(148 days)
Not Found
No
The description mentions "computer analysis" but does not provide any details suggesting the use of AI/ML techniques. The performance studies compare the device to existing technologies like FOTI/DIFOTI and visual examination, which are not inherently AI/ML-based. There is no mention of training or test sets, which are typical for AI/ML development.
No.
The device is used to aid in the diagnosis and detection of dental conditions, not to treat them.
Yes
The intended use explicitly states "Aid in diagnosis of dental pits and fissures and interproximal caries and aid in the detection of dental calculus," directly indicating its diagnostic purpose.
No
The device description explicitly states it contains optical fibers and converts optical signals into electrical signals, indicating the presence of hardware components beyond just software.
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: The D-Carie probe directly interacts with the patient's teeth (an anatomical site) to read optical scattering characteristics in vivo (within the living body). It does not analyze samples taken from the body.
Therefore, based on the provided information, the D-Carie probe is a medical device used for diagnosis, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indication of use of the D-Carie is extended to include aid for diagnosis of inteproximal dental caries. This feature, an object of current submission. is similar in intended use to bitewings x-rays clichés, FOTI/DIFOTI, or visual exam with a manual dental explorer for interproximal caries detection.
Aid in diagnosis of dental pits and fissures and interproximal caries and aid in the detection of dental calculus.
Product codes (comma separated list FDA assigned to the subject device)
NBL
Device Description
The D-Carie probe contains optical fibers that read the optical scattering characteristic of dental carie thru healthy enamel structure above (the marginal ridge over the vulnerable inteproximal area) and convert it into an electrical signal. From that signal a computer analysis identifies the dental caries.
The device can be in either in a new handheld or a tabletop (original) format with the addition or not of the calculus detection feature of the Detectar. Combining features or changing to miniaturized battery powered format does not change the intended use of each functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical fibers
Anatomical Site
dental pits and fissures and interproximal caries; teeth
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro and in vivo studies were conducted to assess both sensitivity and specificity for the D-Carie inteproximal detection. Using bitewings clichés or histological observation as a gold standard, studies have shown that this function is at least equivalent in efficiency to the FOTI/DIFOTI devices or visual examination.
Also bench tests (measuring optical electromagnetic power output and its spectral distribution), in vitro and in vivo trials have shown that : 1) D-Carie and Detectar performance are equivalent to when they these functions are combined in a single unit and 2) that the handheld format (Mini) is at least equivalent to the tabletop version originally presented in all important aspects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity and specificity
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.
K991098, KO50019, K043156, K023367
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.
Not Found
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).
Not Found
§ 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
510(k) Summary
Neks Technologies, Inc. 2816, Joseph Armand Bombardier Laval. Quebec. Canada,H7P 6E2 Contact Person : Dr Naïm Karazivan, D.M.D. President-Founder info@neks.ca Phone: 450.973.3598 x 2602 FAX: 450.395.3881 October 31, 2006
MAR 3 0 2007
1. Identificatioin of the device :
D-Carie/Detectar Models : N121, N123, N133, N134, N135 & N138
- Predicate Devices:
DIFOTI System for Dental Examinations, Electro-Optical Sciences, Inc.(K991098)
Fiberoptic transillumination (FOTI) fiberoptic dental imaging systemspreamendment, various manufacturers (510(k) exempt)
IN EXAM INTRAORAL DENTAL X-RAY SYSTEM, Kavo America (KO50019) and other dental X-Rays System from various manufacturers.
Dental explorer for clinical examination, various manufacturer (510(k) exempt)
D-CARIE, MODEL N121-M1, Neks Technologies (K043156)
DETECTAR, MODEL N123-MI, Neks Technologies (K023367)
3. Device Description and Intended Use:
The indication of use of the D-Carie is extended to include aid for diagnosis of inteproximal dental caries. This feature, an object of current submission. is similar in intended use to bitewings x-rays clichés, FOTI/DIFOTI, or visual exam with a manual dental explorer for interproximal caries detection. The D-Carie probe contains optical fibers that read the optical scattering characteristic of dental carie thru healthy enamel structure above (the marginal ridge over the vulnerable inteproximal area) and convert it into an electrical signal. From that signal a computer analysis identifies the dental caries.
The device can be in either in a new handheld or a tabletop (original) format with the addition or not of the calculus detection feature of the
1
Detectar. Combining features or changing to miniaturized battery powered format does not change the intended use of each functions.
-
- Brief Description of Clinical and Non-clinical Testing:
In vitro and in vivo studies were conducted to assess both sensitivity and specificity for the D-Carie inteproximal detection. Using bitewings clichés or histological observation as a gold standard, studies have shown that this function is at least equivalent in efficiency to the FOTI/DIFOTI devices or visual examination.
- Brief Description of Clinical and Non-clinical Testing:
Also bench tests (measuring optical electromagnetic power output and its spectral distribution), in vitro and in vivo trials have shown that : 1) D-Carie and Detectar performance are equivalent to when they these functions are combined in a single unit and 2) that the handheld format (Mini) is at least equivalent to the tabletop version originally presented in all important aspects.
-
- Conclusions Drawn :
D-Carie inteproximal caries detection is substantially equivalent to the cited predicated devices.
- Conclusions Drawn :
Combining D-Carie and Detectar in the same device (Tabletop Duo Model N133) is substantially equivalent to D-Carie and Defectar in individual units.
The handheld format (Mini Detectar Model N134, Mini D-Carie Model N135 and MiniDuo Model N138) is substantially equivalent to the tabletop format.
These conclusions are based on indications for use, bench, in vitro and in vivo clinical trials, as well as EMC and electrical safety testing.
2
. . .
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Naim Karazivan, D.M.D President Neks Technologies, Incorporated 2816 Joseph Armand Bombardier Laval, Quebec CANADA H7P 6E2
MAR 3 0 2007
Re: K063321
Trade/Device Name: D-Carie/Detectar Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: March 8, 2007 Received: March 12, 2007
Dear Dr. Karazivan:
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 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 - Dr. Karazivan
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sajite Y. Michaud, MD.
Chíu 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
Indication for Use
510(k) Number (if known):_
Device Name: D-Carie/Detectar
Indication for Use: Aid in diagnosis of dental pits and fissures and interproximal caries and aid in the detection of dental calculus.
| Concurrence of CDRH Office of Device Evaluation | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use × (per 21CFR 801.109)
Over-the-counter Use
Susan Grover
un-Off) sion of Anesthesiology, General Hospital, ാന്റി വി Anost Dental Devices
OR
3(k) Number: K063321