Search Results

The VARI-I.ASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

The VARI-LASE procedure kit contains a 600µm fiber and may contain one ore more of the following accessories used to gain endovascular access: 0.035"/ stainless steel guide wire (lengths from 75 to 150cm) 5Fr/25, 45 or 55cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture Kit

The provided text describes a 510(k) premarket notification for a medical device called the "Vascular Solutions Vari-Lase™ Endovenous Laser Procedure Kit." The submission states, "No testing was required to document the safety and effectiveness of this modified procedure kit." Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (VARI-LASE Procedure Kit, K030654) based on a comparison of indications for use, components supplied, and technological characteristics.

Therefore, the study design elements typically found for novel device performance evaluation are not present here. The following information will reflect that no new performance study was conducted.

Acceptance Criteria and Device Performance

Since no new performance testing was conducted for K032805, there are no specific numeric acceptance criteria or reported device performance metrics for this submission. The basis for clearance was substantial equivalence to a predicate device, meaning the new device is considered as safe and effective as the previously cleared predicate without requiring new clinical or non-clinical performance data.

Study Details

1. Sample size used for the test set and the data provenance: Not applicable, as no new performance study was conducted. The submission states, "No testing was required to document the safety and effectiveness of this modified procedure kit."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new performance study was conducted that required expert ground truth establishment.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no new performance study was conducted.

4. 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 device is a laser procedure kit, not an AI-assisted diagnostic or interpretive tool. No MRMC study was performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser procedure kit, not an algorithm. No standalone performance study was conducted.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new performance study was conducted.

7. The sample size for the training set: Not applicable, as no new performance study was conducted, and this is not an AI/machine learning device.

8. How the ground truth for the training set was established: Not applicable, as no new performance study was conducted, and this is not an AI/machine learning device.

Conclusion from the 510(k) Summary:

The conclusion states: "The VARI-LASE Procedure Kit is substantially equivalent to the currently marketed VARI-LASE kit based on a comparison of the indications for use and the components supplied and the technological characteristics of the supplied components." This indicates that the clearance was based on similarity to a previously cleared device (K030654), and thus new performance data was deemed unnecessary by the FDA.

Ask a specific question about this device

The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

The VARI-LASE procedure kit contains a 600µm fiber and may contain one ore more of the following accessories used to gain endovascular access: 0.035" / stainless steel guide wire (lengths from 75 to 150cm) 5Fr/25 or 45cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture Kit

This document is a 510(k) premarket notification for a medical device. It does not describe an AI/ML device, nor does it contain information about acceptance criteria, study performance, or ground truth as requested in the prompt.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a physical medical device (a laser procedure kit for treating varicose veins) and details its substantial equivalence to a previously marketed device, not the performance of an AI model.

The sections for AI/ML device evaluation within your prompt (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to the content of this document.

Ask a specific question about this device