(273 days)
No
The description focuses on the laser technology and its physical parameters (power, pulse duration, frequency, air/water flow) and does not mention any AI or ML components.
Yes
The device is used for "Root Canal Disinfection," which is a treatment for a medical condition.
No
The device is described as a laser system used for root canal disinfection by cutting, removing, shaving, contouring, roughening, and etching tissues, which are therapeutic actions, not diagnostic ones.
No
The device description clearly details a physical laser system with hardware components like a handpiece, fiberoptic cable, and adjustable settings for power, pulse duration, and flow rates. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of this device is "Root Canal Disinfection" and the device description clearly states it's a dental laser system used to perform procedures directly on the patient's tissues (hard and soft tissue, root canal).
- IVDs are used to provide information for diagnosis, monitoring, or treatment. While root canal disinfection is part of a treatment, the device itself is performing a physical action (laser energy application) on the tissue, not analyzing a specimen to provide diagnostic or monitoring information.
- The predicate devices are root canal cleansers. These are also devices used directly in the root canal for treatment, not for in vitro diagnostic testing.
The description of the device and its intended use clearly indicate it is a therapeutic device used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Root Canal Disinfection
- Laser root canal disinfection after endodontic instrumentation
Product codes (comma separated list FDA assigned to the subject device)
GEX, MXF, DZI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root Canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BIOPURE MTAD Root Canal Cleanser K053167, EndoPure Root Canal Cleanser K032361
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K031140, K013908, K030523, K022803, K011041, K012511, K990908, K990219
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 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 |
| 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:
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.
1
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.
2
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.
3
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
4
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
5
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