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The CATHEFFECTS Desai VectorCath™ Mapping System is intended to aid in the determination and analysis of abnormal heart activity. The device is used in conjunction with a 5-electrode catheter to record endocardial potentials to aid in the determination of the direction of the cardiac wavefront and the possible location of the wavefront's source.

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This document (K012089) is an FDA 510(k) clearance letter for the Desai VectorCath Mapping System. It does not contain details about acceptance criteria or a study proving the device meets those criteria.

The letter primarily:

• Acknowledges receipt and review of the 510(k) premarket notification.
• Determines the device is substantially equivalent to legally marketed predicate devices.
• Grants permission to market the device, subject to general controls and applicable additional controls.
• Provides contact information for regulatory questions.

The "Indications For Use" section on page 2 describes the intended purpose of the device but does not specify performance metrics or study results.

Therefore, based solely on the provided text, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets those criteria. This information would typically be found in the 510(k) submission itself, not in the clearance letter.

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