INFRARED EAR THERMOMETER, MODEL KI-8120

K984551 · K-Jump Health Co., Ltd. · FLL · Jan 14, 2000 · General Hospital

Device Facts

• Record ID: K984551
• Device Name: INFRARED EAR THERMOMETER, MODEL KI-8120
• Applicant: K-Jump Health Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jan 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Infared Ear Thermometer is a non-sterile, reusable clinical thermometer intended for the determination of human temperature by radiation emitted via the ear (tympanic temperature).

Device Story

Infrared ear thermometer measures infrared radiation emitted from the tympanic membrane; converts thermal radiation into digital temperature reading. Used in clinical or home settings by clinicians or patients. Provides rapid, non-invasive temperature assessment to assist in monitoring patient health status.

Clinical Evidence

Bench testing only; device conforms to ASTM E1112 standard specifications for electronic thermometers.

Technological Characteristics

Radiation thermometer (tympanic); infrared sensing technology. Conforms to ASTM E1112 standard for electronic thermometers. Reusable, non-sterile device.

Indications for Use

Indicated for the determination of human body temperature via the ear (tympanic) in patients of all ages. Suitable for both clinical and over-the-counter (OTC) use.

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

• Becton Dickinson's Assure Ear Thermometer

Submission Summary (Full Text)

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K984551

510(k) Infrared Ear Thermometer K-Jump Health Co., Ltd.

## 510(k) Summary

| Proprietary Name: | Infared Ear Thermometer | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Common Name: | Radiation Thermometer (Tympanic Temperature) | |
| Classification: | Class II | |
| 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.:<br>Fax:<br>Contact: | 001-886-2-2991378-82<br>001-886-2-2991386<br>Mr. Tseng Chao Man (Daniel) |

The Infared Ear Thermometer is a clinical thermometer intended for the determination of human temperature by radiation emitted via the human ear (tympanic temperature).

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 Infared Ear Thermometer is substantially equivalent to Becton Dickinson's Assure Ear Thermometer.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2000

Jonathan S. Kahan, Esquire Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street N.W. Washington, D.C. 20004-1109

Re: K984551 K-Jump Health Co., Ltd.'s Infrared Ear Trade Name: Thermometer, Model KI-8120 Requlatory Class: II Product Code: FLL November 5, 1999 Dated: November 5, 1999 Received:

Dear Mr. Kahan:

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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Kahan

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 requlation (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" (21 CFR 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/dsmamain.html".

Sincerely yours,

.

imothy A. Ulatowski

Diredtor 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) Infrared Ear Thermometer K-Jump Health Co., Ltd.

## PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

| 510(K) Number: | Unassigned<br>K-Jump Health Co., Ltd. |
|----------------|---------------------------------------|
|----------------|---------------------------------------|

Infared Ear Thermometer Device Name:

- The Infared Ear Thermometer is a non-sterile, reusable Indications for Use: clinical thermometer intended for the determination of human temperature by radiation emitted via the ear (tympanic temperature).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRS, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

**Over-The-Counter Use**
(Optional Format 1.2.96)

(Optional Format 1-2-96)

Palaccio Cucenti
(Division Sign-Off)

Division of Dental, Infection Contr and General Hospital I 510(k) Number

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