(30 days)
The EP-WorkMate® system with an EP-4 stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhythmia mapping.
MapMate™ is indicated for use during clinical electrophysiology procedures.
This application describes a modification to the EP-WorkMate® system that will be offered as an option to customers under the name MapMate™. MapMate™ is comprised of a software module and an electronic interconnection between the EPMedSystems EP-WorkMate® and the BioSense Webster CARTO™ XP Navigation System computer. When the MapMate™ option is utilized, clinicians enter patient data in one system instead of two. A procedure log is created containing the list of map points along with the EP signals. Therefore, valuable time and attention are conserved in the busy EP lab enabling clinicians to focus on the EP case.
The provided text is a 510(k) Summary for the EP-WorkMate® with MapMate™ device. It describes the device, its intended use, and indications for use, but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested table and study details from the input text. The document focuses on establishing substantial equivalence to predicate devices, which is common for 510(k) submissions, rather than presenting detailed performance study results against specific criteria.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).