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510(k) Data Aggregation
(88 days)
The Ceralas G is intended to be used as a surgical instrument for photocoagulation of ocular tissue as well as ablation of tissue of the iris and trabeculum. It is already cleared for photocoagulation of retinal tissue.
The Ceralas G is a complete self-contained compact surgical laser that utilizes a neodymium-doped vttrium aluminum garnet ("Nd:YAG") crystal. The Ceralas G has already been cleared by FDA (K954834) for use as a surgical instrument for photocoagulation of retinal tissue using a hand held fiber optic delivery system. The purpose of this submission is to extend the indications for use of the cleared laser to include photocoagulation of ocular tissue and ablation of tissue of the iris and trabeculum. As explained in this 510(k) notice, the Ceralas G can be attached using an adaptor provided by the Company, without hardware modification, to the Carl Zeiss (K874160 and K925641) or Haag-Streit (K792083) slit lamps, and to the Keeler indirect ophthalmoscopes (K854244 and K942104). No hardware changes have been made to the originally cleared Ceralas G laser. Only certain minor software modifications are required to use the slit lamp as a delivery system. Use of the Ceralas G laser with slit lamps and indirect ophthalmoscopes permits photocoagulation of ocular tissue and ablation of tissue of the iris and trabeculum with the Ceralas G laser. The CeramOptec fiber optic laser delivery system intended for use with the Ceralas G Nd:YAG Laser System has already received clearance from FDA (K935747).
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Photocoagulation of ocular tissue and ablation of tissue of the iris and trabeculum. | The Ceralas G is cleared for these expanded indications for use. |
| Compatibility with Delivery Systems: Compatibility with Carl Zeiss and Haag-Streit slit lamps, and Keeler indirect ophthalmoscopes. | The Ceralas G can be attached to these slit lamps and indirect ophthalmoscopes using an adaptor, without hardware modification. Minor software modifications are required. |
| Similar Treatment Beam Wavelengths: Wavelength of 532 nm (for photocoagulation of ocular tissue). Wavelength within ~3 nm of predicate for ablation of iris/trabeculum. | For photocoagulation, the Ceralas G operates at 532 nm, similar to Biovision and Zeiss Lasers. For iris/trabeculum ablation, the Ceralas G operates at 532 nm, which is within 3 nm of the HGM Laser's largest line at 514 nm (within its 488-529 nm range). |
| Similar Treatment Beam Power Outputs: Power outputs in ranges comparable to predicate devices. | For photocoagulation, Ceralas G provides 0.1 - 3 W, similar to Biovision (0.1 - 3 W), Zeiss (0.1 - 1 W), and Coherent (0.1 - 4 W Argon, 0.05 - 170 W Dye). For iris/trabeculum ablation, Ceralas G provides 0.1 - 3 W, similar to HGM (0.1 - 1 W). |
| Similar Pulsed Mode Exposure Duration: Exposure durations in ranges comparable to predicate devices. | Ceralas G has a pulsed mode exposure duration of 0.1 - 1 sec. This is comparable to Biovision (0.01 - 3 sec), Zeiss (0.01 - 0.5 sec), Coherent (0.01 - 5 sec), and HGM (0.01 - 0.5 sec). |
| Safety and Effectiveness (Clinical Equivalence): No new issues of safety or effectiveness raised by differences in technical characteristics compared to predicate devices. | The submission argues that minor differences in wavelength and power do not raise new safety or effectiveness concerns due to: 1) shared delivery systems, 2) close similarity to relevant predicates for specific applications, and 3) user manual instructions for safe power/exposure duration titration. |
2. Sample Size Used for the Test Set and Data Provenance:
This document does not describe a test set or data provenance in the context of a clinical study or performance evaluation with human subjects or real-world data. The submission focuses on technical equivalence by comparing the Ceralas G's specifications and intended use to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. No ground truth was established by experts for a test set in this submission. The "ground truth" here is the established safety and effectiveness of the existing predicate devices.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication is 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 is not an AI/software device and no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a laser device, not an algorithm.
7. The type of ground truth used:
The "ground truth" used in this 510(k) submission is the established safety and effectiveness of the identified predicate devices. The argument for substantial equivalence relies on demonstrating that the Ceralas G operates with similar technical characteristics and has the same intended use as these legally marketed devices, and that any differences do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set:
Not applicable. This document describes a medical device, not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.
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