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The Aveir Retrieval Catheter is intended to be used in the peripheral vasculature and the cardiovascular system to retrieve and manipulate an Abbott Medical leadless pacemaker (LP). Retrieval and manipulation includes removing the LP from the heart or peripheral vasculature.

The Aveir™ Retrieval Catheter, model LSCR111 comprised of a valve bypass tool, a steerable/deflectable catheter, an integrated guiding catheter with a protective sleeve, and a tri-loop snare, assembled into a single catheter. The tri-loop snare, secured to a shaft, is used to grasp the docking feature on the proximal end of an Abbott Medical Leadless Pacemaker (LP), mate the LP to the Retrieval Catheter, unscrew the LP and retrieve the LP, thereby removing the LP from the patient's heart or peripheral vasculature. The Retrieval Catheter is supplied in a sterile pouch (sterilized via ethylene oxide), is intended for single-use only, and may not be re-sterilized.

This device is an accessory designed to be used with both the Aveir Leadless System and the previous Nanostim Leadless Pacemaker (LP), model number S1DLCP. The Nanostim LP device has not been manufactured or implanted since November 02, 2016. However, the Nanostim LP (model S1DLCP) is currently implanted in patients and in the event these devices need to be retrieved, the Aveir Retrieval Catheter can be used.

The Aveir Retrieval Catheter is intended to be used to retrieve an LP and to be manipulated by a single operator that allows the operator to perform these actions:

• . Advance the Retrieval Catheter from an access site in the groin (utilizing minimally invasive techniques) through the femoral vein into the heart.
• Steer and position the snare towards the docking button of the LP. .
• Snare the docking button of the LP. ●
• Dock the Retrieval Catheter to the LP.
• o Rotate the LP to unscrew the LP helix from the endocardium.
• Protect the LP helix and electrode during retrieval. ●
• Extract the LP through the access site in the groin. o

Apart from the docking mechanism, the Retrieval Catheter and its control system (handle) have the same operating principle as a conventional steerable catheter and control system, while the snare mechanism and dimensions are similar to commercially available snares systems. The Retrieval Catheter is intended to be used with the compatible Aveir Introducer.

The Retrieval Catheter effective length is 105 cm (41.3 in) and the snare loop inner diameter is 16.5mm (0.65 in). The technical details and materials used in this product can be found in the Instructions for Use.

The provided text does not describe an AI medical device. It describes a medical device, the Aveir™ Retrieval Catheter, which is a physical catheter designed to retrieve leadless pacemakers from the cardiovascular system.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), which are typically associated with the development and testing of AI/ML-based medical devices, cannot be extracted from this document.

The document details performance data that focuses on the physical and biological characteristics of the catheter, such as:

• Biocompatibility Testing: Cytotoxicity, sensitization, irritation, acute systemic toxicity, materials mediated pyrogenicity, hemocompatibility, particulate matter.
• Non-Clinical Testing: Physical and dimensional characteristics, tensile strength, torsional strength, deflection, simulated use, liquid leak, corrosion resistance, packaging, and shelf life.
• Animal Testing and Human Factors: Usability validation testing in a simulated use environment and a 182-day chronic GLP retrieval study in ovine subjects to demonstrate safe retrievability of pacemakers.

The document states: "Clinical evaluation is not required for the Aveir Retrieval Catheter." This further confirms that the testing paradigm described is not for an AI/ML device, which would typically involve substantial clinical validation.

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