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The Hansen Medical Transseptal Needle and dilator are intended to create the primary puncture in the interatrial septum for passing an introducer and/or catheter through the septum from the right side of the heart to the left side.

The Hansen Medical Transseptal Needle consists of an outer needle cannula and includes in its proximal end a female luer. The distal section is comprised of flexible thin walled tubing and contains a marker for visibility during fluoroscopy while the distal tip of the needle is ground into a beveled shape. The Hansen Medical Dilator is made of a flexible tube with a fapered end on the distal outer diameter. Attached to its proximal end is a Tuohy Borst® adapter to prevent fluid egress. The adapter includes a side port with a 1-way stopcock to provide flushing capability. The dilator also has imbedded markers at two positions on the distal end to provide visual feedback under fluoroscopy.

The provided document is a 510(k) Summary for the Hansen Medical Transseptal Needle and Dilator. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a study. Therefore, the document does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document indicates that the device is "substantially equivalent in intended use and method of operation to" predicate devices:

• Daig Corp., BRK Transseptal Needle (pre-amendment)
• Thomas Medical Products, Inc., Transseptal Needle/Trocar, K011727
• Thomas Medical Products, Inc., Catheter Introducer Set, K020090 Vessel Dilator (part of the set)

The basis for calling it "substantially equivalent" is stated as: "Based upon the indication for use, the technological characteristics and the design and engineering data provided in this pre-market notification, the Hansen Medical Transseptal Needle and Dilator have been shown to be substantially equivalent to other legally marketed predicate devices."

Therefore, I cannot extract the information required for your questions from this document, as the document focuses on regulatory equivalence rather than detailed performance study results against acceptance criteria.

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