LogoFDA 510(k) Search
K Number
K933841
Device Name
CENTAURI
Manufacturer
PREMIER LASER SYSTEMS, INC.
Date Cleared
1997-05-05

(1370 days)

Product Code
GEX
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
Centauri Er:YAG Laser System
More Information

K932683, K933841

Not Found

No
The summary describes a laser system for dental procedures and provides performance data related to temperature, pulp vitality, surface morphology, structural morphology, adjacent structures, and efficacy. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on the physical effects of the laser and its comparison to traditional methods like drilling.

Yes.
The device is used for therapeutic procedures such as incision, excision, hemostasis, ablation, and vaporization of tissue, as well as removal of caries and cavity preparation.

No

The device is indicated for surgical procedures such as incision, excision, hemostasis, ablation, and vaporization of tissue, as well as removal of caries and cavity preparation. These are therapeutic and preparative procedures, not diagnostic ones.

No

The device is described as a "Centauri Er:YAG Laser System," which is a hardware device that emits a laser for surgical procedures. The summary focuses on the performance of this hardware in various dental applications. There is no mention of software being the primary or sole component of the device.

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

Here's why:

  • Intended Use: The intended use clearly describes procedures performed directly on the patient's tissues within the oral cavity (incision, excision, hemostasis, ablation, vaporization, caries removal, cavity preparation, enamel/dentin modification/etching).
  • IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. This device does not perform such analysis on specimens.
  • Device Description: The device is described as a "Laser System," which is consistent with a therapeutic or surgical device used directly on the patient.
  • Performance Studies: The performance studies focus on the effects of the laser on the patient's tissues (temperature rise, pulp vitality, surface morphology, structural morphology, efficacy of tissue removal and preparation). This is typical for a device used directly on the patient.

Therefore, the Centauri Er:YAG Laser System, as described, is a therapeutic or surgical device, not an In Vitro Diagnostic device.

N/A

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 Er amel prior to acid etching, and Modification or Etching of Dentin prior to acid eichi ig.

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: Temperature measurement
    • Sample Size: Not explicitly stated, measurements taken at various energy outputs and repetition rates with H2O cooling.
    • Key Results: Pulpal temperature rise for various laser settings (20 mJ to 200 mJ at 10 Hz for 2 sec with H2O Cooling) ranged from 0.08°C to 2.3°C. This is significantly below the 5.5°C threshold for irreversible damage to pulp. Drill in Air (10 sec) showed 0.25°C, Drill in H2O (10 sec) showed 0.05°C.
  • Study Type: Pulp Vitality (blinded)
    • Sample Size:
      • Histological evidence: Not specified.
      • Pulp vitality measurements over 1½ year follow-up: Not specified.
      • Pulp vitality measurements on two teeth in each of 33 patients: 66 teeth.
      • Pulp vitality measurements on 125 randomly treated adult teeth: 125 teeth.
    • Key Results:
      • H&E histological evidence over pulpal healing time demonstrates no deleterious effect for laser or control treatment.
      • Pulp vitality measurements over 1½ year follow-up demonstrate no compromise in pulp vitality.
      • 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.
      • 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.
  • Study Type: Surface Morphology (blinded)
    • Sample Size: Not specified (Animal and human studies).
    • Key Results:
      • Animal and human studies using SEM demonstrated no changes in surface morphology except at the treatment site.
      • Animal and human studies using SEM illustrated that the drill and laser show equivalent surface changes at the treatment site.
  • Study Type: Structural Morphology
    • Sample Size: Not specified.
    • Key Results:
      • 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.
      • 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 and surrounded by elevated fused inorganic tissue. No visible cracks radiated from the craters.
  • Study Type: Adjacent Structures
    • Sample Size: Not specified.
    • Key Results:
      • The damage due to inadvertent lasing of adjacent structures is usually less than the drill, since the laser does not cut effectively when defocused.
  • Study Type: Efficacy
    • Sample Size:
      • Multi-site study: 125 randomized human adult teeth.
    • Key Results:
      • Investigators rate caries removal more effective than the drill.
      • Investigators rate cavity preparation with the laser equal to the drill.
      • Investigators rate laser etching much more effective than acid etching.
      • Animal and human studies demonstrate that the Er: Y AG laser is equivalent to standard treatment.
      • 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 and restoration was still adequate after 3 months in 100% of treated teeth.

Key Metrics

Not Found

Predicate Device(s)

K932683, K933841

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the left and has its head turned to the right.

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

1

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 (301) 594-4595. Additionally, for questions on the promotion and 1dvertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

2

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)

3

MAY - 7 1997 K933841

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

Pulp Vitality (all blinded): B.

  • H&E histological evidence over pulpal healing time demonstrates no deleterious 1. effect for laser or control treatment.
  • Pulp vitality measurements over 1½ year follow-up demonstrate no compromise 2. in pulp vitality.
    1. 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.
  • Pulp vitality measurements on 125 randomly treated adult teeth treated by laser 4. and drill show no significant difference between the laser and the control in pulp vitality measurements pre-surgery and after a three month period.

4

Surface Morphology (all blinded): C.

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

Structural Morphology D.

  • The ideal etched tooth presents a roughened dentin or enamel surface and no 1. 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.
  • Hibst and Keller reported on the effective removal of tooth structure with 2. 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.
  • Investigators rate cavity preparation with the laser equal to the drill. 2.
  • Investigators rate laser etching much more effective than acid etching. 3.
    1. Animal and human studies demonstrate that the Er: Y AG laser is equivalent to standard treatment.

5

  • In a multi-site study of 125 randomized human adult teeth, all classes of caries 5. (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 6. and restoration was still adequate after 3 months in 100% of treated teeth.
    が・・。

6

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: Y AG 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.
  • Hibst, R., and Keller, U. 1990. Heat effect of pulsed Er: Y AG laser radiation. SPIE Vol 3. 1200 II. 379-386.
  • Hibst, R., and Keller, U. 1992. Erbium:YAG laser in caries therapy: Indication and 4. first clinical results. ICOLD.
  • Zach, Leo , and Cohen, Gerson. 1965. Pulp response to externally applied heat. O.S., న. O.M., and O.D. 19(4):515-530.
  • Powell, G.L .; Whisenant, B.K .; Morton, T.H. 1990. Carbon dioxide laser oral safety 6. parameters for teeth. Lasers in Surgery and Medicine 13:548-552.
  • Arcoria, Charles J. 1994. Hard tissue effects using multiple wavelength lasers. ICOLD. 7.
  • Paghdiwala, Abid F. 1988. Application of the Erbium: Y AG laser in hard dental tissues: 8. Measurement of the temperatures and depths of cut. ICALEO. 64:192-201.
  • Paghdiwala. Abid F. 1993. Root resection of endodontically treated teeth by 9. Erbium: Y AG laser radiation. J of Endodontics. 19(2):91-94.
  • Kumazaki, M. 1992. Results of etching with the Er: Y AG laser. ISLD. 141-142. 11.