(274 days)
Not Found
Not Found
No
The summary describes a simple physical device (water-filled teether) and contains no mention of AI, ML, image processing, or data analysis typically associated with AI/ML medical devices.
Yes
The device is used for the "temporary relief of pain and discomfort," which describes a therapeutic action.
No
Explanation: The device is described as providing "temporary relief of pain and discomfort" caused by teething, which indicates a therapeutic or palliative function, not a diagnostic one. It does not identify a disease or condition.
No
The device is described as a "Water 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 for the temporary relief of pain and discomfort caused by teething in infants and toddlers. This is a physical, non-diagnostic function.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing information about a person's health status, disease, or condition.
- Device Description: While the description is "Not Found," the intended use clearly points away from a diagnostic purpose.
- No Mention of Diagnostic Technologies: There is no mention of image processing, AI, DNN, or ML, which are often associated with diagnostic devices.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. A water-filled teether does not fit this description.
N/A
Intended Use / Indications for Use
The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.
Product codes
KKO
Device Description
Water 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 and toddlers
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): 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.
Not Found
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.
Not Found
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).
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bebe Toys & Accessories Manufactory, Limited C/O Mr. Paul A. Ware President PW Resources, Incorporated 34 McNamara Street Stoughton, Massachusetts 02072
DEC - 2 2011
Re: K110615
Trade/Device Name: Water Filled Teether Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: November 2, 2011 Received: November 2, 2011
Dear Mr. Ware:
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.
1
Page 2 - Mr. Ware
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 (OS) 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.
Tenthony V. marta
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
2
Section 5
Statement of Indications for Use
K11 0615
510(k) Number (if known): New: submission Device Name: Water Filled Teether
Indications For Use:
The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.
| Prescription Use | _________________ |
|---|---|
| ------------------ | ------------------- |
AND/OR
| Over-The-Counter Use | _________________ √ |
|---|---|
| ---------------------- | --------------------- |
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation(ODE)
(Date)
(Premarket submission 510(k) Number)
Susan Runror
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 16110605