(274 days)
Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
The Waterlase MD is a dental laser device previously cleared by the FDA (K031140) for hard and soft tissue dental indications, including periodontal procedures such as: laser soft tissue curettage, laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, removal of granulation tissue from bony defects, sulcular debridement (removal of diseased, infected, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility), osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours), ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.), osseous crown lengthening, full thickness flap, partial thickness flap, and split thickness flap. The Waterlase MD is capable of soft tissue incision, excision, vaporization, ablation and coagulation. In the periodontal pocket, the Waterlase MD is an effective laser for removing diseased/inflamed tissue, and the diseased epithelium lining from underlying connective tissues. A flexible fiber optic terminated into the handpiece delivers the Waterlase MD laser energy to the end fiber tip and target. A visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment. Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In both hard and soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.
This document is a 510(k) Summary of Safety and Effectiveness for the Waterlase® MD dental laser, seeking expanded indications for use. It primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria.
Therefore, many of the requested sections (e.g., specific acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) cannot be fully populated as they are not explicitly detailed in this type of regulatory submission. The document confirms the device's substantial equivalence based on the same indication as previously cleared devices, implying that the established safety and effectiveness of those predicates extend to the Waterlase® MD for this expanded indication.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance for a study. The submission for a 510(k) is about demonstrating substantial equivalence to a predicate device, not necessarily showcasing new performance data against pre-defined acceptance criteria for a novel functionality. The key "performance" here is that the device can perform the expanded indication in a manner similar to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission does not describe a new clinical study with a test set. It relies on the established safety and efficacy of predicate devices for the specified indication.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new test set or ground truth establishment by experts is detailed in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set with adjudication is detailed.
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 device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for this 510(k) submission is the established clinical effectiveness and safety of predicate devices for the indication of "cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium". This is based on historical clinical evidence and regulatory clearances for those predicates. No new ground truth data is generated for this submission.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not a machine learning or AI device.
Summary of Device Acceptance and Study:
Acceptance Criteria & Reported Performance:
| Acceptance Criteria | Reported Device Performance (from summary) |
|---|---|
| Premarket Notification (510k) Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This means it must: |
- Have the same intended use as a legally marketed predicate device.
- Have the same technological characteristics as the predicate device; OR
- Have different technological characteristics than the predicate device BUT
a. The new device does not raise different questions of safety and effectiveness; AND
b. The new device is as safe and effective as the legally marketed predicate device. | The Waterlase® MD is substantially equivalent because: - Intended Use: The expanded indication ("Waterlase MD Er, Cr. YSG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)") is the same as an indication previously cleared by the FDA for other dental laser devices.
- Technological Characteristics: The document describes the Waterlase MD's existing capabilities (soft tissue incision, excision, vaporization, ablation, coagulation, specified energy delivery, adjustable parameters) for periodontal procedures, which are presumably similar to the predicate devices for this specific indication. The core technology (Er,Cr:YSGG laser) and delivery mechanism are established. |
The "Study" Proving Acceptance:
The "study" in this context is the 510(k) substantial equivalence determination process itself, rather than a specific clinical trial conducted for this submission.
- Study Type: Substantial Equivalence Review based on comparison to predicate devices.
- Methodology: The sponsor (Biolase Technology, Inc.) submitted documentation demonstrating that the Waterlase® MD, when used for the expanded indication of "cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium," meets the criteria for substantial equivalence to existing, legally marketed dental laser devices with the same indication. This generally involves:
- Identification of Predicate Devices: The document lists several equivalent devices: Millennium Dental Technologies, Inc. Periolase Fidelis III Laser System Family; Fotona d.d. Smart CO2; Cynosure, Inc.
- Comparison of Indications for Use: The key point made directly in the "Conclusion" section is: "The indication included herein is the same as the indication that has been previously cleared by the FDA for other dental laser devices."
- Comparison of Technological Characteristics: The document describes the Waterlase MD's existing features relevant to performing the procedure (e.g., soft tissue incision, excision, vaporization, ablation, coagulation, flexible fiber optic delivery, adjustable parameters like power output, pulse duration, repetition rate, air/water flow, spot size). The implication is that these characteristics are comparable to the predicate devices for achieving the intended clinical outcome.
- Safety and Effectiveness Argument: By demonstrating identical intended use and comparable technological characteristics to cleared devices, the submission implicitly argues that the Waterlase® MD raises no new questions of safety or effectiveness for this expanded indication and is as safe and effective as its predicates.
- Outcome: The FDA reviewed the submission (K083927) and determined that the Waterlase® MD is "substantially equivalent" for the stated expanded indication, as evidenced by the FDA's clearance letter dated October 1, 2009.
§ 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.