medical device 510k documentation

Technical File conversion from a 510k submission is easy, but five elements are missing from a 510k that you will need to add.

This blog, Technical File Conversion, offers practical courses of action to consider related to this topic. Below are five parts of a technical file you are likely to be missing in your 510k documents:

1. Technical File Conversion Requires Clinical Evidence – The FDA states that clinical data is unnecessary for most devices cleared by the 510k process. The MD Regulation (Annex II) requires a clinical evaluation to be performed and the evaluation report to be part of the technical file. Once formulated, the report becomes “clinical evidence” of the safety and performance of the medical device for demonstrating conformity with the relevant General Safety and Performance Requirements (GSPRs).

Here’s how to fill this gap using five steps offered by MEDDEV 2.7.1 Rev. 3:

1. Identify the GSPRs requiring clinical support. (e.g., the device “shall not compromise the clinical condition or the safety of patients, or the safety and health of users” and “any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient.”
2. Identify and “data pool” existing clinical data relevant to the device and its intended use. This should include any available post-marketing data on the same or similar device. But it may also comprise data from clinical trials or clinical use of a previous generation or even a substantially similar device. Finally, if you are utilizing standard methodologies in your device, it may be possible to use data showing conformity to recognized standards.
3. Evaluate the data to determine if it’s suitable for establishing the safety and performance of your device. Even some generally unusable studies may produce relevant data. It is vital to perform this evaluation systematically. You might draw a chart listing the relevant ERs on the left and indicate the data source supporting or contradicting it to the right. The evaluation must objectively consider both positive and negative data.
4. Generate any clinical data still needed. Consider methods other than a clinical trial for generating this missing data, e.g., “Data Pull” existing field data of the same or similar devices that may not yet have been ‘pulled’ through your PMS/RM Post-Production Infosystems. If data is unavailable, you may have no choice in generating it through a small-scale clinical trial. If so, keep it small, focused on the questions at hand, and statistically significant.
5. “Bring all the clinical data together” to reach conclusions about your device’s clinical safety and performance. Essentially, conduct a benefit-risk analysis. Involve qualified team members: e.g., experts in medical conditions and device technology.

Now sum it up in a report.

2. General Safety and Performance Requirements Checklist – This central component of the technical file is based on Annex I of the MDR and IVD, respectively. There is no such review in a 510k.

Develop a checklist based on the principles in GHTF N68:2012 containing all of the following columns for each ER:

• Applicable? – y/n; Is the requirement applicable? If not, why.
• The method used to demonstrate conformity –harmonized standard, Common Specification (CS), etc…?
• Specific Standards or CS applied.
• Evidence of conformity  
• The controlled document/s demonstrating fulfillment of the ER.

3. Technical File Conversion Requirest Post-Market Surveillance– The FDA requires PMS activities only if it is mandated due to safety concerns and for Class III or devices with Humanitarian Device Exemptions (HDEs). A PMS plan must then be submitted. Manufacturers may not yet have formulated such a plan.

No worries. If you perform your RM activities in compliance with ISO 14971, you will have an RMP or separate system, including a plan for observations, assessment, and action (ISO 14971:2019 § ten). Reference this in your technical file. What about the PMCF report?  Well, if you’ve performed post-market surveillance, develop one. OTechnical File conversion from a 510k submission is easy, but five elements are missing from a 510k that you will need to add. Otherwise, see the next item below.

4. Technical File Conversion includes a risk management report

While not required by the FDA in your 510k submission, you most likely have fulfilled this ISO 14971 requirement. Reference it in your technical file. Ensure you also confirm in the report that appropriate methods are in place to obtain production and post-production information. If detailed enough, you can also reference the report as a PMCF report.

5. Risk class/applicable classification rule (based on Annex VII of the MDR) – FDA defines Classes I through III, which are not parallel to Classes 1, IIa, IIb, or III in the EU MDR.

Using either of the latter systems, identify the relevant rule, and classify your device—document in your technical file.

If you have finished your 510k technical file conversion, you might want to perform a technical file audit before submission to your notified body.