(88 days)
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Laser Assisted Uvulopaletoplasty (LAUP) This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chroninc palatal snoring. Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Reduction of bacterial level (decontamination) and inflammation Soft tissue crown lengthening Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Treatment of aphthous ulcers Vestibuloplasty
Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples: Removal of beningn lesions from ear, nose and throat. Excision and vaporization of vocal cord nodules and polyps. Incision and excision of carcinoma in-situ. Ablation and vaporization of kyperkeratosis. Excision of carcinoma of the larynx. Laryngeal papillomectomy. Excision and vaporization of herpes simplex I and II.
Arthroscopy: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery. Examples: Menisectomy Synovectomy Chondromalacia
Gastroenterology: Hemostasis, incision, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples: Hemostasis of upper and lower GI bleeding Excision and vaporization of colorectal carcinoma Excision of polyps
General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcer Hepatobiliary Mastectomy Dermabrasion Vaporization & hemostasis of capillary hemangioma Excision, vaporization & hemostasis of abdominal tumors Excision, vaporization & hemostasis of rectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs
GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples: Hemorrhoidectomy Excision, vaporization, and hemostasis of rectal pathology Excision, vaporization, and hemostasis of abdominal tumors
Gynecology: Ablation, excision, hemostasis and vaporization of tissue. Examples: Endometrial ablation Excision or vaporization of condylomata acuminata Vaporization of CIN (cervical intraepithelial neoplasia) Cervical conization Menorrhagia
Neurosurgery: Hemostasis of tissue. Example: Hemostasis in conjunction with meningiomas
Ophthalmology: Retinal photocoagulation Diabetic retinopathy
Pulmonary Surgery: Hemostasis, vaporization, and excision of tissue. Examples: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction
Urology: Hemostasis, vaporization and excision of tissues. Examples: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia.
The Twilight™ dental diode laser system may be used to perform several dental applications. Twilight™ uses advanced laser technology to incise, excise and ablate intraoral soft tissues safely and effectively. A Gallium Aluminum Arsenide (GaAIAs) solid state laser diode provides optical energy to oral soft tissues. A flexible fiberoptic handpiece delivers the Twilight™ laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and pulse may be adjusted to specific user requirements.
The provided document is a 510(k) premarket notification for a medical device called "Twilight™," a dental diode laser system. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with specific acceptance criteria and performance data.
Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and detailed ground truth for test and training sets) are not explicitly available in this type of submission.
The core of this 510(k) is to establish that the Twilight™ laser is "substantially equivalent" to predicate devices already on the market. This often means demonstrating similar technological characteristics, intended uses, and safety profiles, rather than conducting new clinical trials to prove efficacy against specific, new acceptance criteria.
However, based on the information provided, here's what can be inferred and stated regarding your request:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or report specific device performance metrics (e.g., success rates, precision, accuracy) from a dedicated study. The "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to predicate devices, meaning it performs similarly and is as safe and effective for its indicated uses.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Implicit from Substantial Equivalence Claim) |
|---|---|
| Safe and effective operation for indications for use. | The device "incise, excise and ablate intraoral soft tissues safely and effectively." "Twilight™ performs through the same mechanism as other diode laser technologies." |
| Equivalent performance specifications to predicate devices. | Stated as "Equivalent performance specifications." |
| Equivalent intended uses to predicate devices. | Stated as "Equivalent intended uses." |
| Equivalent mechanism of action to predicate devices. | Stated as "performs through the same mechanism as other diode laser technologies." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not provided. This submission does not describe a clinical study with a "test set" in the context of evaluating novel performance. Instead, it relies on the known performance and safety of predicate devices.
- Data Provenance: Not applicable/Not provided. No specific study data is presented. The "evidence of equivalence" is based on comparing the Twilight™ device's specifications and intended uses to those of existing, FDA-cleared predicate devices.
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)
- Number of Experts: Not applicable/Not provided. No clinical study requiring expert-established ground truth is described.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not provided. No clinical study requiring adjudication is described.
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
- MRMC Study: Not applicable. This document pertains to a medical device (laser system) and not an AI/imaging diagnostic device that would typically involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This document is for a physical medical device (laser system), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable/Not provided. No new ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence rests on the established safety and effectiveness of the predicate devices for their approved indications.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not provided. No training set for an algorithm is relevant to this device submission.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable/Not provided.
{0}------------------------------------------------
SEP 1 0 1999
K991994
510(k) Summary of Safety and Effectiveness Information
| RegulatoryAuthority: | Safe Medical Devices Act of 1990,21 CFR 807.92 |
|---|---|
| Company: | BioLase Technology, Inc.981 Calle AmanecerSan Clemente, California 92673 |
| Contact: | Ms. Ioana M. RizoiuBioLase Technology, Inc.981 Calle AmanecerSan Clemente, California 92673(714) 361-1200 (714) 361-0204 Fax |
| Trade Name: | Twilight™ |
| Common Name: | Dental diode laser |
| Classification Name: | Surgical laser instrument |
| Classification Code: | 79 GEX |
| Equivalent Devices: | |
| American Dental Technologies | PulseMaster™ |
| Dentek-LaserSystems | LD-15™ |
| Premier Laser Systems | Aurora™ |
Device Description:
The Twilight™ dental diode laser system may be used to perform several dental applications. Twilight™ uses advanced laser technology to incise, excise and ablate intraoral soft tissues safely and effectively. A Gallium Aluminum Arsenide (GaAIAs) solid state laser diode provides optical energy to oral soft tissues.
