(8 days)
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
- For use on adult and pediatric patients
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal
- · Root canal preparation including enlargement
- · Root canal debridement and cleaning
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
- · Incision and drainage of periapical abscesses.
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Bone Surgical Indications
- " Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- · Osteotomy
Laser Periodontal Procedures
- " Full thickness flap
- · Partial thickness flap
- · Split thickness flap
- · Laser soft tissue curettage
- · Laser removal of diseased, infected, inflamed and necrosed soft issue 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, 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
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
- · Root canal debridement and cleaning
- · 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
- 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
- For use on adult and pediatric patient
The Waterlase® 3.0 hydrokinctic dental laser system is a diverse device utilized to perform a variety of applications. For hard tissue procedures the Waterlase 3.0 uses the Erbium, dental Chromium: Ytrium, Scandium, Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er. YSGG laser energy is applied to incise, excise or ablate these tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues clean.
A flexible fiberoptic handpiece delivers the Waterlase@3.0 laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. to specific user requirements.
This document is a 510(k) Special Summary for the Biolase Technology, Inc. Waterlase® 3.0, an Er,Cr:YSGG laser system. It describes the device, its indications for use, and confirms its substantial equivalence to a previously cleared predicate device (Waterlase® K030523).
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain acceptance criteria or performance data in the traditional sense of a clinical study demonstrating specific efficacy metrics. This is a 510(k) Special Summary, which typically focuses on demonstrating that a modified device is substantially equivalent to a previously cleared predicate device, rather than providing new clinical performance data against specific acceptance criteria. The "performance" described is the device's functional capabilities (e.g., cutting, removing, etching tissues) and its intended applications, which are considered equivalent to the predicate device.
Therefore, a table of acceptance criteria and reported device performance, as would be found in a clinical study report with quantitative outcomes, cannot be extracted from this document. The basis for clearance is substantial equivalence to an existing device, meaning its safety and effectiveness are considered the same as the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
No test set or clinical study data (prospective or retrospective) is mentioned in this 510(k) Special Summary. The demonstration of substantial equivalence relies on device design, technological characteristics, and intended uses being similar to the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No test set or ground truth establishment related to clinical performance is described.
4. Adjudication Method for the Test Set:
Not applicable. No test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The submission is for substantial equivalence to a predicate device, not for a comparative effectiveness study with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a laser system, not an AI algorithm, so the concept of standalone performance for an algorithm is not relevant.
7. Type of Ground Truth Used:
Not applicable. The document does not describe the use of a ground truth in the context of clinical performance evaluation for this submission. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.
8. Sample Size for the Training Set:
Not applicable. The device is a medical instrument (laser system), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this is not an AI algorithm.
Summary of Device Acceptance (based on the provided document):
The Waterlase® 3.0 was accepted by the FDA based on a 510(k) Special Summary demonstrating substantial equivalence to a previously cleared predicate device, the Waterlase® (K030523).
- Acceptance Criteria (Implied by 510(k) Special): The Waterlase® 3.0 must have the same intended use, technological characteristics, and fundamental scientific technology as the predicate device, or have different technological characteristics that do not raise new questions of safety or effectiveness and are supported by appropriate data.
- Study Proving Acceptance: The "study" is the comparison analysis performed by Biolase Technology, Inc. presented in the 510(k) submission, asserting that the Waterlase® 3.0's device description, operational modes, and indications for use are "the same as indications that have been previously cleared by the FDA for the predicate device."
Key Takeaway: This document is a regulatory submission focused on proving equivalence for a laser device, not a report on a clinical trial with specific performance metrics and acceptance criteria. Therefore, most of the requested fields are not applicable to the information contained within.
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JUN 1 3 2008
Biolase Technology, Inc. Special 510(k) Summary Statement Waterlase®3.0 CONFIDENTIAL
CONFIDENTIAL
K081588
510(k) SPECIAL Summary (As required by 21CFR807.92, 21CFR807.81(a)(3), FDA Memorandum #K97-1)
| Date Prepared: | June 3, 2008 |
|---|---|
| Company: | Biolase Technology, Inc.4 CromwellIrvine, CA 92618Tel: (949) 361-1200Fax: (949) 273-6680 |
| Contact: | Ms. Ioana M. RizoiuVP, Clinical R&DTel: (949) 226-8144email: irizoiu@biolase.com |
| Trade Name: | Waterlase® 3.0 |
| Common Name: | Er,Cr:YSGG laser |
| Classification Name: | Surgical laser instrument |
| Classification Code: | 79 GEX, MXF, DZI a Class II device |
| Predicate Devices: | Waterlase®Biolase Technology, IncK030523 (January 30, 2004) |
DEVICE DESCRIPTION:
The Waterlase® 3.0 hydrokinctic dental laser system is a diverse device utilized to perform a variety of applications. For hard tissue procedures the Waterlase 3.0 uses the Erbium, dental Chromium: Ytrium, Scandium, Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er. YSGG laser energy is applied to incise, excise or ablate these tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues clean.
