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The Vari-Lase Endovenous Laser Console is indicated for use in the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

The Vari-Lase Endovenous Laser Console is a software controlled diode laser that provides an output wavelength of 810 nm and operates at a maximum output of 15 W.

The provided text is a 510(k) Premarket Notification for the Vari-Lase Endovenous Laser Console. This document focuses on establishing substantial equivalence to existing predicate devices due to technological characteristics and intended use, rather than presenting a performance study with acceptance criteria and detailed clinical trial results. Therefore, much of the requested information regarding such a study is not available in the provided text.

Here's an analysis based on the information provided:

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

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are presented in this 510(k) notification. The document aims to demonstrate substantial equivalence to predicate devices, implying that its performance is expected to be similar or equivalent, but no specific performance data is reported.

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

Not applicable. The document does not describe a performance study with a test set.

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. The document does not describe a performance study with a test set requiring expert ground truth.

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

Not applicable. The document does not describe a performance study with a test set.

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 device is a laser console for treating varicose veins, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a laser console, not an algorithm.

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

Not applicable. The document does not describe a performance study that would require establishing a ground truth for a test set.

8. The sample size for the training set

Not applicable. The document does not describe a performance study involving a training set.

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

Not applicable. The document does not describe a performance study involving a training set.

Summary of available information:

The 510(k) submission for the Vari-Lase Endovenous Laser Console focuses on establishing substantial equivalence to previously cleared predicate devices (K062822, Vari-Lase Endovenous Laser Console; K051996, Diomed Delta 15 Laser Console). This is based on comparisons of:

• Device classifications: Laser instrument, surgical, powered (21 CFR 878.4810; Product code GEX).
• Technological characteristics: The device is a software-controlled diode laser with an output wavelength of 810 nm and operates at a maximum output of 15 W.
• Indications for Use: Treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

The document does not detail a separate clinical or performance study with defined acceptance criteria and performance metrics for the Vari-Lase Endovenous Laser Console itself. The underlying assumption of a 510(k) substantial equivalence submission is that the new device performs as safely and effectively as the predicate devices, for which safety and effectiveness have already been established.

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The Vari-Lase® 90W laser console is indicated for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels) and in contact mode, for the vaporization, ablation, incision, and excision of soft tissue.

The Vari-Lase® procedure 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 90 Watt Endovenous Laser Console (Vari-Lase Console) is a software controlled diode laser that provides an output wavelength of 810mm. It may be used in conjunction with a cooling system in certain surface treatment applications.

The provided text is a 510(k) summary for the Vari-Lase® 90 Watt Endovenous Laser Console. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it explicitly states:

"No additional testing was completed."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study or testing was conducted or reported in this document. The device's approval seems to be based on its substantial equivalence to previously cleared devices and compliance with relevant medical electrical equipment standards.

Here's a breakdown of why each requested point cannot be addressed from the given input:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided for this specific device. The summary only lists standards with which predicate devices (and by extension, this device through equivalence) are compliant.
2. Sample size used for the test set and the data provenance: No test set or associated data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set or ground truth established for this device.
4. Adjudication method for the test set: Not applicable.
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 device is a laser console, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable as no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

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The Vari-Lase™ procedure is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

The Vari-Lase Console is a software controlled diode laser that provides an output wavelength of 810 nm.

The provided 510(k) summary for the Vari-Lase™ Endovenous Laser Console does not describe any acceptance criteria or a study that proves the device meets such criteria in terms of clinical performance or effectiveness.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the device is substantially equivalent to predicate devices based on indications for use and technological characteristics.
• Non-Clinical Testing: The only testing mentioned is non-clinical, related to compliance with electrical safety standards (EN 60601 series). These are safety and performance standards for the electrical components of the device, not clinical effectiveness studies.
• Absence of Clinical Evaluations: The document explicitly states: "No clinical evaluations of this product have been conducted."

Therefore, based on the provided text, it's not possible to complete the requested table and details about acceptance criteria and a study proving their fulfillment. The device approval appears to be based on substantial equivalence and compliance with engineering safety standards, without clinical performance data in this submission.

Given this, I will answer the questions based on the absence of the requested information, which is a key finding in the provided document.

Acceptance Criteria and Device Performance

No acceptance criteria related to clinical performance or effectiveness are described in the provided document, nor is any device performance data reported from a clinical study. The document explicitly states, "No clinical evaluations of this product have been conducted."

The "Summary of Non-Clinical Testing" refers to compliance with electrical safety standards, which are not direct measures of device clinical performance against specific acceptance criteria.

Additional Study Details (Not Applicable as No Clinical Study was Conducted)

Since no clinical study demonstrating device performance against acceptance criteria was conducted or reported in this 510(k) summary, the following points are not applicable:

2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 device is a laser console, not an AI-assisted diagnostic tool).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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