(63 days)
Not Found
Not Found
No
The summary describes a simple mechanical device for tongue cleaning and contains no mention of AI, ML, image processing, or data analysis typically associated with AI/ML medical devices.
No.
The device is intended for oral hygiene by removing food particles and debris, not for treating a specific medical condition or disease.
No
The "Intended Use / Indications for Use" section states that the device is used to remove food particles and debris and to complement an oral hygiene program, without any mention of diagnosing any condition.
No
The device description is not found, but the intended use describes a physical device ("Ayurvedic Tongue Cleaner") used to remove food particles and debris from the tongue, which is inherently a hardware function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Ayurvedic Tongue Cleaner function: The description clearly states the device is used to remove food particles and debris from the tongue. This is a physical cleaning action performed directly on the body, not a test performed on a sample taken from the body.
The intended use and device description do not involve any analysis of biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The Ayurvedic Tongue Cleaner is a device used to remove food particles and debris from the tongue. It is used to complement an overall oral hygiene program that includes brushing and flossing the teeth and gums. It is not a substitute for any other oral hygiene care such as brushing and flossing the teeth and gums.
Product codes
LCN
Device Description
Ayurvedic Tongue Cleaner
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tongue
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUM. SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 1997
VedaHealth Incorporated C/O Antonio C. Martinez, II Esq General Counsel to Veda Health Incorporated Calello Martiñez P.C. 675 Franklin Avenue Nutley, New Jersey 07110-1209
Re: K971025 Ayurvedic Tongue Cleaner Trade Name: Regulatory Class: Unclassified Product Code: LCN Dated: April 15, 1997 Received: April 21, 1997
Dear Mr. Martinez:
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 regulations affecting your device can be found in the Code of Federal Requlations, 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 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 - Mr. Martinez
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 requlation (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 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,
N. Wiatrowski
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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Page 1 of
K971025 510(k) Number (if known):
Ayurvedic Tonque Cleaner Device Name:
Indications For Use:
The Ayurvedic Tongue Cleaner is a device used to remove food particles . and debris from the tongue.
It is used to complement an overall oral hygiene program that includes brushing and flossing the teeth and gums. It is not a substitute for any other oral hygiene care such as brushing and flossing the teeth and gums.
(PLEASE DO NOT WRITE: BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) WDDI (Division Sign-Off)
Division of Dentel, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801 109) 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 OR
Over-The-Counter User
(Optional Format 1-2-96)