The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.

Device Description

The Oral-B® iO Test Drive Power Brush Trial Program for conventions (e.g. professional, scientific, trade shows), is designed to introduce convention delegates to the newest, most advanced Oral-B electric rechargeable toothbrush as a means to promote good oral hygiene. The program kit contains a power toothbrush consisting of a rechargeable handle, a charger, replacement brush heads, and instructions for the proper use and care of the device. The program kit also contains plastic dental sheaths to prevent soiling and therefore allowing for easier cleaning of the multi-user handle. The sheath is manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device (K132953) for inclusion in the program kit as an accessory. Detailed instructions for cleaning and disinfection of the reusable handle are also included. The program kit is indicated for use as an introductory trial, exclusively within the confines of a convention (e.g. professional, scientific, trade shows), under the direct supervision of a dental professional as part of the Oral-B® iO Test Drive Power Brush Trial Program.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding a powered toothbrush. It concerns the "Oral-B iO Test Drive Power Brush Trial Program Kit" (K200881). The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Oral-B Test Drive Power Brush Trial Program Kit, K141018) and a reference device (Oral-B iO Rechargeable Power Toothbrush, a Class I, 510(k) exempt device).

The information provided does not relate to an AI/ML medical device, a multi-reader multi-case (MRMC) comparative effectiveness study, or the use of AI assistance for human readers. It lists performance data for a physical device, including biocompatibility, electrical safety, software verification, and cleaning/disinfection validation. Therefore, many of the requested categories related to AI/ML device performance and study design (e.g., sample size for test/training sets for AI, expert adjudication, ground truth definition for AI, effect size of AI assistance) are not applicable to this document.

However, I can extract the relevant acceptance criteria and how the device meets them based on the provided "PERFORMANCE DATA" section.

Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (a powered toothbrush) and not an AI/ML algorithm, the "acceptance criteria" are typically defined by compliance with recognized standards and successful completion of specific non-clinical and performance tests to demonstrate safety and effectiveness for its intended use, and ultimately substantial equivalence to a predicate device. The performance data section describes how the device meets these requirements.

Here's a table summarizing the "acceptance criteria" (or performance areas tested for compliance) and the reported device performance:

Acceptance Criteria/Performance Area	Reported Device Performance
Biocompatibility	Tests: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-12). Consistent with ISO 10993 guidance and FDA recommendations. Results: Passed all tests. Confirmed non-cytotoxic, non-sensitizing, and non-irritating, even after cleaning and disinfection. Materials are the same as those used in the predicate and reference device.
Electrical Safety	Standards: UL 1431, IEC 60335-1, IEC 60335-2-52 (as outlined in ISO 20127). Results: Compliant results. Confirms construction addresses risk of fire, shock, and physical injury per specified consensus standards.
Electromagnetic Compatibility (EMC)	Standards: Title 47 CFR Parts 15B, 15C, and 18 of the Federal Communications Commission. Results: Compliant results. Assures unintentional and intentional radiation are within federally prescribed limits across the full RF bandwidth.
Software Verification & Validation	Guidance: FDA guidance documents "General Principles of Software Validation" (Jan 2002) and "Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005). Consistent with "Moderate" Level of Concern. Results: Verification activities demonstrate that the device performs as intended.
Cleaning and Disinfection Validation	Conditions: Simulated normal use and worst-case scenario for wear. Results: Demonstrated satisfactory cleaning and high-level disinfection. Repeated exposure to cleaning and disinfection procedures had no effect on physical characteristics or performance. Established a reuse life of 240 uses and subsequent cleaning and disinfection cycles. (Note: The table on page 7 shows "Reuse Life" for the subject device as "100 cycles" compared to "240 cycles" for the predicate. This seems like a discrepancy or change from the text on page 12, which states 240 uses were established. The 100 cycles value might be a specific finding or target, while 240 cycles was the tested limit without performance degradation.)
Human Factors Usability Testing	Studies: Several formative studies (to develop/test instructions, software, training) and one summative study (to validate user ability to follow instructions). Results: Summative study validated that users, after training, could read and understand labeling and follow instructions (with software aid) to properly clean and disinfect the reusable toothbrush handle.
Substantial Equivalence	Conclusion: Based on intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K141018).

