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The Convoy Advanced Deliver Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.

The Boston Scientific (BSC) Convoy Advanced Delivery Sheath Kit is identical to the BSC Convoy Advanced Delivery Sheath Kit described in K013866, K022067, and K034061 approved on December 14, 2001, September 11, 2002, and January 30, 2004 respectively.

The Convoy Advanced Delivery Sheath Kit consists of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart. The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameters, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a cardiac introducer sheath and primarily focuses on demonstrating substantial equivalence to a predicate device.

Here's why I cannot provide the requested information:

• No Acceptance Criteria or Performance Study: The document does not mention any specific quantitative acceptance criteria for device performance, nor does it describe any study (clinical or analytical) designed to prove the device meets such criteria.
• Focus on Substantial Equivalence: The content outlines the device's description, its intended use, and a comparison to a predicate device, concluding that it is "substantially equivalent." This type of submission relies on demonstrating the new device is as safe and effective as a legally marketed predicate, rather than detailing novel performance studies against specific acceptance metrics.
• Lack of AI-Related Information: All the specific questions you've asked (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth) are highly relevant to the evaluation of AI/ML-driven medical devices. This document describes a physical medical device (introducer sheath) and does not involve any AI components.

Therefore, providing a table of acceptance criteria and reported device performance, or details about studies involving test sets, training sets, experts, or AI performance, is not possible from this document.

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The Convoy Advanced Delivery Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.

The Convoy Advanced Delivery Sheath Kit consists of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart. The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameters, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.

The provided text describes a 510(k) Pre-market Notification for the Convoy Advanced Delivery Sheath Kit, a medical device. However, the text does not contain any information regarding acceptance criteria, reported device performance metrics, or the details of a study (clinical or non-clinical) that proves the device meets specific acceptance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions that "non-clinical testing conducted for the device showed the device met its design-input criteria, and was safe and effective for its intended use," but it does not elaborate on what those criteria were, what the results were, or the specifics of the testing methodology.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence rather than detailed performance and acceptance criteria.

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The Convoy Advanced Delivery Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.

The Convoy Advanced Delivery Sheath Kit consists of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart. The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameter, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75″, lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.

The provided text is a 510(k) summary for the Convoy™ Advanced Delivery Sheath Kit, an intracardiac introducer sheath. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device already on the market, meaning the device is safe and effective for its intended use and performs similarly to the predicate.

Crucially, the provided document does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, or ground truth establishment. The 510(k) summary focuses on comparing the new device to a predicate device (Daig Corporation, Fast-Cath Introducing Sheath) in terms of intended use, device description, single-use aspects, sterilization methods, manufacturer, and classification.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or describe a study proving the device meets acceptance criteria, as this information is not present in the given text. The document is solely a regulatory submission for substantial equivalence based on comparison to an existing device, rather than a report on specific performance testing with predefined acceptance criteria.

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Boston Scientific/EP Technologies Convoy™ Advanced Delivery Sheaths and accessories are designed to facilitate the intracardial placement of interventional devices. The sheath may be exchanged and placed in interventional position after transseptal puncture has been obtained using a different sheath.

The Soft Tip Intracardiac Introducing Sheath Kit consist of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart.

The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameter, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.

The provided 510(k) summary (K013866) for the Convoy™ Advanced Delivery Sheath Kit does not contain information related to software, artificial intelligence, or machine learning. Therefore, it is not possible to describe acceptance criteria, device performance, or study details relevant to AI/ML devices based on this document.

The document discusses an "Intracardiac Introducing Sheath" and focuses on its physical characteristics, intended use, and comparison to a predicate physical device. The "Summary of the Non-clinical Data" section mentions "testing conformed to the requirements of 21 CFR Part 58" and "Non-clinical tests conducted for the Sheath (Good Laboratory Practices) demonstrated substantial equivalence to the predicate device." This indicates that the evaluation was likely based on bench testing of the physical sheath's properties (e.g., dimensions, materials, strength, sterile integrity) rather than performance related to data processing or algorithmic output.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device. The K013866 document pertains to a traditional medical device (a catheter introducer sheath).

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