(287 days)
Not Found
Not Found
No
The summary describes a simple, non-electronic teether and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for performance studies and data sets typically associated with AI/ML devices.
Yes
Explanation: The device is intended to reduce the discomfort of teething by acting as a cold compress, which is a therapeutic effect.
No
Explanation: The device is a teether that acts as a cold compress to reduce discomfort, which is a therapeutic rather than diagnostic function. It does not identify or investigate any diseases or conditions.
No
The device description clearly states "Water Filled Teether," indicating a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The described device is a water-filled teether used as a cold compress applied externally to a baby's gums. It does not involve the examination of any bodily specimens.
- Intended Use: The intended use is to provide comfort during teething by acting as a cold compress, not to diagnose, monitor, or treat a medical condition through the analysis of in vitro samples.
Therefore, this device falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
-User is asked to wash teethers in warm, soapy water, rinse clean, and then to chill them in refrigerator -teether then acts as a cold compress for baby's gums and helps reduce the discomfort of 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
baby's gums
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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/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 an abstract image of an eagle with three stripes representing the branches of government.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2006
Delta Enterprise, Corporation C/O Ms. Maria E. Celis Associate Neville Peterson. LLP 17 State Street, 1911 Floor New York, New York 10004
Re: K052513
Trade/Device Name: Baby Snoopy Water Filled Teether, Model 95367 Regulation Number: 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: June 16, 2006 Received: June 19, 2006
Dear Ms. Celis:
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 H (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 Eederal Register.
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Page 2 - Ms. Celis
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 (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 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/industry/support/index.html.
Sincerely yours.
Clare
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
2
Indications for Use
K652513 510(k) Number (if known):
Device Name:
Indications for Use:
Water Filled Teether
-User is asked to wash teethers in warm, soapy water, rinse clean, and then to chill them in refrigerator -teether then acts as a cold compress for baby's gums and helps reduce the discomfort of teething
Prescription Use_ (Part 21 CFR 801 Subpart D) OR
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Part 21 CFR 801 Subpart D) OR
Over the Counter Use (21 CFR 801 Subpart C)
Susan Dunn
esiblogy, General Hospital ntrul. Dental Devices
Kososki3