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The ScoutPro CS Lead Introducer System facilitates lead implantation in the heart via the coronary sinus.

The ScoutPro accessories are used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left side of the heart via the coronary sinus.

The ScoutPro family of introducer systems and accessories is specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. This submission is in regard to a modification in a hemostatic valve, which is an accessory component of the ScoutPro family. The hemostatic valve is included with the ScoutPro 7F kit and is also separately available. The hemostatic valve will be modified to include a 2-way spigot instead of a 3-way spigot, from a new supplier, Qosina.

This document describes a Special 510(k) for a modification to the BIOTRONIK ScoutPro Hemostatic Valve. Special 510(k)s often refer back to previously cleared predicate devices and generally focus on modifications that do not significantly alter the device's fundamental scientific technology or indications for use. Therefore, the information typically found in a full de novo 510(k) about extensive clinical studies and detailed acceptance criteria may not be present in this type of submission.

Based on the provided text, the device in question is a modified hemostatic valve, which is an accessory component of the ScoutPro 7F kit. The modification involves changing from a 3-way spigot to a 2-way spigot and sourcing the new spigot from a new supplier (Qosina). The manufacturer explicitly states that "No changes have been made to the functionality of the hemostatic valve or any other accessories included within the kit." and that "The usage of the ScoutPro hemostatic valve and ScoutPro 7F kit remains unchanged and the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro accessories in submission #K060807."

This indicates that the acceptance criteria for this Special 510(k) are primarily related to ensuring the modified component does not negatively impact the previously established performance of the overall device and retains substantial equivalence to the predicate device. The primary evidence presented for meeting these criteria is biocompatibility testing and the assertion of no functional changes.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document mentions "a full battery of biocompatibility testing" for the modified hemostatic valves. However, it does not specify the sample size used for this testing or the provenance of any data (e.g., country of origin, retrospective/prospective nature). Given that it's a Special 510(k) for a component modification, the "test set" likely refers to the samples used for this specific biocompatibility testing and potentially functional verification tests in a lab, rather than a clinical study with human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information (experts for ground truth determination) is typically associated with studies involving diagnostic accuracy or efficacy in clinical settings. Since this submission is for a component modification based on maintaining substantial equivalence and successful biocompatibility testing, no information is provided regarding experts establishing ground truth for a test set. The "ground truth" here would be defined by established material safety standards (for biocompatibility) and engineering specifications (for functional equivalence).

4. Adjudication Method for the Test Set

Similarly, adjudication methods (like 2+1, 3+1) are common in clinical trials or diagnostic accuracy studies where human interpretation of results is involved. For a component modification involving biocompatibility and functional equivalence, no adjudication method is described in the provided text. The assessment would rely on standardized laboratory test results against predefined acceptance limits.

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

No MRMC comparative effectiveness study was done or is mentioned. This type of study is relevant for evaluating the impact of AI or assisted technologies on human reader performance, which is not applicable to a modification of a mechanical hemostatic valve.

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

No standalone performance study was done or is mentioned. This section is also related to AI or diagnostic imaging devices, which is not relevant to this medical device modification.

7. Type of Ground Truth Used

For the reported performance related to the modification, the ground truth is established through:

• Biocompatibility Standards: The "full battery of biocompatibility testing" implies adherence to recognized standards (e.g., ISO 10993 series) for material safety.
• Engineering Specifications/Functional Requirements: The statement "No changes have been made to the functionality" suggests that the modified valve meets the original functional specifications of the predicate device.

8. Sample Size for the Training Set

No training set is applicable or mentioned. This concept is primarily relevant to machine learning or AI models, not a mechanical component modification.

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

Not applicable, as there is no training set involved.

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