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The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

The FlexCath Steerable Sheath is a deflectable catheter introducer used to facilitate placement of a catheter through the skin into the artery or vein. It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This application addresses changes to the 12F FlexCath sheath tip and valve assembly.

The FlexCath Steerable Sheath & Dilator (K102176) is intended for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath's deflection facilitates catheter positioning. The predicate devices are K081049 - FlexCath Steerable Sheath & Dilator, Models 3FC10, 3FC12.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state specific sample sizes for each test in the test set. However, it mentions "representative finished sterilized samples" were used for in vivo, ex vivo animal testing, biocompatibility, and mechanical testing. The data provenance is primarily through a series of standardized tests (ISO, USP, AAMI TIR). The source of the animal models for in vivo testing is not specified, but the human cells for hemolysis testing and canine for thrombogenicity testing are mentioned. It is implicitly a prospective study since testing was performed on the modified device to demonstrate performance.

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

Not applicable. This is a medical device, and the "ground truth" for performance is established through adherence to engineering standards and physical/biological test results, not expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device, and the "adjudication" is based on meeting predefined technical and biological specifications outlined in the referenced standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done as this is a medical device and not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the device performance was evaluated in a standalone manner through various functional, mechanical, and biocompatibility tests. There is no "human-in-the-loop" aspect to these performance assessments, as they measure the intrinsic properties and behavior of the device itself.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is based on an objective assessment of physical and biological properties against established industry standards and regulatory guidance. This includes:

• Engineering standards compliance: ISO 11070 for mechanical tests.
• Biocompatibility standards compliance: ISO 10993 series and USP 33 .
• Effectiveness of sterilization: AAMI TIR28:2001.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/algorithm-based system requiring a training set.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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