(233 days)
Class I, III and V cavity preparation for caries removal
Caries removal
Hard tissue surface roughening or etching
The Millennium™ hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to ablate dental 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, yielding 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.
The provided 510(k) summary for K980585, the BioLase Millennium™ hydrokinetic tissue cutting system, focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and proving performance against them in a traditional sense. The submission asserts that the device is substantially equivalent to existing dental handpieces and other caries removal/surface roughening devices.
Here's an analysis based on the provided input:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or a threshold for a specific outcome. Instead, it relies on demonstrating equivalence to predicate devices based on a feature comparison and clinical evaluations.
The "Feature Comparison Table" acts as a form of acceptance criteria by showing that the Millennium™ either matches or improves upon features of predicate devices. The "Reported Device Performance" is implied through the claims of substantial equivalence after "multi-phase in-vitro and in-vivo clinical trials on animals and humans."
| Feature/Criterion | Predicate Devices Performance (implied) | Millennium™ Performance (reported) | Conformance (SE = Substantially Equivalent) |
|---|---|---|---|
| Input Voltage | N/A (varied among predicates) | 115/230 V~, 50/60 Hz | YES |
| Materials | Medical grade plastics, steel, stainless steel, aluminum, brass, electronic parts and components (Same) | Medical grade plastics, steel, stainless steel, aluminum, brass, electronic parts and components | YES |
| Indications for Use | Caries removal, cavity preparation (Microetcher Ab and KV-1 also include surface roughening) | Caries removal, cavity preparation, surface roughening (Class I, III and V cavity preparation for caries removal, Caries removal, Hard tissue surface roughening or etching) | YES |
| Cutting Mode | Mechanical, non-thermal | Mechanical, non-thermal | YES |
| Cutting Medium | Rotating bur (for Dental Handpiece), High speed aluminum oxide (for Microetcher Ab, KV-1) | High speed water droplets (hydrokinetic process) | YES (distinct but claimed equivalent mechanism) |
| Biocompatible Cutting Medium? | N/A (for Dental Handpiece), No (for Microetcher Ab, KV-1) | Yes | YES |
| Spray Flow Control? | Yes (for Dental Handpiece), N/A (for Microetcher Ab, KV-1) | Yes | YES |
| Mode of Operation | Contact (for Dental Handpiece), Non-contact (for Microetcher Ab, KV-1) | Non-contact | YES |
| Overall Safety and Efficacy | Established through predicate device history | Demonstrated through in-vitro, in-vivo and clinical trials on animals and humans. Equivalent performance specifications. Clinical evaluation in randomized, double-blinded trials. Pulp temperature studies. Scanning Electron and Optical Microscopy studies. | YES |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the substantial equivalence was demonstrated through "multi-phase in-vitro and in-vivo clinical trials on animals and humans," including "clinical evaluation in randomized, double-blinded trials."
- Sample Size for Test Set: The document does not specify the sample sizes for the human clinical trials.
- Data Provenance (Country of Origin): The document does not specify the country of origin for the clinical trial data.
- Retrospective or Prospective: The mention of "randomized, double-blinded trials" strongly indicates a prospective study design for the clinical evaluation on humans.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in any clinical trials.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set in the clinical trials.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's performance compared to traditional techniques for direct treatment, not on the improvement of human readers interpreting data generated by the device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The Millennium™ is a physical medical device (a hydrokinetic tissue cutting system), not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device. Its performance is inherently tied to being operated by a human clinician. The "in-vitro" and "in-vivo" studies would evaluate the device's physical cutting capabilities, not an algorithmic output.
7. Type of Ground Truth Used
Based on the nature of the device (a dental cutting system) and the mentioned studies:
- Human Clinical Trials: For caries removal, cavity preparation, and surface roughening, the ground truth would likely be established through direct clinical observation, possibly aided by diagnostic imaging (e.g., radiographs) and histological examination for removed tissue characteristics (e.g., caries completely removed, healthy tissue preserved). The "Pulp temperature studies" imply physiological measurements as part of the ground truth for safety.
- Animal Studies: Similar to human clinical trials, focusing on tissue removal, safety, and healing.
- In-vitro Studies: Ground truth would involve quantitative measurements of material removal, cutting efficiency, heat generation on simulated dental tissues, and potentially microscopic analysis (e.g., "Scanning Electron and Optical Microscopy").
8. Sample Size for the Training Set
The document does not provide information on a separate "training set" or its sample size. For a physical device, the "training set" concept is typically applied to AI algorithms or models. The development and refinement of the Millennium™ would involve iterative design, testing (in-vitro, animal), and then human clinical trials, but not a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a "training set" in the AI/ML context, this question does not apply directly. The ground truth for the underlying research and development of the device would have been established through engineering measurements, materials science analysis, and early biological studies (in-vitro, animal studies) to optimize design parameters before formal clinical trials.
{0}------------------------------------------------
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| REGULATORY | |
|---|---|
| AUTHORITY: | 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: | Dental handpiece |
| CLASSIFICATION CODE: | 76 EFB |
| 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 ablate dental 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
{1}------------------------------------------------
droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, yielding 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, III and V cavity preparation for caries removal
Caries removal
Hard tissue surface roughening or etching
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 which 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.
This device is to be used on adults over eighteen years of age only.
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.
{2}------------------------------------------------
| FEATURE | MillenniumTM | Dentalhandpiece | Microetcher Ab | KV-1 | SE |
|---|---|---|---|---|---|
| InputVoltage: | 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 |
| IndicationsforUse: | Caries removal, cavitypreparation, surfaceroughening | Caries removal, cavitypreparation | Caries removal, cavitypreparation, surfaceroughening | Caries removal, cavitypreparation, surfaceroughening | YES |
| CuttingMode: | Mechanical, non-thermal | Same | Same | Same | YES |
| CuttingMedium: | High speed waterdroplets | Rotating bur | High speed aluminumoxide | High speed aluminumoxide | YES |
| BiocompatibleCuttingMedium? | Yes | N/A | No | No | YES |
| SprayFlowControl? | 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 |
FEATURE COMPARISON TABLE
CONCLUSION:
Millennium™ is substantially equivalent to several available, established dental technologies. Safety and efficacy have been demonstrated through in-vitro, invivo 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
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1999
Mr. Andrew I. Kimmel Vice President for Regulatory Affairs Biolase Technology, Inc. 981 Calle Amanecer San Clemente, California 92673
Re: K980585 Trade Name: Millennium™ Regulatory Class: II Product Code: MXF Dated: July 31, 1998 Received: August 25, 1998
Dear Mr. Kimmel:
This letter corrects our substantially equivalent letter of October 13, 1998 regarding the Product Code.
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 regulation (21 CFR Part 820) and that, through periodic 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
{4}------------------------------------------------
Page 2 -- Mr. Andrew I.Kimmel
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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
{5}------------------------------------------------
Ka80285 510(k) Number (if known):
Millennium™ Device Name:
Indications For Use:
Class I, III and V cavity preparation for caries removal
Caries removal
Hard tissue surface roughening or etching
This device is to be used on adults 18 years of age or older.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K980585 |
| Prescription Use (Per 21 CFR 801.109) | X | or | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.