Samples description of reusable medical devices(non-sterilized) used for bench performance testing that are intended "to be marketed"

[hirohama naoki]

We develop and manufacture reusable medical devices—such as endoscopes and ultrasound diagnostic catheters—as well as their associated system products, which are intended to be reprocessed.

In 2019, the FDA issued guidance regarding bench performance testing to be conducted for 510(k) submissions. According to this guidance, testing should be performed using samples of the final finished device that have undergone environmental conditioning and simulated transportation testing.
We have two questions regarding the "Test Sample Information" section of the FDA's 2019 guidance on bench performance testing for 510(k) submissions:

1. Does "simulated transportation" mean that bench performance testing must be conducted on products that have undergone procedures such as ASTM D4169 or ISTA 3A?
2. Our products (e.g., reusable endoscopes and ultrasound diagnostic catheters) undergo inspection upon delivery and pre-use checks, which help mitigate risks associated with transportation. In this case, is it still necessary to perform simulated transportation and environmental conditioning for 510k bench performance testing?

In the FDA's recognized consensus standards, ASTM D4169 is only linked to ISO 11607, which applies to terminally sterilized products. Additionally, in the webinar we attended, while it was emphasized that durability testing is important for reusable devices, there was no mention of any relationship between ASTM D4169 and durability testing.
We conduct durability testing for reusable devices based on pre-use inspection criteria, and our protocol includes distribution testing. This question, however, pertains to more detailed performance testing.

 

[EmiliaBedelia]

1) "Simulated transportation" does refer to a method like ISTA 3A or D4169. There are many different options for transit simulation - they will vary based on the transportation mode, environmental conditions, and packaging configuration (e.g pallet vs. single parcel).

2) Are these checks/inspections performed by an employee of your company, the hospital, the end user...? Are there inspection criteria, installation qualifications, calibration scripts, preventative maintenance checks, something like that that will show the requirements that the device will meet? If you don't have evidence that the inspections/checks are happening every time and you can't verify what was inspected, then you can't use that as justification for not doing transit simulation.
In any case these checks are also not an "inherent safety by design" RCM....the ship/transit testing verifies the inherent safety of the design (ie, the device is designed maintain its performance after shipping/transit).

The guidance document that you cited includes a whole paragraph on exactly this topic:

Generally, the tested devices should represent the final, finished device that has been subject to all manufacturing processes for the “to be marketed” device (including sterilization, environmental conditioning, simulated transportation,etc.). If you conducted any testing on samples that are not the final, finished (e.g.,sterilized) product or part or component, we recommend that you indicate this in the test report summary and the test report, if known (e.g., if test lab is aware that the test sample is not the final, finished device), along with a justification explaining why this approach is appropriate given any differences that may impact performance of the tested device compared to the final, finished device that is to be marketed.

So yes, you can rationalize not doing preconditioning for all test samples if you can justify why testing on non-conditioning devices will be representative of the device in the field. In my experience, you can show this by separately evaluating shipping/transit/aging/etc. justifying why that testing is sufficient to demonstrate the overall device performance. You may not need to perform every single performance test but you need to identify the relevant preconditioning for your device and consider the aspects that may or may not be impacted. One thing you didn't mention is use life cycles.... is that part of your preconditioning considerations?

3) ISTA 3A and ASTM D4169 are both recognized by FDA. The FDA is especially concerned about shipping/transit testing in context of sterility (as part of the sterile barrier packaging validation) but both of these standards are equally relevant for general use for transportation simulation. There are multiple ASTM and ISTA options - a qualified test lab should be able to help you decide on what procedure will be most appropriate for your package/device and your distribution method. As the manufacturer you have to determine what functional testing is appropriate after conditioning, though.