(368 days)
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Not Found
No
The summary describes a toothbrush with an antibacterial agent and does not mention any AI or ML capabilities.
No
The document states the device is a toothbrush intended for over-the-counter use, and its antibacterial properties are to maintain the cleanliness of the brush itself, not to treat a condition in a user.
No
The device is described as a toothbrush intended for cleaning teeth and preventing bacterial growth on the brush itself, not for diagnosing any medical condition or disease.
No
The device is described as a toothbrush with an antibacterial agent, indicating it is a physical hardware device, not software.
Based on the provided information, the Silver Care Antibacterial Toothbrush is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "over-the-counter use as a toothbrush." This is a personal hygiene device used for cleaning teeth.
- Mechanism of Action: The antibacterial agent works on the toothbrush itself to prevent bacterial growth on the brush, not to diagnose or test for conditions in a biological sample from a human body.
- No mention of biological samples: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such samples.
The antibacterial claims relate to the effectiveness of the silver on the toothbrush bristles in preventing bacterial growth on the brush, not in diagnosing or treating a condition in a person.
N/A
Intended Use / Indications for Use
The Silver Care Antibacterial Toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent maintains the cleanliness of the brush by preventing the growth of bacteria on and between the filaments after use. The Silver Care is effective against E. coli (ATCC 25922), Klebsiella pneumoniae (ATCC 13388), Streptococcus mutans (ATCC 35668), and Pseudomonas aeruginosa (ATCC 27853) at 24 hours of exposure under moist conditions.
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
Over-the-counter use
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
Image /page/0/Picture/1 description: The image is a black and white seal. The seal is circular and contains text around the perimeter. In the center of the seal is a stylized image of an eagle or other bird. The bird is facing to the right and has three lines representing its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spazzolificio PIAVE S.p.A. % Ms. Keila Lacourt Consultant Ganesh Group 212 West 91st Street Apt 812 New York, New York 10024
OCT - 3 2011
Re: K102871
Trade/Device Name: Silver Care Antibacterial Toothbrush Regulation Number: 21 CFR 872.6855 Regulation Name: Manual Toothbrush Regulatory Class: I Product Code: EFW Dated: September 23. 2011 Received: September 26, 2011
Dear Ms. Lacourt:
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.
1
Page 2- Ms. Lacourt
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.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1.5.809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 hup://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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: Silver Care Antibacterial Toothbrush
ations For Use:
The Silver Care Antibacterial Toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent maintains the cleanliness of the brush by preventing the growth of bacteria on and between the filaments after use. The Silver Care is effective against E. coll (ATCC 25922), Klebsiella pneumoniae (ATCC 13388), Streptococcus mutans (ATCC 35668), and Pseudomonas aeruginosa (ATCC 27853) at 24 hours of exposure under moist conditions.
| Prescription Use
| (Part 21 CFR 001 Subpart D) | |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 001 Subpart C) | X |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Susan Runer |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| §10(k) Number: | K102871 |
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