(133 days)
Not Found
No
The description focuses on biofluorescence and optical filtering, with no mention of AI, ML, or image processing that would typically indicate such technology.
No.
The device is used to enhance visualization of oral mucosal abnormalities and aid in defining lesion borders, which is a diagnostic function rather than a therapeutic one.
Yes.
The device enhances the visualization of oral mucosal abnormalities and aids in defining lesion borders, which are functions consistent with aiding in diagnosis.
No
The device description explicitly mentions hardware components like "an array of short wave blue LED's" and a "built in optical filter," indicating it is not software-only.
Based on the provided information, the Bio-Screen device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "adjunct to traditional oral examination" and is used to "enhance the visualization of oral mucosal abnormalities and aid in defining lesion borders." This describes a device used in vivo (on a living patient) for visual examination and enhancement, not a test performed in vitro (on samples outside the body).
- Device Description: The description details the use of blue LEDs and an optical filter to demonstrate and improve visualization of oral tissue in vivo through biofluorescence. This further supports its use as a direct examination tool.
- Lack of IVD Characteristics: IVD devices typically involve analyzing biological samples (blood, urine, tissue samples, etc.) to provide diagnostic information. The Bio-Screen does not mention collecting or analyzing any samples.
Therefore, the Bio-Screen is a medical device used for in vivo examination and visualization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bio-Screen 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 and aid in defining lesion borders.
Product codes
NXV
Device Description
This device uses an array of short wave blue LED's in the technique of biofluorescence to demonstrate abnormal oral tissue It employs a built in optical filter to improve contrast between healthy and abnormal tıssue and improve vısualızatıon
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Not Found
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
192t
510(k) SUMMARY
Submitters Name: Joshua Friedman, D D S
| Address: | AdDent, Inc
43 Miry Brook Rd
Danbury, CT 06810 | JAN 23 2009 |
|----------------------|------------------------------------------------------|-------------|
| Phone: | (203) 778-0200 | |
| Fax: | (203) 792-2275 | FDA CD... |
| Device Name: | Bio-Screen | JAN 16 2009 |
| Common Name | Oral Examination Light | Rec'd |
| Classification Name: | Dental Operating Light | |
Marketed Device of Equivalence: Vizilite, Microlux/DL, Microlux/Blu, Velscope
Description of the Device: This device uses an array of short wave blue LED's ın the technique of biofluorescence to demonstrate abnormal oral tissue It employs a built in optical filter to improve contrast between healthy and abnormal tıssue and improve vısualızatıon
Intended Use. The Bio-Screen 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 and aid in defining lesson borders
Characteristics of the Bio-Screen Compared to Predicate Device The Velscope made by LED Electronics, uses blue light and the principle of biofluorescence for screening and visualization of abnormal oral mucosa Velscope 510(k) No K060920 Companson to other predicate devices is shown on page 10
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Joshua Friedman, D D S President AdDent, Incorporated 43 Miry Brook Road Danbury, Connecticut 06810
JAN 2 3 2009
K082668 Re Trade/Device Name B10-Screen
Regulation Number 21 CFR 872 6350 Regulation Name Ultraviolet Detector Regulatory Class II Product Code NXV Dated January 15, 2009 Received January 16, 2009
Dear Dr Friedman
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your bection by one is substantially equivalent (for the Indications for use stated in the enclosure) to legally marketed predicate devices marketed in murcations for use stated in the enclosed of the enactment date of the Medical Device interstate comments, 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 approval appreation (1 MTT) - 1 82 - 125), rosisions of the Act include controls provisions of the Provins Jisting 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 mayor regulations affecting (PMA), it may be subject to facil acent Regulations, Title 21, Parts 800 to 898 In your device can be found in the South no nouncements concerning your device in the Federal Register
2
Page 2 - Dr Friedman
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issuance of a substantials with other requirements
mean that FDA has made a determination that your devec comples with other Federal agencres mean that HDA has made a decemination that your administered by other Federal agences
of the Act or any Federal statutes and regulations administered by regustrations of the Act or any rederal statues and regurements, including, but not Immted to registration
You must comply with all the Act 's requirements, including practice You must comply with an the Act 3 requirements and 01), good manufacturing practice and listing (21 CFR Part 807), laochity systems (QS) regulation (21 CFR Part 820), and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), requirements as set forth in the quality systems (QS) regulation (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)
the same of the supply of the secure of securely as welcated a This letter will anow you to begin manoning you antial equivalence of your device to a
premarket notification The FDA finding of substantial equivalence and thus, per premarket notification - The FDA midment of sabstantial of 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), office of If you desire specific advice for your device on ossimal fring (CDRH's) Office of
please contact the Center for Devices and Radiological Health's (CDRH's) Office of please contact the Center for Devices and rease note the regulation entitled, "Misbranding by
Compliance at (240) 276-0115 ) Also, please note the researchers regarding Compliance at (240) 276-0115 "Also, production" (21CFR Part 807 97) For questions regarding reference to premarket non really (21 C.I F. F. C.I.T. For weillance and Brometric's postmarket surveillance, please contact CDA 1 6 Original of Corporations regarding the (OSB's) Division of Posimalket Sulverhance at 210 Brootting (MDR)), please contact the
reporting of device adverse events (Medical Devec Reportung (MDR)), please contact the reporting of device adverse events (Medical 2016-3466) You may obtain other general Division of Sulvelliance Systemb at 210 210 210 210 11 11 11 11 11 information on your responsibilities ander and the reach and 638-2041 or (240) 276-3150 or at its Internet address 056-2041 of {2 gov/cdrh/industry/support/index.html
Sincerely yours,
Clothing is mention for
Ginette Y Michaud, M D Acting Director Acting Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
510(k) Number {if known):
Device Name: Bıo-Screen
Indication for Use:
The Bio-Screen is intended to be used by a dentist or health care provider as an The Bio-Screen is intended to be used on a candescent light to enhance the adjunct to traditional oral exammation by Insuracessful ight and orders
visualization of oral mucosal abnormalites and aid in defining lesion borders
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Gunne | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology General Hospital Infection Control, Dental Devices | |
| 510(k) Number | K082668 |