Treatment of hypersensitive teeth
Use on exposed dentin and root sensitivity
Under temporary restoratives and cements where post-operative sensitivity is of concern.

Device Description

PCxx Varnish is 5% Sodium Fluoride Varnish that reduces tooth sensitivity by forming a film when topically applied to enamel and dentin surfaces. The properties, intended use and composition are equivalent to the predicated devices and other current varnishes which are rosin based insoluble mixtures that form a film when applied to tooth surfaces. PCxx Varnish used the same rosin (colophony) and rosin derivatives that are used in predicate devices which include but are not limited to Duraflor, Duraphat and Fluorilaq. The product comes in a single unit dose package containing the varnish and separate applicator brush.

AI/ML Overview

The provided 510(k) summary for the PCXX Fluoride Varnish does not contain the information requested in points 1-9 regarding specific acceptance criteria and a study demonstrating the device meets those criteria.

This 510(k) submission is for a medical device that is a cavity varnish, specifically a 5% Sodium Fluoride Varnish. The basis for substantial equivalence is the technological characteristics and composition being identical to predicate devices. It relies on the assertion that "There are no performance standards established for this product in an ethanol solution. There are no performance specifications to assess how it to be substantially equivalent, performance will be the same."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study, as this information is not present in the provided text.

Here's a breakdown of what is stated, which indirectly addresses some points by explaining why the typical study information is absent in this type of submission:

1. A table of acceptance criteria and the reported device performance

Not provided. The submission explicitly states: "There are no performance standards established for this product... There are no performance specifications to assess how it to be substantially equivalent, performance will be the same." This indicates that the regulatory body does not require specific numerical performance criteria or a comparative performance study for this type of device to demonstrate substantial equivalence, as long as its composition and intended use are identical to established predicates.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. No test set or performance study data is presented.

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)

Not applicable / Not provided. No ground truth establishment is described for a performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. No test set or adjudication process 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 device is a topical varnish, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study would be relevant or conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (varnish), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not provided. No ground truth for device performance is mentioned as the submission relies on equivalency of composition and manufacturing.

8. The sample size for the training set

Not applicable / Not provided. No training set for an algorithm is relevant here.

9. How the ground truth for the training set was established

Not applicable / Not provided.

Summary of the 510(k) Claim:

The 510(k) submission for PCXX Varnish establishes substantial equivalence based on the following:

Identical Composition: "PCxx Varnish used the same rosin (colophony) and rosin derivatives that are used... include but are not limited to Duraflor, Duraphat and Fluorilaq."
Identical Intended Use: "PCxx Varnish is 5% Sodium Fluoride Varnish that reduces tooth sensitivity by forming a film when topically applied to enamel and dentin surfaces." This is presented as equivalent to predicate devices.
No Established Performance Standards: The key argument for not needing a performance study is the absence of specific performance standards for this type of product. The assumption is that if the composition and intended use are the same, the performance will also be the same.

Summary

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113146

Chapter 6 510(k) Summary

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

Submitter Information 1.

Ross Healthcare Inc. 1750 Grant Ave Blaine, WA, 98230

Subject: Abbreviated 510(k) PCXX Fluoride Varnish

Contact Person

Marc N. Ross Phone: 604-521-6626 604-521-6695 Fax: Email: marc@rosshealthcare.org

Date Prepared: October 5, 2011-10-05

1. Device Name
  PCXX Varnish Trade Name: Cavity Varnish Common Name: Classification Name: Cavity Varnish (21 CFR 872.3260)

3. Predicated Devices

Device	Company	K Number
Duraflor	Pharmascience, Inc	K961893
Duraphat	Colgate	K945794
Fluorilag	Pascal Co., Inc.	K030488

4.&5. Description and Intended Use

PCxx Varnish is 5% Sodium Fluoride Varnish that reduces tooth sensitivity by forming a film when topically applied to enamel and dentin surfaces.

The properties, intended use and composition are equivalent to the predicated devices and other current varnishes which are rosin based insoluble mixtures that form a film when applied to tooth surfaces.

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Technological Characteristics 6.

PCxx Varnish used the same rosin (colophony) and rosin derivatives that are used PCXX Vanush ascu the same room (0010) - 100 persons include but are not limited to Duraflor, Duraphat and Fluorilaq.

The product comes in a single unit dose package containing the varnish and separate applicator brush.

Performance and Comparison Data 7.

The sealant used in predicate devises is the same material used in the submitted I he sealant used in predicate devises to the rosin derivative of CAS# 65997-06-0
devices. The sealant used is a colophony, rosin or rosin derivative for this readuct devices. The sealant used is a colophority, room or randards established for this product
in an ethanol solution. There are no performance standards established to this produ in an ethanol solution. There are no perfections of essess thows it to be substantially equivalent, performance will be the same.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

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

JAN 2 3 2012

Mr. Marc N. Ross President Ross Healthcare, Inc. 1750 Grant Avenue Blaine, WA 98230

Re: K113146

Trade/Device Name: PCXX Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: January 6, 2012 Received: January 17, 2012

Dear Mr. Ross:

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. Ross

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,

Wh 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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Chapter 4.

Indications for Use

e (K113146)

510(k) Number :

Device Name:

PCXX Varnish Trade Name: Cavity Varnish Common Name: Classification Name: Cavity Varnish (21 CFR 872.3260)

Indications For Use:

Treatment of hypersensitive teeth ●
Use on exposed dentin and root sensitivity .
Under temporary restoratives and cements where post-operative sensitivity is of . concern.

AND/OR Prescription Use X -(Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 801 Subpart C)

Susan Rumm
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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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.