(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: 1. Have the same intended use as a legally marketed predicate device. 2. Have the same technological characteristics as the predicate device; OR 3. 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: 1. 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. 2. 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.
{0}------------------------------------------------
CONFIDENTIAL
食
510k Summary of Safety and Effectiveness Waterlase® MD Expanded Indications for Use Biolase Technology, Inc. December 30, 2008
10/2
OCT - 1 2009
510(k) Summary of Safety and Effectiveness Information
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company: Biolase Technology, Inc. 4 Cromwell Irvine, CA 92618
Contact:
Ms. Ioana M. Rizoiu Biolase Technology, Inc. 4 Cromwell Irvine, CA 92618 Tel: (949) 226-8144 Fax: (949) 273-6680
Waterlase® MD
Trade Name:
Common Name: Er,Cr:YSGG laser
Classification Name: Surgical laser instrument
Classification Code: 79 GEX, a Class II device
Equivalent Devices:
Millenium Dental Technologies, Inc Fotona d.d. Cynosure, Inc.
Periolase Fidelis III Laser System Family Smart CO2
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.
{1}------------------------------------------------
CONFIDENTIAL
510k Summary of Safety and Effectiveness Waterlase® MD Expanded Indications for Use Biolase Technology, Inc December 30, 2008
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.
Indications for Use:
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)
Contraindications:
All clinical procedures performed with Waterlase MD must be subject to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions, which might contraindicate a local procedure. Such conditions may include, but are not limited to, allergy to local or topical anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.
Conclusion:
The indication included herein is the same as the indication that has been previously cleared by the FDA for other dental laser devices. Substantial equivalency for the Waterlase MD has been determined through comparison to previously cleared dental laser devices.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring. MD 20993-0002
Ms. Ioana Rizoiu Vice President of Clinical Research and Development Biolase Technology, Incorporated 4 Cromwell Irvine, California 92618
- Re: K083927
Trade/Device Name: Waterlase® MD Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use In General and Plastic Surgery and In Dermatology
OCT - 1 2009
Regulatory Class: II Product Code: GEX Dated: September 25, 2009 Received: September 28, 2009
Dear Ms. Rizoiu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2- Ms. Rizoiu
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ht foc
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement
510(k) Number: K_____________________________________________________________________________________________________________________________________________________________
Device (Trade) Name: Waterlase®MD
Indications for 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).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rin Harly for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083927
§ 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.