(239 days)
Not Found
Not Found
No
The summary describes a simple baby teether with no mention of AI or ML technology, image processing, or performance studies related to data analysis.
No
The intended use is "FOR BABY TO CHEW AND PLAY WITH," which describes a recreational or developmental toy, not a device for treating or alleviating a medical condition.
No.
The 'Intended Use' clearly states "FOR BABY TO CHEW AND PLAY WITH," and the 'Device Description' identifies it as a "BABY TEETHER." Neither of these functions relate to diagnosis.
No
The device description clearly states "BABY TEETHER," which is a physical object, 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 BABY TO CHEW AND PLAY WITH." This is a purely recreational and developmental purpose, not related to diagnosing, monitoring, or treating a medical condition by examining samples from the human body.
- Device Description: The device is described as a "BABY TEETHER." Teethers are designed for oral stimulation and soothing during teething, not for diagnostic testing.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring biomarkers or analytes
- Any other activities typically associated with in vitro diagnostics.
Therefore, this device falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
FOR BABY TO CHEW AND PLAY WITH.
Product codes
KKO
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
BABY
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)
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 2 2002
Mr. John Chang Import Manager Angelina Trading, Incorporated 947 South Alameda, #A Los Angeles, California 90021
Re: K014023
Trade/Device Name: Baby Teether, Model 20104 Regulation Number: 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: April 18, 2002 Received: May 7, 2002
Dear Mr. Chang:
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.
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.
1
Page 2 - Mr. Chang
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Patricia Cacciatoffo
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Page | of |
|---|---|
| - | Acres of Acres of Canadian Company of Children Company of Children |
| Property and | 1 |
| 510(k) Number (if known): | K014023 |
|---|---|
| Device Name: | BABY TEETHER |
Indications For Use:
FOR BABY TO CHEW AND PLAY WITH.
SEE NEXT PAGE OF MARKING FOR
USE AND CARE FROM: SUPER BABY
THANKS. & BEST REGARDS
DAVIS - 7/24/02
All Amercia Forwarding Inc
11099 S La Cienega Blvd #220
Los Angeles, CA 90045
Tel 310-649-1996 FX 310-649-1986
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Punor
(Division Sign-Off) (Division Sign-Ont)
Division of Dental, Infection Control,
Division of Dental, Devices Division of Deneral Hospital Devices -1140 510(k) Number .
OR
Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
y.