(26 days)
For the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue.
Examples:
Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Gingivoplasty
Hemostasis and coagulation
Incision and drainage of abscess
Operculectomy
Pulpotomy
Reduction of gingival hypertrophy
Soft Tissue crown lengthening
Vestibuloplasty
Laser Soft Tissue Curettage
Tissue Retraction
Frenectomy and Frenotomy
Gingival Troughing for crown impressions
Gingivectomy
Ginigival incision and excision
Implant Recovery
Leukoplakia
Oral papillectomies
Pulpotomy as an adjunct to root canal therapy
Reduction of bacterial level (decontamination) and inflammation
Treatment of aphthous ulcers
Lesion (tumor) removal
Treatment of canker sores, herpetic and other ulcers of the oral mucosa
Removal of Diseased, Inflamed and necrotic soft tissue within the periodontal pocket
Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithlium
Sulcular debridement (removal of necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices ingluding gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility
Light activation of bleaching materials for teeth whitening
Laser-assisted whitening/bleaching of teeth
The laser source of the QuickLase™DUALDental Lasers or QuickLase™810/980 Dental Laser is an array of Gallium Aluminum Arsenide (GaAlAs), solid state, semiconductor diode lasers. The individual lasers comprising the array are capable of producing invisible infrared laser energy at either 810 or 980 nanometers depending upon the concentration of and construction of the epitaxial layers of the diode. The delivery system consists of a fiber optic cable with a nominal diameter of 400 microns. In all available configurations, that portion of the delivery system that is handled by the operator and/or in contact with the patient can be sterilized by heat, steam, gas, chemicals or combinations thereof. Activation of the laser occurs after the operator either selects or enters the parameters for the procedure, verifies and authorizes the parameters and depresses a footswitch which fires the laser. The footswitch is an on/off switch. The interface for input is electro-mechanical by way of a membrane switch pad. The laser operates in continuous wave or pulse mode which is selected and/or verified by the operator. A visible aiming beam is provided in the form of a visible red laser which emits not more than 5mW (user adjustable and verified) in the 640-650 nanometer wavelength range.
The provided text is a 510(k) summary for the QuickLase™DUAL+ Dental Laser. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with acceptance criteria and detailed performance data.
Here’s an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not define specific quantitative acceptance criteria for its performance. Instead, it relies on the predicate devices' prior clearance and asserts identical performance.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as stated in document) |
|---|---|
| Not explicitly stated. The core claim is "substantial equivalence" to predicate devices cleared under K072995. | "Not substantially equivalent to, they are identical in terms of safety and efficacy." (Page 2) |
| Performance requirements of 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, Dated July 26, 2001. | Device complies with these performance requirements. (Page 3) |
| Compliance with international standards including IEC 60601 and 13485 Standards. | Device tested by Notified Body, CE marked, and complies with these standards. (Page 3) |
| Power densities for treatment are identical to predicate devices. | Tests confirm power densities are identical in all devices, ensuring the exact same efficacy. (Page 3) |
| Similar methods of control, safety features, and performance monitoring to predicate devices. | All comparable devices share similar methods of control, safety features, and performance monitoring. (Page 3) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The submission is based on demonstrating identity/substantial equivalence to a previously cleared device, not on new clinical performance data for the QuickLase™DUAL+.
- Data Provenance: The document states, "These lasers have performed flawlessly in Europe in thousands of procedures over the past 2 years." (Page 2). This implies retrospective observational data from Europe, but no specific study or data set is presented. This is presented as anecdotal evidence supporting the device's history, rather than formal clinical trial data used for the 510(k) clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no new test set requiring expert ground truth establishment was conducted or reported for this 510(k) submission.
4. Adjudication Method
Not applicable, as no new test set requiring adjudication was conducted or reported for this 510(k) submission.
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 "Clinical Performance: None" (Page 3).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a laser surgical instrument, not an AI/algorithm-based diagnostic or therapeutic tool.
7. The Type of Ground Truth Used
Not applicable, as no new test set requiring ground truth was presented. The basis for clearance is the assertion of identity and substantial equivalence to previously cleared predicate devices (TwinWave and TidalWave by Lumen Development and Manufacturing, Inc., K072295). The implicit "ground truth" is that the predicate devices were deemed safe and effective in their previous clearance.
8. The Sample Size for the Training Set
Not applicable. This device is a physical laser system, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this involves a physical medical device, not an AI/machine learning algorithm.
Summary of the Study that Proves Acceptance Criteria:
The "study" presented here is not a traditional clinical trial or performance study with defined acceptance criteria and corresponding results. Instead, it is a demonstration of substantial equivalence to predicate devices that have already received FDA clearance.
The key points of the "proof" are:
- Identity with Predicate Devices: The QuickLase devices are declared to be "identical in terms of safety and efficacy" to the TwinWave and TidalWave devices previously cleared under K072995. The only differences are brand name and cosmetic housing variations (Page 2).
- Non-Clinical Performance Testing: "Tests confirm that the power densities for treatment are identical in all devices insuring that all devices provide the exact same efficacy." (Page 3). This implies engineering and bench testing to verify physical parameters match the predicate.
- Compliance with Standards: The device complies with relevant performance standards (21 CFR 1040.10 and 1040.11) and international standards (IEC 60601 and 13485), as evidenced by CE marking (Page 3).
- Similar Specifications: Detailed comparison showing comparable energy density, fiber delivery systems, aiming beams, physical specifications, methods of control, safety features, and performance monitoring to the predicate and other comparable devices (Page 3).
- History of Use: "These lasers have performed flawlessly in Europe in thousands of procedures over the past 2 years." (Page 2). This serves as real-world evidence of safety and efficacy, albeit not a formal clinical trial for this specific 510(k) submission.
In essence, the "study" is a technical comparison and assertion of equivalence based on the device being functionally identical to one already deemed safe and effective by the FDA.
§ 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.