INFRARED EAR THERMOMETER, MODEL DX-707

K013876 · Jawon Medical Co., Ltd. · FLL · Mar 4, 2002 · General Hospital

Device Facts

• Record ID: K013876
• Device Name: INFRARED EAR THERMOMETER, MODEL DX-707
• Applicant: Jawon Medical Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Mar 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The DX-707 Infrared Ear Thermometer is intended for the intermittent measurement of human body temperature in home care environment. It is intended for use on people of all ages.

Device Story

Hand-held, reusable tympanic thermometer; measures natural thermal radiation from tympanic membrane and auditory canal. Components: IR sensor, Micom IC, LCD module, ambient thermistor, and user interface keys. Powered by internal 3V CR2032 battery. Used in home care environments by patients or caregivers. Device captures infrared signals, processes via internal circuitry, and displays temperature reading on LCD. Provides non-invasive temperature monitoring to assist in health assessment.

Clinical Evidence

Clinical study conducted across four age groups (0-3, 4-10, 11-65, >65 years) with ~39% febrile participants. Comparison study demonstrated equivalent performance to predicate devices. Clinical repeatability was statistically and clinically acceptable. Bench testing confirmed compliance with IEC60601-1, IEC60601-1-2, and ASTM E1965-98 standards.

Technological Characteristics

Hand-held infrared radiation thermometer. Components: IR sensor, Micom IC, LCD, thermistor. Power: 3V CR2032 battery. Standards: ASTM E1965-98, IEC60601-1, IEC60601-1-2. Non-sterile, reusable.

Indications for Use

Indicated for intermittent human body temperature measurement in home care settings for all ages.

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

• Braun ThermoScan® Instant Thermometer (K983295)
• Microlife Digital Infrared Ear Thermometer (K000969)

Submission Summary (Full Text)

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K013876

510(k) Submission

4 2002 MAR

Instant Infrared Thermoscanner, DX-707

SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information in accordance with the requirements
Of SMDA 1990 and 21 CFR 807.92

### Infrared Ear Thermometer, Model DX-707

#### 1. SUBMITTER'S IDENTIFICATION

| Submitter's Name: | Jawon Medical Co., Ltd. |
|----------------------|-------------------------------------------------------------------------------|
| Submitter's Address: | 7F Jeong Ju Bldg., 1451-38 Seocho-Dong,<br>Seocho-Ku, Seoul, Korea |
| Contact Person: | Won-Hee Park/President<br>TEL: [phone] / FAX: [phone] |

#### DEVICE DENTIFICATION 2.

| Trade/Proprietary Name: | Infrared Ear Thermometer, Model DX-707 |
|-------------------------|--------------------------------------------------|
| Common Name: | Radiation Thermometer (Tympanic Thermometer) |
| Classification Name: | Clinical Electronic Thermometer, Class II, 80FLL |

#### INFORMATION OF 510(K) CLEARED DEVICES (PREDICATE DEVICES): 3.

- Braun ThermoScan® Instant Thermometer, K# 983295, Braun ThermoScan (Models IRT . 3020/3520)
- Microlife Digital Infrared Ear Thermometer, K# 000969, model IRIDA1, Microlife . Corporation, 9f, 431 Rui Guang Road, Nei Hu, Taipei 114, Taiwan, Republic of China.

#### DEVICE DESCRIPTION: 4.

The DX-707 Infrared Ear Thermometer is a hand-held, non-sterile, reusable clinical thermometer using an infrared sensor that measures patient body temperature through the opening of the auditory canal. Its operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.

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The DX-707 Infrared Ear Thermometer consists mainly of five parts with the

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associated circuit: (1) IR sensor, (2) Micom IC, (3) LCD module, (4) an ambient temperature sensor (thermistor), and (5) Keys, "I/O", "Measure". The DX-707 thermometer is powered by internal DC 3V battery, size CR2032 and it is supplied with probe cover.

#### INTENDED USES: ર.

The DX-707 Infrared Ear Thermometer is intended for the intermittent measurement of human body temperature in home care environment. It is intended for use on people of all ages.

#### STATEMENT OF TECHNOLOGICAL CHARACTERISTICS: 6.

The DX-707 Infrared Ear Thermometer and the predicate devices have the same general design, incorporate similar technology.

The primary function of the DX-707 Infrared Ear Thermometer is the same as the predicate devices. The device is to be used for the measurement of body temperature. The DX-707 raise no new questions of safety and effectiveness.

Jawon Medical Co., Ltd., concludes that the DX-707 Infrared Ear Thermometer is the substantially equivalent to the predicate devices.

#### PERFORMANCE SUMMARY 7.

The DX-707 Infrared Ear Thermometer has been tested and has proven to function in an equivalent manner as the predicate devices. Based on the results of the bench testing the DX-707 Infrared Ear Thermometer is considered safe and effective when used as intended.

Compliance to applicable voluntary standards includes IEC60601-1 and IEC60601-1-2 requirements. In addition, this infrared thermometer meets the requirements established in ASTM Standard E1965-98, "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature". Full responsibility of the conformance of this product to the standard is assumed by Jawon Medical Co., Ltd.

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### Clinical Results

A comparison study and clinical repeatability testing was performed on the following four ages group; 0-3years, 4-10 years, 11-65 years, and >65 years. Approximately 39% of the patients participating in the study were considered febrile. The comparison study demonstrated that the DX-707 Infrared Ear Thermometer measured ear temperature equivalently to the predicate devices in all age groups. The clinical repeatability is statistically and clinically acceptable.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health, Service

Image /page/3/Picture/2 description: The image is a black and white circular logo. The logo features an abstract image of an eagle in the center. The words "HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2002 MAR

Jawon Medical Company Limited C/O Mr. John So Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-9526

Re: K013876

Trade/Device Name: Infrared Ear Thermometer, DX-707 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 18, 2002 Received: February 20, 2002

Dear Mr. So:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becases or child 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 mensiale conmisees prior to that have been reclassified in accordance with the provisions of Amendinents, of to devroos that nave ooch (Act) that do not require approval of a premarket the rederal I vou, Drug, and Commonsy, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include condors providents or 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 (I MA), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be foundsh further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Flease be advisod that I DTP is issualles on that your device complies with other requirements

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of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with a!l 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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
K. Whilton A

Tim A. Ulatowski Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Submission

(if known): 510(k) Number: Infrared Ear Thermometer, DX-707 Devicc Name:

Indication For Use:

The Infrared Ear Thermometer, Model DX-707 is intended for the intermittent measurement of human body temperature in home care environment. It is intended for use on people of all ages.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINU ON ANOTHER PAGE IF NEEDED)

Concurrent of CDRH, Office of Device Evaluation (ODE)

Palusta Cuccento

Sign-Off) of Dental, Infection Control, eral Hospi החבר

Prescription Use __ (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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