(135 days)
Not Found
No
The device description focuses on mechanical and electrical components and does not mention any AI/ML capabilities or related concepts like algorithms, data processing for learning, or image analysis.
Yes
The device is intended for the "reduction of dental plaque and gingivitis," which are medical conditions, and clinical studies are provided to demonstrate its effectiveness in reducing gingivitis. This falls under the definition of a therapeutic device as it treats or alleviates a medical condition.
No
The device is designed for promotion of good oral hygiene, including reduction of dental plaque and gingivitis, which are therapeutic and preventative functions, not diagnostic.
No
The device description clearly outlines physical components like a brush head, power handle, charger base, magnets, coils, batteries, and electronics, indicating it is a hardware device with electrical and mechanical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For promotion of good oral hygiene, including the reduction of dental plaque and gingivitis." This describes a physical action on the body (cleaning teeth and gums) for therapeutic and preventative purposes, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical device that uses sonic vibrations to clean teeth. It does not involve analyzing biological samples (like blood, urine, saliva, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample collection, or analysis of biological markers.
Therefore, the Sonicare® Advance Model 4900 is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
For promotion of good oral hygiene, including the reduction of dental plaque and gingivitis.
Product codes (comma separated list FDA assigned to the subject device)
JEQ
Device Description
Sonicare® Advance Model 4900 consists of three primary parts: brush head, power handle, and charger base. Central to the brush head are the resonator arm and the torsion bar. The brush head's bristles are mounted in a bristle plate on one end of the arm, two magnets are mounted on the other, and the torsion bar is perpendicular in the middle. A 261-Hz oscillating magnetic flux generated inside the power handle forces the magnets into motion, which then causes the resonator arm to oscillate about the torsion bar. The torsion bar, magnets and bristle plate have a resonant frequency close to the 261-Hz driving frequency, and this enables the system to produce a desired amplitude effect. The bristles vibrate in the direction perpendicular to the bristles' length and nominally perpendicular to the brush's axis.
The oscillating magnetic flux is generated by a stator coil in the power handle, in close proximity to the attachment of the brush head. The flux is controlled by solid-state electronics and powered from two nickel-cadmium rechargeable batteries elsewhere within the handle. Energy for recharging the batteries is transferred from the charger base through a system of induction coils within the power handle and the charger base. Maximum power dissipation by the handle is 3 W.
The charger base runs on standard North American 120 V, 60 Hz power. Internal electronics convert the input power to a 65 kHz output signal for more efficient transfer of power to the handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Various models of the Sonicare® Advance toothbrushes (identical or closely similar in specifications to the Model 4900) have been studied in a total of seven clinical trials (six controlled). Endpoints evaluated in these trials include examination of soft tissues for evidence of injury and indices of gingival inflammation (six trials), as well as pocket probing depth and clinical attachment level (four trials). Collectively, the studies demonstrate that the Sonicares Advance toothbrushes reduce gingivitis.
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
§ 872.6865 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.
0
JUL 0 2 2004
510(k) SUMMARY
Name of 510(k) sponsor:
Philips Oral Healthcare, Inc.
Address:
35301 SE Center Street Snoqualmie, WA 98065 Telephone: 425 396-2000 Fax: 425 396-4825
Contact information:
Ms. Rose DeGiacomo 425 396-2308 Telephone: 425 396-4825 Fax: February 18, 2004 Date summary prepared: Sonicare® Advance Toothbrush (Model 4900) Proprietary name of device: Toothbrush, powered Generic/classification name:
JEQ (Class 1, 21 C.F.R. § 872.6865) Product code (classification):
Legally Marketed Predicate Devices:
TX Electric Toothbrush (K921773)
Dental Air Force Home Dental Cleaning System (K001493)
Device Description and Technological Characteristics:
Sonicare® Advance Model 4900 consists of three primary parts: brush head, power handle, and charger base. Central to the brush head are the resonator arm and the torsion bar. The brush head's bristles are mounted in a bristle plate on one end of the arm, two magnets are mounted on the other, and the torsion bar is perpendicular in the middle. A 261-Hz oscillating magnetic flux generated inside the power handle forces the magnets into motion, which then causes the resonator arm to oscillate about the torsion bar. The torsion bar, magnets and bristle plate have a resonant frequency close to the 261-Hz driving frequency, and this enables the system to produce a desired amplitude effect. The bristles vibrate in the direction perpendicular to the bristles' length and nominally perpendicular to the brush's axis.
The oscillating magnetic flux is generated by a stator coil in the power handle, in close proximity to the attachment of the brush head. The flux is controlled by solid-state electronics and powered from two nickel-cadmium rechargeable batteries elsewhere within the handle. Energy for recharging the batteries is transferred from the charger base through a system of induction
1
coils within the power handle and the charger base. Maximum power dissipation by the handle is 3 W.
The charger base runs on standard North American 120 V, 60 Hz power. Internal electronics convert the input power to a 65 kHz output signal for more efficient transfer of power to the handle.
Intended Use
For promotion of good oral hygiene, including the reduction of dental plaque and gingivitis,
Testing
Various models of the Sonicare® Advance toothbrushes (identical or closely similar in specifications to the Model 4900) have been studied in a total of seven clinical trials (six controlled). Endpoints evaluated in these trials include examination of soft tissues for evidence of injury and indices of gingival inflammation (six trials), as well as pocket probing depth and clinical attachment level (four trials). Collectively, the studies demonstrate that the Sonicares Advance toothbrushes reduce gingivitis.
Conclusions
The results from these tests support the safety and effectiveness of the 4900 model of the Sonicare® Advance toothbrush and its substantial equivalence to the predicate devices.
: :
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, composed of three curved lines that suggest wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 2 2004
Ms. Rose DeGiacomo Corporate Counsel Philips Oral Healthcare 35301 S.E. Center Street Snoqualmie, Washington 98065
Re: K040416
Trade/Device Name: Sonicare® Advanced Toothbrush (Model 4900) Regulation Number: 872.6865 Regulation Name: Powered Toothbrush Regulatory Class: I Product Code: JEQ Dated: June 14, 2004 Received: June 18, 2004
Dear Ms. DeGiacomo:
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.
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Page 2 - Ms. DeGiacomo
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); 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 (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows a handwritten string of characters, "K040416". The characters are written in black ink on a white background. The characters are all connected, and they are all the same size. There is a line drawn underneath the string of characters.
INDICATIONS FOR USE STATEMENT
| Applicant: | Philips Oral Healthcare, Inc. |
|---|---|
| 510(k) Number: | K040416 |
| Device Name: | Sonicare ® Advanced Toothbrush (Model 4900) |
| Indications for Use: |
For promotion of good oral hygiene, including the reduction of dental plaque and gingivitis.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
or
Over-the Counter Use _L
Susan Rums
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: