(86 days)
This product is intended to be used as an accessory to cleaning a toothbrush.
Not Found
I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document is a 510(k) clearance letter from the FDA for a "Toothbrush Wash" device. It primarily states that the device has been found substantially equivalent to a predicate device and can therefore be marketed.
It does not contain any information regarding:
- Acceptance criteria for device performance.
- A study that demonstrates the device meets specific performance criteria.
- Sample sizes used for testing or training sets.
- Data provenance or details about ground truth establishment.
- Information about expert involvement or adjudication methods.
- Details on MRMC studies or standalone algorithm performance.
Therefore, I cannot populate the requested table and answer the subsequent questions.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping, abstract shapes resembling birds in flight, which is the department's symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2000 MAR
Ms. Cheryl A. Little President Cal Huech, Inc. 105 Settler's Trail 31088 Warner Robins, Georgia
K994144 Re : Toothbrush Wash Trade Name: Requlatory Class: I Product Code: EFW December 6, 1999 Dated: December 7, 1999 Received:
Dear Ms. Little:
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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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 obligation you might have under sections 531 through 542 of
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Page 2 -Ms. Little
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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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" (21 CFR 807.97). Other general 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,
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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This product is intended to be used as an accessory to cleaning a toothbrush.
Cheryl O. Little
Cheryl A. Little
12/06/1999
Date
K994144
*Premarket Notification 510(k) Number
Premarket Notification 510(k) Number
Susan Rurrer
(Division Sign-Off) (Division Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Infection Devices , , , / / J Division of Dential The Boy
and General Hospital Day
510(k) Number ---------------------------------------------------------------------------------------------------------ાપા
§ 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.