Premarket Notification: 510(k) FDA

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 medical device (21 CFR 807.92(a)(3)) that is not subject to PMA.¹

The key elements that the FDA uses to evaluate substantial equivalence are:

• Same intended use as the predicate device
• Same technological characteristics as the predicate device
• At least as safe and effective as predicate device

Jordi Labs can assist you in the testing and submission of your 510(k), as well as answering the following questions about your device from the FDA’s guidance document.

• Do the devices have the same technological characteristics?
• Do the different technological characteristics of the devices raise different questions of safety and effectiveness?
• Are the methods acceptable?
• Does the data demonstrate substantial equivalence?

For more information on the 510(k) process, read the FDA’s guidance document here.

Some of the techniques that Jordi deploys in the testing to support a 510(k) include:

Technique	Purpose
ASTM E647-15	Tensile Properties
ASTM F2565-13	Fatigue Crack Growth Rate
ASTM F2695-12	Material Properties
Pyrolysis Mass Spectrometry	Qualitative Polymer & Additive Chemistry
GC/LC-Mass Spectrometry	Quantitative/Qualitative Polymer Additive Chemistry
Gel Permeation Chromatography	Polymer Molecular Weight Distribution
ICP-Mass Spectrometry	Quantitative Inorganic Chemistry
Nuclear Magnetic Resonance Spectroscopy	Functionalization/Crosslink Ratio
Thermogravimetric Analysis	Filler Content

¹https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/