REACH® Antibacterial Toothbrush is used to remove adherent plaque and food debris from teeth to reduce tooth decay. This device is made of a shaft (handle) with synthetic bristles attached at one end. An antibacterial agent has been added to the handle portion. The antibacterial activity is limited to the handle of the toothbrush.

Device Description

Both the modified device and the predicate device are manual toothbrushes consisting of a shaft with synthetic bristles at one end. Antibacterial agents have been incorporated into the devices.

AI/ML Overview

The acceptance criteria and study proving the device meets them are summarized below:

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Study	Acceptance Criteria (Implicit)	Reported Device Performance
Microbiology Study - Zone of Inhibition Test	The "plastic" portion of the toothbrush with antibacterial agent should be effective in inhibiting the growth of bacteria.	The "plastic" portion of the toothbrush with antibacterial agent added was effective in inhibiting the growth of most of the bacteria tested.
Analytical Study - Extraction Study Using HPLC	No detectable antibacterial agent should leach out into a toothpaste/water slurry after 6 hours of simulated brushing, nor into an alcohol/water solution after 24 hours of soaking. (Limit of quantitation = 1 ppm)	HPLC results showed no detectable antibacterial agent in either the toothpaste/water slurry or the alcohol/water solution (limit of quantitation of antibacterial agent = 1 ppm).
Mucous Membrane Irritation - Hamster Cheek	The toothbrush with added antibacterial agent should not cause a significant difference in degree of irritation compared to toothbrushes without antibacterial agent when in contact with oral mucosal tissue.	Results showed no significant difference in degree of irritation between toothbrushes with antibacterial agent and toothbrushes without antibacterial agent.
In vitro Cytotoxicity Study - USP Agar Diffusion	No evidence of cell lysis or toxicity should be observed for the toothbrush with antibacterial agent added.	Results showed no evidence of cell lysis or toxicity for either the toothbrushes with an added antibacterial agent or the toothbrushes without an added antibacterial agent.

2. Sample Size and Data Provenance:

Test Set Sample Sizes:
- Microbiology Study: "several different strains of bacteria" were exposed. The exact number of strains or individual samples is not specified.
- Analytical Study: Not explicitly stated, but implies a sufficient number of samples were run for the HPLC analysis of the two solutions (toothpaste/water slurry and alcohol/water solution).
- Mucous Membrane Irritation: Implies a comparison between "toothbrushes with antibacterial agent" and "toothbrushes without antibacterial agent" in hamster cheek pouches. The specific number of hamsters or toothbrushes is not provided.
- In vitro Cytotoxicity Study: Implies a comparison between "toothbrushes with an added antibacterial agent" and "toothbrushes without an added antibacterial agent" as tested on mammalian cell cultures. The specific number of cell cultures or toothbrush samples is not provided.
Data Provenance: Not explicitly stated, but given Johnson & Johnson Consumer Franchises Worldwide is the submitter and the reports are part of a 510(k) submission, the studies were likely conducted internally or by contract research organizations within the United States. The studies are prospective in nature, designed to evaluate the safety and performance of the modified device.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable as the reported studies are laboratory and preclinical tests, not analyses requiring expert human interpretation of medical images or data. The "ground truth" for these tests comes from the scientific methods themselves (e.g., inhibition zones, HPLC readings, irritation scores, cytotoxicity assays).

4. Adjudication Method:

Not applicable for these types of laboratory and preclinical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a toothbrush, not a diagnostic device involving human readers of medical cases.

6. Standalone Performance Study:

Yes, all the described studies (Microbiology Study, Analytical Study, Mucous Membrane Irritation, and In vitro Cytotoxicity Study) are standalone evaluations of the device's characteristics and performance. They assess the device itself against scientific benchmarks and comparisons to a non-antibacterial version, without human-in-the-loop performance measurement.

7. Type of Ground Truth Used:

The ground truth used for these studies is based on objective scientific measurements and established laboratory protocols:
- Microbiology: Direct observation of bacterial growth inhibition (Zone of Inhibition).
- Analytical: Quantitative chemical analysis using High-Performance Liquid Chromatography (HPLC) to detect specific compounds.
- Mucous Membrane Irritation: Histopathological or macroscopic assessment of tissue irritation in a preclinical model.
- In vitro Cytotoxicity: Observation of cell lysis and viability in mammalian cell cultures following USP guidelines.

8. Sample Size for the Training Set:

Not applicable. These are verification and validation studies (test sets) for a physical device, not an AI/machine learning model that requires a "training set."

