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The EP Dynamics, Inc., LineBacker™ Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.

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This is an FDA 510(k) clearance letter for a medical device (LineBacker Transseptal Introducer). This document does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

FDA 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on meeting specific performance criteria through a detailed study in the same way a PMA (Premarket Approval) might require. The letter primarily confirms that the FDA has reviewed the submission and found the device substantially equivalent for its stated indications for use.

Therefore, I cannot extract the requested information from the provided text.

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The EP Dynamics, Inc. AirBloc™ Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.

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The provided text is a 510(k) premarket notification letter from the FDA to EP Dynamics, Inc. regarding their AirBloc™ Transseptal Introducer. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is related to a traditional medical device (catheter introducer) and not an AI/ML software device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications. The information provided is typical for a traditional medical device submission, focusing on substantial equivalence to a predicate device based on its intended use and general controls, rather than performance metrics from a clinical study for an AI algorithm.

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