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.

AI/ML Overview

The provided text does not contain specific acceptance criteria in a quantitative or tabular format for the Sonicare® Advance Toothbrush (Model 4900). Instead, the submission relies on demonstrating substantial equivalence to predicate devices through clinical trials.

Below is a summary of the information available regarding the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria. Instead, it states that "the studies demonstrate that the Sonicare® Advance toothbrushes reduce gingivitis." This implies that the acceptance criteria were met if the clinical trials showed a statistically significant reduction in gingivitis and no evidence of injury to soft tissues.

Acceptance Criteria (Implied)	Reported Device Performance
Promotion of good oral hygiene	Supported by clinical trials
Reduction of dental plaque	Not explicitly stated as a separate endpoint in the summary, but implied by 'promotion of good oral hygiene'.
Reduction of gingivitis	Studies collectively demonstrate reduction of gingivitis
No evidence of injury to soft tissues	Evaluated in trials, no adverse findings reported
Substantial equivalence to predicate devices	Concluded based on testing results and comparison

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

Sample Size: Not specified. The document only mentions "a total of seven clinical trials (six controlled)."
Data Provenance: Not explicitly stated, but clinical trials typically involve human subjects. The fact that the device is marketed in North America (charger base runs on standard North American 120 V, 60 Hz power) might suggest studies were conducted in relevant regions, but this is an inference. The studies are prospective in nature as they are clinical trials evaluating device performance.

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

This information is not provided. The clinical trials would have involved dental professionals, but their specific number, roles in establishing "ground truth," or qualifications are not detailed in this 510(k) summary. Given the endpoints (gingival inflammation, pocket probing depth, clinical attachment level, soft tissue injury), the experts would likely be dentists, periodontists, or dental hygienists.

4. Adjudication method for the test set:

This information is not provided.

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:

This is irrelevant; the device is a toothbrush, not an AI-powered diagnostic tool requiring human reader involvement or MRMC studies.

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

This is irrelevant; the device is a toothbrush, not an algorithm. Performance is assessed through its physical interaction and biological effect on users.

7. The type of ground truth used:

For the clinical trials, the "ground truth" would have been established through:

Clinical Examination/Indices: Measurement of gingival inflammation (e.g., using gingival indices), pocket probing depth, and clinical attachment level by trained dental professionals.
Visual Assessment: Examination of soft tissues for evidence of injury.

8. The sample size for the training set:

This is irrelevant; the device is a physical toothbrush, not a machine learning model that requires a training set.

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

This is irrelevant; the device is a physical toothbrush, not a machine learning model.

Summary

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K040416

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:

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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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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 _____________________________________________________________________________________________________________________________________________________________

Over-the Counter Use _L

Susan Rums

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

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.