(161 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of a simple water-filled teether, with no mention of AI or ML.
Yes.
The device is intended to "help reduce teething pain," which constitutes a therapeutic effect.
No
Explanation: The device is indicated to soothe and cool teething babies and help reduce teething pain, which is a therapeutic function rather than a diagnostic one. It does not identify a disease, condition, or its extent.
No
The device description clearly states it is a "simple plastic shaped device which is filled with water," indicating it is a physical hardware device, not software.
Based on the provided information, 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.
- Device Description and Intended Use: The description clearly states the device is a "Water-filled teether" intended to be placed in a baby's mouth to soothe teething pain. It does not involve testing any biological samples.
- Lack of IVD-related information: The document does not mention any aspects related to sample collection, analysis, or diagnostic interpretation, which are hallmarks of IVDs.
The device is a physical product used externally (in the mouth) for comfort and pain relief, not for diagnostic purposes.
N/A
Intended Use / Indications for Use
Indicated to soothe and cool teething babies and help reduce teething pain.
Product codes (comma separated list FDA assigned to the subject device)
KKO
Device Description
The proposed Water-filled teether is a simple plastic shaped device which is filled with water. It may be placed in a refrigerator to be cooled and then provided to the teething baby to help sooth any pain from teething. This is an OTC device.
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
Teething babies
Intended User / Care Setting
Home
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)
Non-clinical Testing Summary -
Biocompatibility of Materials -
Materials were evaluated per ISO 10993-1. There are parts and thus their respective materials which have the following patient contact and duration.
The device is consider Direct communicating, Mucosal, Prolonged contact which require the following tests.
- Cytotoxicity (tested per ISO 10993-5) . ●
- Sensitization (tested per ISO 10093-10)
- Irritation (tested per ISO 10993-10) ●
- . Pass / fail criteria was for the each respective ISO 10993 test
Discussion -
All materials were tested according to ISO 10993-1 for the appropriate level of patient contact and duration and found to pass the applicable ISO 10993-1 test requirements.
We performed the following tests:
Standard: 16 CFR 1500 - Mechanical Hazards, Test: 1500.51(b) Impact Test
Standard: 16 CFR 1500 - Mechanical Hazards, Test: 1500.52 Bite test
Standard: 16 CFR 1500 - Mechanical Hazards, Test: 1500.53(e) Torque Test
Standard: 16 CFR 1500 - Mechanical Hazards, Test: 1500.53 (f) Tension Test
Standard: 16 CFR 1500 - Mechanical Hazards, Test: 1500.53 (g) Compression Test
Standard: 16 CFR 1500 - Mechanical Hazards, Test: 1500.3(c)(6)(vi) Flammable solid
Standard: 16 CFR 1500 - Mechanical Hazards, Test: 1500.3(c)(6)(iii) Combustible
Standard: 16 CFR 1500 - Mechanical Hazards, Test: Small part requirement
Standard: 16 CFR 1501 - FHSA, Test: Small part requirement
Standard: ASTM F963-08 Standard consumer safety for toys, Test: 4.1 Material Quality
Standard: ASTM F963-08 Standard consumer safety for toys, Test: 4.6 Small Objects
Standard: ASTM F963-08 Standard consumer safety for toys, Test: 4.7 Accessible Edges
Standard: ASTM F963-08 Standard consumer safety for toys, Test: 4.9 Accessible Points
Standard: ASTM F963-08 Standard consumer safety for toys, Test: 4.22 Teethers and Teething Toys
Standard: ASTM F963-08 Standard consumer safety for toys, Test: 5.16 Promotional materials
Standard: ASTM F963-08 Standard consumer safety for toys, Test: 6.1 Definition and description
Standard: ASTM F963-08 Standard consumer safety for toys, Test: 7.1 Producer's name and address
Standard: ASTM F963-08 Standard consumer safety for toys, Test: Drop Test
Standard: CPSIA 2008 And CA Prop 65 And II. PA 095-1019, Test: Total lead content
Standard: CPSIA And CA Prop 65, Test: 108(a) Phthalates BBP/DBP/DEHP/DnHP/DIDP
Standard: CPSIA And CA Prop 65, Test: ASTM F963-08
Standard: CPSIA And CA Prop 65, Test: Total Cadmium
Standard: CPSIA And CA Prop 65, Test: Soluble Heavy metals
Standard: CPSIA And CA Prop 65, Test: BPA
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.
K992384, MAM Teether (K092781)
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
Premarket Notification 510(k) Section 5 - 510(k) Summary
Water-Filled Teether
510(k) Summary Page 1 of 4
MAY 2 4 2013
Date Prepared
11-Dec-12
Solid Toy Ind. Ltd.
No. 39, Pengfei Road, Pengcheng Community, Dapeng Town, Longgang District Shenzhen City, Guangdong Province, China
Tel - 86-755-84315188 Fax - 86-755-84315979
John Chow - Managing Director Official Contact:
Proprietary or Trade Name: Water-Filled Teether
Fluid-filled teething rings Common/Usual Name:
Classification Code/Name: KKO - Fluid-filled teething ring 21 CFR 872.5550 Class 2
Predicate Devices:
Device Description:
The proposed Water-filled teether is a simple plastic shaped device which is filled with water. It may be placed in a refrigerator to be cooled and then provided to the teething baby to help sooth any pain from teething. This is an OTC device.
K 992384 - Stevenson CPAP/Pro
Indications for Use:
Indicated to soothe and cool teething babies and help reduce teething pain.
