(84 days)
No
The summary describes a manual toothbrush with an antibacterial agent in the handle. There is no mention of any computational or data-driven features that would indicate the use of AI or ML. The performance studies are standard bench and pre-clinical tests for material properties and biocompatibility.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is a manual toothbrush, used for cleaning teeth and reducing tooth decay, which is a preventive measure. However, the FDA typically classifies toothbrushes as Class I devices, which are generally not considered therapeutic. Additionally, the antibacterial activity is limited to the handle and does not directly treat a condition in the user.
No.
The device is a manual toothbrush designed to remove plaque and food debris, which is a therapeutic rather than diagnostic function. Its performance studies focus on mechanical and antibacterial properties, not on detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a manual toothbrush made of a shaft and synthetic bristles, with an antibacterial agent added to the handle. This is a physical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove plaque and food debris from teeth to reduce tooth decay. This is a mechanical action performed directly on the body (teeth), not an in vitro test performed on a sample taken from the body.
- Device Description: The device is a manual toothbrush with an antibacterial agent in the handle. This describes a physical tool for oral hygiene.
- Performance Studies: The studies described are bench testing (microbiology and analytical) and pre-clinical testing (irritation and cytotoxicity). These evaluate the physical and biological properties of the device itself and its interaction with oral tissues, not the diagnostic properties of a sample.
- Lack of IVD Characteristics: There is no mention of analyzing a sample (blood, urine, saliva, etc.) to diagnose a condition, monitor a disease, or determine compatibility.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This toothbrush does not fit that description.
N/A
Intended Use / Indications for 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.
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.
Product codes
EFW
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.
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
Bench Testing:
- Microbiology Study - Zone of Inhibition Test: Evaluated antibacterial activity of the "plastic" portion of the toothbrush (with and without antibacterial agent) before and after simulated use against several bacteria strains. Results showed the antibacterial agent was effective in inhibiting growth.
- Analytical Study - Extraction Study Using HPLC: Determined if antibacterial agent leached into a toothpaste/water slurry after 6-hours simulated brushing or into an alcohol/water solution after 24-hour soaking. HPLC showed no detectable antibacterial agent (limit of quantitation = 1 ppm).
Pre-Clinical Testing:
- Mucous Membrane Irritation - Hamster Cheek: Evaluated irritation potential with antibacterial agent after one week contact with oral mucosal tissue. No significant difference in irritation between toothbrushes with and without antibacterial agent.
- In vitro Cytotoxicity Study - USP Agar Diffusion: Evaluated biocompatibility using an in vitro mammalian cell culture test based on USP guidelines. No evidence of cell lysis or toxicity for either toothbrush type.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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JUL 2 4 1997
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string is "K971589".
| 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 Company |
| 199 Grandview Road | |
| Skillman, New Jersey 08558 | |
| Contact Person | Ms. Lorna-Jane Bremer |
| Senior Regulatory Affairs Associate | |
| Johnson & Johnson Consumer Franchises Worldwide | |
| 199 Grandview Road, Skillman, New Jersey 08858 | |
| Phone: 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:
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.
(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