(90 days)
Not Found
No
The description focuses on standard imaging technology (fiberoptic transillumination, CCD camera) and basic data acquisition/storage. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies for analysis or interpretation.
No
The device is indicated for detection and monitoring of dental caries, which are diagnostic purposes, not therapeutic.
Yes
The device is indicated for "detection of frank or incipient caries lesions" and "monitoring the progression of such lesions," which are diagnostic functions. It uses visible light imaging to visualize dental caries for examination.
No
The device description explicitly states it includes hardware components such as fiberoptic technology, a CCD camera, a small PC, and a computer monitor.
Based on the provided information, the DIFOTI System for Dental Examinations 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.
- DIFOTI System Function: The DIFOTI system uses visible light and a camera to image teeth in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use is for the detection and monitoring of dental caries on the teeth, not through the analysis of bodily fluids or tissues.
Therefore, the DIFOTI system falls under the category of a medical device used for imaging and diagnosis in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DIFOTI System for Dental Examinations is indicated for detection of frank or incipient caries lessions above the gum line, and for monitoring the progression of such lesions.
Product codes
EIA
Device Description
The DIFOTI device is a dental examination system that utilizes visible light delivered with fiberoptic technology for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic charge-coupled device (CCD) camera is used to capture the image(s), a small PC serves for for data acquisition and storage, and a computer monitor is used for image visualization,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Visible light / transillumination imaging
Anatomical Site
Teeth (above the gum line)
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
Safety and performance testing included image quality evaluation, software/hardware hazard analysis, invitro vs. in-vivo performance evaluation, and software verification and validation.
Key Metrics
Not Found
Predicate Device(s)
Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems preamendment, various manufacturers, K933455, K963778
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
Electro-Optical Sciences, Inc. 510(k) Premarket Notification
Trade Name:
JUN 3 O
510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Electro-Optical Sciences, Inc. is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Electro-Optical Sciences chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
DIFOTI Dental Examination System
| Owner/Operator: | Electro-optical Sciences, Inc.
1 Bridge Street, Suite 15
Irvington-on-Hudson, NY 10533 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Site: | Electro-optical Sciences, Inc.
1 Bridge Street, Suite 15
Irvington-on-Hudson, NY 10533
Registration # Not yet assigned |
| Device Generic Name: | Dental examination system |
| Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the
device classification is Class I, General Controls (21 CFR 872.4620, and
872.6640). |
| Predicate Devices: | Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems
preamendment, various manufacturers |
| | Computer Oral Radiography System (K933455) and CDR-CAM (K963778)
Schick Technologies Inc |
Product Description:
The DIFOTI device is a dental examination system that utilizes visible light delivered with fiberoptic technology for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic charge-coupled device (CCD) camera is used to capture the image(s), a small PC serves for for data acquisition and storage, and a computer monitor is used for image visualization,
Indications for Use:
The DIFOTI System for Dental Examinations is indicated for detection of frank or incipient caries lessions above the gum line, and for monitoring the progression of such lesions.
Safety and Performance:
Safety and performance testing included image quality evaluation, software/hardware hazard analysis, invitro vs. in-vivo performance evaluation, and software verification and validation.
Conclusion:
Based on the indications for use, technological characteristics, comparison to predicate devices and performance testing, the DIFOTI Dental Examination System has been shown to be safe and effective for its intended use.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 30 1999
Electro-Optical Sciences, Incorporated c/o Ms. Pamela Papineau Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Aver, Massachusetts 01432
Re : K991098 DIFOTI™ System Trade Name: Requlatory Class: I Product Code: EIA Dated: March 29, 1999 Received: April 1, 1999
Dear Ms. Papineau:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Papineau
this response to your premarket notification Please note: 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.
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 your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to ene regaración Cherocod, "Theremonday" (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,
Patrícia Cueriti/for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Electro-Optical Sciences, Inc.. 510(k) Premarket Notification
Page -1 of
510(k) Number (if known):
Device Name: __ DIFOTI System for Dental Examinations
Indications for Use:
The DIFOTI System for Dental Examinations is indicated for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) OR
Over-the -Counter Use _
Susan Quarn
(Division Sign-Off) Division of Dental, Infection Com and General Ho 510(k) Number
000008