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The ENVOY® Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

The ENVOY® Guiding Catheter is a single lumen, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional/diagnostic devices. The guiding catheter is pre-shaped to facilitate positioning.

The provided document, K140307, describes a 510(k) submission for a line extension of the ENVOY® Guiding Catheter to include a new 7 French (Fr) diameter size. The submission asserts substantial equivalence to the predicate ENVOY® 6 French (Fr) Guiding Catheter (K093184).

Here's an analysis based on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical catheter. For such devices, acceptance criteria are typically defined by compliance with recognized performance standards and successful execution of specific bench tests designed to ensure safety and effectiveness. The document lists the tests performed, which inherently serve as the performance criteria. The "reported device performance" in this context is the successful completion of these tests, demonstrating that the 7Fr Guiding Catheter meets the design requirements and is substantially equivalent to the predicate.

Study Proving Acceptance Criteria Met:

The study that proves the device meets the acceptance criteria is a non-clinical bench testing program combined with biocompatibility testing.

The document states: "Results of verification and validation testing that was conducted on the proposed ENVOY® Guiding Catheter demonstrates that it performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device and therefore, does not raise any new questions of safety and effectiveness."

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

The document does not specify the sample sizes used for each of the performed bench tests. It only lists the types of tests.

Regarding data provenance, the testing was conducted by Codman & Shurtleff, Inc., the device submitter. The document does not explicitly state the country of origin for the testing, but the submitter's address is in Raynham, MA, USA, suggesting the testing was likely conducted in the US. The study is retrospective in the sense that the testing was performed on manufactured devices after their design, as part of the verification and validation process for regulatory submission.

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

This information is not applicable to this type of submission. This 510(k) is for a medical device (catheter) based on substantial equivalence to an existing predicate. The "ground truth" for these types of submissions is established through engineering specifications, recognized standards, and the performance characteristics of the predicate device. Expert human interpretation of data for "ground truth" (like in AI/diagnostic device studies) is not relevant here.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, such as clinical trials or studies establishing ground truth from multiple expert opinions. The testing described here is objective bench testing and standard compliance.

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

No, an MRMC comparative effectiveness study was not done. This device is a guiding catheter, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation with or without AI.

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 refers to AI algorithm performance without human intervention, which is not relevant for a physical medical catheter.

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

The "ground truth" for this device is based on engineering specifications, recognized national and international performance standards (e.g., ISO, AAMI, USP), and the established performance and safety profile of the predicate device. The tests conducted (e.g., dimensional verification, tensile strength, leakage, biocompatibility) are designed to verify that the device meets these pre-defined, objectively measurable criteria.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device. There is no "training set."

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

This information is not applicable as this is not an AI/machine learning device.

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The ENVOY® Guiding Catheter is intended for use un the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

The ENVOY Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

Due to the nature of the provided text, which is an FDA 510(k) summary and clearance letter for a medical device (ENVOY® Guiding Catheter), it does not contain the kind of information typically found in a study describing acceptance criteria for an AI/device performance.

This document is a regulatory submission for a physical medical device, not a software or AI-driven diagnostic tool. Therefore, it does not involve:

• Algorithm performance metrics (like sensitivity, specificity, AUC)
• Sample sizes for test or training sets for AI models
• Expert consensus for ground truth on images (as there are no images being analyzed by AI)
• MRMC studies to compare human reader performance with and without AI assistance
• Standalone algorithm performance studies

The 510(k) summary focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria for an AI output.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other details related to AI study design based on the provided text.

The document primarily states:

• Intended Use: The ENVOY guiding catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
• Substantial Equivalence: The device is substantially equivalent to the previously cleared ENVOY Guiding Catheter (from Cordis Endovascular Systems, Inc.).
• Biocompatibility: All materials are biocompatible.

These points are the core "acceptance criteria" and "performance" relevant to this type of regulatory submission for a physical catheter. They don't lend themselves to the AI-specific questions requested.

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The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature.

The device description of the VISTA BRITE TIP and ENVOY Guiding Catheters is as follows.
• 6 French
• Single lumen catheter featuring a nylon body reinforced with a tightly wound stainless steel braid wire
• The transition segment is designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip.

The provided text is a 510(k) summary for the VISTA BRITE TIP and ENVOY Guiding Catheters. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or reporting on a clinical study where the device performance is measured against such criteria.

Therefore, the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria is not present in the provided document.

Here's why and what information is available:

• Type of Submission: This is a 510(k) premarket notification. The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance characteristics to the predicate. It does not usually require new clinical studies to establish safety and effectiveness from scratch, especially for Class II devices like this one.
• Lack of Performance Criteria and Study: The document explicitly states: "The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards." This indicates that there are no pre-defined quantitative performance criteria that the device must meet in a specific study format. Instead, the focus is on a comparison to an already approved device.
• Basis for Equivalence: The "Summary of Substantial Equivalence" section states: "The VISTA BRITE TIP and ENVOY Guiding Catheters are substantially equivalent to the previously cleared VISTA BRITE TIP and ENVOY Guiding Catheters." This implies that the device's characteristics (design, materials, intended use) are similar enough to existing, approved devices that no new performance study with acceptance criteria is deemed necessary for market clearance.

In summary, the document does not contain the information you requested because its purpose is to demonstrate substantial equivalence, not to report on a study meeting specific performance acceptance criteria.

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The ENVOY Guiding Catheters are intended for the intravascular introduction of interventional/diagnostic devices in the peripheral, coronary and neurovasculature systems.

The 7F, 8F and 9F ENVOY Guiding Catheters are designed for the intravascular introduction of interventional/diagnostic devices into the peripheral, coronary and neurovascular systems.

I am sorry, but the provided text does not contain information about specific acceptance criteria, a study that proves a device meets those criteria, or details regarding sample sizes, expert qualifications, or ground truth establishment.

The document is a US FDA 510(k) premarket notification letter for the ENVOY Guiding Catheter, indicating that the device has been found substantially equivalent to previously marketed devices. It confirms the intended use, classification, and states that biocompatibility tests were successfully performed. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study to prove acceptance criteria.
• Sample sizes for test or training sets.
• Information on data provenance (country, retrospective/prospective).
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for a training set was established.

Therefore, I cannot fulfill your request for this specific information based on the text provided.

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