510(k) Requirements for System vs. Replaceable Parts

Mark Meer

Trusted Information Resource
#1
I'm a bit confused as to the requirements of submitting a pre-market notification (510k) with respect to the "replaceable" (i.e. individually sold) parts of a medical device system.

Consider the following: A stimulator system (includes a stimulator unit, a charger, and some proprietary replaceable electrodes). The system has been 510(k) cleared.

Questions:
  1. The electrodes need to be replaced regularly, and are hence sold separately. Do these also need a 510(k), even though they've been approved as part of the system? I notice that there is a product code for electrodes (GXY), but these all seem to be for generic electrodes that don't specify being part of a particular system. Does it make a difference that the electrodes are exclusively designed for a particular system?
  2. In some cases users might lose the power-supply adaptor to the charger. Can this be sold separately as a replacement part?

Input/advice/links much appreciated.
MM.
 
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MIREGMGR

#2
The best way to handle this issue is to discuss it in detail in the 510(k) submission.

If you don't do that, I don't know of any generally applicable guidance.

If you do do that, and then need to change the plan, I don't know if a Special submission might sometimes be needed.

We have a number of 510(k)ed products, and had more prior to the August 14, 2015 guidance, but none of them have replaceable parts.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
I'm a bit confused as to the requirements of submitting a pre-market notification (510k) with respect to the "replaceable" (i.e. individually sold) parts of a medical device system.

Consider the following: A stimulator system (includes a stimulator unit, a charger, and some proprietary replaceable electrodes). The system has been 510(k) cleared.

Questions:
  1. The electrodes need to be replaced regularly, and are hence sold separately. Do these also need a 510(k), even though they've been approved as part of the system? I notice that there is a product code for electrodes (GXY), but these all seem to be for generic electrodes that don't specify being part of a particular system. Does it make a difference that the electrodes are exclusively designed for a particular system?
  2. In some cases users might lose the power-supply adaptor to the charger. Can this be sold separately as a replacement part?

Input/advice/links much appreciated.
MM.
My understanding is that the electrodes would require a 510(k). Here, it says:

manufacturers of device components are not required to submit a 510(k) unless such components are promoted for sale to an end user as replacement parts.
(Emphasis added)

The power supply adaptor would not need a 510(k) because it doesn't meet the medical device definition.
 

Mark Meer

Trusted Information Resource
#4
My understanding is that the electrodes would require a 510(k).
Unless the regulations are devoid of reason, I would hope this would not be a hard-and-fast rule.

Basically, because there are 2 very different scenarios:

1. The electrodes are designed exclusively for a particular approved system, and are manufactured by the same company that holds the system 510(k).
- In this case, all safety and efficacy considerations with respect to the electrodes (biocompatibility, reliability, ...) would have been considered as part of the system 510(k). ...so there'd be no conceivable justification for the electrodes to have their own 510(k).

2. The electrodes are designed to be generic replaceable components for a range of compatible devices (that may be sold by different firms).
- In this case, there is no guarantee that the electrodes safety and efficacy was part of the compatible devices' 510(k), and hence it makes sense that the electrodes need their own 510(k) approval.

In the latter scenario a separate 510(k) is reasonable, but in the former case I don't see any reason for an additional 510(k) filing...
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Unless the regulations are devoid of reason, I would hope this would not be a hard-and-fast rule.

Basically, because there are 2 very different scenarios:

1. The electrodes are designed exclusively for a particular approved system, and are manufactured by the same company that holds the system 510(k).
- In this case, all safety and efficacy considerations with respect to the electrodes (biocompatibility, reliability, ...) would have been considered as part of the system 510(k). ...so there'd be no conceivable justification for the electrodes to have their own 510(k).

2. The electrodes are designed to be generic replaceable components for a range of compatible devices (that may be sold by different firms).
- In this case, there is no guarantee that the electrodes safety and efficacy was part of the compatible devices' 510(k), and hence it makes sense that the electrodes need their own 510(k) approval.

In the latter scenario a separate 510(k) is reasonable, but in the former case I don't see any reason for an additional 510(k) filing...
2 questions:

1. What prevents those electrodes from being used with other stimulators?

2. Have, in fact, "all safety and efficacy considerations with respect to the electrodes (biocompatibility, reliability, ...) been considered as part of the system 510(k)"? Have all the special controls / guidance specified for the appropriate stand-alone electrodes code (if any, I haven't checked) been satisfied?
 

Mark Meer

Trusted Information Resource
#6
1. What prevents those electrodes from being used with other stimulators?
In my view it really doesn't matter due to the stated intended use and labeling. If the replacement electrodes state explicitly "for use only with X system", any use otherwise would be deliberate misuse.

While this can certainly be considered as a design risk-mitigation (such as, for example, a unique/proprietary connection method), the question you're asking is no different then asking "what prevents it from being deliberately misused"?

...and the risk of deliberate misuse is, for the most part, unpreventable.

2. Have, in fact, "all safety and efficacy considerations with respect to the electrodes (biocompatibility, reliability, ...) been considered as part of the system 510(k)"? Have all the special controls / guidance specified for the appropriate stand-alone electrodes code (if any, I haven't checked) been satisfied?
It turns out that no special controls exist (they've been discontinued).

However, regardless, the difference in intended use between the two cases is important. If the electrodes are intended for use exclusively with a particular device, then in-and-of-themselves (i.e. without the device) they serve no medical function, and hence it seems unreasonable to me to require a separate 510(k).
 
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