(90 days)
To remove plaque and food debris from the surface of the tongue.
The Enfresh Tongue Brush and the predicate tongue brushes, tongue scrapers, and tongue cleaners have very similar principles of operation. They are all manual devices that are used by applying a brushing, scraping, or both brushing and scraping motion to the surface of the tongue to remove plaque and food debris from the surface of the tongue. The handle and the bristles of the Enfresh Tongue Brush and Garry Laboratories's The Tongue Brush are composed of plastic, rubber, and nylon, while Telefax International's OOLI-U (Tongue Scraper) is composed of stainless steel.
This document is a 510(k) premarket notification for the Enfresh Tongue Brush, submitted to the FDA in 1997. It declares substantial equivalence to previously cleared devices rather than providing a study proving specific performance acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated based on the given document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report performance metrics for the Enfresh Tongue Brush. The basis for clearance is "substantial equivalence" to predicate devices, implying that its performance is presumed to be similar to those already on the market and considered safe and effective.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No specific test set or study data is presented for the Enfresh Tongue Brush. The argument for clearance relies on the long history of safe use of similar devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment is mentioned as no specific study data is presented for the Enfresh Tongue Brush.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a manual tongue brush, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual tongue brush.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No specific ground truth was used for this 510(k) submission, as it relies on substantial equivalence to predicate devices with a long history of safe use.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set for an algorithm.
Summary of the document's argument for acceptance:
The Enfresh Tongue Brush was cleared based on its substantial equivalence to existing predicate devices (Garry Laboratories's The Tongue Brush and Telefax International's OOLI-U (Tongue Scraper)). The argument for substantial equivalence is based on:
- Identical Intended Use: To remove plaque and food debris from the surface of the tongue.
- Very Similar Principles of Operation: Manual devices using brushing, scraping, or both motions.
- Very Similar Technological Characteristics: Composed of common, biocompatible materials (plastic, rubber, nylon, or stainless steel) with a long history of safe use in medical devices.
The document explicitly states: "The safety and effectiveness of the Enfresh Tongue Brush is based on the long history of safe use of tongue brushes, tongue scrapers, tongue cleaners, as well as the safe use of manual toothbrushes. ... Thus, the Enfresh Tongue Brush is substantially equivalent to the predicate devices, because the Enfresh Tongue Brush raises no new issues of safety or effectiveness."
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KA73424
DEC - 9 1997
510(k) SUMMARY
Enfresh's Tongue Brush
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Enfresh Products, LLC 12 Norcross Street Suite 200C Roswell, Georgia 30075
Contact Person:
Mr. Martin D. Crosson Enfresh Products, LLC Phone: (770) 594-2763 Facsimile: (770) 594-2763
Date Prepared: September 9, 1997
Name of Device
Enfresh Tongue Brush
Common or Usual Name
Tongue brush
Classification Name
Tongue brush
Predicate Devices
- (1) Garry Laboratories's The Tongue Brush (K901408); and
- Telefax International's OOLI-U (Tongue Scraper) (K970042) (2)
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Intended Use
The Enfresh Tongue Brush and the predicate devices are intended to be used to remove plaque and food debris from the surface of the tongue. These devices are indicated for use several times a day, followed by rinsing the mouth and tongue with water.
Technological Characteristics and Substantial Equivalence
The Enfresh Tongue Brush and the predicate tongue brushes, tongue scrapers, and tongue cleaners have very similar principles of operation. They are all manual devices that are used by applying a brushing, scraping, or both brushing and scraping motion to the surface of the tongue to remove plaque and food debris from the surface of the tongue.
The Enfresh Tongue Brush and the predicate devices also have very similar technical characteristics. The handle and the bristles of the Enfresh Tongue Brush and Garry Laboratories's The Tongue Brush are composed of plastic, rubber, and nylon, while Telefax International's OOLI-U (Tongue Scraper) is composed of stainless steel. Both plastic and stainless steel are durable, biocompatible materials that have a long history of safe use in devices.
Summary Basis for the Finding of Substantial Equivalence
The safety and effectiveness of the Enfresh Tongue Brush is based on the long history of safe use of tongue brushes, tongue scrapers, tongue cleaners, as well as the safe use of manual toothbrushes. The Enfresh Tongue Brush has the same intended use and very similar principles of operation and technological characteristics as the predicate devices. Thus, the Enfresh Tongue Brush is substantially equivalent to the predicate devices, because the Enfresh Tongue Brush raises no new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC -9 1891
DEC = 8 1907
Enfresh Products, LLC C/O Mr. Howard M. Holstein Hogan & Hartson L.L.P. Partner Columbia Square 555 Thirteenth street,N.W. Washington, DC 20004-1109
Re : K973424 Enfresh Tonque Brush Trade Name: Requlatory Class: Unclassified Product Code: LCN September 9, 1997 Dated: Received: September 10, 1997
Dear Mr. Holstein:
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.
Based on the labeling provided, it has been determined that the tongue cleanser sold with the tongue brush is regulated as However, if claims are made that constitute drug cosmetic. use, you must go to the Center for Drugs for further review.
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. ರ್ಥ 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
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Page 2 - Mr. Holstein
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 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 acberizou in your biown, puivalence 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) 594-4692. 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
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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510(k) Number (if known):
Enfresh Tongue Brush Device Name:_
Indications For Use:
To remove plaque and food debris from the surface of the tongue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susar Runnos
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number
Prescription Use √
(Per 21 CFR 801.109)
・・・
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 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.