A flexible fiberoptic handpiece delivers the Twilight™ laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and pulse may be adjusted to specific user requirements.
Indications for Use:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including:
Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy
{1}------------------------------------------------
Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Laser Assisted Uvulopaletoplasty (LAUP) This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chroninc palatal snoring. Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Reduction of bacterial level (decontamination) and inflammation Soft tissue crown lengthening Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Treatment of aphthous ulcers Vestibuloplasty
Cautions and Contraindications:
All clinical procedures performed with Twilight™ must be subjected to the same clinical judgement 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 that might contraindicate a local procedure. Such conditions may include 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:
There are no unique applications, indications, materials or specifications presented herein. Twilight™ is identical to several other diode laser systems cleared by the FDA. Equivalent devices include: Premier, Aurora™(K954316), American Dental
Technologies, PulseMaster™ (K972325) and Dentek, LD-15 ™ (K974057) for general dental soft tissue applications, Premier, Aurora™ (K981379) for pulpotomy and American Dental Technologies, PulseMaster™ (K961269) and Premier, Aurora™ (K974586) for sulcular debridement.
Conclusion:
Twilight™ is substantially equivalent to several available, established dental diode laser products. Twilight™ performs through the same mechanism as other diode laser technologies.
· Evidence of equivalence has been demonstrated through:
{2}------------------------------------------------
- Equivalent performance specifications
- Promotional materials for equivalent systems
- Equivalent intended uses
/
ﺮ ... ﻭ
.
{3}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/3/Picture/10 description: The image shows a partial view of a logo or emblem, featuring a stylized graphic element consisting of three curved lines stacked on top of each other. The lines appear to be thicker at the top and taper slightly as they descend. To the left of the graphic, a portion of text is visible, arranged vertically and curved to follow the shape of the graphic. The text is in a sans-serif font and appears to be part of a larger phrase or title.
SEP 1 0 1999
Ms. Ioana M. Rizoiu Vice President, Clinical Research and Development BIOLASE Technology, Inc. 981 Calle Amanecer San Clemente, California 92673
K991994 Re: Trade Name: TwilightTM Regulatory Class: II Product Code: GEX Dated: June 11, 1999 Received: June 14, 1999 ·
Dear Ms. Rizoiu:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{4}------------------------------------------------
Page 2 - Ms. Ioana M. Rizoiu
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
DUPLICATE
K 99 1994/K²
Page 1 of 3
510(k) Number : K991994
Device Name:
Twilight™
Indications for Use:
Ear, Nose and Throat and Oral Surgery:
Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples:
Removal of beningn lesions from ear, nose and throat. Excision and vaporization of vocal cord nodules and polyps. Incision and excision of carcinoma in-situ. Ablation and vaporization of kyperkeratosis. Excision of carcinoma of the larynx. Laryngeal papillomectomy. Excision and vaporization of herpes simplex I and II.
Arthroscopy:
Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery.
Examples:
Menisectomy Synovectomy Chondromalacia
Gastroenterology:
Hemostasis, incision, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples:
Hemostasis of upper and lower GI bleeding Excision and vaporization of colorectal carcinoma Excision of polyps
General Surgery, Dermatology & Plastic Surgery, and Podiatry:
510(k) Number
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples:
24 Aug 99 13 5
| Matrixectomy |
|---|
| Excision of neuromas |
| Excision of periungual and subungual warts |
| Excision of plantar warts |
| Excision of Keloids |
| Liver resection |
| Excision of cutaneous lesions |
| Hemorrhoidectomy |
| Appendectomy |
(Division Sign-Off)
Division of General Restorative Devices K99199
{6}------------------------------------------------
Page 2 of 3
General Surgery, Dermatology & Plastic Surgery, and Podiatry (continues): Examples:
Debridement of decubitus ulcer Hepatobiliary Mastectomy Dermabrasion Vaporization & hemostasis of capillary hemangioma Excision, vaporization & hemostasis of abdominal tumors Excision, vaporization & hemostasis of rectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs
GI/GU:
Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples:
Hemorrhoidectomy Excision, vaporization, and hemostasis of rectal pathology Excision, vaporization, and hemostasis of abdominal tumors
Gynecology:
Ablation, excision, hemostasis and vaporization of tissue. Examples:
Endometrial ablation Excision or vaporization of condylomata acuminata Vaporization of CIN (cervical intraepithelial neoplasia) Cervical conization Menorrhagia
Neurosurgery:
Hemostasis of tissue. Example:
Hemostasis in conjunction with meningiomas
Ophthalmology:
Retinal photocoagulation Diabetic retinopathy
Signature
(Division Sign Off) Division of General Restorative Devices K 9 9 199 9 510(k) Number
Pulmonary Surgery:
Hemostasis, vaporization, and excision of tissue. Examples:
Tracheobronchial malignancy or stricture
{7}------------------------------------------------
Page 3 of 3
Pulmonary Surgery (continues):
Hemostasis, vaporization, and excision of tissue. Examples:
Benign and malignant pulmonary obstruction
Urology: Hemostasis, vaporization and excision of tissues. Examples:
Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OL
Over-The-Counter-Use _
pcoelle
(Division Sigo-Off)
Division of General Restorative Devices
510(k) Number _**_K991994
§ 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.