The intended use of the fluid filled teether is to help to relieve the teething discomfort of teething. infants by providing a cool soothing effect. The Global Fluid Filled Teether is intended for over-the-counter use.

Device Description

Fluid Filled Teether

AI/ML Overview

This document is a 510(k) submission for a fluid-filled teether, which is a medical device. However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

The provided text is a summary of the 510(k) submission, primarily focusing on the administrative details, intended use, and substantial equivalence determination by the FDA. It states that the Global Fluid Filled Teether is substantially equivalent to a previously cleared device (K031094). Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, and does not require extensive clinical trials or performance studies if the technological characteristics are similar and the intended use is the same.

Therefore, I cannot provide the requested information based on the input text. The information typically requested (such as sample sizes, ground truth, expert qualifications, efficacy studies, etc.) is more relevant for novel or high-risk devices that require more rigorous performance testing and clinical data. For a device like a teether seeking substantial equivalence, such detailed performance studies as those outlined in your request are generally not required for the 510(k) pathway.

Summary

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510k Submission Global Treasures Fluid Filled Teether

Page 6 of 7

K043033
510 (K) SUMMARY

Date of Summary October 28, 2004

Product Name: Fluid Filled Teether

Manufacturer:

Global Treasures Industrial Ltd. Nan Fung Ind. Cit 18 Tin Hau Road Tuen Mun N.T. , HK

Correspondent:

Fran White MDC Associates 163 Cabot Street Beverly, MA 01915

Substantially Equivalent Device:

Fluid Filled Teether Fluid Fined Techer
Manufactured by: Royal King Products Company Limited K031094

Product Description:

Fluid Filled Teether

Intended Use:

ed Use:
The intended use of the fluid filled teether is to help to relieve the teething discomfort of teething. infants by providing a cool soothing effect.

The Global Fluid Filled Teether is intended for over-the-counter use.

Conclusion:

usion:
The Global Fluid Filled Teether is substantially equivalent to the fluid filled teether manufactured to The Global I hald Pinesa Products Company Limited (K031094).

Sponsor Global Treasures, Industrial, Inc. Nan Fung Ind. Cit 18 Tin Hau Road Tuen Mun, N.T., HK

MAR 2 2 2005

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three lines above them that could represent wings or feathers.

MAR 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Global Treasures Industrial Limited C/O Ms. Fran White President MDC Associates 163 Cabot Street Beverly, Massachusetts 01915

Re: K043033

Trade/Device Name: Fluid Filled Teether Regulation Number: 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: February 21, 2005 Received: February 23, 2005

Dear Ms. White:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of (--) +--------------------------------------------------------------------------------------------------------------------------------------referenced above and have determined to legally marketed predicate devices marketed in intications for use stated in the encreasing the enactment date of the Medical Device interstate commence proof to that have been reclassified in accordance with the provisions of Amendments, of to devices that have been formastic act require approval of a premarket the Federal Pood, Drug, and Ocomens , therefore, market the device, subject to the general approval appreation (1 Mill) - The general controls provisions of the Act include controls provisions of the Hon Jane Jacks, good manufacturing practice, requirements rechibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (500 aboutional controls. Existing major regulations affecting (PMA), It may be subject to Suen adata Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sode manouncements concerning your device in the Federal Register.

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Page 2 - Ms. White

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA $ Issualice of a substantials with other requirements
mean that FDA has made a determination that your device Foderal agencies mean that FDA has made a decemmanent that Jour and Jour and Journal Post of Childred to: persistration of the Act or any rederal status and regirements, including, but not limited to: registration
You must comply with all the Act success and monufacturing proctice You must comply with an the Act 3 required in the Art 801); good manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gractice (21 CFR Part 830) and listing (21 CFR Fall 807), additig (21 CFR Pat 820); and if (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); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin matically your and equivalence of your device 10 a
premarket notification. The FDA finding of substantial equivalers and thus, end thus, premarket notification. The FDA miding of substants of 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 device at (240) 276-0115. Also, please note the regulation please contact the Other or Comphanes at (210) - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 entitled, "Wisoranding by reference to premation on your responsibilities under the tall for may obtain other general miormation on Joan Copyright Assistance at its toll-free DIVIsion of Sman Manaka (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runo
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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510k Submission

510k Submission
Global Treasures
Fluid Filled Teether

Page 7 of 7
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510(k) Number:	K043033
Device Name:	Fluid Filled Teether

Indication for Use:
The intended use of the fluid filled teether is to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
The Global Fluid Filled Teether is intended for over-the-counter use.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR	Over the Counter Use(Optional Format 1-2-96)
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Suser Phaner

Pathology, General Hospital,

Medical Devices

K04033

Regulation Number and Section

§ 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.