CENTAURI

• K Number: K932683
• Device Name: CENTAURI
• Manufacturer: PREMIER LASER SYSTEMS, INC.
• Date Cleared: 1997-05-05 ( 1432 days)
• Product Code: GEX
• Regulation Number: 878.4810

Intended Use

The laser is indicated for Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. The additional representative indications include Removal of Caries, Cavity Preparation, Modification or Etching of Enamel prior to acid etching, and Modification or Etching of Dentin prior to acid etching.

Device Description

Not Found

Predicate Devices

K932683, K933841

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser device for dental procedures and does not mention any AI or ML components.

Therapeutic

Yes
The device is used for medical treatment such as incision, excision, hemostasis, ablation, and vaporization of tissue, as well as removal of caries and cavity preparation, which are all therapeutic interventions for medical conditions.

Diagnostic

No

The device is indicated for surgical procedures like incision, excision, and ablation of tissue, as well as removal of caries and cavity preparation. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is described as a "laser" and the performance studies involve physical interactions with teeth (temperature rise, surface morphology, structural morphology, efficacy in removing caries and preparing cavities), indicating it is a hardware device that uses laser technology.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly describes a device used for surgical procedures within the oral cavity (Incision, Excision, Hemostasis, Ablation, Vaporization, Caries Removal, Cavity Preparation, Etching). These are all direct treatments and modifications of tissue within the body.
• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such testing on samples.
• Device Description (or lack thereof): While the description is "Not Found," the intended use and performance studies focus on the physical interaction of the laser with tissue, not on analyzing biological samples.
• Performance Studies: The performance studies evaluate the device's effectiveness in removing tissue, preparing cavities, etching, and its impact on surrounding structures and pulp vitality. These are all related to the device's surgical function, not diagnostic testing.

Therefore, the device described is a surgical laser intended for use in the oral cavity, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The laser is indicated for Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. The additional representative indications include Removal of Caries, Cavity Preparation, Modification or Etching of Enamel prior to acid etching, and Modification or Etching of Dentin prior to acid etching.

Product codes

GEX

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral cavity

Indicated Patient Age Range

The contraindications are for children under the age of 18 years.

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: Benchmarking Study
Sample Size: Not explicitly stated, refers to a publication by Zach and Cohen.
Key Results: Showed that 15% of teeth in dogs where pulpal temperature was raised to 10°F (5.5°C) had irreversible damage. Concluded that if pulpal temperature rises only 5.5 °C, there is no permanent damage to the pulp.

Study Type: Temperature Measurement Study
Sample Size: Not applicable (measurements for different energy outputs).
Key Results:

• 20 mJ, 10 Hz, 2 sec with H2O Cooling: .08°C
• 50 mJ, 10 Hz, 2 sec with H2O Cooling: 1.07°C
• 100 mJ, 10 Hz, 2 sec with H2O Cooling: .84°C
• 150 mJ, 10 Hz, 2 sec with H2O Cooling: 1.12°C
• 200 mJ, 10 Hz, 2 sec with H2O Cooling: 2.3°C
• Drill in Air, 10 sec: .25°C
• Drill in H2O, 10 sec: .05°C

Study Type: Pulp Vitality Study (H&E histological evidence)
Sample Size: Not explicitly stated.
Key Results: Demonstrates no deleterious effect for laser or control treatment.

Study Type: Pulp Vitality Measurement Study
Sample Size: Not explicitly stated.
Key Results: Pulp vitality measurements over 1½ year follow-up demonstrate no compromise in pulp vitality.

Study Type: Pulp Vitality Measurement Study (comparative)
Sample Size: 33 patients, two teeth each.
Key Results: No difference in pulpal vitality pre-surgery, post-surgery and over three months for teeth treated by laser and drill from the same patient.

Study Type: Pulp Vitality Measurement Study (randomized adult teeth)
Sample Size: 125 randomized adult teeth.
Key Results: No significant difference between the laser and the control in pulp vitality measurements pre-surgery and after a three month period.

Study Type: Caries Removal Multi-site Study
Sample Size: 125 randomized human adult teeth.
Key Results: All classes of caries (I-V) were completely removed in 100% of the teeth treated.

Study Type: Cavity Preparation and Restoration Multi-site Study
Sample Size: 125 randomized human adult teeth.
Key Results: All cavity preparation and restoration was still adequate after 3 months in 100% of treated teeth.

