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The RM Electrode® is a contact lens electrode intended to be applied on the cornea and to be used for the measurement and recording of electroretinography (ERG) signals, to support the diagnosis of retinal dysfunctions. It is indicated for use in patients aged 12 years and above undergoing diagnostic full-field electroretinogram (ERG) recording procedures. The RM Electrode® is a single use, disposable device.

The RM Electrode® is a contact lens-type corneal electrode for use in electroretinography (ERG) procedures. Like other corneal electrodes classified under 21 CFR 886.1220 and cleared under product code HLZ, the RM Electrode is used for the measurement and recording of ERG signals, to support the diagnosis of retinal dysfunctions. It has four components, including (1) the contact lens (substrate), which supports the conductive element (electrode ring) and allows light from the stimulus source to enter the eye; (2) the electrode ring, which is the conductive element of the device; (3) the lead wire, which is connected to the electrode ring extension and terminates in an industry standard 1.5mm female "touchproof" connector that connects to a commercially available ERG recording system (not part of the subject device); and (4) heat shrink tubing which covers the electrode ring extension and junction with the lead wire. The device materials were demonstrated to be biocompatible. The RM Electrode® is not a powered device. As with the predicate device (ERG Jet Electrode), it is a passive sensor for recording bioelectric signals from the surface of the eye and transmitting them to an ERG recording system. From an electrical perspective, the device is a single conductor that connects the eye surface to a data recorder.

The Tomey DTL Electrode is intended for use in the measurement and recording of ERG signals from the ocular surfaces of the eye. These measurements are only to be performed by licensed practitioners and trained technicians within a medical environment. There are no differences with respect to the predicate devices for indications for use, or target population.

Tomey DTL Electrode consists of soft silver impregnated nylon fiber threads that are normally placed under the lower eye lid. The electrodes are constructed with 3 to 10 individual fibers between 5 and 20 microns in diameter. The fibers are stabilized at both ends with adhesive attachments. A thin wire is connected to an adaptor cable that permits the electrodes to be used with various ERG Recording systems including the Tomey PE-400/PS-400.