(84 days)
The Fu Hong Industries Limited Soother Teether is a fluid filled teether indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
Not Found
This document is an FDA 510(k) clearance letter for the "Fu Hong Industries Limited Soother Teether". It determines that the device is "substantially equivalent" to legally marketed predicate devices.
The document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined for medical device performance. Instead, the FDA's 510(k) process focuses on showing substantial equivalence to a predicate device, rather than requiring new clinical trials to establish safety and effectiveness from scratch for every new device.
Therefore, I cannot provide the requested information for the following reasons:
- No Acceptance Criteria or Performance Study: The document explicitly states "substantially equivalent" rather than detailing specific performance metrics or a study. The FDA review in this context typically compares the new device's technological characteristics, materials, and intended use against a lawfully marketed predicate device.
- Device Type: This is a teether, which is a Class II device. While Class II devices have "Special Controls," the provided letter does not elaborate on them. For many Class II devices, particularly consumer-facing ones like a teether, the "substantially equivalent" determination does not typically involve the rigorous clinical performance studies (with acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) that would be associated with more complex or higher-risk medical devices (e.g., AI-powered diagnostic tools).
The provided text focuses on regulatory compliance aspects and the determination of substantial equivalence, not on a detailed performance study as you've requested.
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Food and Drug Administration 10903 New Hampshire Avenue. Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FU Hong Industries, Limited C/O Mr. Kevin Walls Principal Consultant Regulatory Insight, Incorporated 5401 South Cottonwood Court Greenwood Village, Colorado 80121
JAN 21 2010
Re: K093370
Trade/Device Name: Fu Hong Industries Limited Soother Teether Regulation Number: 21CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: January 13, 2010 Received: January 14, 2010
Dear Mr. Walls:
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.
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Page 2- Mr. Walls
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/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/ReportalProblem/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/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
510(k) Number (if known): K093370
Device Name: Fu Hong Industries Limited Soother Teether
Indications for Use: The Fu Hong Industries Limited Soother Teether is a fluid filled teether indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
Prescription Use Over-The-Counter Use X . AND/OR (Part 21 CFR 801 Subpart D) (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)
ASBEZIMOS for Dr. K.P. Muliy.
(Division Sign-Off) fivision of Anesthesiology, filleral integtion Control, Dental Der
510(k) Number: KD93370
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§ 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.