcerer]

Hello All,
When I googled FDA Classification for Medical device, I got these definitions:
Class I Medical Devices are simple in design and have little to no potential risk.
Class II Medical devices are more complicated in design and pose a minimal risk. Medical devices classified as type II must follow general policy and special labeling, mandatory performance standards and post market surveillance.

I am looking at the proper classification of DICOM viewer.

One DICOM Viewer I am looking at, RemotEye, this device is listed as FDA Class 1. (Sorry, I am not allow to post a URL to this product here).

The other DICOM Viewer product, Aycan OsiriX Pro listed their device as FDA Class 2. (Again sorry, I am not allow to post a URL)

Can someone please inform me whether a DICOM viewer should be Classified Class 1 or Class 2. Suppose the viewer is for remote viewing.
Thanks in advance.
Sorcerer

 

[sagai]

actually you have to find out the product code and based on that the corresponding CFR, that will give you the classification.
for PACS for example:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.2050

I guess, it is only a guess because I would suggest to check the CFR and product code for your predicate device, it could be okay for you DICOM viewer, but it is only my view, please check.
Cheers

 

[sorcerer]

Thanks for your response. I have combed through all 4 pages at the FDA Product Classification page.
I think these are the pages that provide me with the information you asked me to lookup.
I am still confused because I still cannot find a close match for a DICOM viewer.

There are 3 possible candidates.

And as you know, a PACS is not a DICOM viewer even though most PACS has a primitive viewer built in.

Not so close candidates:
1/ Device = "device, digital image storage, radiological", Regulation Description = "Medical image storage device", Product Code = LMB, Regulation Number = 892.2010, Device Class = 1
2/ Device = "system, digital image communications, radiological", Product Description = "Medical image communications device", Product Code = LMD, Regulation Number = 892.2020, Device Class = 1

The next one is the closest match but still not a DICOM viewer. In fact it is more like a PACS server - then what is LMB (892.2010)?
3/ Device = "system, image processing, radiological", Product Description = "Picture archiving and communications system.", Product Code = LLZ, Regulation Number = 892.2050, Device Class = 2


To add to the confusion, after I read your feedback, I ran into 2 viewer products that has 2 different Product Code:

a/ "VidiStar", "Trade/Device Name: VidiStar PACS & DICOM Viewer Server Software System", "Regulation Name: Picture archiving and communications system", "Regulatory Class: II", "Product Code: LLZ", "Regulation Number: 892.2050"

OK, so this product is a PACS and a viewer and it is a class 2 product.

b/ "VALUE MINISTAR VIEWER", "FDA Classification Name: SYSTEM, DIGITAL IMAGE COMMUNICATIONS, RADIOLOGICAL", "FDA Common Generic Name: DICOM VIEWER", "FDA Product Code: LMD", "FDA Regulation Number: 892.2020"

This is a Class 1 device according to FDA classification. But 892.2020 is not a viewer, it is more like a DICOM gateway.

So I am still confused. I want to find out how to classify a DICOM viewer - a viewing application that can view studies located on a remote (i.e. not self-attached) PACS server.

Thanks in advance.

 

[sagai]

I think you have already answered your own question

You have to have a defined predicate device for the 51ok, otherwise you should submit PMA.
So ... in case the No1 is the most closest (actually it deserve more attention, because it is expected to prove that the predicate is really the predicate), I would not disturb the lion and set the same product code and CFR, surprisingly the one I have already suggested.
Viewers are also submitted as PACS, do not worry
But again, it is up to you and your decision, what is your predicate device.
Cheers!


ps.:
I believe the Dicom viewer is Class II anyway, but you have to have product code and CFR next to that.
Moreover for me, it has Major level of concern and if applicable to your situation, class C in IEC62304.

 

[sorcerer]

Hello Sagai,
Thanks for your response. I would like some clarification and need more feedback!!

If Dicom Viewer is a Class 2 device (mine is a SW viewer), then why did some of the Dicom Viewers I listed, identify themselves as Class 1? One of them actually has a Product Code to identify which group of Class 1 it belongs to.

Does applying for Class 2 medical device take more time than Class 1?

Since medical risk for Class 2 is higher. Could the viewers who identify themselves as Class 1 be approved, because they stated in their product definition that the device is not for diagnostic purposes?

For your suggestion "No1 is the most closest...". Am I understanding it correctly that you were referring to "Regulation Number: 892.2010", "Product Code: LMB"?
FDA describes it as
"
Sec. 892.2010 Medical image storage device.
(a)Identification. A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory."

My viewer is not a storage device, it is a software application. It accesses and displays image studies from a storage device, i.e. a PACS.

Sorry for these bombardment of info. I am new to this regulation stuff.

Thanks in advance.

 

[sagai]

I am happy to discuss subjects we really can and would welcome others join too.

For me ...

The device classification in the CFRs is nothing to do with safety.
It is simple about the fact, if it is Class I, than General Control shall be applied, in case it is Class II, then General Control and Special controls mandated, if Class III , than PMA is the must. That is all.

Well, yes, there is the correlation between device classification and safety level, BUT I do not think this is the main message of the device classification.

If Dicom Viewer is a Class 2 device (mine is a SW viewer), then why did some of the Dicom Viewers I listed, identify themselves as Class 1?

Interested my thoughts?
If it is really a general dicom viewer for diagnostic purpose, it is simple could be because less control should be applied and ruthless capitalists hide the truth and escaping to the fact the FDA does not have enough resources to really challenge all pages of the 51ok submission.
Other option is they are not competent, that also could be the case.
But that can be the option too, that the device really not for diagnostic purpose, that could actually also be the rare case.
Well, reason can be different case by case.

Does applying for Class 2 medical device take more time than Class 1?

Actually, there are about 5+ guidance for Class 2 as a special control to comply with, yes, definitely take more time, I estimate 5 times more on development due to the special controls, but it is very much only my estimate.

Again, it is not about you to select the CFR, it is about you when you have set the predicate device.
So it is not working on the way, that you find out, what is the product code and the cfr, it is determined your predicate device I guess.
Cheers!

 

[Ronen E]

Hi,

I know nothing about DICOM viewers but IMHO - as a general advice - if you can identify a similar product, legally marketed in the USA, with very close intended purpose and technological characteristics, that is duly classified under class I (preferably exempt from 510(k)) - this should be your preferred path. That's my take on "least burdensome approach"

If you can do the above, document your justifications in detail in a controlled document and proceed to comply with the applicable general controls.

Good luck,
Ronen.

 

[sorcerer]

Thank you all for the invaluable feedback. I have a better picture of what need to be done. This case can be closed now.
Have a wonderful day.
Sorcerer

 

[c.mitch]

Hello all,
Sorry to reopen this thread with my comments but I hadn't seen it before.
I agree with all comment above except the one about class according to IEC 62304.
A DICOM viewer can be most of times in class B. I have to respectfully disagree about your classification in class C, Sagai.

My experience with Dicom viewer, in most cases:
Predicate is LLZ, so is candidate for 510k
Moderate level of concern, according to section 16 of 510k
Class B in IEC 62304
If your viewer is connected to the network (like dicom node or other technique), FDA may ask further clarifications about cyber security. Be prepared to anwer to this when you design software.

Regards,

Mitch.

 

[sagai]

This is one of the reason we have this forum, no trouble with that!

I do not understand the logic, how the result of historical sampling of other device clearance records can drive to the conclusion of the determination of safety level of the actual device ...

Cheers!