(21 days)
The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System that has already been cleared by FDA (K983058) for use in the following dental indications: draining fistulas, coagulation and decontamination of extraction sites, frenectomy, excisional biopsy, operculectomy, implant uncovering, gingivectomy, gingivoplasty, degranulation of infrabony defects, enucleate apical troughing for crown and bridge, apthus ulcers, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, exposure of enamel for orthodontic brackets, and surgical exposure to aid in eruption. The purpose of this submission is to expand the indications for use to include pulpotomy and pulpotomy as an adjunct to root canal therapy.
The Cerals D Diode Laser operates with a power range of 1-15W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end.
Here's an analysis of the provided text regarding the Ceralas Diode Laser System and its performance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| No new questions of safety or effectiveness are raised compared to predicate. | "The Ceralas D Laser System's principles of operation, function and intended use are similar to Premier Laser System's Pegasus Nd: YAG laser system and no new questions of safety or effectiveness are raised." |
| Technological identity with previously cleared device. | "There are no technological differences between the previously cleared Ceralas D Laser System and the device subject to this 510(k)submission." |
| Performance suitable for expanded dental indications (pulpotomy and pulpotomy as an adjunct to root canal therapy). | (No specific performance metrics are provided. The FDA's substantial equivalence decision implies that its performance is deemed adequate for these indications based on predicate comparison and the lack of new safety/effectiveness concerns). |
| Operates within specified power range and mode. | "The Cerals D Diode Laser operates with a power range of 1-15W in the CW or pulsed mode." |
| Utilizes specified delivery system. | "The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Performance Data: None required." This indicates that no new empirical test set data was used to demonstrate performance for this particular 510(k) submission. The device relies on demonstrating substantial equivalence to a predicate device and technological identity to a previously cleared version of itself for the expanded indications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no performance data was required or submitted, there was no test set for which ground truth needed to be established by experts.
4. Adjudication Method for the Test Set
Not applicable, as no test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Performance Data: None required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a hardware laser system, not an algorithm. Therefore, a standalone performance study in the context of AI algorithms is not applicable.
7. The Type of Ground Truth Used
No new ground truth was established or used for this 510(k) submission as no performance data was submitted. The grounds for approval are based on predicate device comparison and the lack of technological differences from a previously cleared device.
8. The Sample Size for the Training Set
Not applicable. As a hardware device, there is no "training set" in the context of machine learning. The device's design and operating parameters would have been established through engineering and potentially prior clinical testing, but this 510(k) does not detail such information.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in this context. The core assertion is that the device, being technologically identical to a previously cleared one and similar to a predicate, is safe and effective for the expanded indications without requiring new performance data.
§ 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.