(334 days)
Not Found
No
The summary describes a modification to an existing device (DIAGNOdent®) with a new probe tip. The detection method relies on laser fluorescence and its correlation with materials in calculus, which is a direct physical principle, not an AI/ML algorithm. There is no mention of AI, ML, or any related concepts in the device description, performance studies, or other sections.
No
The device is intended for detection and localization of dental calculus, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states, "For use as an aid in the detection and localization of subgingival dental calculus," which directly indicates a diagnostic purpose. The device name "DIAGNOdent®" also implies diagnosis.
No
The device description explicitly states it is a modification of a device system (DIAGNOdent®) and involves a new accessory probe tip which connects to the existing electronics system. This indicates the device includes hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device uses laser fluorescence to detect and localize subgingival dental calculus in situ (within the mouth). It is not analyzing a sample taken from the body.
- Intended Use: The intended use is for detection and localization in the mouth, not for testing a sample outside the body.
Therefore, based on the provided information, this device falls under the category of a dental device used for diagnostic purposes within the oral cavity, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For use as an aid in the detection and localization of subgingival dental calculus.
Product codes (comma separated list FDA assigned to the subject device)
EJB, NBL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
subgingival dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists' offices
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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
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- 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.
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- 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
$\beta.2$
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- Safety and Effectiveness, comparison to predicate device:
| Comparison
| Areas | DIAGNOdent® K983658 | DETECTAR, K023367 | DIAGNOdent® Perio Tip |
|---|---|---|---|
| Indications | |||
| for use | Detection of Dental Caries | Detection of subgingival | |
| dental calculus | Detection of subgingival | ||
| dental calculus | |||
| Probe | |||
| technology | Fiber Optic | SAME | SAME |
| Light Source | 655 nm |