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K Number
K102871
Device Name
SILVER CARE ANITBACTERIAL TOOTHBRUSH
Manufacturer
PIAVE SPAZZOLIFICIO S.P.A.
Date Cleared
2011-10-03

(368 days)

Product Code
EFW
Regulation Number
872.6855
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the Silver Care Antibacterial Toothbrush. It does not contain the detailed study information required to answer the prompt.

Specifically, the document:

  • Identifies the device, its regulation number, and regulatory class.
  • States the device's indications for use, including claims about its antibacterial effectiveness against specific bacteria at 24 hours of exposure under moist conditions.
  • Confirms a substantial equivalence determination.

However, it does not include:

  1. A table of acceptance criteria and reported device performance: The letter mentions antibacterial effectiveness but doesn't provide specific quantitative targets or reported results from a study in a tabular format.
  2. Sample size used for the test set and data provenance: No information about the sample size (number of toothbrushes, bacterial replicates, etc.) or where the data came from.
  3. Number of experts and their qualifications for ground truth: This information is irrelevant for a device like a toothbrush where performance is measured by laboratory tests, not expert interpretation of data.
  4. Adjudication method: Not applicable for this type of device testing.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this device does not involve human readers interpreting medical images/data.
  6. Standalone performance: While the antibacterial claims are inherently standalone performance, no specific study details are provided.
  7. Type of ground truth: The "ground truth" for the antibacterial claim would be the measured bacterial reduction, but the detailed methodology is missing.
  8. Sample size for the training set: Not applicable, as this is a physical device tested in a lab, not an AI/ML model for which training data would be relevant.
  9. How ground truth for the training set was established: Not applicable.

To provide the requested information, a different document, such as the actual testing report submitted to the FDA, would be necessary.

§ 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.