FDA ISSUES GUIDANCE ON TONOMETER 510(K) SUBMISSIONS
The FDA has issued guidance on premarket notification for 510(k) submissions for tonometers. The guidance can assist manufacturers in preparing premarket submissions for contact and noncontact tonometers used for measuring intraocular pressure (IOP) for glaucoma screening. Tonometers work by applying either a force on the globe of the eye and measuring the amount of indentation or by applying a small, flat disk to the cornea (applanation) and measuring intraocular tension.
The FDA recommends the submission contain a description of the device and its intended use, design requirements, risk analysis methods and performance aspects. The guidance identifies the classification and product codes for tonometers and provides information to help manufacturers address device-related risks in their premarket notifications.
When providing a description of the operating principles and technical specifications, manufacturers should describe the parameters used to measure IOP and any other quantities, such as corneal mechanical properties and geometry, the agency states. Companies should also include main signal processing and computational steps taken in converting a raw signal into an IOP reading and provide tonometer calibration and maintenance methods, the guidance states.