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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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The TorFlex Transseptal Guiding Sheath is indicated for the percutaneous introduction of various devices into heart chambers, including the left atrium via transseptal puncture/perforation.

TorFlex Transseptal Guiding Sheath

The provided document is a 510(k) clearance letter from the FDA for the "TorFlex Transseptal Guiding Sheath". This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the device is substantially equivalent to legally marketed predicate devices, which means that the device's safety and effectiveness are considered comparable to devices already on the market. However, it does not include details of specific performance criteria or a study designed to evaluate them against a set of predetermined acceptance criteria.

Therefore, I cannot provide the requested information from this document.

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To facilitate the placement of devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.

The products identified in this 510(k) notification are splittable, polyethylene introducer catheters. The BD Introsyte™ Autoguard™ Shielded Introducer includes a needle-shielding feature that the BD Introsyte™ Precision Introducer does not include. Autoguard products incorporate springactivated needle-shielding technology. The Autoguard component incorporates a cylindrical needle-shielding barrel, a spring, a needle hub with flash chamber and hydrophobic flow control plug, and a needle. The useractivated Autoguard™ product has a button, which the user pushes to initiate the needle's retraction into the needle-shielding barrel.

The Introsyte introducers are available in sizes ranging from 14 to 24 gauge.

The provided text is a 510(k) summary for a medical device (introducer catheters) and a letter from the FDA. It does not describe any AI device, acceptance criteria or a study proving that an AI device meets acceptance criteria.

The document discusses BD Introsyte™ Precision Introducer and BD Introsyte™ Autoguard™ Shielded Introducer, which are physical medical devices. The "Nonclinical Tests Support Substantial Equivalence" section states: "Side-by-side testing of modified and unmodified devices was conducted to compare product attributes. Data have been provided to demonstrate that product performance and biocompatibility are substantially equivalent between the modified and unmodified devices." This refers to physical and biocompatibility testing of traditional medical devices, not AI performance metrics.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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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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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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