The Oral-B® Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis.

The Oral-B® Test Drive Power Brush Trial Program Kit is indicated for use under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

Device Description

The Oral-B® Test Drive Power Brush Trial Program is designed to introduce potential users to a power toothbrush as a means to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis. The program kit that is used in the trial program contains a power toothbrush consisting of a rechargeable handle, charger, replacement brush heads, and instructions for the proper use and care of the device. Additionally, the program kit contains plastic dental sheaths to prevent soiling of the multi-user handle and instructions for cleaning and disinfection of the reusable handle. The program kit is indicated for use as an introductory trial to a power toothbrush under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

AI/ML Overview

This document is a 510(k) premarket notification for a Class I powered toothbrush. It asserts substantial equivalence to a predicate device and does not involve AI or complex diagnostic criteria. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and AI performance metrics are not applicable to this type of device and submission.

Here's an breakdown of the relevant information provided and why other categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the sense of specific numerical performance metrics for a diagnostic or AI device. For a Class I powered toothbrush, substantial equivalence is primarily based on comparing the new device's intended use, design, dimensions, materials, biocompatibility, and general performance to a legally marketed predicate device.

The document states:

Acceptance Criteria (Implied): The Oral-B® Test Drive Power Brush Trial Program Kit must perform comparably to the predicate device (Oral-B® Rechargeable Toothbrush, K061199) and demonstrate the ability to withstand multiple uses and disinfection without compromising integrity or performance.
Reported Device Performance:
- "Benchtop testing for the program kit was performed under conditions that simulated normal use and worst case scenario for wear. The performance testing demonstrated that the program kit handle can sustain multiple fittings of the brush head onto the reusable handle, and that the integrity of the seal remains intact with normal use."
- "Benchtop testing also demonstrates that the cleaning and disinfection procedure results in satisfactory disinfection of the handle, and that the repeated exposure of the handle to the disinfectant had no effect on the physical characteristics or performance of the device."

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

Sample Size for Test Set: Not explicitly stated numerically. The benchtop testing was conducted on an unspecified number of "program kit handles" and "brush heads" to simulate normal use and worst-case scenarios.
Data Provenance: The testing was "benchtop testing," implying internal lab testing conducted by the manufacturer, Procter & Gamble. No country of origin for test data is specified beyond the manufacturer's location. The testing is prospective in the sense that it was conducted on the device prior to submission, rather than analyzing pre-existing patient data.

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

Not applicable. This is not an AI/diagnostic device that requires expert-established ground truth for performance evaluation. The "ground truth" here is adherence to manufacturing specifications and functional performance.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is detailed as this is not a diagnostic device requiring interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. This is not an AI-assisted diagnostic device, so MRMC studies are irrelevant.

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

Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used

For this device, the "ground truth" effectively refers to:

Functional Performance: The ability of the handle to sustain multiple brush head fittings and maintain seal integrity.
Disinfection Efficacy: The cleaning and disinfection procedure achieving "satisfactory disinfection."
Material Compatibility: The handle's physical characteristics and performance remaining unaffected by repeated exposure to disinfectant.
These are established through engineering and microbiology testing in a lab setting.

8. The sample size for the training set

Not applicable. There is no AI or machine learning component requiring a training set.

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

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 15, 2014

The Procter & Gamble Company Dr. Michael A. Kaminski Regulatory Affairs Manager 1 Procter & Gamble Plaza Cincinnati, Ohio 45202

Re: K141018

Trade/Device Name: Oral-B® Test Drive Power Brush Trial Program Kit Regulation Number: 21 CFR 872.6865 Regulation Name: Toothbrush, Powered Regulatory Class: I Product Code: JEO Dated: August 14, 2014 Received: August 15, 2014

Dear Dr. Kaminski:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

510(k) Number (if known): To Be Assigned

Device Name: Oral-B® Test Drive Power Brush Trial Program Kit

Indications for Use:

The Oral-B® Test Drive Power Brush Trial Program Kit is indicated for use under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

Type of Use (Select one or both, as applicable)

Z Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Oral-B® Test Drive Power Brush Trial Program Kit 510(k)

Page 19 of 81 September 12, 2014

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5. 510(k) Summary

510(k) Submission, Traditional; as required by (21CFR§807.92(c))

510(k) Owner:	The Procter & Gamble Company1 Procter & Gamble PlazaCincinnati, Ohio 45202Telephone: (513) 622-2879 (Attention: Michael A. Kaminski)Facsimile: (513) 277-8009 (Attention: Michael A. Kaminski)Establishment Registration Number: 9915005
Contact Person:	Michael A. Kaminski, Ph.D.Regulatory Affairs ManagerGlobal Product StewardshipThe Procter & Gamble CompanyTelephone: (513) 622-2879Email: kaminski.ma@pg.comFacsimile: (513) 277-8009
Date:	August 14, 2014
Trade Name:	Oral-B® Test Drive Power Brush Trial Program Kit
Common name:	Power Toothbrush
Classification Name:	Toothbrush, Powered
Product Code:	JEQ

Identification of a Legally Marketed Predicate Device

The Oral-B® Test Drive Power Brush Trial Program Kit ("program kit") is substantially equivalent to the Oral-B® Rechargeable Toothbrush marketed by Procter & Gamble, 510(k) Premarket Notification Number: K061199, FDA Product Code JEQ (Class I, 510(k) Exempt).

General Description

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instructions for cleaning and disinfection of the reusable handle. The program kit is indicated for use as an introductory trial to a power toothbrush under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

Intended Use/Indications for Use

The Oral-B® Test Drive Power Brush Trial Program Kit is indicated for use under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

Comparison of Technological Characteristics

The Oral-B® Test Drive Power Brush Trial Program Kit is substantially equivalent to the Oral-B® Rechargeable Toothbrush (K061199) in intended use, design, dimensions, material biocompatibility and performance. The program kit differs from the Oral-B® Test Rechargeable Toothbrush device with regards to the cleaning and disinfections for the handle to permit multiple-users of the reusable handle. The program kit and the Oral-B® Rechargeable Toothbrush are both manufactured by Procter & Gamble Manufacturing GmbH (Marktheidenfeld, Germany) and distributed in the U.S.A. by Procter & Gamble, Co. (Cincinnati, Ohio).

Brief Summary of Non-Clinical Tests and Results

Benchtop testing for the program kit was performed under conditions that simulated normal use and worst case scenario for wear. The performance testing demonstrated that the program kit handle can sustain multiple fittings of the brush head onto the reusable handle, and that the integrity of the seal remains intact with normal use. Benchtop testing also demonstrates that the cleaning and disinfection procedure results in satisfactory disinfection of the handle, and that the repeated exposure of the handle to the disinfectant had no effect on the physical characteristics or performance of the device.

Basis of Substantial Equivalence

The Oral-B® Test Drive Power Brush Trial Program Kit is substantially equivalent to the Oral-B® Rechargeable Toothbrush in intended use, design, dimensions, materials, biocompatibility, and performance.

Accessory Device

The Oral-B® Sheath, manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device for inclusion in the program kit as an accessory device.

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.