Patient Population: Teething babies
Environment of Use: Home
Predicate Device Comparison:
The Water-Filled Teether is viewed as substantially equivalent to the predicate device because:
Indications -
- The indication to soothe and cool teething babies and help reduce teething pain is identical . to the predicate.
Discussion - Identical to MAM Teether (K092781)
Patient Population -
For teething babies ●
Discussion - Identical to MAM Teether (K092781)
1
510(k) Summary Page 2 of 4 11-Dec-12
Technology -
- . The use of a water filled ring is the identical technology to the predicate.
Discussion - Identical to MAM Teether (K092781)
Materials -
- . The materials in patient contact have been tested per ISO 10993-1 as direct communicating, mucosal, prolonged contact for cytotoxicity, sensitization, and irritation. Discussion - Identical to MAM Teether (K092781)
Environment of Use and OTC -
- The environment is home use and OTC. .
- Discussion Identical to MAM Teether (K092781)
Differences -
There are no differences between the predicate and the proposed device which would raise any new safety or risks and thus can be found to be substantially equivalent.
| Attributes | Water-Filled Teether | MAM Teether |
|---|---|---|
| Indications for Use | Indicated to soothe and cool teething | |
| babies and help reduce teething pain. | Developed for the needs of babies who are | |
| having their first teeth It is designed to offer | ||
| optimum comfort and safety for the baby and | ||
| offers all soothing textures and cooling | ||
| comfort in order to ease babies teething pain | ||
| Patient Population | Teething babies | Teething babies |
| Environment of Use | Home | Home |
| Prescriptive | No - OTC | No - OTC |
| Water-filled | Yes | Yes |
| Materials | Tested per ISO 10993-1 as | |
| Direct communication, mucosal, | ||
| prolonged contact | ||
| Cytotoxicity | ||
| Sensitization | ||
| Irritation | Same | |
| Characteristics | ||
| Bacteriological | ASTM F963 - 4.3.6.1 | ASTM F963 - 4.3.6.1 |
| General lead ban - lead | ||
| in substrate | CPSIA Sec 101 | CPSIA Sec 101 |
| Mechanical Hazards | 16 CFR 1500 | 16 CFR 1500 |
| Flammability of solids | 16 CFR 1500 | 16 CFR 1500 |
| Small part requirements | 16 CFR 1501 | 16 CFR 1501 |
| Ban on Phthalates | CPSIA Sec 108, CA prop 65 | CPSIA Sec 108, CA prop 65 |
| Bite test | 16 CFR 1500.52(c) | 16 CFR 1500.52(c) |
2
510(k) Summary Page 3 of 4 11-Dec-12
Non-clinical Testing Summary -
Biocompatibility of Materials -
Materials were evaluated per ISO 10993-1. There are parts and thus their respective materials which have the following patient contact and duration.
The device is consider Direct communicating, Mucosal, Prolonged contact which require the following tests.
- Cytotoxicity (tested per ISO 10993-5) . ●
- Sensitization (tested per ISO 10093-10)
- Irritation (tested per ISO 10993-10) ●
- . Pass / fail criteria was for the each respective ISO 10993 test
Discussion -
All materials were tested according to ISO 10993-1 for the appropriate level of patient contact and duration and found to pass the applicable ISO 10993-1 test requirements.
We performed the following tests:
| Standard | Test |
|---|---|
| 16 CFR 1500 - Mechanical | |
| Hazards | 1500.51(b) Impact Test |
| 1500.52 Bite test | |
| 1500.53(e) Torque Test | |
| 1500.53 (f) Tension Test | |
| 1500.53 (g) Compression Test | |
| 1500.3(c)(6)(vi) Flammable solid | |
| 1500.3(c)(6)(iii) Combustible | |
| Small part requirement | |
| 16 CFR 1501 - FHSA | Small part requirement |
| ASTM F963-08 Standard | |
| consumer safety for toys | 4.1 Material Quality |
| 4.6 Small Objects | |
| 4.7 Accessible Edges | |
| 4.9 Accessible Points | |
| 4.22 Teethers and Teething Toys | |
| 5.16 Promotional materials | |
| 6.1 Definition and description | |
| 7.1 Producer's name and address | |
| Drop Test | |
| CPSIA 2008 | |
| And | |
| CA Prop 65 | |
| And | |
| II. PA 095-1019 | Total lead content |
3
:
.
.
.
.
| 510(k) Summary |
|---|
| Page 4 of 4 |
| 11-Dec-12 |
| Standard | Test |
|---|---|
| CPSIA | |
| And | |
| CA Prop 65 | 108(a) Phthalates |
| BBP/DBP/DEHP/DnHP/DIDP | |
| ASTM F963-08 | |
| Total Cadmium | |
| Soluble Heavy metals | |
| BPA |
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2013
Solid Toy Ind. Limited C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive BONITA SPRINGS FL 34134
Re: K123855
Trade/Device Name: Water-Filled Teether Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: April 5, 2013 Received: April 8, 2013
Dear Mr. Dryden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
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): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Image /page/5/Picture/7 description: This image shows the closing of a letter with a signature. The letter is signed by Anthony D. Watson, who is the Director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health. The letter is signed "Sincerely yours,"
Enclosure
6
Indications for Use Statement
Page 1 of 1
510(k) Number:
K123855
(To be assigned)
Device Name:
Water-Filled Teether
Indications for Use:
Indicated to soothe and cool teething babies and help reduce teething pain.
Over-the-counter use XX Prescription Use or (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner, DDS, MA
Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
cn=Mary S. Runner -S,
0.9.2342.19200300.100.1.1=13000879
50
Date: 2013.05.22 12:03:57 -04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120853