BREATH TAKER by HOFA LLC. | FDA 510(k) Summary

The Breath Taker is intended to be used for the manual removal of bacteria from the human tongue for the purpose of freshening the breath, enhancing taste and improving oral hygiene. It is used by placing the selected scraping edge on the back of the extended tongue then pulling forward with sufficient pressure to scrape the tongue and remove bacteria. The Breath Taker is intended for over-the-counter use as a personal hygiene tool by men and women of all ages and physical conditions.

Device Description

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) approval letter for the "Breath Taker" device does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving those criteria.

The letter explicitly states: "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..."

This indicates that the device was approved based on its substantial equivalence to a predicate device, not necessarily on a de novo study demonstrating performance against specific acceptance criteria. The letter and its enclosure (Indications for Use) focus on the intended use and regulatory classification, not on performance metrics.

Therefore, I cannot provide:

A table of acceptance criteria and reported device performance: This information is not present.
Sample size used for the test set and data provenance: No test study data is described.
Number of experts used to establish ground truth and their qualifications: Not applicable as no specific performance study is detailed.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
Standalone performance: Not mentioned.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How ground truth for the training set was established: Not applicable.

Summary

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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 stylized human figure with three heads, representing the department's focus on health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 10 1997

Mr. Zudhir Nadkarni President BOFA LLC 180 East 2100 South Salt Lake City, Utah 84115

Re : K971887 Trade Name: Breath Taker Regulatory Class: Unclassified Product Code: LCN Dated: May 20, 1997 Received: May 21, 1997

Dear Mr. Nadkarni:

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 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 (Premarket Approval), 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 895. ਨਾ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (2.1 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 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.

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Paqe 2 - Mr. Nadkarni

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) 594-4618. 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 at (301) 443-6597.

Sincerely yours,

Patricia Crescentiffor

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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STATEMENT OF INDICATIONS FOR USE

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Regulation Number and Section

§ 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.