(70 days)
Not Found
No
The 510(k) summary describes a standard digital thermometer conforming to established ASTM standards and does not mention any AI or ML components or capabilities.
No
The device is a thermometer used for measuring body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.
No
Explanation: A diagnostic device is used to identify a disease or condition. This device is a thermometer, used to measure body temperature, which is a vital sign. While changes in body temperature can be indicators of illness, the thermometer itself does not diagnose the illness. It provides information that a healthcare professional might use as part of a diagnostic process, but it is not a diagnostic tool on its own.
No
The device description explicitly states it is a "Baby Pacifier Digital Thermometer" and conforms to physical requirements and operating parameters of ASTM E1112, which is a standard for electronic thermometers, indicating it is a hardware device.
Based on the provided information, the Baby Pacifier Digital Thermometer 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 function: The Baby Pacifier Digital Thermometer measures oral body temperature. This is a direct measurement of a physiological parameter within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states "measurement of oral body temperatures of infants and young children." This aligns with a standard clinical thermometer, not an IVD.
Therefore, the Baby Pacifier Digital Thermometer falls under the category of a clinical thermometer or a medical device for measuring body temperature, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Baby Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.
The Baby Pacifier Digital Thermometer is a non-sterile, reusable thermometer. They are intended for the measurement of oral body temperatures of infants and young children.
Product codes
Firit
Device Description
The Baby Pacifier Digital Thermometer is a non-sterile, reusable thermometer. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral
Indicated Patient Age Range
Infants and young children
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)
PolyMedica Corporation's Basis® Baby-Temp Digital Thermometer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
JUL 2 1998
リ
510(k) Baby Pacifier Digital Thermometer K-Jump Health Co., Ltd.
Page 65
510(k) Summary
| Proprietary Name: | Baby Pacifier Digital Thermometer |
|---|---|
| Common Name: | Pacifier Digital Thermometer |
| Classification: | Unknown |
| Submitter Details: | Polygreen Company, Ltd. |
| a subsidiary of K-Jump Health Co., Ltd. | |
| 136 Wu Kung Road, Wu Ku Industrial Park | |
| Taipei, Hsien | |
| Taiwan, R.O.C. | |
| Tele.: 011-886-2-2991378-82 | |
| Fax: 001-886-2-2991386 | |
| Contact: Mr. Tseng Chao Man (Daniel) |
The Baby Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.
In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.
The Baby Pacifier Digital Thermometer is substantially equivalent to PolyMedica Corporation's Basis® Baby-Temp Digital Thermometer.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1098 JUL
K-Jump Health Company, Limited C/O Mr. Tseng Chao Man (Daniel) President PolyMedica Healthcare, Incorporated 581 Conference Place Golden, Colorado 80401
Re : K981456 Baby Pacifier Digital Thermometer Trade Name: Regulatory Class: II Product Code: Firit Dated: April 23, 1998 April 23, 1998 Received:
Dear Mr. Tseng Chao Man:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Tseng Chao Man
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamaip.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .......
3
510(k) Baby Pacifier Digital Thermometer K-Jump Health Co., Ltd.
PRE-MARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number:
Unassianed K-Jump Health Co., Ltd.
Baby Pacifier Digital Thermometer Device Name:
Indications for Use:
The Baby Pacifier Digital Thermometer is a non-sterile, They are intended for the reusable thermometers. measurement of oral body temperatures of infants and young children.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-The-Counter Use (Optional Format 1-2-96)
Patricio Cuesite
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K9814576