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For the introduction of various types of pacing or defibrillator leads and catheters.

The Thomas Medical Products, Inc. (TMP) Coronary Sinus Guide & Lateral Vein Introducer Kits (CSG/LVI) are intended to access the coronary venous system. either alone or in a telescopic assembly with other introducers. The CSG/LVI Introducers serve as a conduit to quide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. CSG/LVI introducers are intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. CSG/LVI introducers come with various curve configurations and lengths to facilitate access to the coronary sinus OS and sub-selective access to angulated lateral vein branches. CSG/LVI introducers are designed as single use devices and for short term application (< 24 hours). Only medical doctors and medical personnel, who are well trained in cardiology, should apply these introducers.

The Coronary Sinus Guide Introducer has a peel-away sheath with break-away hemostasis valve. The Lateral Vein Introducer has a break-away hub with integrated handle that requires no cutting and provides a secure grip during slicing, reducing, reducing the risk of lead displacement.

The Lateral Vein Introducers have a shaft design with three (3) gradually decreasing stiffness segmentations from proximal to distal. The shaft is reinforced by a metal broid from the proximal end until approximately 0.175 inch from the distal end. The shaft is coated by a medical-grade coating that provides enhanced lubricity when advanced through the Coronary Sinus Guide Introducer.

The proximal end of the CSG/LVI Introducers are equipped with a hemostasis valve that reduces the risk of blood loss and air embolism and a side-port with 3-way stopcock to allow fluid infusion and contrast injection.

There are differing various versions of the introducer curves that are used according to the anatomy of the present coronary vasculature. The distal soft tip has a tapered outer diometer and the distal tip further contains a polymeric x-roy marker for enhanced visibility under fluoroscopy.

Package contents (Coronary Sinus Guide Introducer Kit):

• One (1) Coronary Sinus Guide Introducer
• One (1) P.T.F.E. coated guidewire
• One (1) Curved braided guiding core or non-braided guiding core
• One (1) Straight vessel dilator
• One (1) Transvalvular Insertion Tool (T.V.I.)
• One (1) 18 g XTW needle
• One (1) 12 cc syringe

Package contents (Lateral Vein Introducer Kit):

• One (1) Lateral Vein Introducer
• One (1) Transvalvular Insertion Tool (T.V.I.)
• One (1) Slicer
• One (1) Target Vein Selector Merit Impress Radiology Catheter, K053171

The provided document describes the Coronary Sinus Guide & Lateral Vein Introducer Kits. The study presented focuses on demonstrating the substantial equivalence of the modified device to its predicate devices through various tests.

Here's an analysis of the acceptance criteria and study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document specifies the following test samples:

• Biocompatibility (Coronary Sinus Guide & Lateral Vein Introducer components w/ UV and heat stabilization): XD-3050-00, Gen. III CSG Sheath, Lot 36564 (proposed device).
• Biocompatibility (Lateral Vein Introducer and braided core components): XD-2186-04 (representative sample of proposed device).
• Simulated Use Testing: FCL-156-00 (LVI), FDL-050-00 (BC), XD-3050-00 (CSG) - proposed devices.
• Physical/Dimensional Testing: FCL-156-00 (LVI), FDL-050-00 (BC), XD-3050-00 (CSG) - proposed devices.

The exact numerical sample sizes (e.g., "n=x" for each test) are not explicitly stated in the provided text. The data provenance is retrospective bench testing conducted by the manufacturer, Thomas Medical Products, Inc. (Malvern, PA, USA). The document does not indicate data from any specific country of origin or involve human subjects/clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes a 510(k) submission for a medical device (introducer kits), focusing on bench testing and biocompatibility. There is no mention of "ground truth" derived from expert consensus on clinical data or images for the device's performance. The "ground truth" here is the adherence to established industry standards and internal specifications for device safety and performance, as demonstrated by the various "Pass" results.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies in expert interpretations (e.g., in clinical trials or image labeling). Since this study involves bench testing against predefined criteria, there is no expert adjudication process in this context. The results are reported as meeting or failing the criteria for each specific test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is typically used to assess the impact of AI on human reader performance, usually in diagnostics or image interpretation. This document pertains to the physical and biological characteristics of a medical device, not an AI or diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not done. This concept is relevant to AI algorithms. As explained in point 5, this submission is for a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is based on established industry standards and regulatory guidelines for medical device safety and performance. Specifically:

• Biocompatibility: USP (United States Pharmacopeia) and ISO (International Organization for Standardization) standards (e.g., ISO 10993 series for biological evaluation of medical devices).
• Physical/Dimensional Testing and Simulated Use Testing: Implied internal specifications and engineering requirements to ensure the device performs its intended function safely and effectively, also adhering to general safety principles for catheter introducers.

The study demonstrates that the device, when tested, meets these predefined pass/fail criteria.

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical product, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

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