(33 days)
Not Found
Not Found
No
The description focuses on the physical mechanism of hydrokinetic cutting using a laser and water, with no mention of AI or ML for decision-making, image analysis, or control beyond user adjustments.
Yes
The device is described as a hydrokinetic tissue cutting system used for "incise, excise and ablate intraoral soft and hard water alonitation totatively," which are therapeutic actions. Its indicated uses, such as "cavity preparation" and "caries removal," directly involve treating medical conditions or altering the body's structure and function.
No
Explanation: The device is described as a "tissue cutting system" used for "cavity preparation," "caries removal," and "hard tissue surface roughening or etching." These are all therapeutic and preparatory procedures, not diagnostic ones.
No
The device description clearly details hardware components such as a laser, fiberoptic handpiece, and a system that utilizes atomized water droplets for cutting. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for Class I - V cavity preparation, caries removal, and hard tissue surface roughening or etching. These are all procedures performed directly on the patient's tissues within the mouth.
- Device Description: The device is a laser system that uses hydrokinetic forces to cut tissue. This is a therapeutic and surgical function, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to provide diagnostic information about a patient's health or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to physically alter tissue within the body.
N/A
Intended Use / Indications for Use
Class I - V cavity preparation
Caries removal
Hard tissue surface roughening or etching
Product codes (comma separated list FDA assigned to the subject device)
79 MXF
Device Description
The Millennium™ hydrokinetic tissuc cutting system is a diverse instrument for Pine Millennium - Hydrokins. Millennium™ utilizes advanced laser and performing coverer. comologies to incise, excise and ablate intraoral soft and hard water alonitation totatively. An erbium, chromium, yttrium, scandium, gallium gamet (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral soft and hard
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)
in-vitro and in-vivo clinical trials on animals and humans.
Clinical evaluation in randomized, double-blinded trials.
Pulp temperature studies
Scanning Electron and Optical Microscopy.
Equivalent performance specifications.
Equivalent intended uses.
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.
Not Found
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.
Not Found
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
§ 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.
0
p.3
Image /page/0/Picture/4 description: The image shows a handwritten date, "2/24/99". The numbers are written in black ink on a white background. The handwriting is somewhat cursive, with the numbers slightly slanted.
990219
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 Amanecer | |||
| San Clemente, California 92673 | |||
| CONTACT: | Mr. Andrew I. Kimmel | ||
| BioLase Technology, Inc. | |||
| 981 Calle Amanecer | |||
| San Clemente, California 92673 | |||
| (714) 361-1200 (714) 361-0204 Fax | |||
| TRADE NAME: | MillenniumTM | ||
| COMMON NAME: | Hydrokinetic tissue cutting system | ||
| CLASSIFICATION NAME: | Hydrokinetic dental system | ||
| 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 tissuc cutting system is a diverse instrument for Pine Millennium - Hydrokins. Millennium™ utilizes advanced laser and performing coverer. comologies to incise, excise and ablate intraoral soft and hard water alonitation totatively. An erbium, chromium, yttrium, scandium, gallium gamet (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, 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 - V cavity preparation
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 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.
2
| 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 and electronic parts and components | Same | Same | Same | YES |
| Indications for Use: | Caries removal, cavity preparation, surface roughening, incision, excision and ablation of soft tissues | Caries removal, cavity preparation | Caries removal, cavity preparation, surface roughening | Caries removal, cavity preparation, surface roughening | YES |
| Cutting Mode: | Mechanical, non-thermal | Same | Same | Same | YES |
| Cutting Medium: | High speed water droplets | Rotating bur | High speed aluminum oxide | High speed aluminum oxide | YES |
| Biocompatible | |||||
| Cutting Medium? | Yes | N/A | No | No | YES |
| Spray Flow | |||||
| Control? | Yes | Yes | N/A | N/A | YES |
| Mode of | |||||
| Operation: | Non-contact | Contact | Non-contact | Non-contact | YES |
| Manufacturer: | BioLase Technology, Inc | Dentsply | |||
| Laers Research | |||||
| Midwest | |||||
| Star Dental | |||||
| Siemens | Danville Engineering Inc. | 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 .
3
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. 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
4
Page 1 of 1
K990219 510(k) Number (if known):
Device Name:
Millennium™
Indications for Use:
Class I, II, III, IV and V cavity preparation
Caries removal
Hard tissue surface roughening or etching
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off | |
| Division of General Restorative Devices | |
| 510(k) Number | K990219 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | ----------------------------------------- |
or
| Over-The-Counter-Use | _________________ |
|---|---|
| ---------------------- | ------------------- |