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K Number
K053493
Device Name
BERRY FRUITY TEETHER
Manufacturer
EVENFLO COMPANY, INC.
Date Cleared
2006-02-22

(69 days)

Product Code
KKO
Regulation Number
872.5550
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Evenflo Berry Fruity Teether is a personal use biting device used to cool and soothe the gums during the teething process.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Evenflo Berry Fruity Teether." This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter primarily confirms that the FDA has reviewed the manufacturer's submission and determined that the device is "substantially equivalent" to legally marketed predicate devices. It outlines regulatory requirements for marketing the device and provides contact information for further inquiries.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes and data provenance for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study details.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This information is typically found in the 510(k) submission itself or in a separate study report, neither of which are provided in the input text.

§ 872.5550 Teething ring.

(a)
Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.(b)(1)
Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. 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.