510(K) for an Entire System vs. Separate 510(K) for each Sub-System

G

gadagkar

#1
We have a medical device (system) that is composed of 6 distinct entities (hardware and software). These entities are such that they could be sold separately or together as an entire system.

We are contemplating if there are would be any benefit in filing separate 510(k) for each entity or just one for the entire system. In the 510(k) it would be possible to state that these entities could be combine or sold separately.

Has anyone experienced any specific benefits by intentionally submitting separate 510(K) per sub-system?

Thanks,

Rishi.
 
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D

DaveDavis

#2
I'm not sure I fully understand... do the systems operate completely independent of one another?

How you plan to sell and market the products has a lot to do with the 510(k) submission. Each device, if marketed separately, would need a 510(k). Although it will cost more in filing fees, it makes the decision of when to file a new 510(k) based on a change to an existing device much simpler.

Also, adverse event reporting would not involve the other products.

I've not had very good experiences with FDA when making combination product filings... or listing product as accessories, but then marketing them separately.
 
C

celia4237

#3
Now i have the same question. I am preparing a 510(k) submission for a blood glucose measurement system, and it consists of the blood glucose meters and blood glucose test strips.

If i make the system as a whole when i apply for 510(k), and i point out that the test strips is a accessory of the system, then can i sell the blood glucose test strips separately?

Or i must apply for 510(k) for test strips separately?


Can anyone give me some wisdom?
 
M

MIREGMGR

#4
In our experience, when a device is included as an accessory in a system 510(k), you can sell that accessory-device separately as long as it is labeled for an indicated use only as an accessory to that system.

However, you must have regulatory responsibility for the separate sales. If for instance the accessory is manufactured by a supplier, and you wanted them to handle subsequent accessory sales and fulfillment for you to save you the trouble of doing that kind of maintenance-business, they would have to be a contract-manufacturer-that-distributes, and you would be the manufacturer even though you had no direct involvement...because you would have to have regulatory responsbiility.

When ongoing accessory sales are essential to systems marketing and it's expected to be desirable to have those accessory sales handled by an outside party, it often is easier to have separate 510(k)s.
 
S

sanjay_lingot

#5
you can surely submit as single 510(k) submission if all the device are class_II device.

You can sell seperately as far as they are packed seperately.

with kind regards,

Sanjay Lingot
 

Mark Meer

Trusted Information Resource
#6
Reviving old thread. Got a similar situation:

The system consists of the following dependent components (i.e. they won't do anything on their own...at least without serious deviation from their intended uses):
1. a stimulator
2. an electrode
3. a garment (which essentially just holds the electrode in place)

The electrode and garment are replaceable and hence are intended to be sold separately in their own packaging.

From Post #4:
In our experience, when a device is included as an accessory in a system 510(k), you can sell that accessory-device separately as long as it is labeled for an indicated use only as an accessory to that system.
Can anyone confirm MIREGMGR's experience/advice?
 

duinyk

Involved In Discussions
#7
I am new to this forum, but this thread seems to meet my current needs. So, I am trying to prepare a special 510k for a sterile dilator which has previously been cleared in a set with other accessories. Now we are trying to introduce this product as a stand alone product and will like to file a 510k for it. Does anyone have a sample template of contents of a special 510k for such a situation. Considering that no major modifications have been made to this dilator at all.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
I'm not sure that a special 510k is the right path for this situation.
Was the subject dilator the main device in the original submission, or an accessory?
Perhaps worth considering the pre-sub route.
 

duinyk

Involved In Discussions
#9
I'm not sure that a special 510k is the right path for this situation.
Was the subject dilator the main device in the original submission, or an accessory?
Perhaps worth considering the pre-sub route.
It was listed as an accessory in the previous predicates and main devices. The logic is with the new FDA special 510K expansion pilot program, this device will potentially qualify for this route under the new clauses;

Eligibility for the new pilot depends on three criteria identified by FDA:
  • Proposed changes to device in question have been submitted by the manufacturer that holds 510(k) clearance for that device;
  • Performance data is either unnecessary or may be evaluated using well-established, available methods;
  • Performance data required to support Substantial Equivalence may be reviewed in summary or risk analysis formats
But I do agree a pre-sub will be helpful.
Can I please (anyone) get a special 510K template?
 
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