(87 days)
Not Found
Not Found
No
The device is described as passive eyewear with specific light filtering properties, and there is no mention of any computational or algorithmic processing, let alone AI/ML.
No
The device is described as an accessory worn by healthcare professionals to filter light during an oral exam, not as a device that directly treats a medical condition or ailment.
No
The ViziLite Eyewear is an accessory worn by healthcare professionals to filter ambient light during a chemiluminescent oral exam; it does not diagnose a condition itself.
No
The device is described as "polarized filtered eyewear," which is a physical hardware component, not software.
Based on the provided information, the ViziLite Eyewear is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- ViziLite Eyewear Function: The ViziLite Eyewear is an accessory worn by a healthcare professional during a visual examination of the oral cavity. It filters light to improve visibility during a chemiluminescent oral exam. It does not analyze a sample taken from the patient's body.
- Intended Use: The intended use clearly states it's an "optional accessory worn by health care professionals during chemiluminescent oral exam" to "reduce the effects of ambient light." This is a tool to aid in a visual examination, not a diagnostic test performed on a biological sample.
Therefore, the ViziLite Eyewear falls under the category of a medical device used to facilitate a clinical examination, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ViziLite Eyewear is reusable and intended to be an optional accessory worn by health care professionals during chemiluminescent oral exam.
The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.
Product codes
NXV
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
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)
ViziLite Blue Oral Exam Product
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
172
SECTION 12 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS APR - 4 2008
K080043 ViziLite Eyewear
Submitter's Name: Gary Klinefelter
Address: 5227 North 7th Street
Phoenix, AZ 85014-2800
Phone: 602-266-6700
Fax: 602-234-2318
Consultant: Suzanne Parisian, M.D.
MD Assist, Inc.
Device Name: ViziLite Eyewear
Common Name: Oral Examination Light
Classification Name: Operating Light, Dental
Substantial Equivalence: ViziLite Blue Oral Exam Product
1. INTENDED USE:
The ViziLite Eyewear is reusable and intended to be an optional accessory worn by health care professionals during chemiluminescent oral exam.
INDICATIONS FOR USE: INDICATIONS FOR USE:
The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.
Instructions for Use "VIZILITE EYEWEAR"
The reusable ViziLite eyewear, as supported by clinical testing, allows a trained health care professional the option to use the evewear throughout the ViziLite Plus with TBlue Oral Lesion Marking Procedure for oral chemiluminescent examination without the need for darkening a room and without altering safety and efficacy.
Date of Submission: March 24, 2008
Contact: Mark Bride, DDS
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Following a conventional oral exam with ambient light, the trained health care professional can put on the ViziLite Eyewear for the ViziLite Plus with TBlue Oral Lesion Marking Procedure to improve oral mucosal lesion identification, evaluation and monitoring in patients at increased risk for oral cancer. The "ViziLite" is the system's chemiluminescent light source used for identification and evaluation of oral mucosal changes which can include atypia, dysplasia, leukoplakia, erythroplakia, genetic change or occult lesions.
While still wearing the ViziLite Eyewear, oral lesions identified by ViziLite can be marked using the TBlue Oral Lesion Identification and Marking System to help preserve the anatomic characteristics. The marking dye, when positive, acts as a lesion marker allowing removal of the ViziLite while preserving the anatomic characteristics of the lesion. Whether a lesion marks with dye or not should not alter the clinician's clinical behavior as dictated by the results of the ViziLite examination.
The ViziLite Eyewear can be worn throughout the ViziLite and TBlue Oral Lesion Marking procedure without interfering with the examination.
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Image /page/2/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 4 2008
Mark Bride, DDS Vice President, Medical Affairs Zila, Incorporated 5227 North 7th Street Phoenix, Arizona 85014-2800
Re: K080043
Trade/Device Name: VIZILITE EYEWEAR Regulation Number: 872.6350 Regulation Name: Dental Operating Light Regulatory Class: II Product Code: NXV Dated: March 25, 2008 Received: March 27, 2008
Dear Dr. Bride:
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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Page 2 - Dr. Bride
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,
Suitt. Y. Mckinzie Ovid.
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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SECTION 1- INDICATIONS FOR USE
510(k) Number: K080043
Device Name: VIZILITE EYEWEAR
INDICATIONS FOR USE: The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | X |
| (Per 21 CFR 801.109) | |
| OR | Over-The-Counter Use ___________ |
| (Optional Format 1-2-96) |
Signature
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control & Dental Devices
| 510(k) Number | K080043 |
|---|---|
| --------------- | --------- |