(69 days)
The Evenflo Berry Fruity Teether is a personal use biting device used to cool and soothe the gums during the teething process.
Not Found
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- 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.
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Public Health Service
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FEB 2 2 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ruben D. Colmenares Product Integrity Engineer Evenflo Company, Incorporated 707 Crossroads Court Vandalia, Ohio 45377
Re: K053493
Trade/Device Name: Evenflo Berry Fruity Teether Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: Class II Product Code: KKO Dated: December 14, 2005 Received: December 16, 2005
Dear Mr. Colmenares:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 – Mr. Ruben D. Colmenares
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issuance of a substantal species with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that HDA has made a decemination mat your a viser Federal agencies.
of the Act or any Federal statutes and regulations administered by segistration of the Act or any rederal statutes and reginations and limited to: registration
You must comply with all the Act's requirements and manufacturing progrise You must comply with an the Act 3 requirements integral and manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Part and listing (21 CFK Fall 807), laboling (21 CFR (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); requirements as set form in the quality systems (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section I his letter will anow you to oegh manketing your and stantial equivalence of your device and thus 510(K) premarket nothreation: "The FDT Missing on for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), , If you desire specific advice for your de at (240) 276-0115. Also, please note the regulation please contact the Other or Ochipanian promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miromation on Journational and Consumer Assistance at its toll-free Division of Binan 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital , Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
053493 510(k) Number (if known): _
Device Name: Evenflo Berry Fruity Teether
Indications for Use:
The Evenflo Berry Fruity Teether is a personal use biting device used to cool and soothe the gums during the teething process.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Puono
resistagy, General Hospitz!
§ 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.