Search Results

Date Cleared

2009-12-07

(174 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage.

Device Description

The Waterlase MD dental laser system is a device used to perform a variety of dental soft and hard tissue indications. For hard tissue procedures the Waterlase MD uses the Erbium,Chromium:Yttrium,Scandium,Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, shave, contour, roughen and etch tissues. Soft tissue procedures are performed using two different modes of operation. H and S. where direct Er.Cr. YSGG laser energy is applied to incise, excise or ablate these tissues. For soft tissue procedures the water spray is applied for hydration. cooling or to keep tissues and the field of view clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues and field of view clean.

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.

AI/ML Overview

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily a regulatory filing for an expanded indication for use of the Waterlase MD dental laser system, establishing its substantial equivalency to previously cleared devices.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, study design, sample sizes, expert involvement, or ground truth.

The document discusses the device description, indications for use, contraindications, and regulatory information, but it does not include data from a clinical trial or performance study that would typically involve acceptance criteria. The basis for clearance is "Substantial Equivalence" to another device, meaning it's assumed to perform similarly to an already approved device without necessarily requiring new performance studies against specific acceptance criteria.

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K Number

K083927

Device Name

WATERLASE MD

Manufacturer

Date Cleared

2009-10-01

(274 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K031140

Intended Use

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).

Device Description

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.

AI/ML Overview

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.

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K Number

K090181

Device Name

WATERLASE MD

Manufacturer

Date Cleared

2009-02-11

(16 days)

Product Code

Regulation Number

Type

Special

Panel

WATERLASE AND WATERLASE MD

Reference & Predicate Devices

K071363,K031140

Intended Use

General Indications: Class I, II, III, IV and V cavity preparation; Caries removal; Hard tissue surface roughening or etching; Enameloplasty, excavation of pits and fissures for placement of sealants. Root Canal Hard Tissue Indications: Tooth preparation to obtain access to root canal; Root canal preparation including enlargement; Root canal debridement and cleaning. Root Canal Disinfection: Laser root canal disinfection after endodontic treatment. Endodontic Surgery (Root Amputation) Indications: Flap preparation - incision of soft tissue to prepare a flap and expose the bone; Cutting bone to prepare a window access to the apex (apices) of the root(s); Apicoectomy - amputation of the root end; Root end preparation for retrofill amalgam or composite; Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex. Bone Surgical Indications: Cutting, shaving, contouring and resection of oral osseous tissues (bone); Osteotomy. Soft Tissue Indications including Pulpal Tissues: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excisional and incisional biopsies; Exposure of unerupted teeth; Fibroma removal; Flap preparation - incision of soft tissue to prepare a flap and expose the bone; Flap preparation - incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions); Frenectomy and frenotomy; Gingival troughing for crown impressions; Gingivectomy; Gingivoplasty; Gingival incision and excision; Hemostasis; Implant recovery; Incision and drainage of abscesses; Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomy; Pulp extirpation; Pulpotomy as an adjunct to root canal therapy; Root canal debridement and cleaning; Reduction of gingival hypertrophy; Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; Vestibuloplasty. Laser Periodontal Procedures: Full thickness flap; Partial thickness flap; Split thickness flap; 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 junctional epithelium; Removal of granulation tissue from bony defects; Sulcular debridement (removal of diseased, 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.

Device Description

The Waterlase MD is a dental laser device previously cleared by the FDA for hard and soft tissue dental indications (K031140, K071363). The only changes from the previously cleared device are the addition of the Turbo handpiece, which combines minor software and graphics changes that will be added to the Waterlase MD laser system. This software does not change the operational software, but adds a "Select" icon on the control panel, and unassigned pre-sets fields for use by the dentist to store preferred setting selections. There are no other hardware or software changes to the Waterlase MD device pending herein when compared to the device cleared under K031140 and K071363. Materials used for the Turbo handpiece are the same as those for the MD Gold handpiece. Biocompatibility testing of these materials was conducted in compliance with 21 CFR Part 820, Quality System Regulation, Subpart C, Sec. 820.30 - Design Controls, and ISO 13485-2003, Section 7.3 - Design and Development; documented results (on file) confirmed there is no biocompatibility risk presented by these materials.

AI/ML Overview

This document describes a Special 510(k) submission for the KOGOLFI Waterlase® MD with a new Turbo Handpiece accessory submitted by Biolase Technology, Inc. The core of this submission is to demonstrate substantial equivalence to previously cleared devices (K031140, K071363) by showing that the new accessory does not introduce new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain specific acceptance criteria for performance metrics in the traditional sense of a study with quantitative results. Instead, the "acceptance criteria" for this Special 510(k) is the demonstration of substantial equivalence to predicate devices. This means that:

