DIFOTI SYSTEM

K991098 · Electro-Optical Sciences, Inc. · EIA · Jun 30, 1999 · Dental

Device Facts

• Record ID: K991098
• Device Name: DIFOTI SYSTEM
• Applicant: Electro-Optical Sciences, Inc.
• Product Code: EIA · Dental
• Decision Date: Jun 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended 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.

Device Story

DIFOTI is a dental examination system using visible light fiberoptic transillumination to visualize dental caries. The device captures images of teeth using an electronic charge-coupled device (CCD) camera. A PC performs data acquisition and storage, while a computer monitor displays images for clinician visualization. Used in a clinical setting, the system allows dentists to identify and track the progression of caries lesions above the gum line. By providing enhanced visualization of tooth structure, the device assists clinicians in diagnostic decision-making and monitoring treatment efficacy over time.

Clinical Evidence

No clinical trial data provided. Evidence consists of bench testing, including image quality evaluation, software/hardware hazard analysis, and in-vitro vs. in-vivo performance evaluation. Software verification and validation were also performed.

Technological Characteristics

System utilizes visible light fiberoptic transillumination. Components include a fiberoptic light delivery system, CCD camera for image capture, and a PC for data acquisition, storage, and display. Operates as a digital imaging system for dental diagnostics.

Indications for Use

Indicated for detection and monitoring of frank or incipient dental caries lesions located above the gum line in patients requiring dental examination.

Regulatory Classification

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.

Predicate Devices

• Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems (preamendment)
• Computer Oral Radiography System (K933455)
• CDR-CAM (K963778)

Submission Summary (Full Text)

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Electro-Optical Sciences, Inc. 510(k) Premarket Notification

Trade Name:

JUN 3 O

# 510(k) Summary

K991008

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.<br>1 Bridge Street, Suite 15<br>Irvington-on-Hudson, NY 10533 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Site: | Electro-optical Sciences, Inc.<br>1 Bridge Street, Suite 15<br>Irvington-on-Hudson, NY 10533<br>Registration # Not yet assigned |
| Device Generic Name: | Dental examination system |
| Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the<br>device classification is Class I, General Controls (21 CFR 872.4620, and<br>872.6640). |
| Predicate Devices: | Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems<br>preamendment, various manufacturers |
| | Computer Oral Radiography System (K933455) and CDR-CAM (K963778)<br>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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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