Since this is not an AI/ML device, the following points are largely not applicable or cannot be definitively answered from the provided text:

Sample sizes used for the test set and the data provenance:
- For biocompatibility, electrical safety, EMC, and software, "samples" are devices or components. Specific numbers of units tested are not provided in this summary, but these are typically engineering and lab tests, not clinical studies with human subjects for efficacy.
- For Cleaning and Disinfection Validation, the document mentions testing under "simulated normal use and worst-case scenario for wear" and establishing a "reuse life of 240 uses." This number (240 cycles) could be considered a "sample size" for this specific durability test.
- For Human Factors Usability testing, "several formative and a summative" studies were performed. The number of participants in these studies (i.e., "sample size") is not specified.
- Data Provenance: The manufacturer is Procter & Gamble Manufacturing GmbH (Marktheidenfeld, Germany) and distributed in the U.S.A. by Procter & Gamble, Co. (Cincinnati, Ohio). The studies are non-clinical, not patient data (retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., highly accurate disease labels) is not relevant for this type of device submission. The "ground truth" here is compliance with engineering standards and predefined performance specifications. Expert validation is implicitly part of these standardized testing processes (e.g., certified labs, qualified engineers).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is typically related to expert review of medical images or patient data for ground truth establishment in AI/ML studies.
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: Not applicable. This is a physical powered toothbrush, not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is a software component (Level of Concern - Moderate), but it's part of the device's function (e.g., user interface, power management, potentially guidance for cleaning), not a standalone diagnostic algorithm. The software verification confirms it "performs as intended."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from:
- Compliance with recognized standards: ISO 10993 (biocompatibility), UL 1431, IEC 60335 series, ISO 20127 (electrical safety), 47 CFR Parts 15B, 15C, 18 (EMC).
- Successful completion of pre-defined non-clinical tests: Cleaning/disinfection validation (e.g., microbial reduction, material integrity), Human Factors Usability (user ability to follow instructions).
- Performance against specifications: e.g., reuse life, satisfactory cleaning/disinfection.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

May 25, 2021

The Procter & Gamble Company Michael Kaminski Principal Scientist 8700 Mason Montgomery Road Mason, Ohio 45040

Re: K200881

Trade/Device Name: Oral-B iO Test Drive Power Brush Trial Program Kit Regulation Number: 21 CFR 872.6865 Regulation Name: Powered toothbrush Regulatory Class: Class I Product Code: JEQ

Dear Michael Kaminski:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 27, 2020. Specifically, FDA is updating this SE Letter for typographical errors in the company name and regulatory class as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Michael Adjodha, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6276, Michael.Adjodha@fda.hhs.gov.

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

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

August 27,2020

The Proctor & Gamble Company Michael Kaminski Principal Scientist 8700 Mason Montgomery Road Mason, Ohio 45040

Re: K200881

Trade/Device Name: Oral-B iO Test Drive Power Brush Trial Program Kit Regulation Number: 21 CFR 872.6865 Regulation Name: Powered Toothbrush Regulatory Class: Class I, reserved Product Code: JEQ Dated: August 5, 2020 Received: August 6, 2020

Dear Michael 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. 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.

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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 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.

Bobak Shirmohammadi -S

for Srinivas "Nandu" Nandkumar, Ph. D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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K200881

4. Indications for Use Statement

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

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

Indications for Use:

The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene.

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

X 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)

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The Procter & Gamble Company Mason Business Center Mason, Ohio 45040-9462

5. 510(k) Summary
	K200881
SUBMITTER
510(k) Owner:	The Procter & Gamble Company1 Procter & Gamble Plaza Cincinnati, Ohio 5202Telephone: (513) 206-4331Establishment Registration Number: 9915005
Contact Person:	Michael A. Kaminski Ph.D.Principal Scientist Oral CareThe Procter & Gamble CompanyTelephone: (513) 206-4331 Email: kaminski.ma@pg.com
Date Prepared:	August 26, 2020
DEVICE
Trade Name:	Oral-B® iO Test Drive Power Brush Trial Program Kit
Common Name:	Power Toothbrush
Classification Name:	Toothbrush, Powered
Product Code:	JEO

PREDICATE / REFFERENCE DEVICE

The Oral-B® iO Test Drive Power Brush Trial Program kit") is substantially equivalent to the predicate Oral-B® Test Drive Power Brush Trial Program Kit marketed by Procter & Gamble, Premarket Notification Number: K141018, FDA Product Code JEQ (Class I, 510(k) Exempt).

