(31 days)
The EnSite 3000® System is indicated for patients for whom electrophysiology studies are indicated.
• When used with the EnSite® Catheter, the EnSite 3000® System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
OR
• When used with the EnSite NavX™ Surface Electrode Kit, the EnSite 3000® System is intended to display the position of conventional electrophysiology catheters in the heart.
The EnSite 3000® System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit. Unlike currently available electrode recording catheters, the EnSite Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000® System is a system that facilitates mapping and treatment of arrhythmias. When used with the EnSite catheter, the system is useful for treating patients with complex, non-sustained, or poorly tolerated arrhythmias that are difficult, if not impossible, to map with current mapping techniques. By visualizing the global activation pattern seen on the color-coded isopotential maps in the EnSite 3000® System, in conjunction with the reconstructed electrograms, the electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy. When used with NavX patches, the system is useful in treating patients with simpler arrhythmias by providing non-fluoroscopic navigation and visualization of conventional EP catheters
The provided text is a 510(k) summary for the Endocardial Solutions EnSite 3000® System. It describes the device, its intended use, and states that it has "the same technological characteristics as the legally marketed predicate device."
However, this document does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria. Instead, it states that "The changes made to the EnSite 3000® System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures."
Therefore, I cannot provide the requested information from the given text. The 510(k) summary is a declaration of substantial equivalence to a predicate device, and for such submissions, detailed performance data, especially clinical study results with specific metrics and acceptance criteria, are often not included in the publicly available summary if they are considered proprietary or have already been established for the predicate device.
Based on the provided text, the answer is: The document does not contain the specific acceptance criteria or details of a study that proves the device meets acceptance 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).