The intended use of the Unik Tongue Cleaner is to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene.

Device Description

This is a device consisting of a molded polypropylene plastic handle, similar in appearance to that of a toothbrush, and a U-shaped loop end made of either polypropylene plastic or stainless steel. The device is used by placing the loop end at the back of the tongue and gently dragging it toward the front. The device is designed so that there are no sharp edges.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Unik Tongue Cleaner." It primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device rather than presenting a study for acceptance criteria.

Therefore, many of the requested sections regarding acceptance criteria and a study proving device performance cannot be extracted because such a study is not part of this 510(k) submission. 510(k) submissions for devices like tongue cleaners typically rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies with specific performance metrics.

Here's what can be extracted based on the provided text, and where fields cannot be filled due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Explicitly Stated in a Study)	Reported Device Performance (from a Study)
Not applicable - no specific performance acceptance criteria are defined or reported in a study.	Not applicable - no performance metrics from a study are reported.

Explanation: The document does not define specific quantitative acceptance criteria (e.g., a certain percentage reduction in plaque, or a specific level of bacteria removal) that a study would then need to meet. Instead, the "acceptance criteria" for a 510(k) submission for this type of device are met by demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness principles.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not applicable, as no dedicated performance study (clinical or otherwise with a test set) is described.
Data Provenance: Not applicable.

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)

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable.

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

MRMC Study: No. This device is a physical tongue cleaner and does not involve AI or human readers for diagnostic interpretation.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: No. This device is a physical tongue cleaner and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable, as no performance study requiring ground truth is described. The "ground truth" equivalent in a 510(k) for this device is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Sample Size (Training Set): Not applicable, as no AI/algorithm training is involved.

9. How the ground truth for the training set was established

Ground Truth Establishment (Training Set): Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for a 510(k) submission):

The "study" in this context is the substantial equivalence comparison to the predicate device, not a performance study quantifying specific metrics.

Comparison Basis: The Unik Tongue Cleaner is compared to the Breath-So-Fresh Tongue Cleaner (K972644).
Key Arguments for Substantial Equivalence:
- Same Intended Use: Both devices are intended "to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene."
- Similar Technological Characteristics: Both employ a handle and a loop end to gently scrape the tongue.
- Similar Operating Principle: Both use a U-shaped loop (or spoon-shaped in the predicate) to scrape bacteria and plaque from the tongue surface.
- Similar Use Manner: Both are used by placing the loop end at the back of the tongue and gently dragging it forward.
Differences Acknowledged:
- Loop Shape: Unik Tongue Cleaner has a U-shaped loop; Breath-So-Fresh is spoon-shaped. (This is deemed not to raise new safety/effectiveness issues.)
- Materials: Unik Tongue Cleaner can be all plastic or plastic handle with stainless steel loop; Breath-So-Fresh is entirely plastic. (This is also deemed not to raise new safety/effectiveness issues.)
Conclusion: The submission concludes that because the Unik Tongue Cleaner has the same intended use, similar design, and is used in the same manner as the predicate device, it introduces no new safety or effectiveness issues and is therefore substantially equivalent.

This type of submission relies on the FDA's regulatory framework for 510(k)s, where new clinical data or specific performance metrics are not always required if substantial equivalence to a legally marketed device can be demonstrated.

Summary

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JAN 1 4 1999

510(K) SUMMARY

Submitter: 1.

Unik Products, Inc. Dr. Nathmal Tarfare, President 4786 Mount Vernon Blvd. Hamburg, New York 14075

Contact:

Harry E. Werner, Esq. Lipsitz, Green, et al. 42 Delaware Avenue Suite 300 Buffalo, New York 14202 Phone: (716) 849-1333 (ext. 397) (716) 855-1580 Fax :

Date prepared: October 16, 1998

2. Device Name:

Trade Name: Unik Tongue Cleaner a.
Common/Usual Name: Tongue Cleaner or Tongue Scraper 0.
Classification Name: Scraper, Tongue (per LCN) C.

Predicate Device: 3.

Breath-So-Fresh Tongue Cleaner (K972644) a .

Device Description: 4 .

This is a device consisting of a molded polypropylene plastic handle, similar in appearance to that of a toothbrush, and a U-shaped loop end made of either polypropylene plastic or stainless steel. The device is used by placing the loop end at the back of the tongue The device is and gently dragging it toward the front. designed so that there are no sharp edges.

Intended Use: 5 .

The intended use of the Unik Tongue Cleaner is to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene.

4 - 1

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Technological Characteristics: ୧.

The Unik Tongue Cleaner is similar to the Breath-So-Fresh The Unix Tongue Croaised in that both employ a handle at rongue creater (nop at the other end which is used to gently scrape the tongue. The Unik Tongue Cleaner's loop gencif beraped; the Breath-So-Fresh Tongue Cleaner's loop end is spoon shaped. The Breath-So-Fresh Tongue Cleaner is made entirely of plastic; the Unik Tongue Cleaner is made either of all plastic or a plastic handle with a stainless steel loop end.

The Unik Tongue Cleaner and the predicate device are used in the same fashion: the loop end of the device is placed on the back of the tongue and then gently dragged to the front of the tongue.

Summary to support substantial equivalence: 7.

The Unik Tongue Cleaner employs the same principles as the predicate device to accomplish the same end: use of a generally U-shaped loop to gently scrape bacteria and plaque from the surface of the tongue. Because the Unik praque Cleaner has the same intended use as the predicate device, is similar in design and is used in the same manner as the predicate device, it introduces no new or effectiveness issues and is therefore safety substantially equivalent to the predicate device.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right, resembling a bird-like shape.

JAN 29 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Unik Products, Incorporated C/O Harry E. Werner, Esq. Lipsitz, Green, et al. 42 Delaware Avnenue Suite 300 Buffalo, New York 14202

Re : K983683 Unik Tongue Cleaner Trade Name: Regulatory Class: Unclassified Product Code: LCN October 16, 1998 Dated: Received: October 20, 1998

Dear Mr. Werner:

This letter corrects our substantially equivalent letter of October 16, 1998 regarding the error that was made on the Statement of Indication for Use form.

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 You may, therefore, Food, Drug, and Cosmetic Act (Act). 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਮੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action.

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Page 2 - Mr. Werner

In addition, the Food and Drug Administration (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 pbligation 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 ating 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 Additionally, for questions on Compliance at (301) 594-4692. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note that 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 their toll free number (800) 638A2041 or at (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsmamain.html"

Sincerely

Timothy A. Ulatowski

Directfor

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

510(k) Number (if known): K983683

Device Name: Unik Tongue Cleaner

Indications for Use:

The intended use of the Unik Tongue Cleaner is to The intended use of the Unix fongue build-up on
remove bacteria from and prevent plaque build-in on remove bacteria from and prevent praque and of the follow oral hygiene.

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K983683

Prescription Use	OR	Over-The-Counter
Use (Per 21 CFR 801.109)

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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.