The Oral-B® iO Test Drive Power Brush Trial Program Kit uses as a reference device the Oral-B® iO Rechargeable Toothbrush; a class I, 510(k) exempt device. The reference device is available as an overthe-counter device marketed under regulatory reference number 21 CFR 872.6865. The Oral-B® iO Rechargeable Toothbrush is cited as a reference device because it is for all intents and purposes, the same device as the subject device. The reference device, a 510k exempt device, is compliant with ISO 20127, Dentistry - Powered toothbrushes - General requirements and test methods which we also relied on to demonstrate the performance of the subject device. Additionally, with the exception of the colorant in the adapter which was used in the predicate, all the materials found in the reference device are used in the subject device.

Neither the predicate device nor the reference device have been the subject of any design-related recalls.

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DEVICE DESCRIPTION

INDICATIONS FOR USE

The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene.

The indication for use for the subject device differs from that of the predicate in that we have narrowed the use environment to conventions only. The results in user group, those who will brush their teeth, being a sub population of the predicates target population. The more controlled use environment also allows for the assurance of a regimented and standardized training program to insure proper cleaning and disinfection of the device after use. These differences in indication for use do not affect the safety and effectiveness of the device when used as labeled.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The Oral-B® iO Test Drive Power Brush Trial Program Kit is substantially equivalent to the predicate device. Oral-B® Test Drive Power Brush Trial Program Kit (K141018). The Oral-B® iO Test Drive Power Brush Program Kit that is the subject of this 510(k) differs slightly from the predicate with regards to design, dimensions and materials yet none of these modifications affect the safety or effectiveness of the device. The most notable difference between the Oral-B® iO Test Drive Power Brush Trial Program Kit and the predicate device are a new drive mechanism and elimination of the elastomeric seal that previously presented a physical barrier to saliva and other fluids from potentially contaminating the handle drive shaft. These changes necessitated a change to the reprocessing, including the use of an FDA-cleared high-level disinfectant and is the reason for this pre-market notification. In addition, the target population for the subject device is much more specific in that the Oral-B® iO Test Drive Power Brush Trial Program will be executed at conventions only under the direct supervision of a dental professional and the device cleaned and disinfected by trained professionals. The subject device, the reference and predicate are all manufactured by Procter & Gamble Manufacturing GmbH (Marktheidenfeld, Germany) and distributed in the U.S.A. by Procter & Gamble, Co. (Cincinnati, Ohio).

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The OTC Oral-B® iO Rechargeable Power Toothbrush (reference device) for all intents and purposes, is the same device as the subject device. Marketed as class I, 510k exempt device, the reference device is available for purchase OTC for consumers and satisfies all the requirements of a class I 510k exempt device including compliance with ISO 20127, Dentistry - Powered toothbrushes - General requirements and test methods.

While there are differences in indication for use, use environment, color of the adapter, software and labelling all have been addressed in the 510k with data that supports a finding of substantial equivalence to the predicate.

