(126 days)
Clinpro™ Varnish is a fluoride, calcium and phosphate containing coating for use in:
· Treating hypersensitive teeth
· Treating exposed dentin and root sensitivity
Clinpro™ Varnish is a fluoride, calcium and phosphate containing coating for use in treating hypersensitive teeth and exposed dentin and root sensitivity. Clinpro™ Varnish is moisture and saliva-activated when applied to enamel and dentin. It will spread on and adhere to moist teeth. Clinpro™ Varnish is an alcohol/water-based solution of dental polymer resins. The product is sweetened with xylitol and sucralose. Clinpro™ Varnish contains two fluoride sources, 3% sodium fluoride and 3% strontium fluoride (equivalent to 2.26% fluoride ion). Clinpro™ Varnish provides both an initial release in the first hour and a continued release during the next 24 hours. Clinpro™ Varnish also contains sources of calcium and phosphate, including functionalized tri-calcium phosphate exclusively from 3M ESPE. Clinpro™ Varnish is supplied in unit-dose packages containing 0.50 ml of varnish coating. Each 0.50 ml of Clinpro™ Varnish contains 13.8 mg sodium fluoride and 13.8 mg strontium fluoride, equivalent to 10.4 mg total fluoride ion.
The provided document describes the acceptance criteria and study for the Clinpro™ Varnish, a dental device. However, it's crucial to understand that this document is a 510(k) summary for a medical device and not a report for an AI/ML-based device. Therefore, many of the requested categories (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or not provided in this context.
The acceptance criteria here refer to the device's compliance with established safety and performance standards for its intended use, typically demonstrated through non-clinical (in vitro, biocompatibility) testing, and comparison to legally marketed predicate devices.
Here's the breakdown of the information as much as it can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (from predicate comparison & standards) | Reported Device Performance (Clinpro™ Varnish) |
|---|---|---|
| Intended Use | For treating hypersensitive teeth and exposed dentin and root sensitivity (similar to predicates). | Met: Intended use is consistent with predicate devices. |
| Indications for Use | For treating hypersensitive teeth and exposed dentin and root sensitivity (similar to predicates). | Met: Indications for Use are identical to the primary predicate device (Vanish™ 5% Sodium Fluoride White Varnish). |
| Basic Composition | Film-forming material (rosin varnish for predicates). | Met (with technological difference): Polymer Resin Varnish (film-forming material), which is stated to be "substantially equivalent in performance" to rosin varnishes. Contains fluoride (sodium and strontium), calcium, and phosphate. |
| Fundamental Technology | Dentin tubule occlusion. | Met: Achieves dentin tubule occlusion by forming a hardened resin film after application. |
| Performance (Dentin Tubule Penetration) | Ability to penetrate and occlude dentin tubules. | Met: SEM and optical images show the device forms a "thin film penetrating dentin tubules." |
| Performance (Fluoride, Calcium, Phosphate Release) | Release of active ingredients. | Met: "in vitro fluoride release testing shows that Clinpro™ Varnish provides both an initial release in the first hour and a continued release during the next 24 hours." Contains sources of calcium and phosphate. |
| Physical Properties (Shelf life) | Stable for a specified duration at room temperature. | Met: Stability testing confirms a shelf life of 24 months at room temperature. |
| Biocompatibility | No cytotoxicity, sensitization, irritation/intracutaneous reactivity, or acute systemic toxicity. | Met: Passed biocompatibility testing including cytotoxicity, sensitization, irritation/intracutaneous reactivity, and acute systemic toxicity, conforming to relevant ISO standards. |
| Manufacturing & Risk Management | Compliance with relevant ISO standards for medical devices. | Met: Complies with ISO 14971, ISO 10993-1, -3, -5, -10, -11, -12, and ISO 7405. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it pertains to in vitro and biocompatibility testing, not human clinical trials with 'test sets' in the AI/ML sense. The in vitro tests likely involved dental models or extracted teeth. Biocompatibility tests would involve laboratory animals or in vitro cell cultures. The country of origin of the data is not specified, but the submission is from 3M Company in St. Paul, Minnesota, USA. The studies mentioned are non-clinical and would be prospective in their execution for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. "Ground truth" in the context of this device refers to the physical and chemical properties and biological responses observed in the in vitro and biocompatibility tests, not interpretations by human experts for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for human interpretation tasks, not for the objective measurements of device performance in laboratory settings as 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
This information is not applicable/provided. MRMC studies are for evaluating the performance of AI-assisted human interpretation in diagnostic tasks. This device is a dental varnish, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a physical product (dental varnish), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through:
- In vitro measurements: Objective laboratory measurements of dentin tubule penetration (evaluated via SEM and optical images) and fluoride, calcium, and phosphate release.