9. How Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/machine learning model in this context.

Summary

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JUL 2 4 1997

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Summary	Summarized below is the safety and effectiveness information compiled in support of claims of substantial equivalence (as defined in the FD&C Act).
Submitter	Personal Products Company199 Grandview RoadSkillman, New Jersey 08558
Contact Person	Ms. Lorna-Jane BremerSenior Regulatory Affairs AssociateJohnson & Johnson Consumer Franchises Worldwide199 Grandview Road, Skillman, New Jersey 08858Phone: 908-874-1700 Fax: 908-874-2751
Date of Submission	April 29, 1997
Device Trade Name	REACH® Antibacterial Toothbrush
Device Common Name	Toothbrush
Device Classification	Manual Toothbrush -- Class I Device(Ref. 21 CFR § 872.6855)
Predicate Device	Butler G.U.M. Antibacterial Toothbrush (John O. Butler), a Class I post-amendments 510(k) device (K950993).
Intended Use	Both the modified device and the predicate device are intended to be used to remove adherent plaque and food debris from the teeth to reduce tooth decay.
Technological Characteristics/ Description	Both the modified device and the predicate device are manual toothbrushes consisting of a shaft with synthetic bristles at one end. Antibacterial agents have been incorporated into the devices.

510(k) Summary

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Johnson & Johnson Consumer Franchises Worldwide has conducted a Performance thorough program to evaluate the safety of the Modified Device. This Data program consisted of the following:

Bench Testing

1. Microbiology Studv - Zone of Inhibition Test

The purpose of this study was to evaluate the antibacterial activity of the "plastic" portion of the toothbrush both before and after simulated use. Toothbrushes with antibacterial "plastic" as well as toothbrushes without antibacterial "plastic" were exposed to several different strains of bacteria which may be found on toothbrushes after use. Results showed that the "plastic" portion of the toothbrush with antibacterial agent added was effective in inhibiting the growth of most of the bacteria tested.

2. Analytical Study - Extraction Study Using HPLC

The purpose of this study was to determine whether any of the antibacterial agent contained in the toothbrush was able to leach out into a toothpaste/water slurry after 6-hours of simulated brushing and into an alcohol/water solution after soaking the toothbrush for 24 hours. HPLC results showed no detectable antibacterial agent in either the toothpaste/water slurry or the alcohol/water solution (limit of quantitation of antibacterial agent = 1 ppm).

Pre-Clinical Testing

1. Mucous Membrane Irritation - Hamster Cheek

The purpose of this study was to evaluate the irritation potential of the toothbrush with added antibacterial agent after it remained in contact with oral mucosal tissue in the hamster cheek pouch for one week. Results showed no significant difference in degree of irritation between toothbrushes with antibacterial agent and toothbrushes without antibacterial agent.

2. in vitro Cytotoxicity Study - USP Agar Diffusion

The purpose of this study was to evaluate the biocompatibility of the toothbrush with antibacterial agent added using an in vitro mammalian cell culture test based on United States Pharmacopeia (USP) guidelines. Results showed no evidence of cell lysis or toxicity for either the toothbrushes with an added antibacterial agent or the toothbrushes without an added antibacterial agent.

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Conclusions

The modification to this device does not raise new types of safety or effectiveness questions. Accepted scientific methods were utilized to assess the effects of the modification. On this basis, we conclude that the data provided demonstrate that the Modified Device is safe for its intended use.

Based on the 510(k) Substantial Equivalence Decision-Making Process review as shown and the testing information provided, we believe that the Modified Device is substantially equivalent to the Predicate Device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lorna-Jane Bremer ·Senior Regulatory Affairs Associate Personal Products Company 199 Grandview Road Skillman, New Jersey 08558

JUL 2 4 1997

Re : K971589 Trade Name: Reach Antibacterial Toothbrush Regulatory Class: I Product Code: EFW Dated: April 29, 1997 Received: May 1, 1997

Dear Ms. Bremer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Bremer

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy R. Walbert

Timot Wy 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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INDICATION FOR USE

510(k) Number (if known): K971589

Device Name: REACH® Antibacterial Toothbrush

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off) Division of Dental, Info Courtence of CDRH, Office of Device Evaluation (ODE) and General Hospital De 510(k) Number scription OR Over-The-Counter-Use (Per 21 CFR 801.1

(Optional Format 1-2-96)

000

00007

Regulation Number and Section

§ 872.6855 Manual toothbrush.

(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end 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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.