(69 days)
Dental Soft Tissue Indications for incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excision and Incision Biopsies, Hemostasis and Coagulation, Treatment of canker sores, herpetic and aphthous ulcers, Frenectomy and Frenotomy, Gingival Incision and Excision, Gingivectomy and Gingivoplasty, Incision and Drainage of Abscess, Operculectomy, Oral Papillectomy, Removal of Fibromas and Hyperplastic tissues, Exposure of un-erupted / partially erupted teeth, Implant recovery, Tissue retraction / troughing, Leukoplakia, Pulpotomy, Soft tissue crown lengthening, Vestibuloplasty. Laser Periodontal Procedures, including: Laser soft tissue curettage, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility). Teeth Whitening Procedures, including: Light Activation of bleaching materials for teeth whitening, Laser-assisted whitening / bleaching of teeth.
The PROMETEY ™ diode laser system is a device for delivering laser power to treated surfaces within oral cavity. This power is produced by solid-state laser diodes, which provide a consistent generation of laser power in 810 ± 10 nm spectral region with maximum power of 3 Watts. The laser power is delivered to the treatment site by means of fiber optic cables available in 400, 300 and 200 um core diameters. These cables provide safe transmission of laser power to the surgical site without creating undue risk to a patient or operatory staff by errant or collateral laser emissions. The device features front-panel keypad used to activate 650 nm aiming beam, set power output and select continuous or pulsed operation mode. The distal end of delivery fiber cable is contained within a metal handpiece with a disposable tip /cannula. A standard foot-switch controls initiation /termination of laser power from the delivery fiber.
The PROMETEY™ Soft Tissue Diode Laser system did not conduct a specific study to prove it meets acceptance criteria. Instead, its acceptance was based on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer argued that their device is as safe and effective as existing legally marketed devices, rather than performing a new clinical trial against specific acceptance criteria.
Here's an breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since no specific acceptance criteria were defined for a new study, the "acceptance criteria" here are implicitly defined by the characteristics and proven safety/effectiveness of the predicate devices. The device performance is compared directly to these predicates.
| Feature | Implicit Acceptance Criteria (based on Predicates) | Reported Device Performance (PROMETEY™) |
|---|---|---|
| Wavelength | Similar to 810 ± 20 nm (Odyssey), 810 nm (LaserSmile), 808 ± 5 nm (SoftLase) | 810 ± 10 nm |
| Max Power | At least sufficient for all Indications of Use (predicates range 3.5-10 Watts) | 3 Watts (Stated as sufficient for all Indications of Use) |
| Operation mode | Continuous wave and pulsed | Continuous wave and pulsed |
| Pulse control | Digital emission control | Digital emission control |
| Laser power source | Solid-state diode | Solid-state diode |
| Aiming beam laser | Similar to 630-670 nm, 2-5 mW | 630-650 nm, 2 mW |
| Delivery system | Multi-mode fiber (various diameters) | Multi-mode fiber (400, 300, 200 um) |
| Power requirements | Similar to 100-240 VAC, 50-60Hz, 0.5-1.5 A | 100-240 VAC, 50-60Hz, 0.5 A |
| Cooling system | Fan / air cooled | Fan / air cooled |
| Intended Use | Same as predicate devices | See Indications for Use section |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical "test set" in the sense of patient data was used for a prospective study to establish the device's performance against specific acceptance criteria for this 510(k) submission. The "test" was a comparison of technical characteristics and intended use to existing predicate devices already on the market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No ground truth was established by experts for a specific test set. The "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate devices.
4. Adjudication Method
Not applicable. No adjudication of a test set was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was conducted. The submission focuses on technical and functional equivalence, not comparative effectiveness with human readers.
6. Standalone Performance Study
Not applicable in the sense of a clinical standalone study against specific endpoints. The device's "standalone" performance was assessed by its technical specifications and comparison to the predicate devices, assuming that if the technical specifications are similar to a safe and effective predicate, the new device will also be safe and effective. Safety and performance testing is mentioned, implying engineering and bench testing, but not a clinical standalone study.
7. Type of Ground Truth Used
The ground truth used for the substantial equivalence determination was the established safety and effectiveness of the legally marketed predicate devices (Odyssey 2.4G, LaserSmile, and SoftLase). The FDA's previous clearance of these devices served as the "truth" against which the new device was compared.
8. Sample Size for the Training Set
Not applicable. This device is a hardware medical device, not an AI or algorithm-based software. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.