The Klinly Ultrasonic Tongue Cleaner is indicated to reduce plaque, food debris, and bacteria from the surface of the tongue, and also to help fight bad breath and promote oral hygiene.

Device Description

The Klinly Ultrasonic Tongue Cleaner is a battery-operated device intended to be used to supplement daily oral hygiene care. It operates on two (2) AAA Alkaline batteries. All user-contacting components of the Klinly Ultrasonic Tongue Cleaner are constructed of injection-molded plastics which have demonstrated substantially equivalent biocompatibility according to ISO 10993-1.

The Klinly Ultrasound Tongue Cleaner device is comprised of three principles of operation to supplement daily oral hygiene by tongue cleaning. The device has a tongue scraping head, which:

(1) Operates manually as a standard manual tonque scraper
(2) Produces a low-frequency tactile vibration at 233 Hz, and
(3) Emits ultrasound pressure waves at 1.6 MHz frequency.

AI/ML Overview

The acceptance criteria and the study proving the device meets them are described below for the Klinly Ultrasonic Tongue Cleaner.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Measured Outcome)	Performance Requirement (Implicit)	Reported Device Performance	p-value (Statistical Significance)
Breath Malodor Reduction	Significant reduction in breath malodor	37% reduction in breath malodor	p=0.0002
Tongue Plaque Reduction	Significant reduction in tongue plaque	41% reduction in tongue plaque	p<0.0001
Tongue Bacterial Count Reduction	Significant reduction in tongue bacterial count	75% reduction in tongue bacterial count	p=0.0401

2. Sample Size and Data Provenance for Test Set:

Sample Size: N=19 male and female patients.
Data Provenance: Prospective, single-center clinical study. The country of origin is not explicitly stated in the provided text.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth for breath malodor, tongue plaque, or tongue bacterial counts. Given the nature of these measurements, it is likely that objective metrics or clinical assessments by trained dental professionals were used, but specific details are not provided.

4. Adjudication Method for Test Set:

The document briefly mentions that the study was "blinded." However, it does not specify an adjudication method like 2+1, 3+1, or similar for resolving discrepancies in measurements or observations. It implies that the assessments were made in a standardized clinical manner.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study evaluated the direct effectiveness of the device on patients, not the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical product (Ultrasonic Tongue Cleaner) that a human user operates. It is not an AI algorithm for diagnostic interpretation or image analysis; therefore, a standalone algorithm performance evaluation would not be relevant.

7. Type of Ground Truth Used:

The ground truth was established through direct measurements of clinical parameters in human subjects:

Breath Malodor: Measured clinically (method not specified, but likely an objective score or instrument reading).
Tongue Plaque: Measured clinically (method not specified, but likely a scoring system).
Tongue Bacterial Count: Measured clinically (method not specified, but likely laboratory enumeration from samples).

8. Sample Size for Training Set:

This information is not applicable and not provided. The device is a physical product, not a machine learning model that requires a "training set" in the context of AI/ML. The clinical study of 19 patients serves as the performance evaluation for this device.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as explained in point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

September 6, 2019

KEA Products Ltd. % Robert Bock Official Correspondent Robert T. Bock Consultancy LLC 66 Drovers Lane Brewster, New York 10509

Re: K181986

Trade/Device Name: Klinly Ultrasonic Tongue Cleaner Regulation Number: 21 CFR 872.6865 Regulation Name: Powered Toothbrush Regulatory Class: Class I Product Code: QIA Dated: August 7, 2019 Received: August 8, 2019

Dear Robert Bock:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael Adjodha Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181986

Device Name

Klinly Ultrasonic Tongue Cleaner

Indications for Use (Describe)

The Klinly Ultrasonic Tongue Cleaner is indicated to reduce plaque, food debris, and bacteria from the surface of the tongue, and also to help fight bad breath and promote oral hygiene.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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K181986

510(k) SUMMARY

Applicant:	KEA Products Limited10C, Meyer Ind. Bldg.2 Chong Yip StreetKwun Tong, Kowloon, Hong Kong SAR
Application Correspondent:	Robert T. BockOfficial CorrespondentKEA Products Limited66 Drovers LaneBrewster, NY 10509Telephone: 845.729.3176Email: smilex@comcast.net
Date of summary prepared:	September 6, 2019
Trade Name:	Klinly Ultrasonic Tongue Cleaner
Regulation Description:	Powered toothbrush
Regulation Number:	21 CFR 872.6865
Product code:	QIA

Primary Predicate:

. Cybersonic (K980075) American Dentronics, Incorporated.

Reference Devices:

. Unik Tongue Cleaner (K983683) Unik Products, Inc.
. Sonex Ultrasonic Tooth Brush (K913724) Sonex International Corporation.
. Sonicare Advance Toothbrush, Model 4900 (K040416) Philips Oral Healthcare, Inc.

DEVICE DESCRIPTION:

The Klinly Ultrasound Tongue Cleaner device is comprised of three principles of operation to supplement daily oral hygiene by tongue cleaning. The device has a tongue scraping head, which:

(1) Operates manually as a standard manual tonque scraper
(2) Produces a low-frequency tactile vibration at 233 Hz, and
(3) Emits ultrasound pressure waves at 1.6 MHz frequency.

INDICATIONS FOR USE:

The Kinly Ultrasonic Tongue Cleaner is indicated to reduce plaque, food debris, and bacteria from the surface of the tongue, and also to help fight bad breath and promote oral hygiene.