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	Subject Device	Predicate Device	Reference Device
510(k) Number	To be assigned	K141018	Class I, 510(k) exempt
Product Code	JEQ	JEQ	JEQ
Common Name	Toothbrush, Powered	Toothbrush, Powered	Toothbrush, Powered
Trade Name	Oral-B® iO Test Drive Power Brush TrialProgram Kit	Oral-B® Test Drive Power Brush Trial ProgramKit	Oral-B® iO Rechargeable Power Toothbrush
FDA Class	Class I, 510(k) exempt, Rx	Class I, 510(k) exempt, Rx	Class I, 510(k) exempt, OTC
Regulation	21CFR§872.6865	21CFR§872.6865	21CFR§872.6865
Manufacturer	Procter & Gamble Manufacturing GmbH	Procter & Gamble Manufacturing GmbH	Procter & Gamble Manufacturing GmbH
Sold Sterile	No	No	No
Description	The Oral-B® iO Test Drive Program allowsusers to experience the benefit of brushing withan electric rechargeable toothbrush specificallywithin a convention setting	The Oral-B® Test Drive Power Brush TrialProgram Kit is a rechargeable power toothbrushdesigned to promote good oral hygiene, includingthe reduction of dental plaque for the treatment andprevention of gingivitis.	The Oral-B® iO Power Toothbrush is a rechargeablepower toothbrush designed to promote good oralhygiene, including the reduction of dental plaque forthe treatment and prevention of gingivitis.
Indication for Use	The Oral-B® iO Test Drive Power Brush TrialProgram Kit is intended for use as a powertoothbrush to promote good oral hygiene.The Oral-B® iO Test Drive Power Brush TrialProgram Kit is indicated for use under thedirect supervision of a dental professional,exclusively at conventions (e.g. professional,scientific, trade shows), as part of the Oral-B®iO Test Drive Power Brush Trial Program.	The Oral-B® Test Drive Power Brush TrialProgram Kit is intended for use as a powertoothbrush to promote good oral hygiene,including the reduction of dental plaque, for thetreatment and prevention of gingivitis.The Oral-B® Test Drive Power Brush TrialProgram Kit is indicated for use under thesupervision of a dental professional as part of theOral-B® Test Drive Power Brush Trial Program.	The Oral-B® iO Power Toothbrush is intended for useas a power toothbrush to promote good oral hygiene byremoving adherent plaque and food debris from theteeth to reduce tooth decay and treat and preventgingivitis.
Use Environment	Convention (e.g. professional, scientific, tradeshow) under the direct supervision of a dentalprofessional.	Dental Office under the supervision of a dentalprofessional.	Home
	Subject Device	Predicate Device	Reference Device
Target Population	Convention attendee (e.g. dentist, hygienist,dental researcher) under the direct supervisionof a dental professional (18 years or older).Dental professionals (e.g. dentist, hygienist,assistants, students) responsible for thecleaning and disinfection of the handle will betrained and supervised (18 years or older).	Consumer use under dental professionalsupervision (General population 3 years andabove).Dental professionals (e.g. dentist, hygienist,assistants) responsible for the cleaning anddisinfection of the handle did not receive anytraining or supervision (18 years or older).	Over-the-Counter - General population (3 years andabove)
Components	Oral-B® iO Test Drive Power Brush TrialProgram Kit (2 boxes):• Oral-B® iO Test Drive Power ToothbrushKit (1 box)o Handle (1)o Charger (1)o User Manual (1)• Oral-B® iO Test Drive Refill Kit (1 box)o Oral-B® iO brush heads (25)o Plastic Sheaths (30)o Cleaning and Disinfection QuickReference Guide (1)Cleaning and Disinfection Manual (1)	Oral-B® Test Drive Power Brush Trial ProgramKit (2 boxes):• Oral-B® Test Drive Power Toothbrush Kit (1box)o Handle (1)o Charger (1)o User Manual (1)• Oral-B® Test Drive Refill Kit (1 box)o Oral-B® brush heads (50)o Plastic Sheaths (55)Cleaning and Disinfection Manual (1)	Oral-B® iO Power Brush (1 box):o Handle (1)o Charger (1)o Oral-B® brush heads (vaiable)o User Manual (1)
Model	Program Kit – Product code 80338870Handle - OPO24Brush Head - ORO20Charger - OPO23	Program Kit - D34.503.5eHandle - D34eBrush Head – EB50eCharger - 3757	OTC Kit - Product code 80338571Handle - OPO20Brush Head – ORO15Charger - OPO23
Accessory	Disposable plastic sheath to prevent soiling andfacilitate cleaning (K132953)	Disposable plastic sheath to prevent soiling andfacilitate cleaning (K132953)	No Applicable
Labeling	o User Manualo Cleaning and Disinfection Manual withQuick Start Guideo Training Scripto Checklist for Validation and Revalidation	o User Manualo Cleaning and Disinfection Manual	o User Manual
	Subject Device	Predicate Device	Reference Device
Cleaner	Opti-Cide3 Solution(EPA Reg. No. 70144-1)Micro-Scientific, LLCIngredients: 0.154% n Alkyl (60% C14 30% C155% C12 5% C18) dimethyl benzyl ammoniumchloride,0.154% n Alkyl (68% C12 32% C14) dimethylbenzyl ammonium chloride,21% IsopropanolContact Conditions: 2 min at 20°COrGeneral Purpose Non-AmmoniatedUltrasonic Cleaner (e.g. Crosstex)Crosstex internationalIngredients: <5% Isopropyl alcohol, <5% SodaAsh, <5% Ethoxylated Alcohols Phosphateesters (C8-10)Contact Conditions: 2 min at 20°C	Opti-Cide3 Surface Wipes(EPA Reg. No. 70144-1)Micro-Scientific, LLCIngredients: 0.154% n Alkyl (60% C14 30% C15 5%C12 5% C18) dimethyl benzyl ammonium chloride,0.154% n Alkyl (68% C12 32% C14) dimethylbenzyl ammonium chloride,21% IsopropanolContact Conditions: 30 seconds at 20°C	Not applicable
	Subject Device	Predicate Device	Reference Device
Disinfection	Spaulding classification - Semi-criticalHigh Level DisinfectionResert XL HLD High Level Disinfectant(K091022/K080420)Steris CorporationActive: 2.0% hydrogen peroxideContact Conditions: 8 min at 20°C21 days Maximum Reuse Contact conditionsestablished by simulated use testing withendoscopes.	Spaulding classification - Non-criticalIntermediate Level DisinfectionOpti-Cide 3 Solution(EPA Reg. No. 70144-1)Micro-Scientific, LLCActive: 0.154% n Alkyl (60% C14 30% C15 5% C125% C18) dimethyl benzyl ammonium chloride,0.154% n Alkyl (68% C12 32% C14) dimethylbenzyl ammonium chloride,21% IsopropanolContact Conditions: 3 min at 20°C	Not intended to be disinfected
Reuse Life	100 cycles	240 cycles	5 years
Biocompatibility	Yes - materials plus experience on similardevices plus post-marketing data on similardevices; materials are same as those used in thepredicate and reference device.Risk Assessment ISO 10993-1Cytotoxicity ISO 10993-5Irritation ISO 10993-12Sensitization ISO 10993-10	Yes - materials plus experience on similar devicesplus post-marketing data on this device and similardevices; materials are same as those used in themarketed predicate.	Yes - materials plus experience on similar devices pluspost-marketing data on this device and similar devices;materials are same as those used in the marketeddevice.
Software	Yes - consistent with the Level of Concern -Moderate	Yes - consistent with the Level of Concern -Minor	Yes - consistent with the Level of Concern - Minor
Electrical Safety andElectromagneticCompatibility	UL 1431IEC 60355-1IEC 60335-2-52} ISO 20127Title 47 CFR Parts 15B, 15C and 18	UL 1431IEC 60355-1IEC 60335-2-52} ISO 20127Title 47 CFR Parts 15B, 15C and 18	UL 1431IEC 60355-1IEC 60335-2-52} ISO 20127Title 47 CFR Parts 15B, 15C and 18

