The Silk'n Toothwave is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis.

The Silk'n Toothwave is intended for over-the-counter use.

Device Description

The Silk'n Toothwave device (a.k.a Silk'n H7001 Powered Toothbrush) is a handheld, rechargeable, powered, radiofrequency toothbrush, an over-thecounter device, intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. The Silk'n Toothwave Device is comprised of the handheld, brush head and recharging units. The device utilizes radio frequency (RF) energy and vibration.

The Silk'n Toothwave is comprised of the handle, the brush head, and recharging unit. The brush head is designed with radiofrequency electrodes and bristles. The handheld unit contains the software, programming, and hardware necessary for the device to function. The device is operated by a push button for activation of the radiofrequency and vibration.

The Silk'n Toothwave device is operated by a single mode push-button located on the handle/hand piece user interface board and a set of light indicators informing the lay user of the device operation.

The Silk'n Toothwave device is designed as a rechargeable handheld electrical toothbrush comprised of the charging base unit and a rechargeable power handheld unit. The chargeable base unit is galvanically isolated from the handheld unit. The Silk'n ToothWave Device is electrically safe in accordance with medical device electrical safety standards (IEC 60601-1, IEC 60601-2-2 and IEC 60601-1-11).

The Silk'n ToothWave Device utilizes vibration and low power RF energy technologies. The action of the brush head has a vibration frequency up to 400Hz. The RF generator generates conductive RF energy at 3 MHz, with a maximal output power of 3W.

The handle or hand piece brush head is designed as a medium oval brush head and features an arrangement of bristles surrounding two low profile hidden RF electrodes and a silicon barrier located in-between the two electrodes. The handle or hand piece is equipped with an ON/OFF switch and indicator panel that indicates the device status (RF activation, vibration level, charging, or error).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silk'n Toothwave device, structured according to your request.

Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It references past studies but does not detail the specific acceptance criteria and their direct fulfillment in the same way a full study report might. Therefore, some information requested (like specific numerical acceptance criteria for plaque/gingivitis reduction or the exact methodology for establishing ground truth for training data) is not explicitly present in this summary.

Acceptance Criteria and Reported Device Performance

The document describes the intended use of the Silk'n Toothwave device as promoting good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis. The primary clinical study mentioned in this 510(k) pertains to the reduction of calculus.

Acceptance Criteria (Implied by Intended Use / Study Focus)	Reported Device Performance (Primary Clinical Study)
Reduction of dental plaque	Not explicitly quantified in this 510(k) document
Prevention and treatment of gingivitis	Not explicitly quantified in this 510(k) document
Reduction of calculus (tested in supplemental study)	Statistical significance demonstrated in calculus reduction: - Control group (n=45): 7.7% reduction at 6 weeks, 11.26% at 12 weeks - Test group (ToothWave, n=42): 2.6% reduction at 6 weeks, -1.47% at 12 weeks (Note: The negative value for the test group at 12 weeks (-1.47%) might indicate a slight increase in calculus from baseline at 12 weeks, or more likely, represents a statistically insignificant change or an average that started in reduction but then didn't continue, while still being statistically significant compared to the control).

Study Details

The provided 510(k) references several studies, primarily performed for a previous DeNovo application (DEN190039). The current submission includes an additional study specifically on calculus reduction.

2. Sample size used for the test set and the data provenance

Calculus Reduction Study (additional study in this 510(k)):
- Test Set Sample Size: 90 subjects (randomly assigned to either ToothWave or control brush).
  - ToothWave group (test group): n=42
  - Control group: n=45
- Data Provenance: Salus Research Centre, IN, USA. Prospective.
Previous Studies (submitted in DEN190039 for plaque/gingivitis):
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document, but implied to be prospective based on the description of "single-blinded, double arm randomized prospective study" and "additional self-selection study."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Calculus Reduction Study: The study was conducted by Kim (RDH, PHD) and Jeff Milleman (DDS, MPA). These are likely the experts who established the ground truth (e.g., conducted the Volpe-Manhold Index (V-MI) examinations). The exact number of examiners used for each subject is not specified (e.g., if both examined each subject or if one was primary).
- Qualifications: RDH (Registered Dental Hygienist), PHD, DDS (Doctor of Dental Surgery), MPA (Master of Public Administration).
Previous Studies: Not specified in this document.

4. Adjudication method for the test set

Calculus Reduction Study: The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes the V-MI examinations performed by the named experts.
Previous Studies: Not specified in this document.

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

No, an MRMC comparative effectiveness study was not done. This device is a powered toothbrush, not an AI diagnostic or assistance system for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

Not applicable. This device is a physical product (a toothbrush) that relies on direct human-in-the-loop operation. It is not an algorithm evaluated for standalone performance.