- Biocompatibility testing: Standardized biological assessments demonstrating the device does not cause adverse biological reactions (e.g., cytotoxicity, irritation).
- Comparison to predicate devices: The "ground truth" for substantial equivalence is that the device performs equivalently to existing, legally marketed similar devices that have established safety and effectiveness.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" in the context of this traditional medical device submission.
9. How the ground truth for the training set was established
This information is not applicable/provided. As there is no training set, there is no ground truth established for one.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2015
3M Company Shari Myszka, R.Ph., Pharm.D. Regulatory Affairs Specialist 2510 Conway Avenue St. Paul, Minnesota 55144-1000
Re: K151302
Trade/Device Name: Clinpro™ Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: August 10, 2015 Received: August 12, 2015
Dear Dr. Myszka:
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 - Shari Myszka, R.Ph., Pharm.D.
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Tina
Kiang -S
for 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
Enclosure
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Indications for Use Statement 4.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151302
Device Name Clinpro™ Varnish
Indications for Use (Describe)
Clinpro IM Varnish is a fluoride, calcium and phosphate containing coating for use in:
· Treating hypersensitive teeth
· Treating exposed dentin and root sensitivity
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14)
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3M ES
3. 510(k) Summary
3M ESPE Dental
2510 Conway Avenue St. Paul, MN 55144-1000
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510(k) Summary
This summary of 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Submitter | 3M ESPE Dental2510 Conway AvenueSt. Paul, MN 55144-1000 USA |
|---|---|
| Contact | Shari L. Myszka, R.Ph., Pharm.DRegulatory Affairs SpecialistPhone: (651) 736-6955Fax: (651) 737-9665slmyszka@mmm.com |
| Submission Date | May 13, 2015 |
| Device Name | Clinpro™ Varnish |
| Classification Name | Cavity Varnish |
| Regulation Number | 21 CFR 872.3260 |
| Product Code | LBH |
| Classification Panel | Dental |
| Classification | Medical Device, Class II |
Device 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.
Indications for Use: Clinpro™ Varnish is a fluoride, calcium and phosphate containing coating for use in:
- . Treating hypersensitive teeth
- . Treating exposed dentin and root sensitivity
Predicate Devices:
Vanish™ 5% Sodium Fluoride White Varnish (K092141) Pulpdent® Fluoride Varnish (K093620) Pulpdent® Activ Varnish (K112946) Duraphat® 5% Sodium Fluoride Varnish (K945794)
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3M ESPE
Description of Device:
Clinpro™ Varnish is a fluoride, calcium and phosphate containing coating for use in treating hypersensitive teeth and exposed dentin and root sensitivity. Clinpro™ Varnish is moisture and saliva-activated when applied to enamel and dentin. It will spread on and adhere to moist teeth. Clinpro™ Varnish is an alcohol/water-based solution of dental polymer resins. The product is sweetened with xylitol and sucralose. Clinpro™ Varnish contains two fluoride sources, 3% sodium fluoride and 3% strontium fluoride (equivalent to 2.26% fluoride ion). Clinpro™ Varnish provides both an initial release in the first hour and a continued release during the next 24 hours. Clinpro™ Varnish also contains sources of calcium and phosphate, including functionalized tri-calcium phosphate exclusively from 3M ESPE. Clinpro™ Varnish is supplied in unit-dose packages containing 0.50 ml of varnish coating. Each 0.50 ml of Clinpro™ Varnish contains 13.8 mg sodium fluoride and 13.8 mg strontium fluoride, equivalent to 10.4 mg total fluoride ion.
