(72 days)
But er's Antibacterial Power Toothbrushes are devices that include a handle to be held in the hand and bris les (filaments) at one end to remove adherent plaque and food debris from the teeth to reduce too h decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on : nd between the bristles between uses.
The nylon bristles of the Butler GUM® Vati-Clean™ Toothbrush are impregnated with silver, which provides long-lasting antibacterial protection of the bristles.
The provided document is a 510(k) premarket notification for a medical device, specifically a powered toothbrush. It concerns the substantial equivalence determination for the "Butler GUM® Vari-Clean™ Power Toothbrush."
The document does not contain acceptance criteria or detailed study information typically found in performance studies for medical devices. The primary purpose of this 510(k) submission is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device, not to present novel performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information from the provided text for the following reasons:
- No Acceptance Criteria: The document does not define any specific performance metrics or thresholds for the Butler GUM® Vari-Clean™ Power Toothbrush that would be considered "acceptance criteria."
- No Performance Study: There is no description of a study conducted to demonstrate the device meets any performance criteria. The submission relies on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use.
- No Data on Test Sets, Experts, Adjudication, MRMC, or Ground Truth: Since no performance study is described, there is no information regarding sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, or the type of ground truth used.
- No Information on Training Set: Similarly, for devices relying on demonstrating substantial equivalence, information about training sets for algorithms is not typically present as the device's function is not based on a machine learning model that requires training.
The document mainly focuses on:
- Identifying the applicant and device.
- Describing the device's technological characteristics (nylon bristles impregnated with silver for antibacterial protection).
- Stating its intended use (over-the-counter toothbrush, with antibacterial agent on bristles).
- Identifying a predicate device (Medoral Hygienic Toothbrush, K020776) and arguing for substantial equivalence based on identical bristles.
- The FDA's decision letter confirming substantial equivalence.
In summary, the provided text does not contain the information required to answer your request about acceptance criteria and performance studies. This type of information is typically found in clinical trial reports or detailed performance validation studies, which are not present in this 510(k) summary.
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K 62 2900
Image /page/0/Picture/2 description: The image shows the logo for Butler, a company. The logo is in black and white, with the word "BUTLER" in large, bold letters. To the right of the word "BUTLER" is a symbol that looks like four squares arranged in a larger square. Below the word "BUTLER" is the phrase "A SINSTAR Company" in smaller letters.
JOHN O. BUTLER CO.
4635 W. FOSTER AVENUE
CHICAGO, IL 60630
USA
510(k Application - Butler GUM®
08/30/02
9. 510(lz) SUMMARY
9.1 & ubmitter's Name and Contact Information
| Contact Person: | Kevin G. Yost, PhD., Director, R&D |
|---|---|
| Phone: | (773) 481-6898 |
| Fax: | (773) 777-6099 |
| Email: | kyost@jbutler.com |
John O. Butler Company Sub:nitter Company: 4635 W. Foster Ave. Chicago, IL 60630
Date Prepared: August 30, 2002
9.2 Name of Device and Name/Address of Applicant
Burler GUM® Vari-Clean™ Power Toothbrush
John O. Butler Company 4635 W. Foster Ave. Chicago, IL 60630
9.3 Common or Usual Name
Powered Toothbrushes with Antibacterial Bristles
9.4 Classification Name
Toothbrush, Powered
9.5 Predicate Device
The Butler GUM® Vaxi-Clean™ Power Toothbrush is substantially equivalent to the Medoral Hygienic Toothbrush marketed by Coronet Group North America described in K020776, 6/3/2002.
9.6 Intended Use
The Butler Powered toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses of the toothbrush.
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9.7 "."echnological Characteristics and Substantial Equivalence
- 9.7.1 Technological Characteristics The nylon bristles of the Butler GUM® Vati-Clean™ Toothbrush are impregnated with silver, which provides long-lasting antibacterial protection of the bristles.
- Substantial Equivalence 9.7.2
The nylon bristles of the Butler GUM® Vari-Clean™ Power Toothbrush are identical to the bristles cleared by FDA in K020776, which is the predicate for this 510(k). There is no reason to believe that any new questions of safety and efficacy are raised by the use of the identical bristles in Butler GUM® Vari-Clean™ Power Toothbrushes and the two · devices should be deemed substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three wavy lines emanating from its head, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2002
Dr. Kevin G. Yost Director of R & D John O. Butler Company 4635 West Foster Avenue Chicago, Illinois .60630
Re: K022900
Trade/Device Name: Butler GUM® Vari-Clean™ Power Toothbrush Regulation Number: 21 CFR 872.6865 Regulation Name: Powered Toothbrushes Regulatory Class: I Product Code: JEQ Dated: August 30, 2002 Received: September 3, 2002
Dear Dr. Yost:
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.
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Page 2 - Dr. Yost
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); 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) 594-4613. Additionally, 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 vours.
Clue B/fm
Timothy A. Ulatowski 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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Image /page/4/Picture/0 description: The image shows the word "BUTLER" in bold, black letters. To the right of the word is a symbol that looks like four squares arranged in a 2x2 grid. Below the word "BUTLER" is the word "SUNSTAR", which is smaller and less bold than the word above it. The image appears to be a logo or brand name.
JOHN O. BUTLER Co.
4635 W. FOSTER AVENUE
CHICAGO, IL 60630
USA
510(1) Application - Butler GUM® Vari lean IM Power Toothbrushes 08/30/02
STATEMENT OF INDICATIONS FOR USE
510 k) Number (if known): _1 111229
Apr licant:
John O. Butler Company 4635 W. Foster Avenue Chicago, IL 60630 voice: 773.481.6898 fax: 773.777.6099
Dex ice Name: Powered Toothbrushes with Antibacterial Bristles
Butler GUM® Vari-Clean™ Power Toothbrush Pro rietary Name:
Indications For Use:
But er's Antibacterial Power Toothbrushes are devices that include a handle to be held in the hand and bris les (filaments) at one end to remove adherent plaque and food debris from the teeth to reduce too h decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on : nd between the bristles between uses.
(PLIASE CO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runez
(Division Sign-Off) Division of Anesthesiology, General Hood Infection Control, Dental Devices
510(k) Number: K093660
Prescription Use (Op ional Format 1-2-96) OR
Over-The-Counter Use
✓
CONFIDENTIAL
§ 872.6865 Powered toothbrush.
(a)
Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is 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.