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The GORE Introducer Sheath with Silicone Pinch Valve is indicated for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.

This 510(k) is being submitted for a minor modification to the product configuration made to the GORE Introducer Sheath with Silicone Pinch Valve cleared under K032073. The proposed modification that is subject of this 510(k) submission is to offer an additional 18Fr size introducer sheath to the current product line. No other changes are being made to the GORE Introducer Sheath with Silicone Pinch Valve or its packaging as cleared under K032073.

The provided text is a 510(k) summary for the GORE Introducer Sheath with Silicone Pinch Valve, specifically for a minor modification to add an 18Fr size. This document describes the device, its intended use, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of device performance metrics commonly used for AI/ML devices (e.g., sensitivity, specificity, AUC).

The "studies" mentioned in this document are focused on demonstrating substantial equivalence through various tests, assessments, and comparisons to the predicate device, primarily to show that adding a new size does not raise new safety or effectiveness concerns. These are typically engineering or bench testing and comparison of physical and mechanical properties, not clinical or diagnostic performance studies.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details because this document does not contain that type of information. This submission is for a material/design change to an existing device, not a new device requiring a comprehensive performance study against specific acceptance criteria for diagnostic accuracy.

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Intended to be inserted in the peripheral vasculature to provide a conduit for the insertion of endovascular devices

The GORE Introducer Sheath with Silicone Pinch Valve is an introducer sheath comprised of a sheath with an attached valve system. hemostasis caps and a dilator. The tip of the dilator is tapered to facilitate atraumatic insertion of the sheath. The valve system helps maintain hemostasis during endovascular procedures. The hemostasis caps contain various size holes that allow for various size devices to be introduced while maintaining hemostasis. The GORE Introducer Sheath with Silicone Pinch Valve is supplied as a sterile, single use device.

The document describes the GORE Introducer Sheath with Silicone Pinch Valve and its 510(k) submission for substantial equivalence. It does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/ML device. Instead, it describes general device integrity testing for a conventional medical device.

Therefore, many of the requested fields cannot be filled.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

Missing Information: The document states that "All device integrity test results ... met specified requirements," but it does not define what those specific requirements (acceptance criteria) were, nor does it provide the detailed reported performance data against those criteria. This is common for 510(k) summaries, which often only state that tests were passed.

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not specified.
• Data Provenance: Not applicable/specified. The tests mentioned are "device integrity testing," which typically involves laboratory testing of the physical device rather than studies on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable. The "ground truth" for device integrity testing is typically established by engineering specifications and laboratory measurement standards, not expert consensus on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication Method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: Engineering specifications and laboratory test standards for "device integrity testing."

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML device; it's a conventional medical introducer sheath.

9. How the ground truth for the training set was established:

• Ground Truth Establishment for Training Set: Not applicable.

Summary of the Study Mentioned:

The document mentions "device integrity testing" performed by W. L. Gore & Associates, Inc. The purpose of these tests was to demonstrate that the GORE Introducer Sheath with Silicone Pinch Valve met its specified requirements for device integrity. The conclusion states that "All device integrity test results... met specified requirements," supporting the claim of substantial equivalence to predicate devices. However, the specifics of these tests, including detailed protocols, acceptance criteria, raw data, or sample sizes, are not provided in this summary. This type of testing typically assesses physical properties, mechanical integrity, and functionality (e.g., hemostasis, ease of insertion, durability) of the device.

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The GORE Introducer Sheath is used to facilitate the introduction of guidewires, catherers and other investible medical devices with such introduction.

The GORE Introducer Sheath is designed to provide easy access to the vascular system while providing convenient access to che vaborfally The device allows introduction of angiographic exchanges . catheters, balloon catheters, other relevant catheters, guidewires and endovascular devices into a vessel. The gardewired and theath is composed of biocompatable materials and is provided sterile.

The GORE Introducer Sheath is comprised of the introducer file Gox introducer The introducer sheath is composed of a sheath, sheath hub and cap, and hemostasis valve. The dilator is composed of a dilator tube and dilator valve body .

This is a regulatory submission for a medical device (GORE® Introducer Sheath) seeking substantial equivalence to a predicate device. As such, it does not contain the type of study data and acceptance criteria typically found for diagnostic algorithms or AI-driven devices.

The document states that the GORE® Introducer Sheath is substantially equivalent to a predicate device (FAST-CATH™ Hemostasis Introducer) based on:

• The same manufacturing process
• The same biocompatible materials
• The same quality specifications
• The same packaging materials and process
• The same sterilization process
• Similar indications for use

Therefore, the submission relies on demonstrating similarity to an already approved device rather than presenting new performance data against specific acceptance criteria.

To directly answer your request based only on the provided text, many of the requested fields cannot be filled as they are not relevant to this type of 510(k) submission.

Here's a breakdown of what can and cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This submission doesn't present performance data against specific acceptance criteria for a new device's efficacy, but rather asserts substantial equivalence to a predicate device based on manufacturing, materials, and process similarities.

2. Sample size used for the test set and the data provenance

Not applicable. No "test set" in the context of a performance study is mentioned. The submission is based on comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" establishment by experts is described as this is not a diagnostic device study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No ground truth is established or discussed as this is a device based on substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set mentioned for this type of device submission.

9. How the ground truth for the training set was established

Not applicable. There is no training set or ground truth establishment mentioned.

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