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The Attain 6215 Venogram balloon catheter is indicated for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for venogram imaging. The Attain 6215 Venogram balloon catheter is intended for single use only.

The Medtronic Attain 6215 Venogram balloon catheter is designed for use within the coronary sinus for infusing contrast solutions for venogram imaging. It consists of extruded polymeric tubing with two lumens (inflation and infusion) in the main body of the catheter and a 1.25 cc controlled stroke volume syringe. The inflation lumen features a luer lock and stopcock at the proximal hub. Its distal end opens into a latex balloon, which is located near the catheter tip. The infusion lumen has a luer lock at its proximal hub.

The provided text describes the Medtronic Attain™ 6215 Venogram Balloon Catheter and its 510(k) submission. However, it does not contain the specific information required to complete the requested table and details about a study proving the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices, device description, indications for use, and regulatory clearance. It mentions "compatibility testing and incoming inspection of final packaged device" and "clinical use experience" but does not provide the detailed acceptance criteria or a formal study report with specific performance metrics.

Here's a breakdown of what CANNOT be extracted from the provided text based on your request:

• A table of acceptance criteria and the reported device performance: The document states that the catheter "passed all of the in vitro specified requirements" but does not list these specific requirements or their corresponding performance results.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not mentioned.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical device (catheter), not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for specific performance criteria. The "clinical use experience" suggests real-world performance, but details are lacking.
• The sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

What the document does state regarding performance is:

• "The Attain 6215 Venogram balloon catheter passed all of the in vitro specified requirements, and ensures that the Attain 6215 Venogram balloon catheter meets all of its design and performance requirements."
• "The Attain 6215 Venogram balloon catheter has been used in two Medtronic sponsored IDE clinical studies to facilitate the implantation of left ventricular leads. The Attain 6215 Venogram balloon catheter has performed as expected in the clinical environment during venogram imaging, and left ventricular lead placement via the coronary sinus."

This suggests that some performance evaluation was conducted, but the specifics required to fill out your detailed request are absent from this 510(k) summary. A 510(k) often focuses on demonstrating substantial equivalence rather than presenting a full, detailed performance study report with explicit acceptance criteria and corresponding results in the manner you've requested for an AI device.

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