THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F

K023956 · Mesure Technology Co., Ltd. · FLL · Jun 17, 2004 · General Hospital

Device Facts

• Record ID: K023956
• Device Name: THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F
• Applicant: Mesure Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jun 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The wireless temperature monitor, model ST313C/F, ST314C/F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for wrist and abdomen temperature measurement of the baby less than eight years old, and the baby of eight years old.

Device Story

Wireless temperature monitor (models ST-314C/F, ST313C/F) measures human body temperature; utilizes thermistor sensor; signal processed by hard-wired ASIC circuit; displays temperature on LCD; includes buzzer for alerts; powered by 3.0V DC battery; features automatic low-battery detection. Device intended for use on children under eight years old; applied to wrist or abdomen. Provides digital temperature readout to caregivers; facilitates monitoring of body temperature. Reusable device.

Clinical Evidence

Clinical study compared measurement accuracy of ST313C against predicate RT-9101. Measurements taken at wrist and abdomen locations in children under eight years old following ASTM-E1965 methodology. Results confirmed suitability for intended use.

Technological Characteristics

Electronic thermometer using thermistor sensor; ASIC-controlled hard-wired circuit (non-programmable); LCD display; buzzer; 3.0V DC battery power. Designed/verified per ASTM E1112-98. Complies with EN 60601-1, EN 60601-1-1, and EN 60601-1-2.

Indications for Use

Indicated for measuring human body temperature in children aged eight years and younger via wrist or abdomen placement.

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-9101 (K003326)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(K) SUMMARY

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: (023956.

Submitter's Identifications: Mesure Technology Co., Ltd. 7F, No. 88, Sec. 1, KwangFu Road, Sanchung City, Taipei Hsien, Taiwan, R.O.C.

Contact: Ph. D. John, Chen / General Manager Date of Summary Preparation: June 6, 2003

1. Name of the Device: Wireless temperature monitor, model ST-314C/F, ST313C/F.

- 2. Information of the 510(k) Cleared Device (Predicate Device): Wireless thermometer monitor; model RT-9101 (K003326).
## 3. Device Description:

The Wireless temperature monitor, model ST-314C/F, 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 3.0V 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. Reqarding the performance of ST-314C/F, it was designed and verified according to the US standard ASTM E1112-98.

## 4. Intended Use:

The Wireless thermometer, model ST-314C/F, ST313C/F is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for abdomen and wrist/arm temperature measurement of a body less then eight ages old.

{1}------------------------------------------------

Mesure Technology Co., Ltd.

## 5. Comparison to the 510(k) Cleared Device (Predicate Device):

The Wireless thermometer, model ST-314C/F, ST313C/F is substantially equivalent to the Funai model RT-9101 (K003326).

- 6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: 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. Discussion of clinical report for measurement accuracy:

Clinical test for the comparison of measurement accuracy between ST313C and Funai model RT-9101 are included. The measurement was taken by both ST313C and RT-9101 at wrist and abdomen location for the children less than eight years old according to the method recommended in ASTM-E1965.

The result of clinical report indicates that ST313C is suitable for the indication of intended use.

- 8. Conclusions
The Mesure / Wireless thermometer, model ST-314C/F, ST313C/F, has the same intended use and technological characteristics as the cleared device of Funai model RT-910I. 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 enqineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo contains the symbol of the Department of Health & Human Services, which is an eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2004

Dr. John Chen General Manager Mesure Technology Company Limited 7F, 86, Sec. 1, KwangFu Road Sanchung City, Taipei Hsien, TAIWAN, R.O.C.

Re: K023956

Trade/Device Name: Wireless Temperature Monitor /Model: ST313C/F, ST314C/F Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 10, 2004 Received: May 17, 2004

Dear Dr. Chen:

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 Amerate ents, 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 approvisions 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 (1 Writ), it they of bude of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

{3}------------------------------------------------

#### Page 2 - Dr. Chen

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 moun mat 7 Dr mar and regulations administered by other Federal agencies. or the For ar any 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 alle listing (21 et read 807), systems (QS) regulation (21 CFR Part 820); and if requirements as bet renis 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) I ma reter notification. The FDA finding of substantial equivalence of your device to a promarter learn and a cassification for your device and the 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), 11 you desire specific at .. 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 may overn 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,

Chiu-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications For Use

510(k) Number (if known): K023956

Device Name: Wireless temperature monitor / Model: ST313C/F, ST314C/F.

Indications For Use:

The wireless temperature monitor, model ST313C/F, ST314C/F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for wrist and abdomen temperature measurement of the baby less than eight years old, and the baby of eight years old.

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use V (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

June Rerecce for Adwi 6/17/04

General Hospital. Infection Control, Der

510(k) Number:

Page 1 of 1___