VELSCOPE

K060920 · Led Medical Diagnostics, Inc. · NXV · Apr 27, 2006 · Dental

Device Facts

• Record ID: K060920
• Device Name: VELSCOPE
• Applicant: Led Medical Diagnostics, Inc.
• Product Code: NXV · Dental
• Decision Date: Apr 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6350
• Device Class: Class 2

Intended Use

VELscope is to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities by exciting the tissue with blue light and allowing the direct visualization of the resulting natural tissue fluorescence. VELscope is complimentary to and is intended to be used in combination with a traditional oral mucosal examination with white light.

Device Story

VELscope is an oral examination light system used by healthcare providers to identify oral mucosal abnormalities. The device consists of a Light Source Unit (LSU) and a viewing handpiece. The handpiece emits blue light into the oral cavity, inducing natural tissue fluorescence. Healthy tissue fluoresces bright green, while suspicious tissue exhibits a loss of fluorescence and appears dark. The device is used as an adjunct to traditional white-light oral examinations. By enabling real-time visualization of tissue fluorescence, the device assists clinicians in identifying suspicious areas that may require further investigation, potentially facilitating earlier detection of mucosal abnormalities.

Clinical Evidence

NIH-funded scientific studies are cited as evidence supporting the effectiveness of the VELscope in enhancing the visualization of oral mucosal abnormalities.

Technological Characteristics

System comprises a Light Source Unit (LSU) and a viewing handpiece. Employs a metal halide light source to emit blue light. Utilizes optical filters to block reflected blue light and enable visualization of natural tissue fluorescence. Standalone device for clinical use.

Indications for Use

Indicated for use by dentists or healthcare providers as an adjunct to traditional incandescent light oral examinations to enhance visualization of oral mucosal abnormalities.

Regulatory Classification

Identification

An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.

Predicate Devices

• Vizilite (K003995)

Submission Summary (Full Text)

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K060920

## Section 5 - 510(k) Summary

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Submitter's Name: David Morgan, PhD

201-15047 Marine Dr. Address: White Rock, BC V4B 1C5 Canada

Date of Submission: March 31st 2006

Contact Person: David Morgan, PhD

[phone], ext. 262 Phone:

E-mail: [e-mail]

[phone] Fax:

Device Name: VELscope

Common Name: Oral Examination Light

Classification Name: Operating Light, Dental

Marketed Device of Equivalence: Vizilite

### Description of Device:

VELscope is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination.

The main components of VELscope are the Light Source Unit (LSU) and the viewing Handpiece. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, healthy tissue typically shows up as a brighter green color while suspicious tissue can cause a loss of fluorescence, which thus appears dark.

### Intended Use:

VELscope is to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities by exciting the tissue with blue light and allowing the direct visualization of the resulting natural tissue fluorescence. VELscope is complimentary to and is intended to be used in combination with a traditional oral mucosal examination with white light.

# Characteristics of VELscope compared to Predicate Device:

The VELscope System is substantially equivalent to Vizilite, manufactured by Zila, Inc. The 510(k) number of the predicate device is K003995.

Dated: 3/31/2006

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The VELscope functions similarly and is used for the same purpose as the Vizilite device.

Vizilite uses a 1% acetic acid mouth rinse prior to examination. An acetic acid rinse is not necessary for the use of the VELscope system.

Vizilite uses a chemiluminescent light source that produces a diffused blue-white light. The VELscope system uses a metal halide light to produce a blue light that is directed into the mouth via the VELscope Handpiece.

Essentially, the only difference between the VELscope system and the predicate device is that the VELscope system uses filters to block the reflected blue light to allow the visualization of the natural tissue fluorescence.

### Clinical Studies:

NIH funded scientific studies provide evidence to support that VELscope is effective in enhancing the visualization of oral mucosal abnormalities.

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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 circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2006

Dr. David C. Morgan Senior Vice President Product Development Led Medical Diagnostics, Incorporated #210-15047 Marine Drive White Rock, British Columbia V4B 1C5

Re: K060920

Trade/Device Name: VELscope Regulation Number: 872.6350 Regulation Name: Ultraviolet detector Regulatory Class: II Product Code: NXV Dated: March 31, 2006 Received: April 4, 2006

Dear Dr. Morgan:

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.

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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.

This letter will allow you to continue 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 and additionally Part 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Snute y. Michael Oms.

Chiu 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

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K060920

Indications for Use

510(k) Number (if known):

Device Name: VELscope

Indications For Use:

VELscope is intended to be used by a dentist or heatth-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suza Quarty

Dogv Gene

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