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.

Summary

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FEB 1 2 2008

510k Summarv of Safety and Effectiver Waterlase® MD Expanded Indications for Use Biolase Technology, Inc April 16, 2007 Rev B CONFIDENTIAL

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 CromwellIrvine, CA 92618
Contact:	Ms. Ioana M. RizoiuBiolase Technology, Inc.4 CromwellIrvine, CA 92618Tel: (949) 226-8144Fax: (949) 273-6680
Trade Name:	Waterlase® and Waterlase® MD
Common Name:	Er,Cr:YSGG laser
Classification Name:	Surgical laser instrument
Classification Code:	79 GEX, MXF, DZI a Class II device
Equivalent Devices:
Biolase Technology, Inc.	Waterlase®
Dentsply Intl, Inc.	EndoPure™ Root Canal Cleanser
Dentsply Intl, Inc.	BioPure® MTAD® Root Canal Cleanser

Device Description:

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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.

Indications for Use:

Root Canal Disinfection

Laser root canal disinfection after endodontic instrumentation

Contraindications:

All clinical procedures performed with Waterlase® 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.

Substantial Equivalence:

The purpose of the 510(k) is to expand the Waterlase®, and Waterlase®MD indications for use to include root canal disinfection, an indication that has already been cleared by the FDA for equivalent medical devices. The Waterlase®, and Waterlase®MD have already been cleared by the FDA for indications which relate to root canal procedures and surgical endodontic procedures related to root end amputation. Other indications cleared for this device include cavity preparations class I, II, III, IV and V, cutting, shaving, contouring and resection of osseous tissue, osteotomy, hard tissue roughening or etching, enameloplasty, soft tissue procedures and periodontal procedures related to surgery and the periodontal pocket. The Waterlase®, and Waterlase®MD indications enumerated above have been cleared by the FDA as part of the 510(k) submissions K031140, K013908, K030523, K022803, K011041, K012511, K990908, and K990219. For the indication on root canal disinfection requested with this submission. the Waterlase®, and Waterlase®MD are equivalent to the following products: BIOPURE MTAD Root Canal Cleanser K053167, and EndoPure Root Canal Cleanser K032361. Comparison between Waterlase®, and Waterlase®MD and the predicate devices is included in Table 1. Based on the comparison, the Waterlase®, and Waterlase®MD are substantially equivalent in relation to previous clearances.

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Equivalency was further substantiated through 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. Copies of the study reports are included under section 8, titled Performance Data.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

FEB 1 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BIOLASE Technology, Inc. % Ioana Rizoiu VP, Clinical Research & Development 4 Cromwell Irvine, California 92618

Re: K071363 Trade/Device Name: Waterlase® and Waterlase® MD Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, MXF Dated: January 4, 2008 Received: January 8, 2008

Dear Ioana 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 such 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.

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); good manufacturing practice requirements as set

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Page 2 – Ioana Rizoiu

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, permits your levice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsiblities 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 vours.

Mark N. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K071363

Device (Trade) Name: Waterlase® and Waterlase® MD

Indications for Use:

Root Canal Disinfection

Laser root canal disinfection after endodontic instrumentation
Prescription Use X (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

510(k) Number.

Concurrence of CBRH Office of Device Evaluation (ODE)

(Division Sign-Off

Division of General, Restorative,
and Neurological Devices

Regulation Number and Section

§ 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.