(50 days)
The Ceralas D Laser System is indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions: papillectomy: vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth: leukoplakia; removal of hyperplastic tissues; treatment of aphthous ulcers; and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
The Ceralas D Laser System is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide (GaAlAs) semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode; (2) a cooling module containing the laser diode, thermoelectric coolers, heat sink fins and fans; (3) an optics module containing a beamsplitter for control of optical power; (4) front control and display panel; and (5) RFI-shielded, transformer power supply and control electronics. Interchangeable fiber optic delivery systems are coupled to the laser via an SMA 905 connector to deliver laser radiation to the target tissues. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The wavelength for the Ceralas D Laser System is 980 ± 30nm, and its laser aiming beam wavelength is 635nm+10nm. The power output ranges from 1-15 Watts. The delivery systems for the Ceralas D Laser System consist of an optical fiber fitted with an SMA 905 connector at the proximal end. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath.
The Ceralas Diode Laser System (Model D15) received 510(k) clearance based on substantial equivalence to predicate devices, without requiring new performance data. The provided document does not contain explicit acceptance criteria or a study demonstrating the device meets such criteria in terms of analytical or clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the submission focuses on establishing equivalence based on technological characteristics and previously cleared indications for use.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or provide a table of performance metrics (like sensitivity, specificity, accuracy, etc.) for the Ceralas Diode Laser System. The submission states "Performance Data: None required." This indicates that for this 510(k) submission, the FDA did not mandate a new study demonstrating specific performance metrics for the expanded indications, relying instead on the established safety and effectiveness of the predicate devices and the lack of significant technological changes.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance:
No test set or associated data is described in the provided document. The submission explicitly states "Performance Data: None required," indicating that a study with a test set was not conducted or submitted for this specific 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as no test set or ground truth establishment process is described.
4. Adjudication Method for the Test Set:
Not applicable, as no test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done or reported. The submission focuses on establishing substantial equivalence based on technological characteristics and predicate device performance, not on demonstrating improved human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The Ceralas Diode Laser System is a surgical instrument, not an AI or algorithm-based device that would require standalone performance evaluation in the context of diagnostic accuracy.
7. The Type of Ground Truth Used:
Not applicable, as no ground truth for a performance study is described. The "ground truth" for this 510(k) submission appears to be implicit in the established safety and effectiveness of the predicate devices and the scientific understanding of diode laser technology for the stated indications.
8. The Sample Size for the Training Set:
Not applicable, as the Ceralas Diode Laser System is a physical medical device (laser system), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
There is no specific "study" described in the provided document that proves the device meets explicit acceptance criteria in terms of performance metrics. The basis for clearance is substantial equivalence to predicate devices. The document highlights that:
- No significant changes have been made to the Ceralas D Laser System hardware or software since its previous FDA clearances (K951775, K964497).
- The device's technological characteristics (e.g., wavelength, power output, delivery system) are similar to its predicate devices. While there are minor differences (e.g., wavelength compared to Premier Laser Systems' Aurora Diode Dental Laser), the submission argues these "do not raise new questions of safety and efficacy."
- The expanded intended uses for intraoral and extraoral soft tissue are comparable to the uses for which predicate devices (including earlier versions of the Ceralas D Laser System and other dental diode lasers) have already been cleared.
Therefore, the "proof" for meeting acceptance criteria in this specific 510(k) relies on the established safety and effectiveness of the predicate devices and the demonstration that the Ceralas Diode Laser System, with its expanded indications, is substantially equivalent and does not introduce new questions of safety and effectiveness compared to these previously cleared devices. The FDA's concurrence letter confirms this by stating, "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976."
§ 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.