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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.

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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 and VenaCure EVLT NeverTouch Procedure Kits include a variety of procedural accessories:

• NeverTouch Fiber with Sheath-Loc Fitting
• Tre' Sheath Introducer with Dilator
• Teflon Coated Stainless Steel Guidewire (lengths from 70cm to 200cm)
• 0.018 Guidewire (Lengths from 45cm to 200cm)
• Micro Access Components:
• 21 gauge Entry Needle
• 5F x 10cm Sheath/Dilator
• 0.018" x 45cm Guidewire
• 19 gauge Entry Needle (optional)

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 the various procedural accessories detailed above.

The provided document is a 510(k) premarket notification for a medical device (VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or performance efficacy study against predetermined endpoints.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details.

The document primarily describes the device, its intended use, and discusses non-clinical performance and material testing (e.g., leak resistance, tensile strength, biocompatibility) to support substantial equivalence. These tests are usually for safety and basic functionality rather than effectiveness against clinical endpoints.

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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.

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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.

This document is a 510(k) Summary for a medical device called the "VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kit." It's a submission to the FDA for market clearance, not an AI performance study. Therefore, most of the requested information regarding acceptance criteria for AI devices and associated studies is not applicable.

However, I can extract the information that is present in the document which relates to the device's performance assessment for its 510(k) clearance.

Here's a breakdown of the relevant information:

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

The document does not specify quantitative acceptance criteria with numerical targets. Instead, it describes "non-clinical performance testing" comparing the device to a predicate device. The implied acceptance criterion for these tests is "substantially equivalent" to the predicate, meaning the device performs similarly and meets the same safety and effectiveness standards.

Regarding the AI-specific questions, these are not applicable to this document as it describes a physical medical device, not an AI system.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Not Applicable: This document describes non-clinical performance testing of a physical medical device, not an AI algorithm. There is no "test set" in the context of data for an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • Not Applicable: As above, this is not an AI study.

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

   • Not Applicable: As above, this is not an AI study.

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: As above, this is not an AI study.

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

   • Not Applicable: As above, this is not an AI study.

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

   • Not Applicable in the AI context: For this physical device, the "ground truth" (or reference standard) is established by recognized engineering and biocompatibility standards (e.g., ISO 10993-1) and the performance of the predicate device.

8. The sample size for the training set

   • Not Applicable: This is not an AI study.

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

   • Not Applicable: This is not an AI study.

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The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kit is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

AngioDynamics VenaCure EVLT NeverTouch Direct Procedure Kits are offered with the following components:

• 600um Fiber with markings on the fiber to aid in withdrawal
• Introducer Sheath and Dilator
• Entry Needle
• Guidewire

The provided text describes the AngioDynamics VenaCure EVLT NeverTouch Direct Procedure Kit and its substantial equivalence to a predicate device. However, it does not contain the specific information required to answer your request about acceptance criteria for a study and the device performance against those criteria.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed results from a clinical or performance study with defined acceptance criteria and statistical analysis.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• No Acceptance Criteria or Reported Performance: The document states that the device is substantially equivalent based on "non-clinical performance testing in accordance with ISO 10993 and in-house test criteria," which included a list of tests (Fiber to Tip Tensile, Fiber to SMA Tensile, Fiber output Testing, Surface Visual, Depth Marks, Simulated Use Testing, Biocompatibility per ISO 10993-1). However, it does not list specific acceptance criteria for these tests nor does it report the quantitative or qualitative results of these tests against any such criteria.
• No Study Details: The document mentions "non-clinical performance testing," but it does not describe a "study" in the sense of a clinical trial or a statistically designed performance evaluation with sample sizes, ground truth establishment, expert involvement, or adjudication methods.
• No Information on AI/Algorithm Performance: The device described is a medical kit for a surgical procedure (laser treatment for varicose veins). There is no mention of an AI or algorithm in its function, so questions related to standalone algorithm performance, MRMC studies, or human reader improvement with AI assistance are not applicable.

In summary, the provided text only states that non-clinical testing was performed and supports substantial equivalence, but it lacks the detailed performance data and study design information you've requested.

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