(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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.