Study Type: Surface Morphology Study (Animal and human studies using SEM)
Sample Size: Not explicitly stated.
Key Results: No changes in surface morphology except at the treatment site.
Key Results: The drill and laser show equivalent surface changes at the treatment site.

Study Type: Structural Morphology (Reference to Hibst and Keller)
Sample Size: Not applicable (published report).
Key Results: Effective removal of tooth structure with ultrastructural changes in enamel and dentin. No fissures or cracks. Surface was scaled and roughened without signs of thermal damage.

Study Type: Structural Morphology (Reference to Paghdiwala)
Sample Size: Not applicable (published report).
Key Results: At 430 mJ, hydroxyapatite has vaporized, developing pores and surrounded by elevated fused inorganic tissue. No visible cracks radiated from the craters.

Study Type: Efficacy Study (Investigator ratings)
Sample Size: Not explicitly stated.
Key Results: Investigators rate caries removal more effective than the drill.
Key Results: Investigators rate cavity preparation with the laser equal to the drill.
Key Results: Investigators rate laser etching much more effective than acid etching.

Study Type: Animal and Human Studies (Efficacy)
Sample Size: Not explicitly stated.
Key Results: Demonstrate that the Er:YAG laser is equivalent to standard treatment.

Key Metrics

Temperature increase in °C, Percentage of teeth with irreversible damage, Pulp vitality measurements, Percentage of caries removed, Percentage of adequate cavity preparation and restoration.

Predicate Device(s)

K932683, K933841

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and 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

( olette Cozean, Ph.D. MAY 5 1007 I'resident, CEO Premier Laser Systems, Inc. . . ...... 3 Morgan I vine, California 92618

l- e: K932683 and K933841 Trade Name: Centauri Er:YAG Laser System Regulatory Class: II Product Code: GEX Dated: April 28. 1997 Received: April 30, 1997

l )ear Dr. Cozean:

We have reviewed your Section 510(k) notifications 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 ( osmetic Act (Act). You may, therefore, market the device, subject to the general controls rrovisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and rohibitions 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, I'arts 800 to 895. A substantially equivalent determination assumes compliance with the ( inod Manufacturing Fractice for Medical Devices: General (GMP) regulation (21 CFR Part { 20) and that, through periodic

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Page 2 - Colette Cozean, Ph.D.

JMP 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, 17DA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submissions does not affect any >bligation you might have under sections 531 through 542 of the Act for devices under the Blectronic 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 notifications. The FDA finding of substantial equivalence of your device to a egally marketed predicate device results in a classification for your device and thus, permits vour 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 [phone]. Additionally, for questions on the promotion and 1dvertising of your device, please contact the Office of Compliance at [phone]. 41so, 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 [phone] or [phone] or at its internet address 'http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

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 - I. .

& K933841 51Cik) Number (if known) K932683

Centauri Er:YAG Laser System Device Name:

Indical ons For Use:

The laser is indicated for Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. The additional representative indications include Removal of Caries, Cavity Preparation, Modification or Etching of Er amel prior to acid etching, and Modification or Etching of Dentin prior to acid eichi ig.

The contraindications are for children under the age of 18 years.

:P:EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDE DI

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K932.683
510(k) Number: 1933841

Press: iphon lise tire: 21 CFR 801.109! റ്റു

Over-The-Counter Use

(Optional Format 1-2-96)

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SUMMARY OF SAFETY AND EFFICACY

Temperature A.

,

In a benchmark publication on temperatures which cause pulpal damage, Zach and Cohen showed that 15 % of teeth in dogs where pulpal temperature was raised to 10°F (5.5°C) had irreversible damage. These findings have been substantiated by Powell, et. Al. Therefore, if the pulpal temperature rises on only 5.5 °C, one may conclude that there is no permanent damage to the pulp of the tooth due to the laser treatment.

| Energy Output | Repetition Rate | Time with H2O
Cooling | Temperature in °C |
|---------------|-----------------|--------------------------|-------------------|
| 20 mJ | 10 Hz | 2 sec | .08° |
| 50 mJ | 10 Hz | 2 sec | 1.07° |
| 100 mJ | 10 Hz | 2 sec | .84° |
| 150 mJ | 10 Hz | 2 sec | 1.12° |
| 200 mJ | 10 Hz | 2 sec | 2.3° |
| Drill in Air | not applicable | 10 sec | .25° |
| Drill in H2O | not applicable | 10 sec | .05° |

