MI VARNISH by GC AMERICA INC. | FDA 510(k) Summary

MI Varnish is a fluoride varnish with Recaldent™ (CPP-ACP) that has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification.

Device Description

MI Varnish is a fluoride varnish (5% sodium fluoride with CPP-ACP) which has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification. MI Vamish is packed in unit dose and can be applied on teeth with a disposable brush.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MI Varnish device, structured to answer your specific questions.

Acceptance Criteria and Device Performance Study for MI Varnish

Based on the provided 510(k) summary (K102808), the device MI Varnish is a fluoride varnish intended for desensitizing action when applied to tooth surfaces. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing direct clinical efficacy against predefined acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are primarily around demonstrating comparable physical and chemical properties to legally marketed predicate devices, and the "study" is a summary of physical tests.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by demonstrating similarity to predicate devices. The reported device performance is presented as a comparison against these predicates.

Parameter	Acceptance Criteria (Implied by Predicate Devices)	MI Varnish Reported Performance
pH	Similar to Duraflor (6.8) and Vanish Varnish (6.4)	6.6
Consistency (mm)	Similar to Duraflor (40±1) and Vanish Varnish (26±1)	39±2
Total Fluoride (wt %)	Similar to Duraflor (2.2±0.1) and Vanish Varnish (2.6±0.1)	2.4±0.1
Chemical Composition	Similar to Duraflor and Vanish Varnish (with specific exceptions for Recaldent, Hydrogenated rosin, and Diethylene glycol monoethyl ether, which are addressed in substantial equivalence argument)	Contains 5% Sodium Fluoride, CPP-ACP, Hydrogenated rosin, Diethylene glycol monoethyl ether.
Mode of Action	Substantially equivalent to predicate devices	Yes (stated as substantially equivalent)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for the individual physical tests (pH, consistency, total fluoride). It provides mean values with standard deviations (e.g., 39(2) for consistency), which implies that multiple measurements were taken for each parameter.

Test Set Sample Size: Not explicitly stated, but implied to be multiple measurements for each physical property.
Data Provenance: The tests were conducted "According to GC Corporation R&D test methods." The manufacturing origin of the device, GC America Inc. (Alsip, IL, USA), implies the tests were likely performed in a controlled R&D environment associated with the submitter. The document does not specify a country of origin for the data beyond that. The data is retrospective, as it refers to tests performed prior to the 510(k) submission date.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission. The "ground truth" for the physical and chemical properties is established by direct measurement using specified test methods, not by expert consensus or interpretation against a test set. There were no human readers involved in evaluating the performance metrics provided.

4. Adjudication Method for the Test Set

Not applicable. The performance is based on direct physical and chemical measurements rather than requiring expert adjudication.

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 not a diagnostic imaging or AI device. It's a dental material (fluoride varnish), and the submission does not involve an MRMC study or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a dental material, not a software or AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics presented (pH, consistency, total fluoride) is based on instrumental and analytical measurements according to established R&D test methods. For the overall substantial equivalence claim, the ground truth is established by comparing the device's characteristics and intended use to those of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Section 6 - 510(k) Summary

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Image /page/0/Picture/1 description: The image shows the alphanumeric string "K102808" in a handwritten style. The characters are bold and slightly slanted, with the "K" being the largest and most distinct character. The numbers are connected, giving the impression of a continuous flow.

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DEC 2 2 2010

GC AMERICA IN

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitter Information: GC AMERICA INC.
  3737 W. 127ª Street Alsip, IL 60803
  Contact Person: Mark Heiss, D.D.S. Phone: (708) 897-4042 Fax: (708) 897-4031

Alternate Contact: Lori Lappo Phone: (708) 897-4036 Fax: (708) 897-4031

Date Prepared: September 20, 2010

1. Device Name:
  Proprietary Name: MI Varnish Classification Name: Cavity Varnish (21CFR 872.3620) Device Classification: Class II Product Code: гвн
Predicate Devices: 3.