Technological Characteristics:
The basic composition, fundamental technology and intended use of Clinpro™ Varnish are substantially equivalent to the predicate devices. Clinpro™ Varnish is a fluoride, calcium and phosphate containing coating to provide immediate and sustained relief of dental pain or hypersensitivity. The immediate relief of hypersensitivity is achieved by the hardened resin film that forms immediately after application and occludes the dentin tubules. Clinpro™ Varnish is unique formulation that utilizes novel resin polymer coating technology to incorporate the additional sources of fluoride, calcium and phosphate. In vitro fluoride release testing shows that Clinpro™ Varnish provides both an initial release in the first hour and a continued release during the next 24 hours.
The table below summarizes the basic composition, fundamental technology and intended use of Clinpro™ Varnish and the predicate varnishes:
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| Vanish™ | Pulpdent® | Pulpdent® | Duraphat® | Clinpro™ |
|---|---|---|---|---|
| 5% SodiumFluorideWhite Varnish | FluorideVarnish | ActivVarnish | 5% SodiumFluorideVarnish | Varnish |
| PrimaryPredicate | ReferencePredicate | ReferencePredicate | ReferencePredicate | SubjectDevice |
| K092141 | K093620 | K112946 | K945794 | K151302 |
| Basic Composition | ||||
| Rosin Varnish | Rosin Varnish | Rosin Varnish | Rosin Varnish | Polymer ResinVarnish* |
| Fundamental Technology | ||||
| Dentin TubuleOcclusion | Dentin TubuleOcclusion | Dentin TubuleOcclusion | Dentin TubuleOcclusion | Dentin TubuleOcclusion |
| Indication for Use | ||||
| Treatment ofHypersensitiveTeeth andExposed Dentinand RootSensitivity | Treatment ofDentalHypersensitivity | Treatment ofDentalHypersensitivity | Treatment ofDentalHypersensitivity | Treatment ofHypersensitiveTeeth andExposed Dentinand RootSensitivity |
- The polymer resin varnish and the predicate rosin varnishes are film forming materials that block dentin tubules and act as carriers for the fluoride, calcium and phosphate. The synthetic polymer resin was selected due to its lower variability in composition and properties as compared to the naturally-sourced rosins and is substantially equivalent in performance to the rosin varnishes.
Performance Data:
In vitro testing was conducted with Clinpro™ Varnish and the predicate devices, Vanish™ 5% Sodium Fluoride White Varnish, Pulpdent® Active Varnish and Duraphat® 5% Sodium Fluoride Varnish. Properties evaluated include dentin tubule penetration and in vitro fluoride, calcium and phosphate release. SEM and optical images show that the devices form a thin film penetrating dentin tubules. In vitro fluoride release testing shows that Clinpro™ Varnish provides both an initial release in the first hour and a continued release during the next 24 hours. Clinpro™ Varnish utilizes a resin polymer coating technology to incorporate the additional sources of fluoride, calcium and phosphate as compared to the predicate devices that utilize a rosin polymer coating.
All varnishes function as film forming materials that block dentin tubules for use in treating dental hypersensitivity. Clinpro™ Varnish and Varnish™ Varnish are indicated for use on exposed dentin and root sensitivity for treating dental hypersensitivity as well.
Stability testing was conducted by evaluating the physical properties of the device at various storage conditions to confirm a shelf life at room temperature of 24 months. Biocompatibility testing for the device included cytotoxicity, sensitization, irritation/ intracutaneous reactivity and acute systemic toxicity.
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3M ESPI
Performance Standards:
Clinpro™ Varnish complies with the following ISO standards:
· ISO 14971:2007, Medical Devices - Application of Risk Management to Medical Devices
• ISO 10993-1:2009, Biological Evaluation of Medical Devices – Part 1:
Evaluation and Testing Within a Risk Management Process
· ISO 10993-3:2009, Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity and Reproductive Toxicity
· ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
· ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
· ISO 10993-11:2006, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
• ISO 10993-12:2012, Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials
• ISO 7405:2008, Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Substantial Equivalence Statement:
Results of the nonclinical and clinical testing demonstrate that Clinpro™ Varnish is substantially equivalent to the legally marketed predicate devices in terms of intended use, indications for use, basic composition, fundamental technology, delivery presentation, directions for use, physical properties and biocompatibility.
§ 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.