Search Results

VenaCure EVLT NeverTouch Procedure Kit: The AngioDynamics VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

VenaCure EVLT NeverTouch Direct Introducer Sheath: The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Introducer Sheath is indicated for use with the VenaCure EVLT NeverTouch Direct Procedure Kit to introduce the laser fiber into the peripheral vasculature.

VenaCure EVLT NeverTouch Direct Procedure Kit: The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of variose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

VenaCure EVLT NeverTouch and NeverTouch Direct Fiber Procedure Kits should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower extremity.

VenaCure EVLT NeverTouch Procedure Kit: The VenaCure EVLT Fiber Procedure Kits include single use disposable devices for use with a laser for the treatment of varicose veins. In addition, the Trè-Sheath Introducer is available both in the kits and provided individually. The main components of the NeverTouch Procedure Kit are identified below:

• 600μ VenaCure EVLT NeverTouch Fiber
• 4Fr Tre' Sheath Introducer
• 0.035" Guidewire
• 19 Gauge or 21 Gauge Entry Needle

VenaCure EVLT NeverTouch Direct Fiber Procedure Kit: The VenaCure EVLT NeverTouch Direct Procedure Kits is comprised of single use disposable devices for use with a laser for the treatment of varicose veins. The VenaCure EVLT NeverTouch Direct Fiber Procedure Kits are comprised of

• 21 Gauge Entry Needle
• 0.018" Guidewire
• Introducer Sheath/Dilator Assembly
• Fiber

This document is a 510(k) Pre-market Notification for the AngioDynamics VenaCure EVLT NeverTouch Procedure Kits and NeverTouch Direct Procedure Kits. It seeks to establish substantial equivalence to a predicate device.

Based on the provided text, the submission does not describe any new studies or performance tests as the device itself hasn't changed. The submission explicitly states:

"The proposed VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits and the predicate VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits are identical to one another (and therefore substantially equivalent) in all aspects, not limited to design, materials, manufacturing, specifications, dimensions, and indication for use. The difference is the proposed VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits is an update to the labeling." (Page 5, Section G)

And, "Modifications made to the VenaCure EVLT NeverTouch and NeverTouch Direct Procedure Kits were limited to updating the labeling." (Page 5, Section H)

Therefore, the submission is not presenting new acceptance criteria or a study to prove the device meets new criteria. Instead, it leverages the previous testing and substantial equivalence determination for the predicate device (K171921) and reference devices (K170695 and K112600) because the changes are limited to labeling, and do not affect the device's technical characteristics, functionality, or performance.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such new study or criteria are presented in this 510(k) submission.

The document implies that the original predicate device (K171921) and reference devices (K170695 and K112600) met their acceptance criteria through non-clinical testing. However, the details of those past studies (sample size, experts, ground truth, etc.) are not included in this document.

Ask a specific question about this device

The VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

The VenaCure EVLT Tre' Sheath is a 4F sheath used during endovascular venous laser treatment procedures. The sheath is used as a conduit for placing a laser fiber. The product will be offered in 25, 45, 65 and 90cm lengths. The VenaCure EVLT Tre' Sheath will be provided both as a standalone product and also packaged with a variety of procedural accessories.

The provided document is a 510(k) summary for a medical device (VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kit). It details the device's intended use and claims substantial equivalence to a predicate device.

Crucially, this document describes a traditional medical device, not an AI/ML-based device. Therefore, the concepts of "acceptance criteria for an AI algorithm," "sample size for a test set," "ground truth establishment," "MRMC studies," "standalone performance," or "training sets" as they relate to AI/ML are not applicable here.

The "performance data" mentioned in the document refers to non-clinical performance and material testing for the physical device, such as tensile strength, torque, and biocompatibility, as per regulatory requirements for medical devices.

If this were an AI/ML device, the detailed information about studies and acceptance criteria would be essential. However, for a physical medical device submission, the focus is on demonstrating safety and effectiveness through different types of testing and comparison to legally marketed predicate devices.

Therefore, I cannot extract the requested information as it pertains to AI/ML device validation from this document.

Ask a specific question about this device