(85 days)
For removal of caries and for cavity preparation in primary and secondary teeth.
DeL2940 Dental Erbium Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. Delivery is via fiber optic with a quartz contact tip. At 10 pulses per second an a pulse energy of 1 Joules, the average power from the laser is 10 watts.
The provided text describes a 510(k) Premarket Notification for the DeL2940 Dental Erbium Laser. It outlines the device's intended use and presents summaries of nonclinical and clinical performance data to demonstrate substantial equivalence to a predicate device. However, it does not explicitly define specific numerical acceptance criteria for performance metrics. Instead, it states that the studies "supported the safety and effectiveness" of the Er:YAG laser.
Therefore, I cannot fill out Table 1 with specific acceptance criteria and reported device performance values. The document focuses on demonstrating substantial equivalence rather than meeting pre-defined quantitative performance targets.
Here's a breakdown of the other requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit numerical acceptance criteria are provided in the document. The studies aimed to demonstrate "safety and effectiveness" and "substantial equivalence" rather than meeting pre-defined quantitative performance thresholds for the device itself.
| Metric (No specific criteria provided) | Acceptance Criteria (No specific criteria provided) | Reported Device Performance (No specific criteria provided) |
|---|
2. Sample Size Used for the Test Set and Data Provenance
- Nonclinical Studies:
- Bovine Studies: 22 teeth.
- Canine Studies: 174 teeth. One study compared laser treatment to a drill.
- Data Provenance: Not explicitly stated, but implies laboratory studies.
- Clinical Studies (Test Set):
- Foreign Data: 245 human teeth (18 extracted, 23 scheduled for extraction, 204 in vivo).
- Domestic Data (IDE Study): 94 pediatric subjects and 121 adult subjects.
- Data Provenance: Foreign data from four clinical studies. Domestic data from an IDE study. Both are prospective clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set in either the nonclinical or clinical studies.
4. Adjudication Method for the Test Set
The document does not provide information on any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not explicitly mentioned. One canine study compared the laser treatment to a drill, which suggests a comparative study, but it's not described as an MRMC study involving human readers and AI. The document is about a laser device, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable as the device is a medical laser system, not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for the studies would be:
- For caries removal: Successful removal of carious tissue, likely confirmed visually and perhaps tactilely by dental professionals or researchers.
- For cavity preparation: Successful preparation of a cavity meeting clinical standards for restorative dentistry.
- For safety: Absence of adverse events, excessive thermal damage, or other complications.
The document does not detail how "ground truth" was formally established beyond supporting "safety and effectiveness."
8. The Sample Size for the Training Set
This question is not applicable as the device is a medical laser system, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a medical laser system, not an AI model that requires a training set.
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K992013
510(k) Premarket Notification – Additional Information DeL2940 Dental Erbium Laser: Hard Tissue Disease Continuum Biomedical August 24, 1999
510(k) Summary
| Submitter: | Continuum BiomedicalA Medical Division of Continuum Electro-Optics, Inc.6533 Sierra LaneDublin, CA 94568 |
|---|---|
| Contact: | Laurie A. RidenerRegulatory Affairs Officer |
| Date SummaryPrepared: | June 15, 1999 |
| Device Trade Name: | DeL2940 Dental Erbium Laser, DeLite Dental Erbium Laser |
| Common Name: | Medical laser system |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Centauri Er: YAG Dental Laser System, Premier Laser Systems, Inc. |
| Device Description: | DeL2940 Dental Erbium Laser consists of three interconnected sections: the power supply,the water cooling system and the optical bench. Delivery is via fiber optic with a quartzcontact tip. At 10 pulses per second an a pulse energy of 1 Joules, the average power fromthe laser is 10 watts. |
| Intended Use: | For removal of caries and for cavity preparation in primary and secondary teeth. |
| Comparison: | The DeL2940 Dental Erbium Laser is substantially equivalent to the Centauri Er: Y AG DentalLaser System (Premier). |
| NonclinicalPerformance Data: | Data was provided on two bovine studies (22 teeth) and two canine studies (174 teeth). Oneof the canine studies compared the laser treatment to the drill. All studies supported thesafety and effectiveness of the Er: Y AG laser for caries removal and cavity preparation. |
| Clinical PerformanceData: | Foreign data was provided from four clinical studies for a total of 245 human teeth (18extracted, 23 scheduled for extraction and 204 in vivo). All studies supported the safety andeffectiveness of the Er.YAG laser for caries removal and cavity preparation. Domestic datawas provided from an IDE study for a total of 94 pediatric subjects and 121 adult subjectstreated with the DeL2940 Dental Erbium Laser. |
| Conclusion: | The DeL2940 Dental Erbium Laser is substantially equivalent to other currently marketederbium dental lasers for the removal of caries and for cavity preparation in primary andsecondary teeth. |
| Additional Information: | None requested at this time. |
PROPRIETARY DATA: This document and information contained herein may not be reproduced, used or disclosed without written permission of Continum Biomedical, A Medical Division of Continum Electro-Optics, Inc.,
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 8 1999
Ms. Liza A. Burns Regulatory Affairs Consultant Continuum Biomedical, Inc. 6533 Sierra Lane Dublin, California 94568
Re: K992013
Trade Name: DeL2940 Dental Erbium Laser, DeLite Dental Erbium Laser Regulatory Class: II Product Code: GEX Dated: June 15, 1999 Received: June 15, 1999
Dear Ms. Burns:
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. A 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 regulations.
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Page 2 - Ms. Liza A. Burns
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 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 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,
Sincerely, years,
Sallie M. Weaver, Ph.D., M.D.
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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| 510(k) Number (if known): | K992013 |
|---|---|
| Device Name: | DeL2940 Dental Erbium Laser, DeLite Dental Erbium Laser |
| Indications for Use: | For Removal of Caries and for Cavity Preparation in Primary and Secondary Teeth. |
(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 | K992013 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| OR Over-the-Counter Use |
(Optional Format 1-2-96)
PROPRIETAR Y DATA: This document and information contained herein may not be reproduced, used or disclosed without written permission of Continual Biomedical. A Medical Division of Continuan Electro-Optics, Inc.
§ 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.