BABY PACIFIER DIGITAL THERMOMETER

K981456 · K-Jump Health Co., Ltd. · FLL · Jul 2, 1998 · General Hospital

Device Facts

• Record ID: K981456
• Device Name: BABY PACIFIER DIGITAL THERMOMETER
• Applicant: K-Jump Health Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jul 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Baby Pacifier Digital Thermometer is a non-sterile, reusable thermometers. They are intended for the measurement of oral body temperatures of infants and young children.

Device Story

The Baby Pacifier Digital Thermometer is a reusable, non-sterile electronic thermometer designed for oral temperature measurement in infants and young children. The device integrates a temperature sensor into a pacifier form factor. It operates by measuring oral temperature and displaying the result, allowing caregivers to monitor infant health. It is intended for over-the-counter use by parents or guardians. The device conforms to ASTM E1112 standards for electronic thermometers and meets safety standards for baby pacifiers.

Clinical Evidence

No clinical data provided. The device relies on bench testing for compliance with ASTM E1112 standards for electronic thermometers and safety standards for baby pacifiers.

Technological Characteristics

Electronic thermometer integrated into a pacifier form factor. Conforms to ASTM E1112 standard specification for electronic thermometers. Meets safety standards for baby pacifiers. Non-sterile, reusable device.

Indications for Use

Indicated for the measurement of oral body temperatures in infants and young children.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Basis® Baby-Temp Digital Thermometer (PolyMedica Corporation)

Submission Summary (Full Text)

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# JUL 2 1998

リ

K981456

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.<br>a subsidiary of K-Jump Health Co., Ltd.<br>136 Wu Kung Road, Wu Ku Industrial Park<br>Taipei, Hsien<br>Taiwan, R.O.C.<br>Tele.: 011-886-2-2991378-82<br>Fax: [phone]<br>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.

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 .......

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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