(570 days)
All teethers instruct consumer to: .
- Clean before use with a damp cloth and mild soap. Air dry. o
- o Not dishwasher safe
- Freezer safe ◆
Teether acts as an aid in relieving an infant's gums due to teething. .
Fluid Filled Teether - Gel
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as requested. The document is an FDA 510(k) clearance letter for a "Fluid Filled Teether - Gel" (K092025), which indicates that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classification, general controls, and compliance requirements.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, or retrospective/prospective nature.
- Information on the number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval, not a technical study report detailing performance metrics and study methodologies.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Bob Coughlin Kids II 555 North Point Center Suite 600 Alpharetta, Georgia 30022
Re: K092025
Fluid Filled Teether-Gel Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: Class II Product Code: KKO Dated: December 6, 2010 Received: December 6, 2010
JAN 2 7 2511
Dear Mr. Coughlin:
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. 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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
http://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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Wh for
Anthony Watson, MS, MBA Division 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
JAN 2 7 2011
510(k) Number (if known):
Device Name: Fluid Filled Teether - Gel
Indications For Use:
All teethers instruct consumer to: .
- Clean before use with a damp cloth and mild soap. Air dry. o
- o Not dishwasher safe
- Freezer safe ◆
Teether acts as an aid in relieving an infant's gums due to teething. .
Prescription Use
AND/OR
Over-The-Counter Use √
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quaos
Division Sign-Off) Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices ാസ്ട്രീംസ് of Antonol, Dental Devices
§10(k) Number: K062025
§ 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.