(179 days)
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No
The summary describes a simple mechanical interdental toothbrush with an antibacterial agent, with no mention of AI or ML capabilities.
No
The device is a toothbrush designed for cleaning teeth and reducing tooth decay, which is a preventive measure rather than a therapeutic treatment for an existing disease or condition. The antibacterial agent's purpose is for maintaining the brush's cleanliness, not for direct therapeutic effect on the user.
No
Explanation: The device is an interdental toothbrush intended for plaque and food debris removal, which are preventative and cleaning functions, not diagnostic ones.
No
The device description clearly identifies it as a "Butler Antibacterial Interdental Toothbrush," which is a physical object used for cleaning teeth. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to remove plaque and food debris from between the teeth, which is a mechanical action performed directly on the body, not on a specimen taken from the body.
- The purpose of an IVD is to provide information about a physiological or pathological state. This device's purpose is to clean teeth and maintain the cleanliness of the brush itself, not to diagnose, monitor, or screen for any medical condition.
The description clearly indicates a device for oral hygiene, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Butler Antibacterial Interdental Toothbrush is intended to remove adherent plaque and food debris from between the teeth to reduce tooth decay. The addition of the antibacterial agent is intended to maintain the cleanliness of the interdental brush between uses and to have no effect on the user of the device.
Product codes
EFW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
ിക്കും
പ്രാപ
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 1998
John O. Butler Company C/O Mr. Thomas J. Muldoon Burditt & Radzius, Chartered 333 West Wacker Drive, Suite 2600 Chicago, Illinois 60606-1218
Re : K974761 Butler Antibacterial Interdental Toothbrush Trade Name: Regulatory Class: I Product Code: EFW Dated: March 19, 1998 Received: March 20, 1998
Dear Mr. Muldoon:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸਿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 (FD/) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Muldoon
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) 594-4692. 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"(21CFR 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/dsma/dsmamain.html".
r
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure -------
2
510(k) Number (if known):
Device Name: Butler Antibacterial Interdental Toothbrush
solo will be the coup in a may a securities and a
Indications For Use:
Interdental Toothbrush । Antibacterial The Butler intended to remove adherent plaque and food debris from between the teeth to reduce tooth decay. The addition of the antibacterial agent is intended to maintain the cleanliness of the interdental brush between uses and to have no effect on the user of the device.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Risser
(Div:
D
fection Control,
and Conspital Devices
510(k) Number K97474)
Prescription Use
(21 CFR 801.109) OR Over-the-counter Use
অগ্নিয়ার
পাশে না না না না।
পাশে না না না না না না না।
বাংলাদেশ
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