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The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Ceralas D1470 contains an ELVeS Kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the saphenous veins.

The provided 510(k) summary for the Biolitec Inc.'s 15W Ceralas Diode 1470nm Laser System (Model D1470) does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format of a diagnostic test.

Instead, this submission is centered on demonstrating substantial equivalence to existing predicate devices.

However, I can extract the relevant information regarding performance claims and the basis for market clearance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a specific clinical trial or test set with a defined sample size for performance evaluation in the context of diagnostic accuracy. The "performance testing" mentioned is likely related to engineering and bench testing to demonstrate the laser's physical characteristics (e.g., power output, wavelength stability) and safety, rather than a clinical outcome study with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The submission is not about a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. There's no mention of a test set requiring adjudication in the context of this 510(k) submission.

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

Not applicable. This is a laser system, not a diagnostic imaging or AI-assisted diagnostic device where MRMC studies are typically performed.

6. Standalone Performance

The device is a standalone laser system. Its "performance" is inherent in its operation (e.g., light delivery, power). The document states "Performance testing... demonstrates no significant difference" compared to predicate devices, implying fundamental functional equivalency.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic AI is not relevant here. The "truth" established for this device's acceptance is its ability to perform its intended function (delivering laser light for soft tissue procedures and treatment of varicose veins) safely and effectively, which is assessed through comparison to established predicate devices and technical specifications.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device.

Summary of the Study/Evidence:

The "study" presented here is a demonstration of substantial equivalence rather than an independent clinical trial to establish new safety and efficacy endpoints. The manufacturer's approach is to assert that the Biolitec 15W Ceralas D 1470nm Diode Laser is as safe and effective as three identified predicate devices (CoolTouch CTEV Nd:YAG, CoolTouch CT3S Nd:YAG, and Sciton Profile Multi-Platform System) because:

• It has the same intended uses and similar indications (treatment of reflux of saphenous veins associated with varicose veins and varicosities).
• It has substantially similar technological characteristics.
• Performance testing (likely bench and engineering tests, not clinical patient studies) showed no significant difference compared to the predicate devices.
• Any minor technological differences raise no new concerns regarding safety or effectiveness.

Therefore, the acceptance criteria are implicitly met by demonstrating that the new device does not introduce new safety or efficacy concerns compared to legally marketed devices already established as safe and effective for the indicated uses.

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The AngioDynamics, Inc. NeverTouch II Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of variose veins and varicosties associated with superficial reflux of the great saphenous vein, and for the treatment of incomprence and reflux of superficial veins of the lower extremity.

Not Found

The provided document is a 510(k) premarket notification for a device modification, specifically for the "AngioDynamics, Inc. NeverTouch II 400µm Fiber and VenaCure Procedure Kit." This is not a study or research paper describing acceptance criteria and a study to prove a device meets those criteria. Instead, it's a regulatory submission affirming substantial equivalence to a legally marketed predicate device.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria, device performance results, sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

Here's why each point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: The document states "Performance Standards: None Established" in section (j). It doesn't present any specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for the modified device or report performance metrics against such criteria. The submission is based on substantial equivalence, implying that if the modified device is substantially similar to the predicate and doesn't introduce new risks, specific performance testing against novel criteria isn't always required in the same way a de novo device might.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned. This is a regulatory filing, not a clinical study report.
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): No mention of experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there's no test set or study described.
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 surgical fiber, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth is mentioned.
8. The sample size for the training set: Not applicable. No training set is mentioned.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth is mentioned.

The document is a communication from the FDA granting clearance for a modified medical device based on its substantial equivalence to previously cleared predicate devices, without detailed performance studies being explicitly presented within this particular submission.

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