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510(k) Data Aggregation
(119 days)
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 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.
This document describes the 510(k) summary for Biolitec's 15W Ceralas D 1470nm Diode Laser (Model D1470). It is a special 510(k) notice for a modification to a previously cleared device. The primary claim is substantial equivalence to predicate devices, rather than a de novo clinical study proving novel performance. Therefore, many of the typical acceptance criteria and study details for a new device are not explicitly present in this summary.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are provided in this 510(k) summary. The basis for clearance is "substantial equivalence" to existing legally marketed devices.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use/Indications | Substantially similar to predicate | "The Ceralas 1470 has the same intended uses and similar indications... as its predicate devices." |
| Technological Characteristics | Substantially similar to predicate | "The Ceralas D1470 has substantially similar technological characteristics as compared to the previously cleared Ceralas D1470." |
| Safety and Effectiveness | As safe and effective as predicate | "The Ceralas D1470 is as safe and effective as the cleared Ceralas D1470 and the Cool Touch CTEV laser." |
| New Safety/Effectiveness Issues | No new issues raised | "The minor technological differences between the Ceralas D1470 and its predicate device raises no new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or clinical study with a specific sample size designed to prove the device meets acceptance criteria. The clearance is based on substantial equivalence to predicate devices. This typically involves demonstrating that the modified device does not raise new questions of safety or effectiveness compared to a device already on the market, often through bench testing, engineering analysis, and a comparison of design specifications. Therefore, there is no explicit test set data with a sample size or data provenance mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. As no explicit clinical test set or study is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable, as no explicit clinical test set or study is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. This 510(k) summary focuses on demonstrating substantial equivalence of a modified device, not on comparative effectiveness against human readers or other devices in an MRMC setting.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The Ceralas D1470 is a surgical laser, not an diagnostic algorithm or AI system. Its performance is related to its physical properties and clinical application by a surgeon.
7. Type of Ground Truth Used
Not explicitly stated in terms of a clinical ground truth for a study. The "ground truth" for the substantial equivalence claim is the established safety and effectiveness of the existing predicate devices (Biolitec's previously cleared Ceralas D1470 and Cool Touch CTEV 1320 Nd: YAG Laser).
8. Sample Size for the Training Set
Not applicable. This device is a laser, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a laser, not a machine learning algorithm.
In summary:
The provided 510(k) summary for the Biolitec Ceralas D 1470nm Diode Laser demonstrates substantial equivalence to predicate devices (Biolitec's previously cleared Ceralas D1470 and the Cool Touch CTEV 1320 Nd: YAG Laser) for its safety and effectiveness. This strategy for regulatory clearance does not typically involve the detailed clinical study methodologies (e.g., test set sample sizes, expert ground truth, MRMC studies) that would be common for novel diagnostic devices incorporating AI or requiring de novo clinical validation. The acceptance criteria essentially revolve around demonstrating that the modified device does not introduce new safety or effectiveness concerns compared to its predicates.
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(120 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness comparable to predicate devices for intended use. | The Ceralas D1470 is "as safe and effective" as the predicate devices (CoolTouch CTEV Nd:YAG, CoolTouch CT3S Nd:YAG, Sciton Profile Multi-Platform System). |
| Technological Characteristics substantially similar to predicate devices. | The Ceralas D1470 has "substantially similar technological characteristics" to the predicate devices. |
| Intended Use/Indications for Use aligned with predicate devices. | The Ceralas D1470 has the "same intended uses and similar indications" as its predicate devices. Specifically, it's indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. |
| No new issues of safety or effectiveness raised by minor technological differences. | "The minor technological differences between the Ceralas D1470 and its predicate device raises no new issues of safety or effectiveness." |
| Demonstrated performance equivalent to predicate devices. | "Performance testing of the Ceralas D1470 demonstrates no significant difference as compared to the cleared CoolTouch CTEV Nd:YAG laser, the CoolTouch CT3S Nd:YAG laser, and the Sciton, Inc., Profile Multi-Platform System." |
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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