(79 days)
Pulpdent Copal Varnish with Fluoride is a resin-based varnish that is applied to enamel or dentin for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film.
Copal Varnish with Fluoride is a resin-based varnish that is applied to enamel or dentin for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film.
The provided text is for a 510(k) premarket notification for a dental varnish. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics typically associated with AI/ML devices or devices requiring detailed performance studies.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details cannot be fully extracted or accurately inferred from the provided documents. The documents explicitly state that the device's safety and effectiveness are established by its substantial equivalence to predicate devices that "have been on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems."
Here's an attempt to address the points based on the available information, noting where the information is not present or not applicable in this context:
1. Table of acceptance criteria and the reported device performance
No explicit acceptance criteria or quantitative performance metrics (like sensitivity, specificity, AUC) are provided in the document. The substantial equivalence is based on design, composition, performance (in a general sense, meaning it functions similarly), and intended use being comparable to predicate devices. The "performance" is implicitly accepted as established by the long-term safe and effective use of the predicate devices.
2. Sample sized used for the test set and the data provenance
No specific test set or clinical study with a defined sample size is described. The demonstration of safety and effectiveness relies on substantial equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a dental varnish, not an AI/ML diagnostic device, so MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (dental varnish), not an algorithm.
7. The type of ground truth used
Not applicable in the context of a performance study for this device. The "ground truth" for its safety and effectiveness is the established history and regulatory acceptance of its predicate devices.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
Summary of the basis for acceptance from the document:
The acceptance of "Copal Varnish with Fluoride" is based on demonstrating substantial equivalence to already legally marketed and established predicate devices. The document explicitly states:
"Copal Varnish with Fluoride is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products list have been on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems."
Therefore, the "study" that proves the device meets "acceptance criteria" (which are implicitly the criteria for substantial equivalence to the predicates) is the comparison presented in the 510(k) summary, which highlights the similarities in:
- Design
- Composition
- Performance (general function for treating dental hypersensitivity)
- Intended Use
The FDA's decision to clear the device (K100503) indicates that they accepted this argument of substantial equivalence.
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MAY 1 2 2010
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EXHIBIT 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
May 11, 2010
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: 617-926-6666 Fax: 617-926-6262 ken@pulpdent.com
DEVICE: Trade Name: Copal Varnish with Fluoride Classification Name: Cavity Varnish Class: Il FDA Product Code: 76 LBH, 21 CFR Part 872.3260
PREDICATE DEVICES:
DVF Varnish, Scientific Pharmaceuticals Copalite, Cooley & Cooley Duraphat, Colgate Oral Pharmaceuticals
DESCRIPTION AND INTENDED USE:
Copal Varnish with Fluoride is a resin-based varnish that is applied to enamel or dentin for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film.
COMPARISON WITH PREDICATE PRODUCTS:
Copal Varnish with Fluoride is substantially equivalent in design, composition, performance, and intended use to the predicate products listed above.
| Product | 510(k) Number | Description | Intended Use | Composition |
|---|---|---|---|---|
| PulpdentCopal Varnish withFluoride | K100503 | Copal-based fluoridevarnish | To treat toothhypersensitivity | Alpha copalDenatured ethanolFluoride mineral sourceWaterFlavorant |
| ScientificPharmaceuticalsDVF Varnish | K982915 | Colophony-basedvarnish with fluoride | To treat toothhypersensitivity | Ethyl alcoholColophonySodium fluorideWater |
| Cooley & CooleyCopalite | ------ | Copal-based varnish | To treat toothhypersensitivity. | CopalEthyl ether anhydrousChloroform |
| ColgateDuraphat | K945794 | Rosin-based fluoridevarnish | To treat toothhypersensitivity. | RosinEthyl alcoholSodium fluorideWaterFlavorant |
SAFETY AND EFFECTIVENESS:
Copal Varnish with Fluoride is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products list have been on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
MAY 1 2 2010
Re: K100503
Trade/Device Name: Pulpdent Copal Varnish with Flouride Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: February 16, 2010 Received: February 23, 2010
Dear Mr. Kenneth J. Berk:
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. Kenneth J. Berk
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
h for
Anthony D. Watson, B.S., M.S., M.B.A. 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: K 100503
Pulpdent Copal Varnish with Fluoride Device Name:
Indications For Use:
Pulpdent Copal Varnish with Fluoride is a resin-based varnish that is applied to enamel or dentin for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kei. iMuly for. M.S.R
(Division Sign-Off) Division of Anesthesional General Hospital Infection Control, Dentai Devices
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510(k) Number: K100503
§ 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.