(32 days)
Not Found
No
The description focuses on mechanical and sonic cleaning mechanisms, ergonomic design, and basic timing features. There is no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as a toothbrush, intended for cleaning teeth and preventing tooth decay and gum disease, which are generally considered hygiene and preventative care, not therapeutic intervention for existing conditions. Its predicate device also confirms it is a toothbrush.
No
Explanation: The device is described as a toothbrush intended for cleaning teeth and preventing tooth decay and gum disease, not for diagnosing any medical condition.
No
The device description clearly states it is a "2.4 volt rechargeable battery operated toothbrush" with "rapidly vibrating bristles," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The provided description clearly states that this device is a toothbrush. Its function is to clean teeth and remove plaque within the mouth. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is for oral hygiene and plaque removal, not for diagnosing any medical condition based on in vitro analysis.
Therefore, based on the provided information, this device is a Class II medical device (as indicated by the predicate device K921773, which is a sonic toothbrush) used for oral hygiene, not an IVD.
N/A
Intended Use / Indications for Use
- Operates at over 30,000 strokes per minute to help remove plaque bacteria ●
- Sonic waves penetrate beyond the bristle tips, for superior cleaning. .
- Ergonomic design with rubberized Comfort-Grip surface. .
- Two-minute timer helps ensure dentist recommended brush time. .
Product codes
JEQ
Device Description
This 2.4 volt rechargeable battery operated toothbrush is a sonic wave plaque remover with rapidly vibrating bristles that penetrate the most difficult-to-clean areas of your mouth - Places your standard toothbrush might miss. It's also gentle, with seven speeds you can adjust to your own sensitivity level. This effective combination of ergonomics and technology brings you an easy, everyday way to prevent tooth decay and gum disease.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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OCT - 1 2001
HOME
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510(k) Summary Statement
May 4, 2001 Submission Date:
David Vanderlin Contact: Director of Engineering, Product Compliance (248) 863-3000 ext. 1292 - tel. (248) 863-3100 - fax
| Classification Name: | Toothbrush, Powered |
|---|---|
| Common/Usual Name: | Sonic Toothbrush |
| Proprietary Name: | SonicWave™ Sonic Plaque Remover |
| HD-500 | |
| Classification: | Class II |
Description:
This 2.4 volt rechargeable battery operated toothbrush is a sonic wave plaque remover with rapidly vibrating bristles that penetrate the most difficult-to-clean areas of your mouth - Places your standard toothbrush might miss. It's also gentle, with seven speeds you can adjust to your own sensitivity level. This effective combination of ergonomics and technology brings you an easy, everyday way to prevent tooth decay and gum disease.
Intended Use:
- Operates at over 30,000 strokes per minute to help remove plaque bacteria. .
- Sonic waves penetrate beyond the bristle tips, for superior cleaning. .
- Ergonomic design with rubberized Comfort-Grip surface. .
- Two-minute timer helps ensure dentist recommended brush time. .
Substantial Equivalence Claim:
The SonicWave™ Sonic Plaque Remover is substantially equivalent to the current versions of the following model:
- K921773 1. Sonicare Model TX-1 Sonic Toothbrush.
Substantial equivalence is claimed because manufacturing technology, operating principles, intended uses and safety standards are the same for all models. Functional differences, i.e. seven speed levels, do not adversely affect safety or efficacy. Other differences are cosmetic in nature.
3000 Pontiac Trail Commerce Township, MI 48390 Phone: (248) 863-3000 Fax (248) 863 - 3100
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 1 2001
Mr. David Vanderlin Director of Engineering, Product Compliance Homedics. Incorporated 3000 Pontiac Trail Commerce Township, Michigan 48390
Re: K012914
Trade/Device Name: SonicWave™ Sonic Plaque Remover Regulation Number: 872.6865 Regulation Name: Sonic Toothbrush Regulatory Class: I Product Code: JEQ Dated: May 4, 2001 Received: August 30, 2001
Dear Mr. Vanderlin:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Reich
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 531-542 of the Act; 21): CFR 1000-1050.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Tim ny A. Ulatowski Director 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
Applicant: HoMedics, Inc.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Sonic Wave™ Sonic Plaque Remover
Indications For Use:
- Operates at over 30,000 strokes per minute to help remove plaque bacteria ●
- Sonic waves penetrate beyond the bristle tips, for superior cleaning. .
- Ergonomic design with rubberized Comfort-Grip surface. .
- Two-minute timer helps ensure dentist recommended brush time. .
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Division Sign-Off)
510(k) Number K062944
Over-the-Counter Use
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number
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