What Is A Predicate Device

The premarket notification (510(k)) pathway requires a submission to the FDA to show that a device is safe and effective through demonstrating its substantial equivalence to a previously cleared device. This previously cleared device is the predicate. In most situations a more recently cleared device is used as the predicate, but any device that has been cleared (and not removed from the market by the FDA) may be used.

Let's look at the Halo Ambulatory Infusion System (K140783) as an example. We can see from their submission summary that they chose four devices to compare their new device with:

CADD-Legacy PCA Model 6300 (K982839)
ambIT Continuous Ambulatory Infusion Pump (K033325)
CADD-Solis VIP Ambulatory Infusion Pump (K111275)
Zyno Medical Administration Set (K120685)

The use of multiple predicate devices is acceptable and often used to help demonstrate substantial equivalence. Also, the use of previous generation devices by the submitting company is common. For each predicate, a comparison to the submitted device is made showing the equivalence of the intended use and main technological characteristics.

Device submission and clearance can be made easier with proper predicate selection, and using PathSurveyor's search technology can help narrow the field. If you require any assistance or are ready to develop your device, contact us at in2being for a free consultation.