(70 days)
For use on adult and pediatric patients for the following:
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
The Millennium™ hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to incise, excise and ablate intraoral soft and hard tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result.
The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, vielding quick and clean mechanical tissue removal.
A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
This document describes the BioLase Technology, Inc. Millennium™ hydrokinetic tissue cutting system, intended for various dental applications.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" for the Millennium™ device in terms of specific performance metrics (e.g., specific percentages for accuracy, sensitivity, or specificity). Instead, substantial equivalence to existing predicate devices (dental handpieces, microetchers) is demonstrated through a feature comparison table and qualitative statements regarding safety and efficacy.
| Feature | Acceptance Criteria (Implied by Predicate Devices) | Reported Millennium™ Performance | Meets Criteria? |
|---|---|---|---|
| Indications for Use | Caries removal, cavity preparation, surface roughening (for microetchers), incision, excision, and ablation of soft tissues (implied by combined predicates) | Caries removal, cavity preparation, surface roughening, incision, excision and ablation of soft tissuesSpecifically for adult and pediatric patients for Class I-V cavity preparation, caries removal, hard tissue surface roughening or etching, enameloplasty, excavation of pits and fissures for placement of sealants. | YES |
| Cutting Mode | Mechanical, non-thermal | Mechanical, non-thermal | YES |
| Cutting Medium | Rotating bur (dental handpiece), High speed aluminum oxide (microetcher) | High speed water droplets | YES |
| Biocompatible Cutting Medium? | N/A (Yes for standard handpieces; No for microetchers) | Yes (advantage over microetchers) | YES |
| Spray Flow Control? | Yes (dental handpiece) | Yes | YES |
| Mode of Operation | Contact (dental handpiece), Non-contact (microetcher) | Non-contact | YES |
| Safety | Safe for dental applications, no undue risks | Demonstrated through multi-phase in-vitro and in-vivo clinical trials on animals and humans, including pulp temperature studies. | YES |
| Efficacy | Effective for stated indications | Demonstrated through multi-phase in-vitro and in-vivo clinical trials on animals and humans. | YES |
The basis for acceptance is stated as "substantially equivalent" to predicate devices, which implies that the device performs with comparable safety and efficacy for its intended use.
2. Sample Sizes Used for the Test Set and Data Provenance
The document states: "reported results from multi-phase in-vitro and in-vivo clinical trials and Feature Comparison Table demonstrate that Millennium™ is substantially equivalent..." and "Safety and efficacy have been demonstrated through in-vitro, in-vivo and clinical trials on animals and humans."
- Test Set Sample Size: The specific sample sizes for the in-vivo human clinical trials are not provided in the summary.
- Data Provenance: The document does not specify the country of origin for the data. The studies performed include both in-vitro and in-vivo (on animals and humans), indicating a mix of pre-clinical bench testing and prospective clinical investigation. The term "reported results" suggests the studies were already completed at the time of submission (retrospective for the submission itself, though the trials were prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The summary broadly refers to "clinical evaluation in randomized, double-blinded trials" but does not detail the process or experts involved in establishing ground truth for the clinical outcomes.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable to this type of device (a dental cutting system). The device itself performs a physical action, not an interpretative task requiring human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
This is not applicable as the Millennium™ is a physical surgical device, not an AI algorithm. Its performance is always a "human-in-the-loop" scenario, as a dentist or dental professional operates it.
7. Type of Ground Truth Used
The ground truth for the performance of the Millennium™ device appears to be based on:
- Clinical Evaluation: Outcomes from "randomized, double-blinded trials" on humans, assessed by clinicians to determine safety and efficacy (e.g., caries removal, cavity preparation success, patient comfort, extent of tissue removal).
- Pulp Temperature Studies: Objective physiological measurements to ensure safety (e.g., avoiding thermal damage).
- Scanning Electron and Optical Microscopy: Objective imaging to assess the quality of tissue cutting and surface preparation, and potentially to corroborate efficacy.
- Equivalent Performance Specifications: Comparison to established predicate devices based on their known performance.
8. Sample Size for the Training Set
This is not applicable as the Millennium™ is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the Millennium™ is a physical device, not an AI/ML algorithm.
