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The Vessix™ Guide Sheath is designed to be used for the introduction of interventional and diagnostic devices through the vasculature to the renal arteries.

Vessix™ Guide Sheath is a 7F guide sheath designed to perform as an introducer sheath and guide catheter for the introduction of interventional and diagnostic devices through the vasculature to the renal arteries. The Vessix Guide Sheath has been optimized for torque to allow access to both renal arteries during procedures. The guide sheath has an effective length of 45 cm and is available in two curve shapes: RDC (renal double curve) and LIMA (left internal mammary artery).

The guide sheath has a braided shaft design to maximize torque response, and a pre-formed tip shape (either RDC or LIMA) to enable access. It is equipped with a Tuohy-Borst valve (hemostatic valve) to prevent bleeding and a sidearm with a three-way stopcock to allow for flushing and introduction of contrast media. It is also packaged with a dilator to help with delivery over a guidewire. The guide sheath can accommodate guidewires with diameters less than or equal to 0.038 in (0.97 mm). The distal 15 cm of the outer surface of the guide sheath has a hydrophilic coating (Bioslide™). The distal tip is radiopaque to help with placement.

A polycarbonate hub is adhesively bonded to the proximal section of the guide sheath. It incorporates a luer fitting which serves as a junction to the hemostatic valve.

Here's an analysis of the provided text regarding the Vessix™ Guide Sheath. It's important to note that the provided text describes a 510(k) submission for a medical device (guide sheath), which involves proving substantial equivalence to a predicate device, not typically a clinical study with human readers or AI.

The information primarily focuses on bench testing and biocompatibility testing, which are common for physical medical devices, especially those that are fundamentally similar to existing technology. Therefore, many of the requested categories related to clinical studies, human readers, and AI assistance will be addressed by stating that such information is not applicable or not provided in this specific document.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" with numerical targets and then report specific "device performance" values against those targets in the format of a table as typically seen in clinical study reports. Instead, it lists the types of tests performed to demonstrate that the device meets requirements for its intended use and is substantially equivalent to the predicate. The "reported device performance" is implied to be "passed" or "conformed" to the requirements for each test.

The document states: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, this device may be considered substantially equivalent to the predicate device."

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

• Sample Size: The document does not specify the sample sizes for each of the bench or biocompatibility tests. This level of detail is typically found in the full test reports, not usually in the 510(k) summary itself.
• Data Provenance: The data comes from bench testing (in-vitro performance) and biocompatibility testing conducted by Boston Scientific Corporation for the Vessix™ Guide Sheath. This is not clinical human data; it's laboratory testing of the device itself.
• Country of Origin of Data: Not explicitly stated, but assumed to be performed according to international standards (e.g., ISO, ASTM) within the regulatory framework of the US (FDA).
• Retrospective or Prospective: Not applicable as this refers to device testing, not clinical data collection.

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

This information is not applicable to this type of device submission. The "ground truth" for bench testing and biocompatibility is established by engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and validated test methods. It does not involve human expert consensus in the way an imaging study would.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies, often for assessing ambiguous cases or establishing ground truth from multiple expert opinions. This document describes laboratory and physical testing of a medical device.

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

No, an MRMC comparative effectiveness study was not done. The document does not mention any studies involving human readers, AI assistance, or comparative effectiveness in a clinical setting. The submission focuses on substantial equivalence based on technological characteristics and performance testing.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (guide sheath), not a software algorithm or AI-powered system, so this type of study is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on:

• Engineering Specifications: Defined dimensions, material properties, and functional performance requirements (e.g., burst pressure, tensile strength, kink resistance).
• Biocompatibility Standards: Established criteria from standards like ISO 10993 for biological safety.
• Predicate Device Comparison: The predicate device (Terumo Destination Renal Guiding Sheath K081045) serves as a benchmark for substantial equivalence, implying that its performance characteristics (if not explicitly exceeded or matched) were considered acceptable.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set."

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

This is not applicable as there is no training set for this device.

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