(84 days)
The Medoral Hygienic Toothbrush with DENTOSAN® Filaments is a toothbrush to remove plaque and debris from the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.
The Medoral Hygienic Toothbrush is a toothbrush with DENTOSAN® filaments. The DENTOSAN® filament is a nylon filament impregnated with an anti bacterial agent to prevent the growth of bacteria on and between the filaments after use of the toothbrush.
The provided text refers to a 510(k) summary for a "Medoral Hygienic Toothbrush with DENTOSAN® Filaments," a manual toothbrush with antibacterial properties. The summary describes the device, its intended use, and its technological characteristics. It also states that "The effect of the antimicrobial agent was tested and found to be effective using worst case testing for useful life, simulated use extraction testing and antimicrobial effectivity. Additionally, the filament was determined to be biocompatible using the methods recommended in ISO 10993 Biological Testing of Medical and Dental Materials and Devices."
However, the provided document does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria in the format requested.
Here's an attempt to answer the questions based only on the provided text, highlighting the missing information:
1. A table of acceptance criteria and the reported device performance
The document mentions "worst case testing for useful life, simulated use extraction testing and antimicrobial effectivity." It also states "The antimicrobial agent used is the DENTOSAN® filament does not raise any new safety or effectiveness concerns." and "The biocompatibility and effectiveness of the antibacterial agent was tested using established scientific methods and test protocols."
However, it does not provide specific numerical acceptance criteria (e.g., "bacterial reduction by X%") or the reported device performance data against those criteria.
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.
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 as the device is a toothbrush, and the testing described (antimicrobial effectivity, biocompatibility) typically involves laboratory assays rather than expert interpretation of images or clinical outcomes in the usual sense of "ground truth" for medical imaging AI. Therefore, no experts would be establishing "ground truth" in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the relevant studies described are laboratory-based antimicrobial and biocompatibility tests, not studies requiring human adjudication of results.
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
An MRMC study is not applicable or mentioned for this device. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images, where AI might assist readers. This device is a manual toothbrush.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to a manual toothbrush. It refers to AI-driven algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the antimicrobial effectiveness, the "ground truth" would likely be established by quantitative measurements of bacterial reduction using standardized microbiology laboratory methods (e.g., colony forming units count).
For biocompatibility, the "ground truth" is established by validated biological assays as per ISO 10993, comparing the device's material with established safety benchmarks.
The document does not explicitly detail these "ground truth" methods but refers to "established scientific methods and test protocols" and ISO 10993.
8. The sample size for the training set
This question is not applicable to this device. A "training set" is relevant for machine learning or AI models, which are not described or implied for this manual toothbrush.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as point 8.
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Section E - 510(k) Summary
1020776
March 5, 2000
| Applicant: | CORONET GROUP North America, LLC175 Dwight Road, Suite 200Longmeadow, MA 01106Phone: 413-565-4602 Fax: 413-565-4603 |
|---|---|
| Application Preparer &Correspondent | Thomas E. FerariMedical Device Consultant181 Dixon RoadQueensbury, NY 12804Phone - 518-792-2258 Fax: 518-792-2274email - tferari@aol.com |
| Proprietary Device Name:Common Device Name:Classification Name: | Medoral Hygienic Toothbrush with DENTOSAN® FilamentsAntibacterial Toothbrush FilamentManual Toothbrush (Class I Device Ref 21CFR 872.6855) |
| Predicate Devices: | Reach Antibacterial Toothbrush K971589Crest Toothbrush with Microshield K973236Butler Antibacterial Interdental Toothbrush K974761 |
Device Description: The Medoral Hygienic Toothbrush is a toothbrush with DENTOSAN® filaments. The DENTOSAN® filament is a nylon filament impregnated with an anti bacterial agent to prevent the growth of bacteria on and between the filaments after use of the toothbrush.
Intended Use: The Medoral Hygienic Toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent maintains the cleanliness of the brush by preventing the growth of bacteria on and between the filaments after use.
Technological Characteristics: The DENTOSAN® filament is impregnated with a high level of silver to prevent the growth of bacteria on or between the toothbrush bristles. The active ingredient is distributed throughout the nylon filament and provides long lasting antimicrobial action.
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Substantial Equivalence Assessment: All of the predicate devices are toothbrushes with antibacterial ingredients incorporated into them. Although the antibacterial agents (triclosan and chlorhexidine/zinc oxide) are different, in the predicate devices, their effect is comparable to the silver used in the DENTOSAN® filament. The effect of the antimicrobial agent was tested and found to be effective using worst case testing for useful life, simulated use extraction testing and antimicrobial effectivity. Additionally, the filament was determined to be biocompatible using the methods recommended in ISO 10993 Biological Testing of Medical and Dental Materials and Devices.
Summary:
The antimicrobial agent used is the DENTOSAN® filament does not raise any new safety or effectiveness concerns. The biocompatibility and effectiveness of the antibacterial agent was tested using established scientific methods and test protocols. Therefore, the Medoral Hygienic Toothbrush with DENTOSAN® filaments is believed to be substantially equivalent to the predicate devices.
Image /page/1/Picture/3 description: The image shows the date 3/5/02. The date is written in a simple, sans-serif font. The numbers are clearly legible.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2002
C/O Mr. Thomas E. Ferari Medical Device Consultant Coronet Group North America, LLC 181 Dixion Road Queensbury, New York 12804
Re: K020776
Trade/Device Name: Medoral Hygienic Toothbrush with DENTOSAN® Filaments Regulation Number: 872.6855 Regulation Name: Toothbrush with Antibacterial Filament Regulatory Class: I Product Code: EFW Dated: March 5, 2002 Received: March 11, 2002
Dear Mr. Ferari
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Mr. Ferari
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613dditionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patricio Cusenite ffor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K02076
Section D - Statement of Indications for Use
| 510(k) Number: | TBD |
|---|---|
| Applicant: | CORONET GROUP North America, LLC175 Dwight Road, Suite 200Longmeadow, MA 01106Phone: 413-565-4602 Fax: 413-565-4603 |
| Proprietary Device Name: | Medoral Hygienic Toothbrush with DENTOSAN® Filament |
Intended Use: The Medoral Hygienic Toothbrush with DENTOSAN® Filaments is a toothbrush to remove plaque and debris from the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.
ABgotz for Dr Ruener
(Division Sign Division of Dental, Infection Control, and General Hospital 5 10(k) Number _
§ 872.6855 Manual toothbrush.
(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.