(304 days)
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No
The 510(k) summary describes a topical fluoride varnish, which is a chemical substance, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is a topical fluoride varnish for the treatment of dentin hypersensitivity, which is a condition but does not inherently classify it as a therapeutic device in the sense of actively treating or curing a disease or medical condition beyond symptom relief for a dental issue.
No
A diagnostic device identifies or characterizes a disease or condition. This device is a topical fluoride varnish for the treatment of dentin hypersensitivity, indicating it is a therapeutic device, not a diagnostic one.
No
The 510(k) summary describes a topical fluoride varnish, which is a physical substance applied to teeth, not a software program.
Based on the provided information, the Vella® 5% Sodium Fluoride Varnish with NuFluor® and Xylitol® is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "a topical fluoride varnish for the treatment of dentin hypersensitivity." This describes a product applied directly to the body (topically) to treat a condition.
- Definition of IVD: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description does not mention analyzing samples from the body, performing tests on biological specimens, or providing diagnostic information based on such analysis.
Therefore, the Vella® 5% Sodium Fluoride Varnish is a therapeutic device applied directly to the teeth, not an IVD.
N/A
Intended Use / Indications for Use
Vella® 5% Sodium Fluoride Varnish with NuFluor® and Xylitol® is a topical fluoride varnish for the treatment of dentin hypersensitivity.
Product codes
LBH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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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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§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2014
Preventive Technologies, Incorporated Mr. Kenneth S. Peterson Vice President, Research and Development 4330C Matthews-Indian Trail Road Indian Trail, North Carolina 28079
Re: K140350
Trade/Device Name: Vella 5% Sodium Fluoride Varnish with NuFluor® and Xylitol® Regulation Number: 21 CFR 872.3620 Regulation Name: Cavity varnish Regulatory Class: II Product Code: LBH Dated: November 7, 2014 Received: November 12, 2014
Dear Mr. Peterson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Peterson
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
(21 CFR § 807.87(h), 807.92)
510(K) Number: K140350
| Device Name: | VELLA® 5% Sodium Fluoride Varnish with
NuFluor® and Xylitol® |
| -------------- | ----------------------------------------------------------------- |
|---|
Indications for Use:
Vella® 5% Sodium Fluoride Varnish with NuFluor® and Xylitol® is a topical fluoride varnish for the treatment of dentin hypersensitivity.
Prescription Use X AND/OR (21 CFR 801 Subpart D)
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)