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510(k) Data Aggregation
K Number
K990494Device Name
MODIFICATION OF NOGA
Manufacturer
Date Cleared
1999-09-03
(198 days)
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
BIOSENSE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the NOGA system is catheter-based cardiac mapping.
The NOGA system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG, intracardiac electrograms and intracavity or intravascular blood pressure may also be displayed in real time on the display screen.
Device Description
The Biosense NOGA system is designed to acquire, and display electro-mechanical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of a plurality of intracardiac electrograms with their respective endocardial locations. In the NOGA system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a Biosense sensor. The NOGA system also allows presentation of electroanatomical maps as a function of time over the cardiac cycle (electromechanical maps).
The NOGA system enables cardiac mapping using a non-fluoroscopic catheter tip location technology. The NOGA system also uses this technology to collect additional information about the heart chamber geometry as a function of time over the cardiac cycle.
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