(25 days)
Not Found
Not Found
No
The summary describes a laser device for oral procedures and focuses on performance studies related to temperature, pulp vitality, morphology, and efficacy compared to traditional methods like drilling and acid etching. There is no mention of AI, ML, image processing, or any data analysis techniques that would suggest the use of such technologies.
Yes
The device is described as a laser indicated for various procedures in the oral cavity, including Incision, Excision, Hemostasis, Ablation of Tissue, Vaporization of Tissue, Removal of Caries, Cavity Preparation, Modification or Etching of Enamel, and Modification or Etching of Dentin. These are all therapeutic applications. The performance studies also focus on the efficacy and safety of these therapeutic actions.
No
This device is described as a laser indicated for therapeutic procedures like incision, excision, hemostasis, ablation, and vaporization of tissue. The "Summary of Performance Studies" focuses on evaluating its efficacy and safety in performing these treatments, not on diagnosing conditions.
No
The intended use and performance studies clearly describe a laser device used for physical procedures in the oral cavity, indicating a hardware component.
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 oral cavity (incision, excision, hemostasis, ablation, vaporization, caries removal, cavity preparation, enamel/dentin modification/etching). IVDs are used to examine specimens taken from the body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: While "Not Found" is listed, the intended use strongly suggests a device that interacts directly with tissue, not one that analyzes samples.
- Performance Studies: The performance studies focus on the device's effects on tissue (temperature, pulp vitality, surface/structural morphology, adjacent structures) and its efficacy in performing surgical procedures (caries removal, cavity preparation, etching). These are typical performance metrics for surgical or therapeutic devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
In summary, the device is a laser intended for surgical and therapeutic procedures within the oral cavity, which falls outside the definition of 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 Enamel prior to acidentify, and Modification or Etching of Dentin prior to acid etching.
Product codes
GEX
Device Description
Centauri Er:YAG Laser Systems
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
oral cavity
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
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Summary of Performance Studies
The document describes several studies:
- Temperature Study: Measures temperature rise in pulp with H2O cooling at different energy outputs (20 mJ, 50 mJ, 100 mJ, 150 mJ, 200 mJ) and repetition rate (10 Hz) over 2 seconds. Also compares to drill in air and H2O over 10 seconds.
- Pulp Vitality Studies (all blinded):
- 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, post-surgery and over three months.
- Pulp vitality measurements on 125 randomly 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.
- Surface Morphology Studies (all blinded):
- 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.
- Structural Morphology: Describes the ideal etched tooth and various studies on enamel and dentin changes with laser ranging from 50 - 430 mJ, showing no fissures or cracks and effective removal of tooth structure.
- Adjacent Structures: Discusses that damage to adjacent structures due to inadvertent lasing is usually less than the drill.
- Efficacy Studies:
- 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:YAG laser is equivalent to standard treatment.
- Multi-site study of 125 randomized human adult teeth, all classes of caries (I-V): completely removed in 100% of the teeth treated.
- 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.
- Clinical procedures on children 18 years of age and under:
- Phase I: 51 laser procedures, approximately 12% on primary teeth with no reported complications, no anesthesia requested.
- Phase II: 130 laser procedures, approximately 15% on primary teeth with no reported complications.
- Additional patient data: 219 laser procedures, approximately 22% on primary teeth with no reported complications.
- Total: 400 laser procedures on children, approximately 19% on primary teeth with no reported complications.
Key Metrics
- Temperature: Range from .05°C to 2.3°C increase.
- Pulp Vitality: No deleterious effect, no compromise, no difference.
- Surface Morphology: No changes except at treatment site, equivalent surface changes to drill.
- Caries Removal (125 adult teeth): 100% effective.
- Cavity Preparation & Restoration (125 adult teeth): 100% adequate after 3 months.
- Complications in Children (400 procedures): No reported complications (0%).
Predicate Device(s)
Not Found
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.
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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):
- H&E histological evidence over pulpal healing time demonstrates no 1. 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 3. drill from the save patient show no difference in pulpal vitality pre-surgery, postsurgery and over three months.
-
- Pulp vitality measurements on 125 randomly 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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C. Surface Morphology (all blinded):
- 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. ultrasructural 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.
Adjacent Structures E.
- 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.
- Animal and human studies demonstrate that the Er: Y AG laser is equivalent 4: to standard treatment.
2
- In a multi-site study of 125 randomized human adult teeth, all classes of caries (I-ડ. 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.
- In Phase I, 51 laser procedures were performed on children 18 years of age and 7. under. Six procedures or approximately 12% of these were performed on primary teeth with no reported complications, and no anesthesia was requested by the patient in any of these procedures.
- In Phase II, 130 laser procedures were performed on children. Eighteen 8. procedures or approximately 15% were performed on primary teeth with no reported complications.
-
- In the additional patient data submitted, 219 laser procedures were performed on children. Forty-eight procedures of approximately 22% were performed on primary teeth with no reported complications.
- A total of 400 laser procedures were performed on children 18 years of age and 10. under with no reported complications. Sixty-eight of these procedures or approximately 19% were performed on primary teeth with no reported complications.
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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three lines representing its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUM. SERVICES. USA" in a circular arrangement.
OCT 9 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Mojica Premier Laser Company 3 Morgan Irvine, California 92618
Re: K983211 Centauri Er:YAG Laser Systems Trade Name: Regulatory Class: ı i Product Code: GEX Dated: September 08, 1998 Received: September 14, 1998
Dear Ms. Mojica:
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 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. ਮੁ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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, 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 requlations.
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Page 2 - Ms. Lisa Mojica
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,
Cella 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): K983211
Device Name: Er:YAG Laser System
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 acidentify, and Modification or Etching of Dentin prior to acid etching.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K98321/ |
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
Or
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |