(108 days)
The FiteBac® Antimicrobial Cavity Cleanser with 2% K21 QAS is an antimicrobial aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.
The FiteBac® Antimicrobial Cavity Cleanser is an antimicrobial 2% K21 Quaternary Ammonium Silanefunctionalized (QAS) aqueous ethanolic solution intended for cleansing and moistening/re-wetting of prepared dental surfaces. It is recommended for use upon completion of tooth preparation or etching, prior to sealing dentinal tubules. FiteBac® Antimicrobial Cavity Cleanser acts on the microorganisms in the table below, and not only removes debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface.
The provided text describes the 510(k) premarket notification for the "FiteBac® Antimicrobial Cavity Cleanser." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study design for a novel device. The core of the submission emphasizes that the subject device is identical in formulation and manufacturing to the predicate device, with the only addition being an expanded antimicrobial claim.
Because the submission is for substantial equivalence and not a de novo clearance or PMA, the typical structure for reporting acceptance criteria and a study for a new device's performance against specific metrics is not present. Instead, the focus is on a comparative analysis with a legally marketed predicate.
Here's an analysis based on the provided document, addressing your questions to the extent possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study for a new device. Instead, it relies on demonstrating that the subject device (FiteBac® Antimicrobial Cavity Cleanser) is substantially equivalent to its predicate device (K190271 FiteBac® Cavity Cleanser) in all aspects except for an expanded antimicrobial claim.
The "performance" reported is related to the antimicrobial effectiveness shown in referenced literature.
| Metric/Trait | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Subject Device) |
|---|---|---|
| Formulation | Identical to Predicate | 2% K21 QAS |
| Manufacturing Process | Identical to Predicate | Same as Predicate |
| Intended Use | Equivalent to Predicate, with expanded claim | Cleansing and moistening/re-wetting of cavity preparations, antimicrobial |
| Principle of Operation | Equivalent to Predicate | Cleansing and re-wetting of carious preparations |
| Material Performance | Equivalent to Predicate | Same as Predicate |
| Biocompatibility | Equivalent to Predicate | Yes (Same as Predicate) |
| Antimicrobial Activity | Effective reduction of specified microorganisms | Demonstrated reduction of Streptococcus mutans, Actinomyces naeslundii, Lactobacillus acidophilus, and Candida albicans |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document refers to "in vitro studies" in referenced literature to demonstrate antimicrobial effectiveness. It does not explicitly state custom sample sizes or data provenance for a new test set specifically conducted for this 510(k) submission. Instead, it refers to existing published studies and "Data on File."
- Sample Size: Not specified for a single comprehensive study. The studies cited are in vitro (likely laboratory-based) using "dentin blocks impregnated with each microorganism."
- Data Provenance: The referenced studies are peer-reviewed publications (e.g., Dent Mater. 2018, Clin Oral Investig. 2020) and "Data on File." This suggests the data is likely from research institutions or internal company tests. The country of origin is not specified but commonly, such journals have international contributions. The studies are by nature prospective in their experimental design.
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 question is not applicable in the context of this 510(k) submission. The "ground truth" for antimicrobial effectiveness in in vitro studies is established through standardized microbiological testing methods, not through expert consensus in a clinical setting with human readers. The experts involved would be microbiologists and researchers conducting the experiments. Their qualifications are inherent in their authorship of peer-reviewed scientific publications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where discrepant readings or diagnoses need to be resolved by a consensus panel of experts. The studies mentioned here are in vitro laboratory experiments on antimicrobial efficacy, which do not involve such adjudication processes.
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 cavity cleanser, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a chemical cleanser and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "antimicrobial effectiveness" claim is based on microbiological assay results (i.e., direct measurement of microorganism reduction) from controlled in vitro experiments. This is the scientific standard for validating antimicrobial claims.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, this question is not relevant.
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June 25, 2020
Largent Health, LLC % Elizabeth O'keeffe Director of Regulatory Affairs Secure BioMed Evalutations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188
Re: K200614
Trade/Device Name: FiteBac Antimicrobial Cavity Cleanser Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: March 28, 2020 Received: May 28, 2020
Dear Elizabeth O'keeffe:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K200614
Device Name
FiteBac® Antimicrobial Cavity Cleanser
Indications for Use (Describe)
The FiteBac® Antimicrobial Cavity Cleanser with 2% K21 QAS is an antimicrobial aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.
Type of Use (Select one or both, as applicable) 図 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
PSC Publishing Services(301)443-6740 EF
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K200614
6 510(k) Summary
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the FiteBac® Antimicrobial Cavity Cleanser is provided below.
| Date | March 6, 2020 |
|---|---|
| Submitted by | Largent Health, LLC3698 Largent Way NW, Suite 101Marietta, GA 30064Phone: 770-218-6221 |
| 510(k) Contact | Secure BioMed EvaluationsElizabeth O'Keeffe, Ph.D.7828 Hickory Flat Highway Suite 120Woodstock, GA 30188770-837-2681 (direct)Regulatory@SecureBME.com |
| Trade Name | FiteBac® Antimicrobial Cavity Cleanser |
| Common Name | Varnish, Cavity |
| Code -Classification | LBH: Class II |
| Predicate Device | K190271 FiteBac® Cavity Cleanser |
Device Description
The FiteBac® Antimicrobial Cavity Cleanser is an antimicrobial 2% K21 Quaternary Ammonium Silanefunctionalized (QAS) aqueous ethanolic solution intended for cleansing and moistening/re-wetting of prepared dental surfaces. It is recommended for use upon completion of tooth preparation or etching, prior to sealing dentinal tubules. FiteBac® Antimicrobial Cavity Cleanser acts on the microorganisms in the table below, and not only removes debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface. In vitro studies, referenced below, demonstrated a reduction in the following microorganisms.
| Microorganisms Susceptible to FiteBac® Antimicrobial Cavity Cleanser |
|---|
| Streptococcus mutans1 |
| Actinomyces naeslundii1 |
| Lactobacillus acidophilus2 |
| Candida albicans3 |
1 Gou YP, Li JY, Meghil MM, et al. Quatemary ammonium silane-based antibacterial and anti-proteolytic cavity cleanser. Dent Mater. 2018;34(12):1814-1827.
2 Daod U. Burrow MF, Yu CKY. Effect of a novel quaternary ammonium silane cavity disinfectant on cariogenic biofilm formation. Clin Oral Investig. 2020;24(2):649-661.
3 Data on File
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Indications for Use
The FiteBac® Antimicrobial Cavity Cleanser with 2% K21 QAS is an antimicrobial aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.
Technological Characteristics
As the subject device is identical in formulation and manufacture, the subject device has substantially equivalent technological characteristics to the predicate device in terms of principles of operation, intended use, material performance, and biocompatibility.
Non-clinical Testing – Bench Study Comparison
As the subject device has the same formulation and manufacturing as the predicate device, the subject device has mechanical and physical properties identical to the predicate device. No additional biocompatibility testing was conducted for this submission.
In the referenced literature, the subject device underwent antimicrobial effectiveness testing against Streptococcus mutans, Actinomyces naeslundii, Lactobacillus, and Candida albicans. Briefly, dentin blocks impregnated with each microorganism were treated with the subject device to determine the effectiveness of the subject device at reducing the microorganism from the dentin, in the reduction of each microorganism.
Substantial Equivalence Summary (Conclusion)
FiteBac® Antimicrobial Cavity Cleanser subject device has equivalent intended use, principles of operation and the exact same technological characteristics as the predicate device FiteBac® Cavity Cleanser (K190271). Although the subject device includes and expanded antimicrobial claim, the subject device and the predicate device are the same formulation with the same manufacturing process. FiteBac® Antimicrobial Cavity Cleanser subject device is as safe and effective as the predicate device currently cleared for marketing in the United States and does not raise additional questions of safety and effectiveness.
| Trait | FiteBac® Antimicrobial Cavity Cleanser™(Subject Device) | FiteBac® Cavity Cleanser™(Predicate Device) | Comparison/Equivalent to |
|---|---|---|---|
| 510(k) number | TBD | K190271 | N/A |
| FDA Regulation | 872.3260 | 872.3260 | Equivalent |
| Product Code | LBH | LBH | Equivalent |
| ProductClassification | Class II | Class II | Equivalent |
| Use | Prescription UsePart 21 CFR 801 Subpart D | Prescription UsePart 21 CFR 801 Subpart D | Equivalent |
A comparison of the subject device to the predicate device is shown in the following table.
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| Trait | FiteBac® Antimicrobial Cavity Cleanser™(Subject Device) | FiteBac® Cavity Cleanser™(Predicate Device) | Comparison/Equivalent to |
|---|---|---|---|
| Indications forUse | The FiteBac® Antimicrobial CavityCleanser with 2% K21 QAS is anantimicrobial aqueous ethanolic solutionintended for cleansing andmoistening/re-wetting of cavitypreparations | The FiteBac® Cavity Cleanser is a 2% K21QAS aqueous ethanolic solutionintended for cleansing andmoistening/re-wetting of cavitypreparations | Equivalent plusAntimicrobialClaim |
| Principle ofOperation | Cleansing and re-wetting of cariouspreparations | Cleansing and re-wetting of cariouspreparations | Equivalent |
| Composition | 2% K21 QAS | 2% K21 QAS | Equivalent |
| AvailableConfigurations | Liquid | Liquid | Equivalent |
| Size | 8 mL | 8 mL | Equivalent |
| Package | Low Density Polyethylene Bottles | Low Density Polyethylene Bottles | Equivalent |
| Biocompatibility | Yes | Yes | Equivalent |
§ 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.