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

Calculus Reduction Study: Expert clinical assessment using the Volpe-Manhold Index (V-MI) for calculus measurements. This is a recognized clinical index.
Previous Studies (Plaque/Gingivitis): Implied to be expert clinical assessment based on the study design (single-blinded, randomized prospective study for plaque and gingivitis). Specific indices are not mentioned in this summary but are standard for such studies.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" in this context would refer to the device development leading to its final design, which is not quantified in terms of a sample size.

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

Not applicable. As above, there is no "training set" in the context of an AI/ML algorithm to establish ground truth for. The development of the device would involve engineering, safety testing, and pre-clinical studies, but not a "ground truth" for a training set in the way you're asking.

Summary

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January 13, 2023

Home Skinovations Ltd. % Amit Goren Regulatory Manager A. Stein Regulatory Affairs Consulting Ltd. 18 Hata'as St. Suite 21 Kfar Saba, 4442518 ISRAEL

Re: K214078

Trade/Device Name: Silk'n Toothwave Regulation Number: 21 CFR 872.6866 Regulation Name: Radiofrequency Toothbrush Regulatory Class: Class II Product Code: QMJ Dated: December 15, 2022 Received: December 15, 2022

Dear Amit Goren:

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.

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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 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 (QS) 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 E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K214078

Device Name Silk'n Toothwave

Indications for Use (Describe)

The Silk'n Toothwave is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis.

The Silk'n Toothwave is intended for over-the-counter use.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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Description 303 (Part 2 of 2: Support 2)

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

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510(K) SUMMARY THE SILK'N TOOTHWAVE

510(k) Number K214078

Applicant Name:

Company Name:	Home Skinovations Ltd.
Address:	Tavor Building, POB 533Yokneam Iillit 2069206 Israel
Tel:	+972(4)9097440
Fax:	+972(4)9097471
E-mail:	amit@asteinrac.com

Contact Person:

Official Correspondent:	Amit Goren
Company Name:	A. Stein - Regulatory Affairs Consulting Ltd
Address:	18 Hata'as St.Kfar Saba 4442518 IsraelTel: + 972-9-7670002Fax: +972-9-7668534E-mail: amit@asteinrac.com
Date Prepared:	January 11, 2023
Trade Name:	Silk'n Toothwave
Classification Name:	21 CFR 872.6866; (Product codes: QMJ)
Common Name:	Radiofrequency Toothbrush
Classification:	Class II Medical Device

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Predicate Devices:

The predicate device, is the previously cleared Silk'n Toothwave device, manufactured by the applicant (Home Skinovations Ltd.), and is the exact same device as the subject device of this 510k application:

Manufacturer	Device	510(k) No.
Home Skinovations Ltd.	Silk'n Toothwave	DEN190039

Device Description:

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The Silk'n Tootwave supports the placement of the following components:

Charging cradle with USB cable & transparent base, .
Handle or hand piece, ●
Brush head, ●
USB wall adaptor, ●
Warranty booklet ●
User Manual ●

Following are the Silk'n Toothwave device specifications:

Model No.	H7001
Technology	DentalRF™ and vibration
Vibration	0, 275Hz, 300Hz or 400Hz
Radiofrequency	3MHz ±0.3MHz, up to 3W
Package size	(W) 165 (H) 227 (D) 80 [mm]
System weight	115 g
Adapter	YH-S06U0500600 (USA)
Input	100-240V, 50/60Hz, 0.2A
Output	5.0Vdc, 0.6A

Intended Use/Indication for Use:

The Silk'n Toothwave is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis.

The Silk'n Toothwave is intended for over-the-counter use.

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Performance Standards:

The Silk'n Toothwave device has been tested and complies with the following FDA recognized consensus standards:

[Rec. Number 19-4] ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
[Rec. Number 19-18] IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
[Rec. Number 19-14] IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
[Rec. Number 6-389] IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential per
[Rec. Number 5-89] IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

[Rec. Number 13-79] IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes

[Rec. Number 19-13] IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
[Rec. Number 19-33] IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

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[Rec. Number 4-238] ISO 20127 First edition 2005-03-15 Dentistry -Powered toothbrushes - General requirements and test methods

The device was also tested to comply with the following standards:

IEC 60335-2-52:2002, Safety of Household and Similar Electrical Appliances Part 2: Particular Requirements for Oral Hygiene Appliances.

EN55014-1:2006 Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus – Part 1: Emission

EN55014-2:2006 Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 2: Immunity

EN61000-3-2:2014 Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions (equipment input current up to and including 16A per phase)

EN61000-3-3:2013 Electromagnetic compatibility (EMC) – Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <16 A per phase and not subject to conditional connection

EN61000-6-1:2007 Electromagnetic compatibility (EMC) - Part 6-1: Generic standards – immunity for residential, commercial and light-industrial environments

EN55011: 2009+A1 Industrial, scientific and medical (ISM) radio-frequency disturbance characteristics - Limit and methods of measurement.

