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The Attain Assist™ CS Access Catheter is a left-heart CS catheter intended to enable access to the left heart via the coronary sinus.

The Medtronic Attain Assist™ CS Access Catheter is a sterile, single-use intravascular catheter used to facilitate access to the left heart via the coronary sinus. The device consists of a braid reinforced catheter shaft with a curve at the distal end and a hub luer connection with a strain relief and a detachable cap at the device. The detachable cap prevents leakage from the catheter when a guide wire is not being used. At the distal end of the catheter shaft, six (6) radiopaque marker bands are embedded into the shaft which provide a visual aid under fluoroscopy during device positioning in the left heart. A stainless steel tip is attached to the distal edge of the braided catheter shaft to provide an atraumatic lead for the catheter during delivery. The Attain Assist™ CS Access Catheter is compatible with guide catheters with inner diameter of 6.5Fr or greater. The device is supplied as a single use sterile device.

This document is a 510(k) premarket notification for the Attain Assist CS Access Catheter. This type of notification demonstrates substantial equivalence to a legally marketed predicate device, rather than proving that the device meets certain acceptance criteria through a study with specific performance metrics.

Therefore, the information requested in the prompt, such as acceptance criteria, reported device performance, sample size for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment, are not typically part of a 510(k) submission for a device like this.

The relevant sections of the document explicitly state:

• "Clinical studies were not deemed necessary for the Attain Assist™ CS Access Catheter since bench testing was sufficient to demonstrate substantial equivalence by way of comparison to a legally marketed predicate device." This confirms that no clinical studies (which would typically assess performance against acceptance criteria) were performed or submitted.
• The document focuses on comparing the Attain Assist CS Access Catheter to a predicate device, the Attain Command™ + SureValve™ Guide Catheter, based on technological characteristics, materials, and non-clinical engineering tests.

The "Acceptance Criteria" for this submission are not performance-based metrics that the device had to achieve in a clinical study, but rather a demonstration of substantial equivalence to a predicate device based on its design, materials, and non-clinical bench testing.

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