What is 510(k)?

Each person who wants to market medical device in US, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements. Before marketing a device, each submitter must receive an order from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the US. This order “clears” the device for commercial distribution. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device) that is not subject to PMA.

Writing a 510(K) Submission

Writing a successful 510(K) FDA submission is a difficult and demanding task, but using the following PREDICATE formula, this task becomes much easier.

The major issues to consider during the preparation of FDA 510k submission include:

  • Product
  • Research
  • Equivalence
  • Difference
  • Intended use
  • Comparison
  • Assurance
  • Testing
  • Equilibrium

 

Product – Know Your Medical Device as Well as You Possibly Can

The first step in the process is to know your product as well as you possibly can. Although, since the development of a product represents a long -term endeavor, often extending over a decade if not longer, you should know it pretty well by the time it comes to writing a submission! It is a fact though that some data may have been lost or indeed forgotten because of changes in personnel or poor documentation practices. It is therefore essential that you take the time to collect and review all the information gathered and knowledge learned about the product both throughout the development stage and later in the process.

Describe your product in a clear and consistent way so that a reviewer can easily understand what your device is all about. We don’t want him to fall asleep or lose interest so keep it sharp and engaging.

Needless to say, the descriptive information for the medical device should include, at the very least, information about the operational principles or mechanisms of the device which achieve its intended effect, together with a description of its proposed conditions of use.

Don’t forget to make sure that the product description is consistent throughout the 510(k) submission, including the proposed labeling.  Attention to detail is important here.

Research – Perform Comprehensive Research on Similar FDA 510(k) approved products

The next step is to perform comprehensive research on similar approved products found in the FDA 510(k) database. There are several simple techniques by which to identify potential predicate devices and these are all explained well on the FDA official website – “How to Find and Effectively Use Predicate Devices”.

Be warned! The identification of potential predicates could be a time-consuming task but keep at it!  The 510(k) summaries or statements of cleared products may contain valuable information which could be crucial to the success of your own 510(k) submission and, therefore, they are worth reading, laborious as this may be at the time.

From my own personal experience, if sufficient time is spent on this task, your patience honestly will eventually be rewarded. In this initial stage, you are already beginning to build a substantial equivalence comparison table.

510(K) Equivalence – Your Medical Device Has to Be Equivalent to the Predicate Device

A new device does not need to be identical to the predicate device for it to be found substantially equivalent to the predicate device.

Substantial Equivalence means that the device has the same intended use and the same technological characteristics as the predicate device.

Alternatively, your medical device could have different technological characteristics and the submission should then contain information that demonstrates that the device is as safe and effective as a legally marketed device and does not raise questions as to the difference in safety and effectiveness compared to the predicate device.

FDA guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” defines the term “different technological characteristics” to mean that ”there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device”.

Compare the features between your product and the other predicate devices that you’ve selected.  You can list product codes, indications for use, technology, composition, biocompatibility tests, sterility, packaging and other relevant characteristics.

FDA recommends a tabular format for comparing technological characteristics. Any characteristic that is the same as the predicate(s) should be explicitly stated.

Difference – FDA Evaluates the Difference Between Your and Predicate Device

FDA will evaluate the differences between the new device and the predicate device to determine their effect as regards safety and effectiveness.

Put yourself in the shoes of the FDA reviewer. Identify the differences between your product and the potential predicate devices in your list.  Good practice for you and time saving for the reviewer.

If your product does not have the same technological characteristics as the predicate device, you should provide sufficient information, including appropriate clinical or scientific data, that demonstrates that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness in comparison with the predicate device.

Any differences in technological characteristics should be identified and a rationale provided as to why they do not raise different questions of safety and effectiveness.

Keep putting yourself in the reviewer’s shoes.

It is always a good idea to involve your scientific team throughout the preparation of 510(k)-submission to assess if there is sufficient information available to demonstrate substantial equivalence.

Intended use – Your Device Should Have the Same Intended Use as a Predicate Device

As a prerequisite for the substantial equivalence, a new device should have the same intended use as a predicate device and this should be explicitly stated.

The term intended use means the general purpose of the device or its function and encompasses the indications for use.

The term, indications for use, as defined in 21 CFR 814.20(b)(3)(i), is “a general description of the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended”.

Consistency between the indications for use statement and the proposed labeling will facilitate the review of the 510(k) submission.

The relationship between the indication for use and intended use is explained well in the FDA guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]”.

Inventiveness Could be a Key for Success of Your 510(k) Submission

Frequently, the success of the 510(k) submission will depend on the creativity of the regulatory affairs professional and other team members involved in the compilation of the submission.

So, you too can be inventive and propose, for example, a test which could provide additional evidence for the substantial equivalence argumentation. The bottom line is that your product will be defined as substantially equivalent to another product only if you show it to be so.  A little creative effort spent at this stage may reap rewards.

Comparison – Now You’re Ready to Make a Final Comparison

You are now ready to make your final comparison table and choose your best option for the predicate device. Be careful to be consistent in your choice throughout the submission.

Don’t hesitate to use a reference device if you can. For example, if the FDA has already cleared a similar formulation for another condition, you may list that device as a reference device in addition to the predicate device(s) you’ve selected.

Besides the comparison table, the submission must include a discussion as to why any differences between the subject and predicate(s) do not impact upon safety and effectiveness.

Assurance – Provide Reasonable Assurance of Safety and Effectiveness

Although the 510(k) process involves a comparison of a new device to a predicate device rather than an independent demonstration of the safety and effectiveness of the new device, as is required for approval of a Premarket Approval (PMA), in both cases FDA will look for a “reasonable assurance of safety and effectiveness.”

Testing – Don’t Forget Any Specific Test or Product Guidance

We’re reaching the final steps of our guide for successful FDA 510k submission and now you have to identify the tests performed by the applicants of the selected predicate devices. This information is usually included in the 510(k) summary or statement. If your medical device comes into direct or indirect contact with the human body, you will have to do a basic battery of biocompatibility tests, such as cytotoxicity, sensitization and irritation. You may need to undertake additional tests, depending on the nature of the body contact and its duration, as explained in the FDA Guidance “Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”.

Don’t forget to check whether the device has a device-specific guidance document and special controls document.

Equilibrium – Show Sufficient Evidence for Substantial Equivalence

Your submission has to be balanced between the information provided for the product and the data available for the predicate device(s) to which the substantial equivalence is claimed.

The evidence necessary to show substantial equivalence will increase as differences between the new device and the predicate device increase especially if those differences significantly affect, or may significantly affect, safety or effectiveness.

 

If you need help to define your roadmap for a successful 510(k) file submission, do not hesitate to contact our experts and request a preliminary meeting.

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