New 510(k) for non-patient contacting material change

[chriseng]

Hi everybody,

I have a question that I thought was pretty straight forward but somehow after reading more and more into it I got rather confused and am now questioning my initial conclusion.
My company is thinking of changing the material of one component, in this case moving from a 3D printed device control handle to an injection molded one.
The only component that is up for change is the device control handle that the user/physician uses. This is not a patient contacting part (neither direct nor indirect) it is however held and operated by the user/physician. I should note that the component will only be touched by users wearing PPE since this device is used in the operating room.

Reading Flowchart C (Material changes) of "Deciding When to Submit a 510(k) for a Change to an Existing Device" C3 "Will the changed material directly or indirectly contact body tissues or fluids?" I thought the answer here would be NO since it does not interact with the patient. However reading further down it mentions: "Both direct and indirect patient and user contact should be considered in answering this question.".

Now my question here is would this mean that we would need to file a new 510(k) for this process/material change or would a letter-to-file be sufficient.

Thanks for any advice that can be given!
Chris

 

[planB]

Following the definition given in FDA's guidance 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"':

Indirect contact – term used for a device or device component through which a fluid or gas passes, prior to the fluid or gas coming into physical contact with body tissue (in this case the device or device component itself does not physically contact body tissue)

,neither the PPE-wearing physician nor the patient have indirect contact to the handle. So I would agree with your answer to the flowchart being NO.

Scenarios outside of the intended use, such as unlikely cross-contamination through spill-over of e.g. patient body fluids, surgical rinsing solutions as well as the physician touching both the handle and the surgical site may be addressed in a biological risk assessment as an optional add-on for completeness' sake.

HTH,

 

[chriseng]

Thanks for the input! This is essentially the same conclusion I got to.
Yes, the risk assessment is going to be taken into account, following Flowchart B 5.2 and from our initial assessment there is no indication outside of clinical malpractice that would cause any tissue contact.

Considering that the device will not be contacting the patient there will also be no testing following ISO 10993. We do have documentation from the manufacturer stating that the material is safe and considered biocompatible in its molded form. Which from my understanding should be sufficient in our case.