Selecting a predicate device for FDA 510(k) approval

Greeting everyone!
I'm hoping to benefit from the experience of this group and ask a slightly off-topic question...

What's the best way of selecting an existing medical device to claim substantiate equivalence? In my area of medical monitors there’s a huge number of devices already FDA approved and selecting a predicate is as complex as a hospital selecting the right monitor to purchase. I’ve tried using FDA’s website to access the approved devices database but it’s awfully clumsy and difficult to relate to legally marketed devices.

I understand that to claim substantial equivalence, it must:

• have the same intended use, and
• have the same technological characteristics as the predicate device, or:
  • have the same intended use, and
  • have different technological characteristics and the information in the 510(k):
    • does not raise new questions of safety and effectiveness, and
    • demonstrate it is as safe and effective as the predicate.

And that the Predicate Device can be a hybrid of several legally marketed devices.

Anything I've missed? But most importantly, what's the most efficient way of getting through this process. I don't have the resources of a huge marketing department and competitive analysis.

Thanks!

[Edit for more info:]

I'm aware of FDA's sketchy flowchart titled: 510(k) "Substantial Equivalence" Decision-Making Process (detailed), but think it's come about for FDA staff to check the legitimacy of 510(k) submissions.

Is there anywhere that lists the intended use statements of legally marketed devices?

A starting point for you might be your competitor's 510(k)s for a similar device.

Thanks Al,
I realized as I wrote this that the answer should fall out of a thorough competitive analysis. I tried the route you suggested and found it difficult - perhaps many of the competitors claims are for unapproved devices as I couldn't find them in the FDA's database, or they were acquired from another company and the approval is still in their name.

Looks like I've got a lot or research to do...

Le Chiffre said:

Thanks Al,
I realized as I wrote this that the answer should fall out of a thorough competitive analysis. I tried the route you suggested and found it difficult - perhaps many of the competitors claims are for unapproved devices as I couldn't find them in the FDA's database, or they were acquired from another company and the approval is still in their name.

Looks like I've got a lot or research to do...

Click to expand...

Can you search by product code?

That's probably a better approach, although it's a combination monitor that could fit several product codes. I'll search through them, thanks again, Al. :

Also search the regulations.

Le Chiffre said:

That's probably a better approach, although it's a combination monitor that could fit several product codes. I'll search through them, thanks again, Al. :

Click to expand...

Search for individual product codes. I did the same thing for a device that delivered cold therapy and compression therapy.

Search the product codes individually, then locate devices with similar features. You can have as many predicates as necessary. You could essentially have a separate predicate for each feature, if you needed to.

You can also search by brand names.

Be sure to read the guidance documents carefully, and be sure that you're classifying your device correctly.

Good Luck,
Chris Ford

My experience:

1) Look for your competor's device, such as manufacturer name, model#
2) Use FDA 510k database search it.
3) Find the product code what they used, and check the product code described in 21CFR book to make sure it is the right product code.
4) Search the product code via the same database, and find all the approved devices.
5) Enter each FDA approval letter to see the detailed intended use.

NOTE, do not choose the device which has indicated that "Clinical data" are used in their 510k summary as your predicate device, otherwise, FDA will challange you later during review process. They will request the clinical data from you.

Hii..

Even I had followed the same approach as above mentioned for our product's 510(k) approval.
It worked well for my case.

You can give a try, which seems to be one of the best ways to find predicate devices.

Gud day!
Sreenu

How can I see my predicates' 510K full submission?