TABLE 1 - Pulp Temperatures
-----------------------------	--

B. Pulp Vitality (all blinded):

:

• 1. H&E histological evidence over pulpal fiealing time demonstrates no deleterious effect for laser or control treatment.
• 2. Pulp vitality measurements over 1½ year follow-up demonstrate no compromise in pulp vitality.
• 3. Pulp vitality measurements on two teeth in each of 33 patients treated by laser and drill from the same patient show no difference in pulpal vitality pre-surgery, postsurgery and over three months.
• 4. Pulp vitality measurements on 125 randomly treated adult teeth treated by laser and drill show no significant difference between the laser and the control in pulp vitality measurements pre-surgery and after a three month period.

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• ડ. In a multi-site study of 125 randomized human adult teeth, all classes of caries (I-V) were completely removed in 100% of the teeth treated.
• In a multi-site study of 125 randomized human adult teeth all cavity preparation ર. and restoration was still adequate after 3 months in 100% of treated teeth.

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C. Surface Morphology (all blinded):

• 1. Animal and human studies using SEM demonstrated no changes in surface morphology except at the treatment site.
• 2. Animal and human studies using SEM illustrated that the drill and laser show equivalent surface changes at the treatment site.

D. Structural Morphology

• 1. The ideal etched tooth presents a roughened dentin or enamel surface and no evidence of cracking, fissuring or charring. The dentin demonstrates open , dentinal tubules. Organic material has been vaporized leaving the inorganic components of the tooth - leaving greater tooth surface area. In addition, a cavity preparation should show no remaining evidence of caries and a crater created by removal of tooth structure below the margin of the preparation.
• 2. Hibst and Keller reported on the effective removal of tooth structure with ultrastructural changes in enamel and dentin. There were no fissures or cracks. The surface was scaled and roughened without signs of thermal damage. Laser dosimetries ranged from 50 - 350 mJ.
• Paghdiwala showed at 430 mJ, hydroxyapatite has vaporized, developing pores 3. and surrounded by elevated fused inorganic tissue. No visible cracks radiated .. . . . . . . from the craters.

E. Adjacent Structures

• Adjacent structures to the treated tooth surface include soft tissue, proximal teeth 1. and underlying bone. The damage due to inadvertent lasing of adjacent structures is usually less than the drill, since the laser does not cut effectively when defocused.

F. Efficacy

• Investigators rate caries removal more effective than the drill. 1.
• 2. Investigators rate cavity preparation with the laser equal to the drill.
• Investigators rate laser etching much more effective than acid etching. 3.
• Animal and human studies demonstrate that the Er:YAG laser is equivalent to র্বা standard treatment.

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BIBLIOGRAPHY

• Walsh, J.T.; Flotte, T.J.; Deutch, T.F. 1989. Er:YAG laser ablation of tissue: Effect of 1. pulse duration and tissue type on thermal damage. Lasers in Surg and Med. 9:314-326.
• Hibst, R., and Keller, U. 1989. Experimental studies of the application of the Er.YAG 2. laser on dental hard substances: I. Measurement of the ablation rate. II. Light microscopic and SEM investigations. Lasers in Surg and Med. 9:38.
• 3. Hibst, R., and Keller, U. 1990. Heat effect of pulsed Er: Y AG laser radiation. SPIE Vol 1200 II. 379-386.
• Hibst, R., and Keller, U. 1992. Erbium:YAG laser in caries therapy: Indication and 4. first clinical results. ICOLD.
• 5. Zach, Leo, and Cohen, Gerson. 1965. Pulp response to externally applied heat. O.S., O.M., and O.D. 19(4):515-530.
• ર્. Powell, G.L .; Whisenant, B.K .; Morton, T.H. 1990. Carbon dioxide laser oral safety parameters for teeth. Lasers in Surgery and Medicine 13:548-552.
• 7. Arcoria, Charles J. 1994. Hard tissue effects using multiple wavelength lasers. ICOLD.
• 8. Paghdiwala, Abid F. 1988. Application of the Erbium: YAG laser in hard dental tissues: Measurement of the temperatures and depths of cut. ICALEO. 64:192-201.
• 9. Paghdiwala, Abid F. 1993. Root resection of endodontically treated teeth by Erbium: YAG laser radiation. J of Endodontics. 19(2):91-94.
• Kumazaki, M. 1992. Results of etching with the Er:YAG laser. ISLD. 141-142. 11.