(199 days)
The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.
Teething Ring – Water or Gel Filled
This document is a 510(k) premarket notification for a Teething Ring - Water or Gel Filled. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way medical device AI/software studies typically do.
The FDA 510(k) clearance process for this type of device (a physical teething ring) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring specific performance studies with quantitative metrics like sensitivity, specificity, or reader improvement.
Therefore, I cannot provide the requested information because it is not present in the provided text. The document is primarily a regulatory clearance letter and an "Indications For Use" statement.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Mr. Joseph H. Hakim President Luv n' care. Limited 3030 Aurora Avenue Monroe, Louisiana 71211
MAR - 1 2010
Re: K092494
Trade/Device Name: Teething Ring - Water or Gel Filled Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: February 17, 2010 Received: February 17, 2010
Dear Mr. Hakim:
We have reviewed your Section 310(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.
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Page 2- Mr. Hakim
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.
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 /ucm 1 1 5809.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/defaul t.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,
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
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| INDICATIONS FOR USE | |
|---|---|
| K 092494 | |
| 510(k) Number: | (Submitted) - K092494 |
| Device Name: | Teething Ring – Water or Gel Filled |
| Indications For Use: | |
| The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon. | |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| Concurrence of DRRH, Office of Device Evaluation (ODE) | |
| Prescription Use | OR Over-The-Counter Use |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| R.B.Betz DDS for Dr. K.P. Mabry | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |
| 510(k) Number: | K092494 |
:-
§ 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.