(382 days)
No
The description focuses on the physical components, power source, and the use of radiofrequency and vibration for cleaning. There is no mention of AI, ML, or any adaptive or learning capabilities.
Yes.
The device is intended for the "prevention and treatment of gingivitis," which defines it as a therapeutic device.
No
The device is described as a powered toothbrush intended to promote good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis. Its function is to provide therapy and prevention, not to diagnose a condition.
No
The device description explicitly states that the Silk'n Toothwave is comprised of a handheld unit, brush head, and recharging units, and that the handheld unit contains hardware necessary for the device to function. This indicates it is a physical device with integrated hardware, not solely software.
Based on the provided information, the Silk'n Toothwave is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Silk'n Toothwave Function: The Silk'n Toothwave is a powered toothbrush that uses radiofrequency energy and vibration to directly interact with the oral cavity for cleaning and improving oral hygiene. It does not analyze any biological samples.
The device's intended use, description, and performance studies all focus on its direct application to the teeth and gums for mechanical and energy-based cleaning and treatment of oral conditions, not on the analysis of biological specimens.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
QMJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity (teeth and gingiva)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
Description 303 (Part 2 of 2: Support 2)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY THE SILK'N TOOTHWAVE
510(k) Number K214078
Applicant Name:
| Company Name: | Home Skinovations Ltd. |
|---|---|
| Address: | Tavor Building, POB 533 |
| Yokneam 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 Israel | |
| Tel: + 972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-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 |
4
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:
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.
5
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).
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
7
[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