(50 days)
TONGUE KILEAN IS INDICATED AS PART OF THE ORAL HYSIENE DALLY TO REMOVE PLAQUE FROM THE SURFACE Of THE TONGUE
Softek's Tongue Klean is a simple device which is used to scrape build up of plaque from the surface of the tongue. Tongue Klean is easy to use and does not present any undue risk to the user of Tongue Klean.
The provided document is a 510(k) premarket notification for a medical device called "Tongue Klean," a tongue scraper. It primarily establishes substantial equivalence to a predicate device ("OOLITT") and details regulatory communication from the FDA.
Based on the content, here's an analysis against your requested information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc.) are provided in this document. The submission is for a simple, unclassified device (tongue scraper) and focuses on substantial equivalence rather than performance data from a clinical study.
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 test set or clinical data is mentioned.
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 or expert involvement for a test set is mentioned.
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 device is a manual tongue scraper, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual tongue scraper, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for performance evaluation is mentioned. The "ground truth" for this submission is based on the functional equivalence to a legally marketed predicate device for the purpose of removing plaque from the tongue.
8. The sample size for the training set
Not applicable. This device is a manual tongue scraper, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
Summary of Device and Approval Context:
The "Tongue Klean" is a simple, unclassified medical device (tongue scraper) intended to remove plaque from the surface of the tongue as part of daily oral hygiene.
The approval for this device (K973175) is based on substantial equivalence to a predicate device, the "OOLITT." This means the FDA determined that "Tongue Klean" is as safe and effective as the predicate device because it has similar design, technological characteristics, and indications for use. For such a low-risk, unclassified device, extensive clinical trials or performance studies with acceptance criteria and ground truth are typically not required. The regulatory pathway relies on demonstrating that the new device is fundamentally no different in safety and efficacy than an already legally marketed device.
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OCT 1 4 1997
SUMMARY OF 510(k)
TRADE NAME: Tongue Klean CLASSIFICATION NAME: Tongue Scraper COMMON NAME: Tongue Scraper
OOLITT, D.T. Corp., Premarket Notification K 962941 Predicate Device:
Device Description
Softek's Tongue Klean is a simple device which is used to scrape build up of plaque from the surface of the tongue. Tongue Klean is easy to use and does not present any undue risk to the user of Tongue Klean.
Substantial Equivalency:
Softek Tongue Klean is similar in design and has the same Technological characteristics as "OOLITT" and has same indications for use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Promila Gupta Softek Enterprises 5245 S. Hanover Way Englewood, Colorado 80111
OCT 1 4 1997
Re : K973175 Tongue Klean Trade Name: Regulatory Class: Unclassified Product Code: LCN Dated: August 18, 1997 Received: Auqust 25, 1997
Dear Mr. Gupta:
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 Requlation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory 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
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Page 2 - Mr. Gupta
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, 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 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) 594-4618. 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
Ulatowski Timot y A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
. Enclosure
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| 510(k) Number (if known): | |
|---|---|
| Device Name: | TONGUE KLEAN |
| Indications For Use: |
TONGUE KILEAN ાં ટ INDICATED for ೧೭೯ નિર્ડ PART THE ORAL HYSIENE DALLY TO OF FROM THE SURFACE PLAQUE REMOVE TONGUE Of THE
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rummer
(Division Sign-Off) Division of Dental, Infection Control and General Hosp 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
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(Optional Format 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.