StarBright™ 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.

Device Description

StarBright™ 5% Sodium Fluoride Varnish is a rosin based 5% sodium fluoride varnish. This device is available in tray form unit doses of 0.25 and 0.40 mL. Fluoride ions within StarBright™ 5% Sodium Fluoride Varnish may react with calcium and phosphate ions in saliva to form crystals in exposed dentin tubules, such as in exposed root surfaces, leading to protection by blocking external stimuli thereby reducing hypersensitivity.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "StarBright™ 5% Sodium Fluoride Varnish." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on its performance against quantitative metrics in a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria tables, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or detailed ground truth types.

Here's why the information is not present and what the document does contain:

Type of Device: The device is a "Cavity Varnish" (Product Code: LBH), regulated as Class II. This is a dental material, not an AI/ML-based diagnostic or imaging device.
Regulatory Pathway (510(k)): The 510(k) pathway for medical devices largely relies on showing that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics, intended use, and performance, often through bench testing and biocompatibility. It does not generally require large-scale clinical trials or detailed performance metrics against ground truth, especially for a well-established device type like a fluoride varnish.
Lack of AI/ML Component: The device is a chemical preparation. It does not involve any artificial intelligence, machine learning, image analysis, or diagnostic algorithms. Therefore, concepts like "test set," "training set," "ground truth experts," "adjudication," "MRMC study," and "standalone algorithm performance" are not applicable to this product.

What the document does include relevant to its regulatory pathway:

Identified Predicate Devices: The submission identifies several predicate devices (e.g., Duraflor ®, 3M Vanish, Nupro Model 13016901, Enamelast) to which StarBright™ 5% Sodium Fluoride Varnish is considered substantially equivalent.
Technological Characteristics and Intended Use: It states that the device has the same intended use (cavity varnish, treatment of dentin hypersensitivity) and similar technological characteristics (rosin-based 5% sodium fluoride varnish, paste formulation, unit dose packaging, applied with a brush) as the predicate devices.
Non-clinical Performance Testing: It mentions that non-clinical performance testing (fluoride release, tubule occlusion, cytotoxicity, sensitization, irritation) was conducted to support substantial equivalence. The document states these tests "demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices." This is the closest it comes to performance, but it's not quantitative "acceptance criteria" on a diagnostic metric.
No Clinical Performance Testing: The document explicitly states, "Clinical performance data was not included." This further supports that the type of study design you're asking about (which often involves clinical endpoints or diagnostic accuracy) was not a requirement for this specific 510(k) submission.

In summary, as the input document describes a chemical dental product undergoing a 510(k) review based on substantial equivalence, the requested information pertaining to AI/ML device performance and clinical studies (e.g., MRMC, standalone algorithm performance, expert ground truth) is not applicable or present in this document.

Summary

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

September 22, 2014

Nanova Biomaterials, Incorporated Mr. Andrew Ritts Senior Scientist 3806 Mojave Court Columbia, MO 65202

Re: K140349

Trade/Device Name: StarBright™ 5% Sodium Fluoride Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: August 1, 2014 Received: August 8, 2014

Dear Mr. Ritts:

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. Ritts

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,

Mary S. Runner -S

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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Confidential

Nanova Biomaterials, Inc. StarBright™ 5% Sodium Fluoride Varnish 510(k) Notification K140349

Section 4. Indications for Use Statement (As Required by 21 CFR 807.87(e))

510(k) Number (if known): K140349

Device Name: StarBright™ 5% Sodium Fluoride Varnish

Indications For Use:

StarBright™ 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

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Nanova Biomaterials, Inc. StarBright™ 5% Sodium Fluoride Varnish 510(k) Notification K140349

Section 5. 510(k) Summary

1)	Submitted By:	Nanova Biomaterials, Inc3806 Mojave Ct.Columbia, MO 65202USA(573)-875-6682
	Contact Person: Andrew Ritts	Phone: (573) 823-3114
	Secondary Contact: Kathryn Giddens	Phone: (573) 864-1701
2)	Establishment Registration No.:	NA
3)	Date Prepared:	July 1st, 2014
4)	Device Trade Name:	StarBright™ 5% Sodium Fluoride Varnish
5)	Device Common Name:	Dental Varnish
6)	Device Classification Name:	Cavity Varnish
7)	Classification Panel:	Class II
8)	Device Class:	Dental

9) Predicated Devices: StarBright™ 5% Sodium Fluoride Varnish is believed to be substantially equivalent to the following marketed products:

510(k)Number	Name of Device	ProductCode	Company
K961893	Duraflor ®	LBH	Pharmascience, Inc.
K092141	3M Vanish	LBH	3M ESPE
K103160	Nupro Model 13016901	LBH	Cao Group, Inc.
K132109	Enamelast	LBH	Ultradent Products, Inc

Indication for Use:

StarBright™ 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.

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Nanova Biomaterials, Inc. StarBright™ 5% Sodium Fluoride Varnish 510(k) Notification K140349

Section 5. 510(k) Summary - Cont.

1. Device Description: StarBright™ 5% Sodium Fluoride Varnish is a rosin based 5% sodium fluoride varnish. This device is available in tray form unit doses of 0.25 and 0.40 mL.
  Fluoride ions within StarBright™ 5% Sodium Fluoride Varnish may react with calcium and phosphate ions in saliva to form crystals in exposed dentin tubules, such as in exposed root surfaces, leading to protection by blocking external stimuli thereby reducing hypersensitivity.
1. Substantial Equivalence:
  The document, "Guidance on the CDRH Premarket Notification Review Program, 6/30/86 (K86-3)" was used to determine substantial equivalence:

a) The applicant device has the same intended use as the 510(k) cleared predicates listed above.

b) The technological characteristics of this product are believed to be substantially equivalent as those for the predicate devices and other rosin based products currently on the market. This device and its predicates are substantially equivalent in composition and material. StarBright™ 5% Sodium Fluoride Varnish is a paste formulation delivered in unit dose packaging and applied on the tooth surface with a disposable brush, similar to several 510(k) cleared products already on the market.

13). Non-clinical performance testing: Non-clinical performance testing on StarBright™ including fluoride release and tubule occlusion support substantial equivalence to the listed predicates. Biological testing included cytotoxicity, sensitization, and irritation. The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
14). Clinical performance testing: Clinical performance data was not included.

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Nanova Biomaterials, Inc. StarBright™ 5% Sodium Fluoride Varnish 510(k) Notification K140349

Section 5. 510(k) Summary - Cont.

Conclusion:

Nanova Biomaterials Inc. believes that StarBrightTM 5% Sodium Fluoride varnish is substantially equivalent to the currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.

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.