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Non-Clinical (Bench) Performance Data:

Bench testing was conducted and submitted to the FDA in DEN190039. The purpose of the bench tests was to demonstrate that the Silk'n Toothwave device performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements.

The following tests were conducted:

Validation of the RF performance specifications including output power, . voltage output, radiofrequency, pulse cycle, waveform, and pulse duration;
Temperature performance testing to evaluate the temperature change of . the device, structures of the oral cavity (including skin, tissue, and dental restorations), and toothpaste under worst-case conditions;
An assessment of mechanical output specifications and physical . properties including vibration frequency, tuft retention, brush head strength, and battery voltage; and
. Use life and durability testing.
Software validation testing .
Biocompatibility testing .

Pre-Clinical (Animal) Performance Data:

Animal studies were submitted to the FDA as part of DEN190039. No further animal studies were conducted and submitted in this 510(K)-file submission.

Clinical Performance Data:

A single-blinded, double arm randomized prospective study entitled "Safety and Efficacy of the ToothWaveTM Toothbrush (Model H7001) Home Use Device for Reduction of Dental Plaque and Calculus and Treatment and Prevention of Gingivitis ToothWave™ Clinical Study" was conducted and included a usability study. An additional self-selection study was also conducted in "Toothwave Usability and Self-Selection Study", and a clinical report with safety data was provided based on an additional single-blinded, double arm, randomized prospective study to evaluate the device used at the highest frequency.

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These studies were submitted in DEN190039.

An additional single-blind, double arm prospective study was conducted to further evaluate the effect of ToothWave™ on calculus. The study was held at the Salus Research Centre, IN, USA, by Kim (RDH, PHD) and Jeff Milleman (DDS, MPA), in subjects with a moderate amount of visible calculus on the tongue side of their lower anterior teeth. Ninety (90) subjects were randomly assigned to either ToothWave™ or the control brush, a powered toothbrush. Treatment was defined as a timed two minutes teeth brushing, twice a day, during a three-month test period, returning at weeks 3, 6 and 12 for safety and Volpe-Manhold Index (V-MI) examinations. Each at home toothbrush session was self- documented in a designated diary.

At the completion of the study, the study result differences between baseline and V-MI examination at 6 and at 12 weeks were statistically significant with the control group (n=45) 7.7% at 6 weeks and 11.26% at 12 weeks vs the test group (n=42) which were 2.6% at 6 weeks and -1.47% at 12 weeks. After the study, participants were advised to return to their regular dentist appointments.

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Substantial Equivalence:

The currently submitted Toothwave device is the exact same device as the FDA cleared Toothwave, which was previously submitted, and FDA cleared as part of the DeNovo application (DEN190039). Therefore, the current device includes the same design, technological features, user interface and hardware components as the cleared device. The safety features, compliance with safety standards, and all patient contact materials, remain unchanged and since no difference was made in the technological characteristics there are no safety concerns to be considered.

Additional clinical study as specified in the clinical performance data section to evaluate the performance of the ToothWave device on supragingival calculus levels. The clinical study results were added to the device user manual.

Based on the fact that all device characteristics remained unchanged, it can be concluded that the ToothWave device submitted in this 510k application is substantially equivalent to its predicate, the FDA cleared Toothwave device.

Regulation Number and Section

§ 872.6866 Radiofrequency toothbrush.

(a)
Identification. A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy 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 II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested, and detailed protocols must be provided for each test conducted:
(i) Validation of the radiofrequency performance specifications including output power, voltage output, radiofrequency, pulse cycle, waveform, and pulse duration;
(ii) Temperature performance testing to evaluate the temperature change of the device, structures of the oral cavity (including skin, tissue, and dental restorations), and toothpaste under worst-case conditions;
(iii) An assessment of mechanical output specifications and physical properties including vibration frequency, tuft retention, brush head strength, and battery voltage; and
(iv) Use life and durability testing.
(2) A label comprehension and self-selection study must demonstrate that the intended user population can understand the package labeling and correctly choose the device for the indicated use.
(3) Usability performance evaluation must demonstrate that the user can safely and correctly use the device, based solely on reading the directions for use.
(4) The patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Electrical safety, thermal safety, mechanical safety, battery safety, and electromagnetic compatibility (EMC) testing must be performed.
(6) Software verification, validation, and hazard analysis must be performed.
(7) Labeling must include:
(i) Information on how the device operates, including images or illustrations;
(ii) A detailed summary of the device technical specifications;
(iii) A warning which states that the use of this device is not a substitute for regular visits to a dentist for routine clinical care;
(iv) Instructions on how to clean and maintain the device; and
(v) The use life and disposal of the components of the device.