(23 days)
Not Found
No
The description focuses on the physical mechanism of fluorescence visualization and does not mention any computational analysis or interpretation of the images using AI/ML.
No.
The device is used to enhance the identification and visualization of oral mucosal abnormalities. It is a diagnostic aid, not a therapeutic device.
Yes
The device is used to enhance the identification and visualization of oral mucosal abnormalities, which are diagnostic activities. It helps identify "suspicious tissue that may require further investigation."
No
The device description explicitly mentions hardware components: a Light Source Unit (LSU) and a viewing Handpiece.
Based on the provided information, the VELscope device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The VELscope directly visualizes tissue in situ (within the body) using fluorescence. It does not involve collecting and analyzing samples like blood, urine, or tissue biopsies in a laboratory setting.
- The intended use describes direct visualization. The description clearly states that the device is used 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." This is a direct examination technique, not an in vitro test.
- The device description reinforces direct visualization. It describes the Handpiece emitting light into the oral cavity and allowing for real-time examination.
Therefore, the VELscope falls under the category of a medical device used for direct examination and visualization, not an IVD.
N/A
Intended Use / Indications for 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.
VELscope is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities.
Product codes (comma separated list FDA assigned to the subject device)
NXV
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified health-care providers, dentist or health-care provider
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)
NIH funded scientific studies provide evidence to support that VELscope is effective in enhancing the visualization of oral mucosal abnormalities.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 872.6350 Ultraviolet detector.
(a)
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.(b)
Classification. Class II.
0
Section 5 - 510(k) Summary
ילי" ליינו 17 מינו
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
(604) 541-4614, ext. 262 Phone:
E-mail: david.morgan@led-md.com
(604) 541-4613 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
1
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.
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 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.
3
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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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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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