(85 days)
This device is intended to clean and sanitize toothbrushes before and after normal oral use.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "Toothbrush Mate." This document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as described in the prompt.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text. The document is a regulatory approval letter, not a study report.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an abstract human figure, represented by three curved lines that suggest a profile view of a person's head and shoulders.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1999
Mr. Nabil Azo AZO Enterprise 6114 N. Sacramento Chicago, IL 60659
K992435 Re : Trade Name: Toothbrush Mate Requlatory Class: I Product Code: EFW Dated: June 21, 1999 Received: July 22, 1999
Dear Mr. Azo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
{1}------------------------------------------------
Page 2 - Mr. Azo
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sia will equivalence of your device to a legally marketed predicate device results in a classification for your markees problems, 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ons regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Pulicai Caccantiffor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number: K992435
Device Name: Bacti-Stop Cleaner and Sanitizer Toothbrush Mate
Indications for Use:
This device is intended to clean and sanitize toothbrushes before and after normal oral use.
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use (Per 21 CFR 801.109)
Over-I
Optional
Over-The-Counter Use Optional Formate 1-2-96)
Susan Runser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(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.