The 510(k) notification should include a physical description of the new device, together with an explanation of its intended use, principles of operation, power source, composition, and other information necessary to understand the device. If the notification is for an accessory, it should describe a typical device with which the accessory will be used. All variations of the new device that will be marketed should be listed.
Manufacturers should look at their descriptions from the point of view of the reviewer, in order to spot information that will be necessary to understand the narrative about the device. In many cases, a picture is better than a thousand words. Together with the narrative, it is a good idea to include labeled diagrams, photographs or pictures, engineering drawings, schematics, and any other visual aids. When appropriate, identify all parts of the device—internal and external, assembled, unassembled, and interchangeable—and explain the functions of all significant parts. The device description should include the physical dimensions of the device—for example, its length, width, height, diameter, and weight. Identify any parts intended for single use only.