(15 days)
The Rhythmlink Disc Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
Rhythmlink Disc Electrodes are non-invasive, Cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), Electroencephalography (EEG), and Evoked Potentials (EP). Rhythmlink Disc electrodes have a disc manufactured with a variety of materials which include; silver, Ag/AgCL, ABS Molded Gold Plated and Gold. See appendix "C" for part numbers and descriptions. The disc is permanently adhered to a lead wire. The joint is then covered by a heat shrink tube or is molded into the disc so as not allow exposed lead wires and provide a strain relief. The lead wires are covered using polyurethane (PU), polyvinylchloride (PVC), Silicone or Teflon cover. The lead wires terminate using a molded touch proof connector that conforms to DIN 42-802 for electrical safety.
I am sorry, but the provided text from the K061148 submission only describes the device (Rhythmlink Disc Electrodes), its intended use, and the FDA's clearance letter. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.
This type of submission (510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy or meet specific performance metrics. The FDA's decision is based on comparing the new device to existing ones, often relying on engineering and performance standards rather than clinical study data.
Therefore, I cannot fulfill your request for the tables and details about a study, as that information is not present in the provided document.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).