(42 days)
Not Found
Not Found
No
The summary contains no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is intended for cosmetic purposes (fresher breath) rather than treating or preventing a disease.
No
The intended use is to remove food and debris, which is a therapeutic or hygiene function, not a diagnostic one. It does not mention identifying or characterizing a disease or condition.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To remove food and debri from the mouth resulting in fresher breath." This describes a physical action performed on the body (the mouth) for a cosmetic or hygiene purpose.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used to diagnose, monitor, or screen for diseases or conditions.
- Lack of Diagnostic Activity: The device's function is purely mechanical removal of debris. It does not analyze any biological samples or provide any diagnostic information about the user's health.
Therefore, based on the provided description, this device falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
To remove food and debri from the mouth resulting in fresher breath.
Product codes
LCN
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, rendered in a stylized, minimalist design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hemant K. Thakur, M.D. President & C.E.O Beyond 21ST Century, Incorporated >> 13706 West 75th Place Lenexa, Kansas 66216-4229
JUL 18 1997
K972131 Re : Breath Ace Breathfreshener Trade Name: Requlatory Class: Unclassified Product Code: LCN Dated: June 4, 1997 Received: June 6, 1997
Dear Dr. Thakur:
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, qood 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Dr. Thakur
through 542 of the Act for devices under the Electronic chrough 312 or enc 110 rovisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k), premarket notification. The FDA ... ... ating of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets produce, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo 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: K972131 Device Name: Breath Ace Breathfeshener
Indications For Use:
To remove food and debri from the mouth resulting in fresher breath.
Image /page/2/Figure/4 description: The image shows the word "COPY" in a bold, outlined font. The word is slightly tilted to the right. The letters are not perfectly smooth, giving them a slightly rough or textured appearance.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dentat, Infection Control,
and General Hospital Devices
510(k) Number 972131
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(optional Format 1-2-96)