Creating an FDA Traditional 510(k) eSTAR - Device Description
Continuing from last time, I will explain the section in eSTAR called Device Description. This might be the section where regulatory affairs personnel put in the most effort. However, if you have application forms or IFUs for similar devices on hand, I don't think it will be that difficult.
In addition, applications for US Class II medical devices using eSTAR (Traditional 510(k)) are summarized in the magazine below. In particular, for the Biocompatibility section, I have also posted paid articles that are more useful for practical work and save time, including examples of descriptions and inquiries I have actually experienced. Please take a look if you are interested.
1. General Device Characteristics:
Here, you answer questions in a questionnaire format, and the items you need to describe later are determined based on the results. For example, if you answer that it includes software, a section called "Software/Firmware, Cybersecurity, and Interoperability" will appear in the eSTAR form, where you must describe software-related information (e.g., inputs/outputs, V&V, etc.).
I'm sure you won't get lost, but if you do, please be sure to check the help text (click the "?" surrounded by a blue box). Not limited to this section, the help text contains summaries of guidance and CFR content, which is very important.
2. Description:
You will first be hit with the question, "Please provide a Device Description Summary." If you are creating your own 510(k) Summary, you can just write something like, "510(k) Summary is attached in 'Administrative Documentation' section." If you are using the 510(k) Summary automatically generated by the FDA, you need to fill it in, so please enter the operating principle and specifications as requested by the question.
2-1. Comprehensive Device Description and Principles of Operation Documentation:
Within the Description section, this item is the main one. You need to write various information in the attached file. However, since the content varies depending on the device, it is difficult to explain. Therefore, I will list the items that might be written using an endoscope system as an example, so I hope you can grasp the general content. When you actually write it, please make sure to look at the help text properly.
– System configuration
– Functions and operating principles of each component
– Tools that can be used in combination and their functions
– Past application history
2-2. Device Pictures, Illustrations, Schematics, and/or Diagrams:
I think you should include "a diagrammatic figure representing the entire system," "a figure showing the names of each part as described in the IFU," and "figures necessary to explain the operating principle." You might be wondering why they make you separate the figures, but I'm sorry, I don't know either.
2-4. System/Kit Components and Accessories:
For example, if you are applying for a kit that includes already approved devices, such as a syringe or guidewire for an introducer kit used in intervention, select Yes. In this case, please attach a declaration statement stating that "all components are approved," a list of the component devices and their approval numbers, and external drawings of those component devices.
2-5. Guidance and Special Controls Adherence:
Depending on the device, additional items that must be specially managed are set, and you must describe whether you can comply with them. Please check carefully as there are special controls such as "conducting clinical trials" or "complying with this guidance." Confirmation of special controls is described in the CFR where the definition of each device is stated. Note that some devices do not have special controls.
A 510(k) is an application that demonstrates substantial equivalence to a legally marketed device, and you must designate a predicate device. Furthermore, which predicate device you choose is a critical aspect from a regulatory standpoint. I hope the following article will be able to explain that part.
Thank you once again for your valuable time today.