(29 days)
For use as an aid in the detection and localization of subgingival dental calculus.
The provided text for device K0600080 is a 510(k) summary and not a full study report or clinical trial document. Therefore, it does not contain detailed information about specific acceptance criteria, study sizes, ground truth establishment, or specific performance metrics as would be found in a comprehensive clinical study.
The document primarily focuses on establishing substantial equivalence to a predicate device, the DIAGNOdent® 2095 (K042394), by demonstrating that the new device, DIAGNOdent® 2190 with Periodontal Probe, has the "SAME" indications for use and similar technical specifications. The conclusion statement mentions "bench, in-vitro, and clinical studies" were conducted, but no details of these studies or their results are provided in this extract.
As a result, I cannot provide a detailed table of acceptance criteria versus reported performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, or training set details from the information given.
However, based on the principle of establishing substantial equivalence, we can infer that the implicit acceptance criterion would be that the device performs at least as well as the predicate device in its intended use, or that any differences do not raise new questions of safety or effectiveness.
Here is what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria (Inferred): Performance comparable to the predicate device (DIAGNOdent® 2095, K042394) for "detection and localization of subgingival dental calculus." The document does not specify quantitative acceptance criteria for clinical performance. It relies on demonstrating similarity in technology and intended use.
- Reported Device Performance: Not explicitly stated in quantitative terms. The document concludes that "In all important respects, the DIAGNOdent® 2190 with periodontal probe is substantially equivalent to the DIAGNOdent® K042394." This implies similar performance, but no specific metrics are given.
| Feature / Performance Area | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Indications for Use | Aid in detection and localization of subgingival dental calculus, same as predicate. | SAME |
| Overall Safety & Effectiveness | Comparable to predicate device. | Substantially equivalent to predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified, beyond the mention of "bench, in-vitro, and clinical studies."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified.
4. Adjudication method for the test set
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not specified. This device is a laser fluorescence device, not an AI system, so this type of study would not be applicable in the context of "human readers improve with AI vs without AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as it's a diagnostic device in the hands of a practitioner, not a standalone algorithm. Its performance is inherent in its ability to detect fluorescence indicating calculus.
7. The type of ground truth used
- Not specified. Given the indication for "detection and localization of subgingival dental calculus," ground truth would likely involve direct visual inspection by an expert, tactile probing, or potentially histological examination of extracted teeth/calculus if an in-vitro study was involved.
8. The sample size for the training set
- Not applicable/specified. This type of device does not typically involve a "training set" in the machine learning sense. Its detection mechanism is based on physical principles (laser fluorescence) rather than learned patterns from data.
9. How the ground truth for the training set was established
- Not applicable/specified, for the same reasons as #8.
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K0600080
FEB 8 2006
EXHIBIT 2 510(k) Summary KaVo Dental Corporation 340 East Main Street Lake Zurich, Illinois 60047 Toll Free: 800 323 8029 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 e-mail: info@kavousa.com Contact: John Miller, Director of RA/QA December 26, 2005
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- Identification of the Device: Proprietary-Trade Name: KaVo DIAGNOdent® 2190 with periodontal probe Classification Name: Dental Hand Instrument, Laser Fluorescence Caries Detection Device, Product Codes NTK Common/Usual Name: Laser fluorescence caries detection device
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- Indications for Use (intended use): For use as an aid in the detection and localization of subgingival dental calculus.
Image /page/0/Figure/7 description: The image shows two different DIAGNOdent periodontal probes. The first probe is the DIAGNOdent 2095 Periodontal Probe (K042394), and the second probe is the DIAGNOdent 2190 Periodontal Probe. Both probes have two parts labeled as "Part 1" and "Part 2".
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p.2 KD60080
| Comparison Areas | DIAGNOdent® 2095With periodontal probe, K042394 | DIAGNOdent® 2190With periodontal probe |
|---|---|---|
| Indications for use | For use as an aid in the detection and localization of subgingival dental calculus. | SAME |
| Probe technology | Fiber Optic with sapphire tip. | Probe is integrated into the body of the hand held unit, with sapphire tip. |
| Construction | Base unit with fiber optic detachable probes | Hand held unit with detachable probe tips |
| Light Source | 655 nm <1 mw Laser | SAME |
| Laser power class | Class II | Class I |
| Returned light | Fluorescence | Fluorescence |
| Sterilization | Probe tip only, autoclave | SAME |
| User interface | Numeric and audible tonesLED numbers | SAME exceptLCD numbers |
| Power source | 6- AA Alkaline battery | 1- AA Alkaline battery |
| Target population | Dentists' offices | SAME |
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- Safety and Effectiveness, comparison to predicate device:
-
- Conclusion: In all important respects, the DIAGNOdent® 2190 with periodontal probe is substantially equivalent to the DIAGNOdent® K042394. This conclusion is based on indications for use, bench, in-vitro, and clinical studies, as well as EMC and electrical safety testing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract image of an eagle with three heads, symbolizing service to the people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle emblem. The seal is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 8 2006
KaVo Dental Corporation C/O Mr. Danial Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K060080
Trade/Device Name: DIAGNOdent® 2190 with Periodontal Probe Regulation Number: 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NTK Dated: January 10, 2006 Received: January 10, 2006
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Kamm
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvised that I DA s issualled on that your device complies with other requirements Incall that FDA nas muce a december and regulations administered by other Federal agencies. of the Act of ally receitar statutes and regulations. but not limited to: registration You must comply with an the Fict of tot 8 104 21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 067), advailing (21 CFR Part 820); and if requirents as set form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mational your substantial equivalence of your device to a premarket notification. - The PDF Intaling or colassification 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), II you desire specific advice for your de research as a more and the regulation and any and entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syvette H. Michaud, Dmd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: __________ DIAGNOdent® 2190 with Periodontal Probe
Indications For Use:
For use as an aid in the detection and localization of subgingival dental calculus.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suser Russe
A.C.A., Local Issues
Page 1 of 1
§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.