DIFOTI USB 2.0 SYSTEM

K043068 · Electro-Optical Sciences, Inc. · NTK · Dec 29, 2004 · Dental

Device Facts

• Record ID: K043068
• Device Name: DIFOTI USB 2.0 SYSTEM
• Applicant: Electro-Optical Sciences, Inc.
• Product Code: NTK · Dental
• Decision Date: Dec 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1745
• Device Class: Class 2

Intended Use

The DIFOTI USB 2.0 System 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 USB 2.0 System (Model B) is a dental examination device using visible light from an internal diode laser source delivered via fiberoptics. It performs transillumination imaging of teeth to visualize dental caries. A CMOS camera captures images, which are transmitted via USB 2.0 to a PC for acquisition, storage, and visualization on a monitor. Used in dental clinics by practitioners to detect and monitor caries lesions above the gum line. The system aids clinicians in identifying decay, facilitating clinical decision-making regarding treatment or monitoring. Benefits include non-invasive visualization of caries.

Clinical Evidence

Bench testing only. Evidence included image quality evaluation, software hazard analysis, and in-vitro vs. in-vivo performance evaluation to demonstrate safety and effectiveness.

Technological Characteristics

Dental examination system using visible light diode laser source; fiberoptic delivery; CMOS camera sensor; USB 2.0 connectivity to PC; Class IIa laser product; software-based image acquisition and display.

Indications for Use

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

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems (preamendment)
• Computer Oral Radiography System (K933455)
• CDR-CAM (K963778)
• DIFOTI System for Dental Examinations (K991098)

Submission Summary (Full Text)

{0}------------------------------------------------

K043068

# 510(k) Summary

DEC 2 9 2004 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, as follows:

| Trade Name: | DIFOTI USB 2.0 System<br>(a/k/a DIFOTI System for Dental Examinations, Model B) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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>Establishment Registration # 2438478 |
| Device Generic Name: | Dental examination system |
| Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device<br>classification is Class I, General Controls (21 CFR 872.4620, and 872.6640),<br>According to the regulations (21 CFR 1040.10(b)15) under the Radiation Control<br>for Health and Safety Act of 1968, as amended, the device also is a Class I medical<br>laser product that incorporates a laser of higher class (Class IIa). |
| 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. |
| | DIFOTI System for Dental Examinations (K991098),<br>Electro-Optical Sciences, Inc. |

## Product Description:

The device known as the DIFOTI USB 2.0 System, also known as the DIFOTI System for Dental Examinations, Model B, is a dental examination system that utilizes visible light from an internal diode laser source. delivered with fiberoptic technology, for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic (CMOS) camera is used to capture the image(s). The light and the camera are connected via a USB 2.0 cable to a small PC that serves for data acquisition and storage, and the computer monitor is used for image visualization.

### Indications for Use:

The DIFOTI USB 2.0 System (DIFOTI System for Dental Examinations, Model B) is indicated for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.

### Safety and Performance:

Safety and performance testing included image quality evaluation, software hazard analysis, in-vitro 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2004

Michael Greenebaum, Ph.D. Director of Research Electro-Optical Sciences, Inc. 1 Bridge Street, Suite 15 Irvington-on-Hudson, New York 10533

Re: K043068

Trade/Device Name: DIFOTI USB 2.0 System Regulation Number: 21 CFR 872.1745 Regulation Name: Laser fluorescence caries detection device Regulatory Class: II Product Code: NTK Dated: November 4, 2004 Received: November 8, 2004

Dear Dr. Greenebaum:

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.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 - Michael Greenebaum, Ph.D.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Melkersen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

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

November 1, 2004 DIFOTI System for Dental Examinations, Model B

Page

510(k) Number (if known):

Device Name: __ DIFOTI USB 2.0 System

Indications for Use:

The DIFOTI USB 2.0 System is indicated for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-the -Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerson

and New

510(k) Number K04 3068