(299 days)
The JeJe Teether is intended for infants to play with and chew on, and to help soothe teething infants.
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.
The JeJe Teether is a relatively simple medical device (Class I) and as such, the "study" demonstrating its acceptance primarily revolves around safety evaluations rather than complex clinical performance studies typical of more advanced devices.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Industry standards for consumer toy safety | Device meets industry standards for consumer toy safety. |
| Flammability hazards | Acceptable |
| Mechanical hazards | Acceptable |
| Material composition (PVC free) | Found to be PVC free |
| Substantial Equivalence to Predicate Devices | Found substantially equivalent to other Class I non-fluid filled teething rings in commercial distribution. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for the "test set" in the way one would for a clinical trial. The performance evaluations were conducted to verify that the device meets industry standards for consumer toy safety. This likely refers to testing a sufficient number of units to ensure consistency and compliance, but a specific number is not provided.
Data Provenance: Not explicitly stated, but implies the testing was performed on the manufactured JeJe Teether device itself. Given it's a 510(k) submission, the safety evaluations would typically be pre-market data, conducted by or for the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
No information is provided about experts establishing "ground truth" for the safety evaluations. These evaluations typically rely on standardized test protocols and mechanical/chemical analyses, not expert consensus in the diagnostic sense. The determination of "substantial equivalence" is made by the FDA based on the submission.
4. Adjudication Method for the Test Set
Not applicable. The "performance evaluations" are likely objective tests (e.g., measuring flammability, impact resistance, material composition) against predefined standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The JeJe Teether is a physical product, not an imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this question is not applicable to the JeJe Teether. The device is a physical product, not an algorithm. Its performance is inherent to its design and materials.
7. The Type of Ground Truth Used
For the safety evaluations, the "ground truth" would be the objective results of standardized tests against established safety benchmarks (e.g., "does not ignite under X conditions," "withstanding Y force without breaking," "presence/absence of PVC chemicals").
For the substantial equivalence determination, the "ground truth" is the characteristics and performance of existing, legally marketed predicate devices that the FDA has already cleared. The JeJe Teether is compared to these predicates.
8. The Sample Size for the Training Set
Not applicable. The JeJe Teether is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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 DriveOxnard, 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 Rings21 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.
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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.
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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.
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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
§ 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.