(41 days)
Not Found
No
The description focuses on direct visualization of natural tissue fluorescence and does not mention any computational analysis, algorithms, or learning processes applied to the visual data.
No
The device is used to enhance the visualization of oral mucosal abnormalities and to aid in determining appropriate margins for surgical excision, which is a diagnostic and surgical planning tool, not a therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section states that VELscope is intended to "enhance the visualization of oral mucosal abnormalities..." and "help identify diseased tissue..." to aid in determining surgical margins. This describes a diagnostic function. The "Device Description" also notes that "suspicious tissue that may require further investigation can be quickly identified," further indicating its role in identifying abnormalities for diagnosis.
No
The device description explicitly mentions hardware components: a Light Source Unit (LSU) and a viewing Handpiece that emits blue light and allows for real-time examination. This indicates it is a hardware-based device, not software-only.
Based on the provided information, the VELscope device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. IVDs typically involve testing biological samples like blood, urine, tissue biopsies, etc., outside of the body to diagnose or monitor a condition.
- VELscope is a direct visualization system. It uses light to examine tissue within the oral cavity in real-time. It does not involve collecting and analyzing samples in a laboratory setting.
- The description focuses on visualization and enhancement. The intended use and device description clearly state that VELscope is an "adjunct to traditional oral examination" and a "direct visualization system" to "enhance the visualization" of oral mucosal abnormalities.
Therefore, VELscope falls under the category of a medical device used for direct examination and visualization, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
VELscope is intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia. VELscope excites the tissue with blue light and allows 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 incandescent (white) light.
VELscope is further intended to be used by a surgeon adjunctively to his/her clinical assessment to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
Product codes
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, surgeon (dental), dentist
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)
Peer-reviewed and published scientific studies provide evidence to support that:
- VELscope is effective in helping detect occult cancerous and dysplastic lesions.
- VELscope can help an oral surgeon assess the extent of occult diseased tissue around a clinically apparent precancerous or cancerous lesion and thus aid in determining the appropriate margin for surgical excision.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
1 of 2
Section 5 - 510(k) Summary
APR 5 - 2007
Submitter's Name: David Morgan, PhD
- 201-15047 Marine Dr. Address: White Rock, BC V4B 1C5 Canada
Date of Submission: February 14 2007
Contact Person: David Morgan, PhD
E-mail: david.morgan@led-md.com
(604) 541-4614, ext. 262 Phone:
(604) 541-4613 Fax:
Device Name: VELscope
Common Name: Oral Examination Light
Classification Name: Ultraviolet detector
Marketed Device of Equivalence: VELscope (K060920)
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 intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia. VELscope excites the tissue with blue light and allows 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 incandescent (white) light.
VELscope is further intended to be used by a surgeon adjunctively to his/her clinical assessment to help identify diseased tissue around a clinically apparent lesion and thus
Dated: 2/14/2007
1
K070523
20/2
aid in determining the appropriate margin for surgical excision.
Characteristics of VELscope compared to Predicate Device:
The VELscope System is substantially equivalent to the VELscope System already cleared under 510(k) - K060920.
As compared to the predicate device, the VELscope system now has expanded indications for use based on recently published clinical data in peer-reviewed publications. These indications:
- Explicitly state the possibility of helping detect oral cancer and dysplasia .
- . Explicitly state the possibility of helping detect mucosal abnormalities that may not be visible or apparent to the naked eye.
- Include a new indication for use by surgeons as an aid to identifying diseased . tissue around a clinically apparent lesion to help determine the appropriate margin for surgical excision.
Clinical Studies:
Peer-reviewed and published scientific studies provide evidence to support that:
- VELscope is effective in helping detect occult cancerous and dysplastic lesions .
- VELscope can help an oral surgeon assess the extent of occult diseased tissue . around a clinically apparent precancerous or cancerous lesion and thus aid in determining the appropriate margin for surgical excision.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features the department's name encircling a symbol. The symbol consists of a stylized representation of three human figures connected by flowing lines, suggesting unity and collaboration. The overall design is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 5 - 2007
David C. Morgan, Ph.D. Senior Vice President LED Dental, Incorporated 201-15047 Marine Drive White Rock, British Columbia Canada V4B 1C5
Re: K070523
Trade/Device Name: VELscope Regulation Number: 872.6350 Regulation Name: Ultraviolet Detector Regulatory Class: II Product Code: NXV Dated: February 14, 2007 Received: February 23, 2007
Dear Dr. Marine:
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
Page 2 -Dr. Marine
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 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylia Y. Michaud Dins.
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
4
Image /page/4/Picture/0 description: The image shows a handwritten string of characters, "K070 523". The characters are written in black ink on a white background. A horizontal line is drawn under the string of characters.
Indications for Use
510(k) Number (if known):
VELscope Device Name:
Indications For Use:
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 that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia.
VELscope is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
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)
Kee Muling fn MSR
ion of Anesthesiology, General Hospital,
cuon Control, Dental Devices
2(k) Number: K070523
Page 1 of