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The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.

BIOTRONIK's Selectra CS lead introducer system is a combination of guiding catheters and implantation accessories used to facilitate access to the coronary venous system for suitable leads and catheters. The Selectra CS lead introducer system consists of several individually available guiding catheters with various different curve shapes and the Selectra accessory kit. The Selectra Accessory Kit includes the following components in a single sterile package: 1 Selectra Slitter Tool, 1 guide wire, 4 transvalvular insertion (TVI) tools, 1 syringe, 1 torque tool, 2 check valves, 2 stopcocks, 2 sealing caps. The catheters are available as inner (5F) and outer (7F) catheters which jointly form a telescope system, and allow probing of the ostium of the coronary sinus, access to the coronary sinus, introduction of contrast media for angiography, and positioning of left ventricular leads, also called coronary sinus (CS) leads. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.

The provided text describes a 510(k) premarket notification for the BIOTRONIK Selectra CS Lead Introducer System. This document focuses on the substantial equivalence of the device to previously cleared predicate devices and does not contain information about the performance of an AI/ML device. Therefore, it is impossible to describe the acceptance criteria and study as requested in the prompt for an AI/ML device.

The information present in the document can be summarized as follows:

Device Description:
The Selectra CS lead introducer system is a combination of guiding catheters and implantation accessories used to facilitate access to the coronary venous system for suitable leads and catheters. It consists of individually available guiding catheters with various curve shapes and the Selectra accessory kit. The catheters are available as inner (5F) and outer (7F) catheters that form a telescope system.

Indications for Use:
The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.

Comparison with Predicate Device:
The subject device has minor modifications compared to the predicate device, including:

• Additional models with shorter overall working length and same diameter.
• A modified blister package.
• A longer shelf life.
• Manufacturing changes without affecting performance criteria.
• Stopcock produced from a different polycarbonate material.
• Updated labeling for inventory management, UDI compliance, and international standards.

Performance Data and Acceptance Criteria:
The performance testing aimed to demonstrate that the modified catheters meet the same performance criteria as the predicate devices. The following tests were conducted using the same test methods and acceptance criteria as for the predicate devices:

Missing Information (as this is not an AI/ML device submission):

• Sample size used for the test set and data provenance
• Number of experts used to establish the ground truth
• Qualifications of those experts
• Adjudication method
• MRMC comparative effectiveness study or human reader improvement with AI
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

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