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The Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery is intended for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. The 6238TEL guide catheters are indicated for use with an outer guide catheter delivery system, forming a dual-catheter assembly.

The Attain Select 6238TEL Guide catheter set for left-heart delivery consists of a set of 3 catheters, one straight catheter; one catheter with a 90° curved tip and one catheter with a 180°curved tip. The Attain Select 6238TEL guide catheters are designed to facilitate access to the coronary sinus and left-heart venotomy. The catheters provide a pathway for the delivery of contrast medium and transvenous devices such as guide wires and guide catheters. The Attain Select 6238TEL guide catheters are provided sterile and are intended for single use only.

The catheters, which have a working length of 70cm, also have radiopaque, flexible tips. The catheter functions as an inner catheter and, when used with an outer guide catheter, forms a dual-catheter assembly. The Attai.1 Select 6238TEL guide catheters feature a lumen that allows for the passage of guide wires up to 0.89 mm (0.035 in) in diameter. The guide catheters have a maximum outer diameter of 7 French (2.4 mm) and may be used with delivery systems that accept a 7 French (2.4 mm) transvenous device. Medtronic recommends using the guide catheters with Medtronic Attain Fixed Shape catheters or the Medtronic Attain Deflectable catheter.

The provided document is a 510(k) Summary for a medical device (Attain Select™ 6238TEL Guide Catheter Set for Left-Heart Delivery) seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or a clinical trial with human subjects.

Instead, the summary focuses on device integrity testing, biocompatibility, and sterilization validation to demonstrate that the new device is as safe and effective as its predicate devices, which is the basis for 510(k) clearance.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable to the type of information presented in this regulatory submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

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