Company	Device	K Number
A.R. Medical Inc.Pharmascience, Inc.	Duraflor	K961893
3M ESPE Dental Products	Vanish Varnish, 5% SodiumFluoride White Varnish	K092141
GC Corporation	MI Paste Plus	K070854

1. Device description and Intended Use
  MI Varnish is a fluoride varnish (5% sodium fluoride with CPP-ACP) which has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification. MI Vamish is packed in unit dose and can be applied on teeth with a disposable brush.

The applicant device, MI Varnish is substantially equivalent to Duraflor and Vanish Varnish in intended use. Both devices are fluoride varnish as Cavity Varnish, and used for desensitizing action when applied to teeth.

Image /page/0/Picture/18 description: The image contains two logos. The logo on the left is a diamond shape with the text "CERTIFIED TO ISO 13485" inside. The logo on the right is a globe with the text "DTA" in the center and the word "MEMBER" above it.

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The chemical composition is similar to the predicate devices (Duraflor and Vanish Varnish) with the exception of Recaldent (CPP-ACP). Recaldent is found in the predicate device MI Paste Plus.

5. Components and Mode of Action

The applicant device, MI Varnish is a paste formulation delivered in unit dose package and applied on the tooth surfaces with a disposable brush.

The chemical components of MI Varnish are similar to that of Duraflor. Components of MI Varnish that have been used in approved devices, MI Paste Plus (GC Corporation), Cavit G K875133 (3M ESPE Dental products)/Vanish Varnish, K092141 (3M ESPE Dental products) are listed in the chemical formulation.

The mode of action of the applicant device is substantially equivalent to that of the predicate devices, Duraflor and Vanish Varnish.

6. Technological characteristics:

MI Varnish contains two new components that have not been used in dental varnish or predicate devices.

Hydrogenated rosin is a rosin derivative. It is made with hydrogenation treatment of usual rosin (CAS No. 8050-09-7). Rosin (Colophony) and other rosin derivatives are used as adhesive agents in FDA approved dental varnishes. These include Duraflor, Vanish Varnish, Enamel Pro Varnish, K062683 (Premier), and the other fluoride varnishes.

Rosin and hydrogenated rosin are structurally similar. Hydrogenated rosin retains the basic structure of rosin and has extra conjugated double bonds. The difference is reflected in appearance, color and physicochemical properties between rosin and derivatives, but not on toxicological properties.

Diethylene glycol monoethyl ether is a solvent of polyvinyl acetate. The compound is already being used in Japan as medical device in "Caviton EX" for temporary filling material. (The number: 221AABZX00131000 is approved by Health and Welfare Ministry in Japan)

7. Summary of Physical tests:

	pH	Consistency(mm)	Total fluoride(wt %)
MI Varnish	6.6	39(2)	2.4(0.1)
Duraflor	6.8	40(1)	2.2(0.1)
Vanish Varnish	6.4	26(1)	2.6(0.1)

Summary of Performance Specifications

According to GC Corporation R&D test methods.

As described above, the applicant device, MI Varnish is substantially equivalent to comparative devices, such as Duraflor and Vanish Varnish.

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Description of Safety and Substantial Equivalence: 8.
The applicant device is substantially equivalent to the predicate devices in its intended use.

Most of the chemical components in MI Varnish have been used in the predicate devices. MI Varnish contains two new components, however, one is a rosin derivative and another one is already being used as medical device in Japan. So, we believe that this fact well supports the compatibility of MI Varnish, and the safety of the applicant device is substantially equivalent to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mark Heiss, DDS Director -Academic and Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

DEC 2 2 2010

Re: K102808 Trade/Device Name: MI Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: September 27, 2010 Received: September 28, 2010

Dear Dr. Heiss:

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 – Dr. Heiss

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 vours.

hh 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

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Indications for Use

K10 2808 510(k) Number (if known): Device Name: MI Varnish

DEC 2 2 2010

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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 Quarrer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102808

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Regulation Number and Section

§ 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.