A flexible fiberoptic handpiece delivers the Waterlase@3.0 laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the
{1}------------------------------------------------
power output, pulse energy, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. to specific user requirements.
INDICATIONS FOR 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
-
- For use on adult and pediatric patients
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal
- · Root canal preparation including enlargement
- · Root canal debridement and cleaning
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
- · Incision and drainage of periapical abscesses.
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Bone Surgical Indications
- " Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- · Osteotomy
Laser Periodontal Procedures
- " Full thickness flap
- · Partial thickness flap
- · Split thickness flap
- · Laser soft tissue curettage
- · Laser removal of diseased, infected, inflamed and necrosed soft issue within the periodontal pocket
{2}------------------------------------------------
- · 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, 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
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
- · Root canal debridement and cleaning
- · 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
{3}------------------------------------------------
- · 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
- For use on adult and pediatric patient
CONTRAINDICATIONS:
All clinical procedures performed with the Waterlase 3.0 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 the patient's physician is advisable when doubt exists regarding treatment.
Conclusion:
The indications included herein are the same as indications that have been previously cleared by the FDA for the predicate device. Substantial equivalency for the Waterlase 3.0 has been determined through comparison to a previously cleared device.
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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The seal is black and white and appears to be a scanned or reproduced image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2008
Biolase Technology, Inc. % Ms. Ioana M. Rizoiu VP. Clinical R&D 4 Cromwell Irvine, California 92618
Re: K081589 Trade/Device Name: Waterlase® 3.0 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 Dated: June 3, 2008 Received: June 5, 2008
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 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
{5}------------------------------------------------
Page 2 - Ms. Ioana M. 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 a legally marketed predicate device results in a classification for your device and thus, permits your device 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 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,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K08 1589
Device Name: Waterlase® 3.0
Indications for Use:
General Indications *
- Class I, II, III, IV and V cavity preparation 제
- . Caries removal
- l Hard tissue surface roughening or etching
- 치 Enameloplasty, excavation of pits and fissures for placement of sealants
- For use on adult and pediatric patients
Root Canal Hard Tissue Indications
- 트 Tooth preparation to obtain access to root canal
- 트 Root canal preparation including enlargement
- Root canal debridement and cleaning I
Endodontic Surgery (Root Amputation) Indications
- E Flap preparation - incision of soft tissue to prepare a flap and expose the bone,
- 8 Cutting bone to prepare a window access to the apex (apices) of the root(s).
- 트 Apicoectomy - amputation of the root end.
- Root end preparation for retrofill amalgam or composite. 트
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Bone Surgical Indications
- I 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 ■
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KV8
{7}------------------------------------------------
- 페 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 세 impactions)
- 트 Frenectomy and frenotomy
- 제 Gingival troughing for crown impressions
- 트 Gingivectomy
- I Gingivoplasty
- Gingival incision and excision 트
- 트 Hemostasis
- 트 implant recovery
- 트 Incision and drainage of abscesses
- . Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
- 후 Leukoplakia
- 피 Operculectomy
- 프 Oral papillectomies
- 트 Operculectomy
- 트 Oral papillectomies
- l Pulpotomy
- Pulp extirpation
- " Pulpotomy as an adjunct to root canal therapy
- 프 Root canal debridement and cleaning
- Reduction of gingival hypertrophy ■
- 발 Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues
- (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
- 보 Soft tissue crown lengthening
- 포 Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- .. Vestibuloplasty
- For use on adult and pediatric patient
Laser Periodontal Procedures
- I Full thickness flap
- I Partial thickness flap
- I Split thickness flap
.
- . Laser soft tissue curettage
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Laser soft tissue curettage
510(k) Number K081589
Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal
- pocket 트 Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium
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- . Removal of granulation tissue from bony defects
- l 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)
- 피 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
Prescription Use X Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter
(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)
Nijel Osh for mkn
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K081589
§ 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.