(299 days)
Not Found
Not Found
No
The summary describes a simple vibrating teether with no mention of AI or ML capabilities, data processing, or performance metrics related to algorithmic analysis.
No.
Explanation: The device is intended for infants to play with and chew on, and to help soothe teething infants, which classifies it as a consumer product (toy) rather than a therapeutic device. Its purpose is comfort and play, not treatment of a disease or medical condition.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "intended for infants to play with and chew on, and to help soothe teething infants." This purpose is for comfort and play, not for detecting, diagnosing, or monitoring a disease or condition.
No
The device description explicitly states it is a "vibrating teething ring" constructed of "ABS resin plastic material" and is "battery-operated," indicating it is a physical hardware device, not software only.
Based on the provided information, the JeJe Teether is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for infants to play with, chew on, and soothe teething. This is a physical interaction with the device, not a diagnostic test performed on a biological sample.
- Device Description: The description details a vibrating teething ring made of plastic. This is a physical product for oral use, not a device designed to analyze biological materials.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on toy safety standards (flammability, mechanical hazards), not diagnostic accuracy or performance metrics relevant to IVD devices (sensitivity, specificity, etc.).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The JeJe Teether does not fit this description.
N/A
Intended Use / Indications for Use
The JeJe Teether is intended for infants to play with and chew on, and to help soothe teething infants.
Product codes (comma separated list FDA assigned to the subject device)
MEF
Device Description
The JeJe Teether is a vibrating teething ring that is designed for infants to play with and chew on. The device is battery-operated and vibrates when activated. The JeJe Teether is constructed of ABS resin plastic material and is circular in shape.
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
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)
The JeJe Teether was subjected to several performance evaluations to verify that the device meets industry standards for consumer toy safety. The JeJe Teether was found to be acceptable in all applicable categories including flammability and mechanical hazards. The product was found to be PVC free.
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 (The text states, "The JeJe Teether is substantially equivalent to other Class I non-fluid filled teething rings that are in commercial distribution." but does not provide K/DEN numbers.)
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
Vibe 2000 JeJe Teether VIDC 2000 Premarket 510(k) Notification
SUMMARY OF SAFETY AND EFFECTI SECTION 14:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 14.1
| a. Company Name: | Vibe 2000 |
|---|---|
| b. Company Address: | 511 Iguera Drive |
| Oxnard, CA 93030 | |
| c. Company Phone: | (805) 377-2709 |
| d. Contact Person: | Mario Gonzalez |
| e. Date Summary Prepared: | December 19, 2003 |
DEVICE IDENTIFICATION 14.2.
| a. Trade/Proprietary Name: | JeJe Teether |
|---|---|
| b. Classification Name: | Non-fluid Filled Teething Rings |
| 21 CFR 872.5550 |
IDENTIFICATION OF PREDICATE DEVICES 14.3
The JeJe Teether is substantially equivalent to other Class I non-fluid filled teething rings that are in commercial distribution.
DEVICE DESCRIPTION 14.4
The JeJe Teether is a vibrating teething ring that is designed for infants to play with and chew on. The device is battery-operated and vibrates when activated. The JeJe Teether is constructed of ABS resin plastic material and is circular in shape.
1
SUBSTANTIAL EQUIVALENCE 14.5
The JeJe Teether is substantially equivalent to other non-fluid filled teething rings in commercial distribution. The JeJe Teether has the added feature of being able to vibrate when activated.
The fundamental technical characteristics of the JeJe Teether are similar to those of other commercially available teething rings. The JeJe Teether is equivalent to other teething rings in design, functionality, materials and intended use.
INTENDED USE 14.6
The JeJe Teether is intended for infants to play with and chew on, and to help soothe teething infants.
TECHNOLOGICAL CHARACTERISTICS 14.7
The JeJe Teether was subjected to several performance evaluations to verify that the device meets industry standards for consumer toy safety. The JeJe Teether was found to be acceptable in all applicable categories including flammability and mechanical hazards. The product was found to be PVC free.
510(K) CHECKLIST 14.8
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2004
Vibe 2000 C/O Ms. Carol White President Patterson Consulting Group, Incorporated 21911 Erie Lane Lake Forest, California 93030
Re: K034017
Trade/Device Name: JeJe Teether Regulation Number: 872.5550 Regulation Name: Teething Ring Regulatory Class: I Product Code: MEF Dated: July 29, 2004 Received: August 3, 2004
Dear Ms. White:
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.
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Page 2 - Ms. White
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/dsma/dsmamain.html
Sincerely vours.
Susan Runon
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
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Vibe 2000 JeJe Teether Original Premarket 510(k) Notification
INDICATION FOR USE
1034017 510(k) Number: To Be Assigned By FDA Device Name: JeJe Teether Indications for Use: The JeJe Teether is intended for infants to play with and chew on, and to help soothe teething infants.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suara Ryan
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
103401 510(k) Number:
OR
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use