How to Select the Right Predicate Device for a 510k

Not sure how to select the right predicate device for your 510k application?

There are many factors to consider and it can be overwhelming at times. This article will give you the oversight and understanding that you need to choose the correct predicate device for your next 510k application.

What is a predicate device and why do you need one for your 510(k)?

A predicate device, also known as a predicate, is defined by the FDA as “a device that is lawfully marketed in the United States and is similar to the new device that is the subject of the premarket notification submission.”  Generally, 510(k) devices are Class II devices, meaning that they are of medium-risk.  Such devices are not life-supporting or life-sustaining, but are not overly simplified, such as tongue depressors.  In addition to the Class II designation, 510(k) devices must not be de novo devices, meaning it must not be a new technology or first of its kind. 510(k) are “me too” medical devices, which may only be differentiated by an improved design or a more elegant mode-of action than its predicates.  To qualify for a 510(k), the new device must be “substantially equivalent” to its predicate.

To select the right predicate device, you must first identify l predicate devices on the market. This can be done by first identifying the intended use of your device, and then searching the FDA’s 510k database for devices that perform the same function as yours. Once you have identified all predicate devices, you must then determine which predicate device is most similar to your new device.  A spreadsheet can facilitate this process with clear columns to identify the similarities and dissimilarities between your device and its potential predicates.  For example, one row in the spreadsheet may compare the patient-contact materials of construction for each of the devices, and another column may compare the operating ranges for the device.  The device or devices with the greatest number of similarities to your proposed device could then be selected as a predicate.

How can you determine which predicate device is right for your product submission?

When comparing predicate devices, it is important to consider both the similarities and the differences between your device and the predicate devices. The predicate device should be similar enough to your device that the FDA will believe that your device is as least as safe and effective as the predicate device, but it should also be different enough from other predicate devices on the market that the FDA will see it as requiring a new medical device clearance.

The easiest way to do this is to compare your device to each predicate device on the following criteria:

– Indications for use (what diseases or conditions is it used for?)

– Intended use (for what purpose is the product used?

– Technology (computer driven or manual? What is the power source?)

– Device design (patient contact materials, mode of action)

What are some common mistakes when selecting a predicate device?

One common mistake when selecting a predicate device is choosing a device that is no longer marketed in the United States. Another common mistake is choosing a predicate device that is not similar enough to your new device. It is important to make sure that you choose a predicate device that meets all of the FDA’s requirements. One of the most common mistakes made is not having a predicate device that is similar enough to your new device. The predicate device should be similar enough to your device that the FDA will believe that your device is as safe and effective as the predicate device, but it should also be different enough from other predicate devices on the market that the FDA will see it as a new and novel device. Another mistake is failure to employ sufficient design controls during the development of your device.  The predicate devices were previously cleared by the FDA, and findings of “substantial equivalence” may require development of a new prototype to ensure your device clearly meets the requirement.

What are the consequences of selecting the wrong predicate device?

If you select the wrong predicate device, your 510k application may be denied, thus delaying product development.  If you fail to meet the design control requirement, your company  may face other penalties. The FDA may also require you to submit a new 510k application with a different predicate device.  Improvements to your existing device may require a “Special 510(k)” in which you demonstrate that your improved version is substantially equivalent to your initial version of the device.  To fulfill the requirements of a Special 510(k) the firm must include evidence of design controls.

How can you be sure that the predicate device you choose will meet FDA requirements?

The best way to ensure that the predicate device you choose will meet FDA requirements is to consult with an experienced 510k consultant. A 510k consultant can help you identify all predicate devices on the market, determine which predicate device is most similar to your new device, and compare your device to the predicate device on the criteria listed above.

When it comes to choosing the right predicate device for your 510k application, there is no one-size-fits-all answer. The predicate device you choose should be based on a number of factors, including the similarity of your device to other predicate devices on the market and the FDA’s requirements for predicate devices. By working with an experienced 510k consultant, you can be sure that you select the right predicate device for your 510k application.

What should you do if there’s no suitable predicate device available for your product submission?

If there is no predicate device available that meets the FDA’s requirements for your new device, you may be able to submit a de novo request. A de novo request is a request for the FDA to classify your device as a new and novel Class II device. De novo requests are typically only granted for devices that are low to moderate risk.

If you are considering submitting a de novo request, it is important to consult with an experienced 510k consultant. A 510k consultant can help you.