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MAY 2 7 1999
990908
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: | Mr. Andrew I. KimmelBioLase Technology, Inc.981 Calle AmanecerSan Clemente, California 92673(714) 361-1200 (714) 361-0204 Fax | |||
| TRADE NAME: | Millennium™ | |||
| COMMON NAME: | Hydrokinetic tissue cutting system | |||
| CLASSIFICATION NAME: | Hydrokinetic device | |||
| CLASSIFICATION CODE: | 79 MXF | |||
| EQUIVALENT DEVICES: | ||||
| Dental handpiece | Dentsply | |||
| Dental handpiece | Star Dental | |||
| Dental handpiece | Siemens | |||
| Microetcher Ab | Danville Engineering, Inc. | |||
| KV-1 | Kreativ, Inc. |
DEVICE DESCRIPTION:
The Millennium™ hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to incise, excise and ablate intraoral soft and hard tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result.
{1}------------------------------------------------
The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, vielding quick and clean mechanical tissue removal.
A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
INDICATIONS FOR USE:
Class I - V cavity preparation
Caries removal
Hard tissue surface roughening or etching
Enameloplasty, excavation of pits and fissures for placement of sealants
CAUTIONS AND CONTRAINDICATIONS:
All clinical procedures performed with Millennium™ 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. This Premarket Notification, reported results from multi-phase in-vitro and in-vivo clinical trials and Feature Comparison Table demonstrate that Millennium™ is substantially equivalent to the Dental handpiece in terms of safety and efficacy.
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FEATURE COMPARISON TABLE
| FEATURE | Millennium ™ | Dental handpiece | Microetcher Ab | KV-1 | SE |
|---|---|---|---|---|---|
| Input Voltage: | 115/230 V~50/60 Hz | N/A | N/A | N/A | YES |
| Materials: | Medical grade plastics,steel, stainless steel,aluminum, brass andelectronic parts andcomponents | Same | Same | Same | YES |
| Indications for Use: | Caries removal, cavitypreparation, surfaceroughening, incision,excision and ablationof soft tissues | Caries removal, cavitypreparation | Caries removal, cavitypreparation, surfaceroughening | Caries removal, cavitypreparation, surfaceroughening | YES |
| Cutting Mode: | Mechanical, non-thermal | Same | Same | Same | YES |
| Cutting Medium: | High speed waterdroplets | Rotating bur | High speed aluminumoxide | High speed aluminumoxide | YES |
| BiocompatibleCutting Medium? | Yes | N/A | No | No | YES |
| Spray FlowControl? | Yes | Yes | N/A | N/A | YES |
| Mode ofOperation: | Non-contact | Contact | Non-contact | Non-contact | YES |
| Manufacturer: | BioLase Technology,Inc | DentsplyLaers ResearchMidwestStar DentalSiemens | Danville EngineeringInc. | Kreativ Inc. | YES |
CONCLUSION:
Millennium™ is substantially equivalent to several available, established dental technologies. Safety and efficacy have been demonstrated through in-vitro, in-vivo and clinical trials on animals and humans. Technically, Millennium™ performs through the same mechanical mechanism as other technologies but has the benefit of using a biocompatible agent as its cutting medium. Evidence of equivalence has been demonstrated through:
- . Clinical evaluation in randomized, double-blinded trials
- . Pulp temperature studies
- . Scanning Electron and Optical Microscopy
- . Equivalent performance specifications
- Promotional materials for equivalent systems .
- . Equivalent intended uses
- . Feature comparison table
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MENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Book 1 2 Nint
Mr. Andrew I. Kimmel Vice President for Regulatory Affairs Biolase Technology, Inc. 981 Calle Amanecer San Clemente, California 92673
Re: K990908
Trade Name: Millennium Regulatory Class: II Product Code: MXF Dated: March 15, 1999 Received: March 18, 1999
Dear Mr. Kimmel:
This letter corrects our substantially equivalent letter of May 27, 1999 regarding the Indication for Use by adding the phrase, "For use on adult and pediatric patients."
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 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). 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 Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic OS inspections. FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.
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Page 2 -- Mr. Andrew I. Kimmel
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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
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Page 1 of 1
510(k) Number (if known): 990908
Device Name:
Millennium™
Indications for Use:
For use on adult and pediatric patients for the following:
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
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-The-Counter-Use _
tsa
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number L990908
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.