(90 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
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets such criteria.
The text is a 510(k) clearance letter from the FDA to "Fu Hong Industries Limited" for a "Soother Teether" device. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. This letter primarily focuses on regulatory approval and compliance, not on performance studies or acceptance criteria for the device's functional performance. There are no details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case comparative effectiveness studies.
- Standalone performance studies.
- Type of ground truth used.
- Sample size or establishment of ground truth for training sets.
The document states the "Indications for Use" of the device, which is "to help to relieve the teething discomfort of teething infants by providing a cool soothing effect." However, it does not describe how this effect was quantified, measured, or what criteria were used to determine its effectiveness.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2005
FU Hong Industries Limited C/O Mr. Kevin Walls Regulatory Affairs Consultant Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127
Re: K052531
Trade/Device Name: Fu Hong Industries Limited Soother Teether Regulation Number: 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: November 28, 2005 Received: November 29, 2005
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.
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 (1 Nr.), it has of 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 Eederal Register.
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Page 2 - Mr. Walls
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be advised that 122 to to mination that your device complies with other requirements mount that i Drimas made statutes and regulations administered by other Federal agencies. or the Act of any I ederal the Act's requirements, including, but not limited to: registration r od intest comply with as a 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if requirenches as bet form in adiation 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 510(k) rins leter notification. The FDA finding of substantial equivalence of your device to a premaired predicate device results in a classification 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), rr you desire speeme at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 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
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Indications for Use
510(k) Number (if known): 42522531
2004年 2008年 11:40 000 2 2 5 00 4 24 2007 2007 000 2007 000 200 2007 000 1 0 200 10 200 000 000
AKO: K : EXIDA | YANIM : 1 4K : PK : RK : RK : REA TEN : KE
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)
15 годишна стати композиции и везманиции комуници и представились мерельность коему продожения коев г. на сельма
Susan Russo
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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.