(334 days)
For use as an aid in the detection and localization of subgingival dental calculus.
This submission is for a modification of a device system cleared under K983658, the DIAGNOdent®. The modification is in the form of a new accessory probe tip which can be connected to the unmodified DIAGNOdent® electronics system. The probe tip is longer and more slender to allow for the periodontal use. In-vitro and preclinical studies have shown that that laser fluorescence is correlated with materials in calculi and concrements. The researchers identified the method of subgingival calculi detection to be a reproducible, objective method for assessing the root surface. Although the intensity of the detection was influenced by surrounding media, the differences between cementum and calculus was highly significant in media like air, electrolytic solution and blood.
The provide 510(k) summary does not contain sufficient information to describe the acceptance criteria and study that proves the device meets the acceptance criteria as requested. Specifically, the document mentions "in-vitro and preclinical studies" and "clinical studies" were conducted but does not provide details on the study design, sample sizes for test sets, data provenance, ground truth establishment, or specific performance metrics and their acceptance criteria.
Here's a breakdown of the information that is available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated or quantified in the provided text.
- Reported Device Performance: The document only states that "in-vitro and preclinical studies have shown that that laser fluorescence is correlated with materials in calculi and concrements" and that "the method of subgingival calculi detection to be a reproducible, objective method for assessing the root surface." It also notes that "the differences between cementum and calculus was highly significant in media like air, electrolytic solution and blood." No specific metrics (e.g., sensitivity, specificity, accuracy, precision) or numerical results are provided for the device for the subgingival calculus detection.
2. Sample size(s) used for the test set and the data provenance:
- Sample Size: Not provided.
- Data Provenance: Not provided. The studies cited are general scientific papers, not necessarily the specific studies conducted for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided.
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 mentioned. The device is for direct detection, not AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a "Laser Fluorescence Caries Detection Device" (specifically, a periodontal probe accessory). It functions as a diagnostic tool that provides a reading, which a human then interprets. The summary doesn't describe an "algorithm only" performance study in the way AI would be evaluated. However, the in-vitro and preclinical studies would likely represent a standalone assessment of the device's ability to detect calculus. Specifics are lacking.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied for the in-vitro studies that the "ground truth" would be the known presence of calculus in the samples tested. For preclinical studies, it would likely be confirmed by expert visual inspection or other established diagnostic methods. However, the specific method is not explicitly stated.
8. The sample size for the training set:
- Not applicable as this is not described as an AI/machine learning device requiring a training set. The device operates on direct physical principles (laser fluorescence).
9. How the ground truth for the training set was established:
- Not applicable.
{0}------------------------------------------------
P-1
AUG 2 - 2005
EXHIBIT 2 510(k) Summary KaVo America 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 Franz, President August 30, 2004
-
- Identification of the Device: Proprietary-Trade Name: KaVo DIAGNOdent® Perio Tip Classification Name: Dental Hand Instrument, Laser Fluorescence Caries Detection Device, Product Codes EJB, NBL Common/Usual Name: Periodontal Probe
- Equivalent legally marketed device: DIAGNOdent® K983658 and DETECTAR, K023367 . 2.
- Indications for Use (intended use): For use as an aid in the detection and localization of 3. subgingival dental calculus.
-
- Description of the Device: This submission is for a modification of a device system cleared under K983658, the DIAGNOdent®. The modification is in the form of a new accessory probe tip which can be connected to the unmodified DIAGNOdent® electronics system. The probe tip is longer and more slender to allow for the periodontal use. In-vitro and preclinical studies have shown that that laser fluorescence is correlated with materials in calculi and concrements 46. The researchers identified the method of subgingival calculi detection to be a reproducible, objective method for assessing the root surface". Although the intensity of the detection was influenced by surrounding media, the differences between cementum and calculus was highly significant in media like air, electrolytic solution and blood".
a. M. Folwaczny, R. Heym, A. Mehl and R. Hickel, "Subgingival Calculus detection with Fluorescence induced by 655 nm InGaAsP Diode Laser Radiation", J. Periodontol, June 2002, p 597-601
b. F. Krause, A. Braun, M. Frentzen, "The possibility of detecting subgingival calculus by laserfluorescence in vitro", Lasers Med. Sci. (2003) 18: 32-35
{1}------------------------------------------------
$\beta.2$
-
- Safety and Effectiveness, comparison to predicate device:
| ComparisonAreas | DIAGNOdent® K983658 | DETECTAR, K023367 | DIAGNOdent® Perio Tip |
|---|---|---|---|
| Indicationsfor use | Detection of Dental Caries | Detection of subgingivaldental calculus | Detection of subgingivaldental calculus |
| Probetechnology | Fiber Optic | SAME | SAME |
| Light Source | 655 nm <1 mw Laser | Two LEDs. The first is inthe red area of the visiblespectrum (RED-LED) andshows a wavelength peakat 635 in a band between600 and 670nm. Thesecond LED is in the nearinfrared spectrum (NIR-LED) and shows awavelength peak at 880nanometers in a bandbetween 800 and 900nm. | 655 nm <1 mw Laser |
| Returnedlight | Fluorescence | Not specified.(proprietary) | Fluorescence |
| Sterilization | Probe tip only, autoclave | SAME | SAME |
| Targetpopulation | Dentists' offices | SAME | SAME |
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
AUG 2 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kavo America Corporation C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K042394
Trade/Device Name: DIANGOdent® Perio Tip Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: July 27, 2005 Received: July 28, 2005
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 predicated 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 your 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.
{3}------------------------------------------------
Page 2 - Mr. Kamm
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ours
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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
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)
Suoer Rurse
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic
510(k) Number: K02344
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.