(139 days)
Not Found
No
The device description and intended use clearly indicate a simple physical product (a teether) with no mention of any computational or data-driven capabilities. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is intended to relieve teething discomfort by providing a cool soothing effect, which is a therapeutic purpose.
No
The device, a fluid-filled teether, is intended to relieve teething discomfort and soothe infants. It does not perform any diagnostic function.
No
The device description clearly states "Fluid Filled Teether," which is a physical object, not software. The intended use also describes a physical interaction ("providing a cool soothing effect").
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to relieve teething discomfort in infants by providing a cool soothing effect. This is a physical interaction with the body, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as a "Fluid Filled Teether," which is a physical object used for chewing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a disease or condition
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This fluid-filled teether does not fit that description.
N/A
Intended Use / Indications 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.
Product codes
KKO
Device Description
Fluid Filled Teether
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
infants
Intended User / Care Setting
over-the-counter use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.
2
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
3
510k Submission
| 510k Submission |
|---|
| Global Treasures |
| Fluid Filled Teether |
| Page 7 of 7 |
|---|
| ------------- |
| 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) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
Suser Phaner
Pathology, General Hospital,
Medical Devices
K04033