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PERFORMANCE DATA

Biocompatibility Testing

Biocompatibility was demonstrated through testing that was consistent with ISO 10993 and FDAs guidance on how to use ISO 10993-1 within a risk management process. The subject device is intended to come in limited direct contact with intact skin and limited indirect contact with oral mucous membranes. The results from cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-12) studies passed all tests in conformity with the standards and moreover the testing confirmed that after cleaning and disinfection the subject device was non-cytotoxic, non-sensitizing, and non-irritating.

Electrical Safety and Electromagnetic Compatibility

Electrical safety testing in accordance with UL 1431. IEC 60335-1 and IEC 60335-2-52 (as outlined in ISO 20127) was applied with compliant results. This testing confirms that the construction of the system addresses risk of fire, shock and physical injury to the degree specified by these consensus standards.

Electromagnetic compatibility testing was performed with compliant results in accordance with the Title 47 CFR Parts 15B, 15C and 18 of the Federal Commission. This testing assures that the unintentional and intentional radiation are within the federally proscribed limits across the full RF bandwidth.

Software Verification and Validation Testing

Software verification and validation was completed in accordance with the FDA guidance documents, "General Principles of Software Validation" (issued January 11, 2002). Supporting documentation, consistent with the software's Level of Concern statement, has been submitted in accordance with the FDA guidance document "Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005). The results from the verification activities demonstrate that the device performs as intended.

Cleaning and Disinfection Validation Testing

Cleaning and disinfection validation testing for the program kit was performed under conditions that simulated normal use and worst-case scenario for wear. The testing demonstrated that the cleaning and disinfection procedures result in satisfactory cleaning and high-level disinfection of the device, and that the repeated exposure of the handle to cleaning and disinfection procedures had no effect on the physical characteristics or performance of the device. Repeated exposure of the device to simulated use conditions including cleaning and disinfection established the reuse life of 240 uses and subsequent cleaning and disinfection cycles.

Human Factors Usability testing

Several formative and a summative Human Factors Usability studies were performed to evaluate the ability of the users of the device to read and comply with the instructions for use for the assembly, operation, and care of the Oral-B® iO Test Drive Power Toothbrush. The formative studies were designed and conducted to help develop and test the use instructions, software and training necessary to insure proper cleaning and disinfection of the reusable handle. The

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summative study was designed and performed to validate that the users of the iO Oral-B® Test Drive Power Brush Trial Program could after training, read and understand the product labeling and follow the instructions with the aid of the software to properly clean and disinfect the reusable toothbrush handle.

CONCLUSION

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K141018).

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.