(69 days)
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Not Found
No
The summary describes a simple teething device and contains no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics associated with AI/ML algorithms.
No
The device is described as a "personal use biting device used to cool and soothe the gums during the teething process," which indicates it provides comfort rather than treating a disease or condition.
No
Explanation: The device is described as a "biting device used to cool and soothe the gums during the teething process," which indicates a therapeutic or comfort-providing function rather than a diagnostic one.
No
The device is described as a "biting device" and a "teether," which are physical objects, not software. The description does not mention any software components or functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Evenflo Berry Fruity Teether Function: The intended use of the Evenflo Berry Fruity Teether is a "personal use biting device used to cool and soothe the gums during the teething process." This is a physical device used externally and directly on the body, not a test performed on a biological sample.
Therefore, based on the provided information, the Evenflo Berry Fruity Teether does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Evenflo Berry Fruity Teether is a personal use biting device used to cool and soothe the gums during the teething process.
Product codes
KKO
Device Description
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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
gums
Indicated Patient Age Range
Not Found
Intended User / Care Setting
personal use
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
FEB 2 2 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ruben D. Colmenares Product Integrity Engineer Evenflo Company, Incorporated 707 Crossroads Court Vandalia, Ohio 45377
Re: K053493
Trade/Device Name: Evenflo Berry Fruity Teether Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: Class II Product Code: KKO Dated: December 14, 2005 Received: December 16, 2005
Dear Mr. Colmenares:
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 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. Ruben D. Colmenares
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issuance of a substantal species with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that HDA has made a decemination mat your a viser Federal agencies.
of the Act or any Federal statutes and regulations administered by segistration of the Act or any rederal statutes and reginations and limited to: registration
You must comply with all the Act's requirements and manufacturing progrise You must comply with an the Act 3 requirements integral and manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Part and listing (21 CFK Fall 807), laboling (21 CFR (QS) regulation (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);
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 I his letter will anow you to oegh manketing your and stantial equivalence of your device and thus 510(K) premarket nothreation: "The FDT Missing on 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 de at (240) 276-0115. Also, please note the regulation please contact the Other or Ochipanian promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miromation on Journational and Consumer Assistance at its toll-free Division of Binan 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
053493 510(k) Number (if known): _
Device Name: Evenflo Berry Fruity Teether
Indications for Use:
The Evenflo Berry Fruity Teether is a personal use biting device used to cool and soothe the gums during the teething process.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Puono
resistagy, General Hospitz!