DIGITAL TEMPERATURE MONITOR; MODEL KY-01

K030219 · Kang Ying Medical Appliances, Inc. · FLL · Aug 5, 2003 · General Hospital

Device Facts

• Record ID: K030219
• Device Name: DIGITAL TEMPERATURE MONITOR; MODEL KY-01
• Applicant: Kang Ying Medical Appliances, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Aug 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Digital temperature monitor, model KY-01 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for abdominal temperature measurement of a body less then eight ages old, and the measurement of oral, armpit and rectal temperature for all ages.

Device Story

Digital temperature monitor (model KY-01) uses thermistor sensor to measure human body temperature. Device comprises thermistor, reference resistor, buzzer, ASIC-controlled circuit, and LCD. Powered by 1.5V DC battery; ASIC detects low battery and displays warning. Device is reusable; intended for abdominal (patients <8 years), oral, armpit, and rectal use. Operated by user to obtain digital temperature reading for clinical decision-making.

Clinical Evidence

Bench testing only. Device verified for performance according to ASTM E1112-98 standard. Compliance with EN 60601-1, EN 60601-1-1, and EN 60601-1-2 safety standards confirmed.

Technological Characteristics

Thermistor-based temperature sensor; ASIC-controlled hard-wired circuit (non-programmable); LCD display; buzzer; 1.5V DC battery power. Standards: ASTM E1112-98, EN 60601-1, EN 60601-1-1, EN 60601-1-2.

Indications for Use

Indicated for human body temperature measurement. Abdominal measurement for patients <8 years old; oral, armpit, and rectal measurement 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

• Wireless thermometer monitor; model RT-910I (K003326)

Submission Summary (Full Text)

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#### Kang Ying Medical Appliances Inc. AUG - 5 2003

### 510(K) SUMMARY

ATTACHMENT >

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92.

The assigned 510(k) number is: __ K030219 Submitter's Identifications: Kang Ying Medical Appliances Inc. No. 44, Laen 1, Gangyan Rd., Gangshan Jen, Kaohsiung County, Taiwan, 820, R.O.C.

Contact: Mr. Ching-Chu, Chen / QA Manager Date of Summary Preparation: May 6, 2003

- 1. Name of the Device: Digital temperature monitor, model KY-01.
- 2. Information of the 510(k) Cleared Device (Predicate Device): Wireless thermometer monitor; model RT-910I (K003326).
- 3. Device Description:

The Digital temperature monitor, model KY-01, are the electronic thermometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control.

From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.

This system uses a 1.5V DC battery for operation of complete system whenever the battery is low. the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of KY-01, it was designed and verified according to the US standard ASTM E1112-98.

- 4. Intended Use:
The Digital temperature monitor, model KY-01 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for abdominal temperature measurement of a body less then eight ages old, and the measurement of oral, armpit and rectal temperature for all ages.

- 5. Comparison to the 510(k) Cleared Device (Predicate Device): The Digital temperature monitor, model KY-01 is substantially equivalent to the Funai model RT-9101 (K003326).
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: ଚ. Compliance to applicable voluntary standards includes ASTM E1112: 1998, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.
- 7. Conclusions

The Kang Ying digital temperature monitor, model KY-01, has the same intended use and technological characteristics as the cleared device of Funai model RT-9101. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2003

Mr. Chen Ching-Chu Quality Assurance Manager Kang Ying Enterprise, Incorporated No. 25, Tai-I 1 Street Jen-Te Hsiang, Tainan County TAIWAN, R.O.C

Re: K030219

Trade/Device Name: Digital Temperature Monitor/Model: KY-01 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 24, 2003 Received: July 24, 2003

Dear Mr. Ching-Chu:

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.

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 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.

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Page 2 - Mr. Ching-Chu

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); 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runser

Susan Runner, DDDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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**ATTACHMENT** /

# Indications for Use Statement

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510(k) Number (if known):_K030219

Device Name: Digital temperature monitor / Model: KY-01

### Indications For Use :

The Digital temperature monitor, model KY-01 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for abdominal temperature measurement of a body less then eight ages old, and the measurement of oral, armpit and rectal temperature for all ages.

Patricia Cuccente

ision Sian-Off ion of Anesthesiology, General Hospital. tion Control. Dental Devices

510(k) Number: K030219

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

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