(245 days)
Not Found
Not Found
No
The device description and intended use clearly indicate a simple mechanical device (a teether) with no mention of AI or ML capabilities.
No
The device is a fluid-filled teether intended to relieve teething discomfort, which is not typically classified as a therapeutic device in a medical sense. It provides symptomatic relief rather than treating a disease or condition.
No
Explanation: The device is a fluid-filled teether intended to relieve teething discomfort in infants by providing a cool, soothing effect. It does not perform any diagnostic function such as identifying, assessing, or monitoring a disease or condition.
No
The device description clearly states "Fluid Filled Teether," which is a physical object and not software.
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 when chewed. This is a physical interaction with the body for comfort, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as a "Fluid Filled Teether." This is a physical object for oral use.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, this device falls under the category of a general medical device (specifically, likely a Class I or Class II device depending on the specific regulations and risks), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended purpose of the fluid filled teether is to relieve the teething discomfort of infants by giving cool soothing effect when the cool teether is chewed on.
Product codes
KKO
Device Description
Fluid Filled Teether
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
infants
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular emblem that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 2003
Mr. Dalbir Singh Khurana President Royal King Infant Products Company Limited 73/4 Moo 1 Khaelie Krathumbae, Samutsakor, THAILAND 74110
Re: K031094
Trade/Device Name: Fluid Filled Teether Regulation Number: 872.5550 Regulation Name: Teething Ring Regulatory Class: I Product Code: KKO Dated: September 8, 2003 Received: September 11, 2003
Dear Mr. Khurana:
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 (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
1
Page 2 - Mr. Khurana
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at (301) 594-4613. 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 Division 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/dsma/dsmamain.html
Sincerely yours,
Susanne Pasu D for Chiu len
Chiu Lin, Ph.D. Director Division of Anesthesiology, General I Iospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Astatement of Indications for use@
510(k) Number (If Known): K031694
Device Name :Fluid Filled Teether
Indications For Use :
The intended purpose of the fluid filled teether is to relieve the teething discomfort of infants by giving cool soothing effect when the cool teether is chewed on.
(Please do not write below this line-continue on another page if NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | IC03)094 |
I'rescription Use ______ OR Over- The Counter Use ✔️
(Per 21 CFR 801.109) (Optional format 1-2-96)
CI