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The VARI-LASE Wire Fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

The Vari-Lase Wire Fiber is a 600um core laser fiber that is 3.5 meters in length. The distal tip of the fiber is encased in a ceramic and platinum/iridium (provides ultrasound visibility during clinical use) and includes a distal floppy spring tip.

The provided 510(k) summary for the Vari-Lase® WireFiber focuses on demonstrating substantial equivalence to a predicate device through bench testing. It does not contain information about clinical studies with human subjects, AI/algorithm performance, ground truth establishment by experts, or MRMC studies.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not applicable. The testing was described as "Bench testing" and indicated physical property assessments and simulated clinical use, not testing on a clinical data test set.
• Data Provenance: Not applicable. No clinical data was used.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable. Ground truth was not established by experts, as no clinical data or expert review was mentioned.
• Qualifications: Not applicable.

4. Adjudication Method:

• Adjudication Method: Not applicable. No expert review or adjudication process was described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission relies solely on bench testing and comparison to a predicate device.
• Effect Size of AI Improvement: Not applicable, as this is a device and not an AI/algorithm, and no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No, a standalone performance study was not done. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable. The "ground truth" for this submission was based on the performance of the device in various bench tests (e.g., measuring energy transmission, tensile strength, etc.) and confirming it met suitability criteria, rather than clinical outcomes or expert consensus on patient data.

8. Sample Size for Training Set:

• Sample Size: Not applicable. No training set was used as this is a physical device and not an AI/algorithm.

9. How Ground Truth for Training Set Was Established:

• Ground Truth Establishment: Not applicable. No training set or associated ground truth was established.

Summary of Study:

The "study" described in the 510(k) summary is purely bench testing. This testing involved:

• Energy transmission assessment: To ensure the fiber effectively transmits laser energy.
• Integrity of the tip following simulated clinical use: This included evaluations of:
  • Tensile strength of the ceramic/metal tip.
  • Burn-back characteristics.
  • Torque response.
  • Torsional strength.
• Biocompatibility testing: To ensure the materials are safe for use in the human body.

The conclusion of these bench tests was that they "confirmed the suitability of the device for its intended use" and supported its substantial equivalence to the predicate device (Vari-Lase Endovenous Bright™ Tip Fiber). The 510(k) process in this instance primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through non-clinical testing for devices with similar technological characteristics and intended use.

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