Acceptance Criteria (Implicit for Special 510(k))	Reported Device Performance
No change in Indications for Use: The new accessory (Turbo Handpiece) should not alter the intended clinical applications as previously cleared for the Waterlase MD.	Met: "The indications included herein are the same as the indications that have been previously cleared by the FDA for the Waterlase®MD (K031140, K071363)." The provided "Indications for Use" section lists the exact same indications as the predicate devices.
No change in Contraindications: The new accessory should not introduce any new contraindications.	Met: "All Contraindications remain the same as for the previously cleared device, Waterlase®MD (K031140)." The document explicitly states this.
No change in fundamental technology or mode of operation that would raise new questions of safety or effectiveness: The changes should be minor and not impact the core safety and performance characteristics of the laser system.	Met: "The only changes from the previously cleared device are the addition of the Turbo handpiece, which combines minor software and graphics changes that will be added to the Waterlase MD laser system. This software does not change the operational software, but adds a 'Select' icon on the control panel, and unassigned pre-sets fields for use by the dentist to store preferred setting selections. There are no other hardware or software changes to the Waterlase MD device pending herein when compared to the device cleared under K031140 and K071363." This demonstrates the changes are superficial.
Biocompatibility of new materials (if any) meets established standards: Any new materials introduced by the accessory must be biocompatible.	Met: "Materials used for the Turbo handpiece are the same as those for the MD Gold handpiece. Biocompatibility testing of these materials was conducted in compliance with 21 CFR Part 820, Quality System Regulation, Subpart C, Sec. 820.30 - Design Controls, and ISO 13485-2003, Section 7.3 - Design and Development; documented results (on file) confirmed there is no biocompatibility risk presented by these materials." This confirms biocompatibility was addressed and meets regulatory requirements.
Overall substantial equivalence demonstrated: The new device (Waterlase MD with Turbo Handpiece) is as safe and effective as the predicate devices and does not introduce new questions of safety or effectiveness. This is the overarching "acceptance criterion" of a 510(k) submission, especially a Special 510(k).	Met: "Substantial equivalency for the Waterlase MD with the Turbo Handpiece has been determined through comparison to the previously cleared Waterlase MD." This is the explicit conclusion of the submission, and the FDA's clearance letter affirms this determination.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No separate "test set" or clinical study data (in terms of patient samples) is referenced for this Special 510(k). This type of submission relies on the existing safety and effectiveness data of the predicate devices. The changes applied (Turbo Handpiece, minor software/graphics) are considered "minor" enough not to necessitate new clinical testing on human subjects for performance.

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. As no clinical test set was used for performance evaluation, there were no experts establishing ground truth in this context. The "ground truth" for this submission are the established safety and effectiveness profiles of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set was used.

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 device is a dental laser system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a physical laser system requiring human operation, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices (Waterlase® MD, K031140, K071363), which were cleared by the FDA based on their own submissions likely involving a combination of performance testing, bench testing, biocompatibility testing, electrical safety testing, and potentially clinical data or reliance on existing scientific literature for similar devices. For this Special 510(k), the "ground truth" is that the modifications do not alter these established profiles.

8. The sample size for the training set:

Not applicable. There is no AI model or "training set" mentioned or implied by the nature of this submission. The "software" changes are described as minor graphical and preset additions, not a learning algorithm.

9. How the ground truth for the training set was established:

Not applicable, as no training set was used.

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K Number

K071363

Device Name

Manufacturer

Date Cleared

2008-02-12

(273 days)

Product Code

GEX,MXF

Regulation Number

Type

Panel

Reference & Predicate Devices

K031140,K013908,K030523,K022803,K011041,K012511,K990908,K990219,K053167,K032361

Intended Use

Root Canal Disinfection

Laser root canal disinfection after endodontic instrumentation

Device Description

The Waterlase® !Waterlase® MD dental laser system is a device used to perform a variety of dental soft and hard tissue indications. For hard tissue procedures the Waterlase® Waterlase MD uses the Erbium, Chromium: Yttrium, Scandium, Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, shave, contour, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er, Cr. YSGG laser energy is applied to incise, excise or ablate these tissues. For soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues and the field of view clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues and field of view clean.
A flexible fiberoptic terminated into the handpiece delivers the Waterlase Waterlase MD laser energy to the end fiber tip and target. As 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Waterlase® and Waterlase® MD dental laser systems, seeking to expand their indications for use to include root canal disinfection. However, the document does not contain specific acceptance criteria, reported device performance metrics in a defined study, or the details typically associated with such studies as requested in the prompt.

Instead, it refers to "performance data, including in-vitro evaluation of anti-microbial efficacy of the Er,Cr:YSGG (Waterlase®) and the evaluation of the temperature rise which related to the safety of these devices during root canal disinfection." It states that "Copies of the study reports are included under section 8, titled Performance Data." This section ("Performance Data") is not provided in the given text extract.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor the detailed study information using only the provided text.

Based on the available text, I can extract the following limited information:

Study Types Mentioned (but not detailed):
- In-vitro evaluation of anti-microbial efficacy of the Er,Cr:YSGG (Waterlase®)
- Evaluation of temperature rise related to safety during root canal disinfection.
Purpose of the Studies: To substantiate equivalency for the expanded indication of root canal disinfection.
Ground Truth for these studies (implied based on stated purpose):
- For anti-microbial efficacy: Likely microbiological assays measuring bacterial reduction.
- For temperature rise: Likely direct temperature measurements in a simulated root canal environment.

All other requested information (acceptance criteria, specific performance metrics, sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided 510(k) summary.

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K Number

K071734

Device Name

WATERLASE MD DERM

Manufacturer

Date Cleared

2008-01-25

(213 days)

Product Code

Regulation Number

Type

Panel