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COMPARISON OF INDICATIONS FOR USE:

SUBJECT DEVICE	PRIMARY PREDICATE	REFERENCE DEVICE
Klinly Ultrasonic Tongue Cleaner	Cybersonic (K980075)	Unik Tongue Cleaner (K983683)
Indications for use	Indications for use	Indications for Use
The Kinly Ultrasonic TongueCleaner is indicated to o reduceplaque, food debris, and bacteriafrom the surface of the tongue,and to help fight bad breath andpromote oral hygiene.	Use to remove surface tonguedebris, residue, plaque or filmybuild-up that results from eating,drinking, smoking or other types ofconsumption which can lead tobad breath. Also may be used toremove salivary tongue plaquesand residue that naturallyaccumulate during sleep orbetween cleanings.	To remove bacteria from andprevent plaque build-up on thetongue to help fight bad breathand promote oral hygiene.

The subject device Indications for Use includes an indication to reduce bacteria from the surface of the tongue, which is not found in the Primary Predicate Indications for Use. Additional differences in wording do not impact the substantial equivalence.

The Reference Device Unik Tongue Cleaner (K983683), is identified for this difference, as it is a manual tongue scraper indicated to remove bacteria (from the surface of the tongue).

Further reference devices used for technological comparisons do not include any component-specific language that would raise any concern related to the substantial equivalence of the subject device.

TechnologicalCharacteristics	SUBJECT DEVICE	PRIMARY PREDICATE
Scraping edge	Klinly Ultrasonic Tongue CleanerMolded plastic (ABS) curvedscraping edge, rounded	Cybersonic (K980075)Molded plastic flat scraping edge
Scraping action	Manually operated scraping action(patient applies pressure as theyare scraping to remove debris)	Same as Subject Device
Target Population	Adults and adolescents 12 yearsand older	Same as Subject Device
Anatomical sites	Surface of the tongue	Same as Subject Device
Intended use	reducing tongue debris	Same as Subject Device
Tactile vibration	Low-frequency (233 Hz)	None
Ultrasound pressurewaves	1.6 Mz from piezoelectrictransducer in the device	None
Energy source	two AAA (3.0 VDC) alkalinebatteries	None

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS :

The subject device is similar to the primary predicate devices are intended as a manual tongue scraper. Both devices are made from molded plastic and intended to be used on the surface of the tongue, operated manually by the patient applies pressure to the device handle while scraping to remove debris). The subject device is different as it is powered by two AA batteries, which power and control the device, piezoelectric transducer for the low-frequency tactile vibrations, and electronics which generate the 1.6 MHz ultrasound pressure waves.

The reference device Sonicare Advanced Toothbrush (K040416) is different than the subject device as it is a powered toothbrush; however, it is also powered and generates low-frequency tactile vibrations (261 Hz), similar to the subject device.

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The reference device Sonex Ultrasonic Toothbrush (K913724) is different than the subject device as it is a powered toothbrush; however, it is also similarly powered and generates the same ultrasound pressure waves as the subject device (at 1.6 Mhz).

Any small differences in the technological characteristics between the subject, primary predicate, and reference devices have been addressed through non-clinical performance testing and do not impact the substantial equivalence of the subject device.

NON-CLINICAL TESTING:

The Klinly Ultrasonic Tongue Cleaner has conducted the following testing to demonstrates substantial equivalence to the predicates according to the following:

Biocompatibility: Assessment per FDA Guidance - Biological Evaluation of medical devices – ISO 10993-1 including:

. Cytotoxicity Test according to ISO 10993-5: 2009, Biological evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity
. Sensitization Test according to ISO 10993-10:2010 Part 10: Test for irritation and skin sensitization.
. Irritation Test according to ISO 10993-10:2010 Part 10: Test for irritation and skin sensitization.

Electrical Safety: Requirements for medical electrical equipment used in the home - IEC 60601-1

EMC: Requirements for Electromagnetic Compatibility of Medical Equipment – IEC 60601-1-2

Software: Moderate Level of Concern - Documents and testing provided according to FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Performance Bench Testing: Bench testing to validate the technical specifications and functionality of the device, including the vibratory and ultrasonic frequencies as well as duty cycles.

Shelf Life: Durability testing to demonstrate that the subject device maintains acceptable performance throughout the use life proposed in the labeling.

CLINICAL DATA:

The following data was submitted to demonstrate substantial equivalence in labeling:

A prospective 30 days, non-randomized, blinded, single-center clinical study was performed. The study had nineteen (N=19) male and female patients, ranging in age from 23 to 49 years, who all completed the study using the Klinly Ultrasonic Tongue Cleaner.

The study evaluated the changes in Breath Malodor, Tongue Plaque, and Tongue Bacteria Counts between the baseline and the 30 days endpoint of the study, demonstrating:

. Breath Malodor reduction of 37% at p=0.0002
. Tonque Plaque reduction of 41% at p<0.0001
Tonque Bacterial Count reduction of 75% at p=0.0401

There were no protocol deviations and no adverse events.

CONCLUSION:

Based on the the information presented above, the Klinly Ultrasonic Tongue Cleaner demonstrates substantial equivalence to the Primary Predicate and Reference Devices.

Regulation Number and Section

§ 872.6865 Powered toothbrush.

(a)
Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is 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.