5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.

K050303 · Mesure Technology Co., Ltd. · FLL · Feb 25, 2005 · General Hospital

Device Facts

• Record ID: K050303
• Device Name: 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.
• Applicant: Mesure Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Feb 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device measures the body temperature of a patient by means of a sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axially or rectal temperature measurements for home use on people of all ages.

Device Story

Electronic digital thermometer; uses thermistor sensor to detect body temperature; signal processed by ASIC (Application Specific IC) circuit; displays temperature on LCD. Powered by 1.5V DC battery; includes low-battery detection. Designed for home use by patients of all ages; oral, axillary, or rectal application. Provides rapid temperature reading; aids in monitoring patient health status.

Clinical Evidence

Bench testing only. Device verified against ASTM E1112-00 standard for clinical thermometers and EN 60601-1, EN 60601-1-1, and EN 60601-1-2 safety and electromagnetic compatibility standards.

Technological Characteristics

Thermistor-based temperature sensing; ASIC-controlled signal processing; 1.5V DC battery power; LCD display; buzzer for audible feedback. Complies with ASTM E1112-00, EN 60601-1, EN 60601-1-1, and EN 60601-1-2. Hard-wired control circuit (non-programmable).

Indications for Use

Indicated for oral, axillary, or rectal body temperature measurement in patients of all ages. Intended for home 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

• Thermometer, model ST8631 (K021048)
• 10-second Digital Thermometer, model ST87, ST89, ST80, and ST8B (K040156)

Submission Summary (Full Text)

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#### 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, and the relevant 510(k) submission ouidance.

The assigned 510(k) number is: ಗಡಿಸಿ 0 3ರ 3 Submitter's Identifications: Company: Mesure Technology Co., Ltd. Address: 7F, No. 88, Sec. 1, KwangFu Road, Sanchung City, Taipei Hsien, Taiwan, R.O.C. Contact person: John Chen / Ph. D.

- 1. Name of the Device: 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X and ST8B30X/ST8B40X.
- 2. Information of the 510(k) Cleared Device (Predicate Device): , Thermometer, model ST8631 (K021048) and 10-second Digital Thermometer, model ST87, ST89, ST80, and ST8B (K040156).

## 3. Device Description:

The 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X, 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 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X and ST8B30X/ST8B40X it was designed and verified according to the US standard ASTM E 1112-00.

### 4. Intended Use:

The device measures the body temperature of a patient by means of a sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axially or rectal temperature measurements for home use on people of all ages.

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

Since the new models 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X were developed from the cleared device ST8631 through the design control procedures of Measure Technology Co., Ltd. with only the small change in sensor wire material and wiring construction so as to shorten the measuring time, the new device is substantial equivalence to that of device being modified, ST8631(K021048) and 10-second Digital Thermometer, model ST87, ST89, ST89, and ST8B.(K040156).

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Mesure Technology Co., Ltd.

- 6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1112: 2000, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.

# 7 Conclusions

The Mesure 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X have the same intended use and technological characteristics as the cleared device of Measure's model ST8631. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate 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 ST8631 (K021048) and 10-second Digital Thermometer, model ST87, ST89, ST80, and ST8B (K040156).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2005

Mr. John Chen Mesure Technology Company Limited 7F, No. 86/88 Sec 1, Kwang Fu Road Sanchung City, Taipei Hsien, TAIWAN

Re: K050303 Trade/Device Name: 5 Sec Digital Clinical Thermometer / Models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST840X, and ST8B30X/ST8B40X. Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 5, 2005 Received: February 8, 2005

Dear Mr. 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 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 vour 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. 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 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 vour 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/industry/support/index.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

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# Indications For Use

14050303 510(k) Number (if known):

# Device Name: 5 Sec Digital Clinical Thermometer / Models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X.

Indications For Use:

The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital 1.CD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (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)

Cim

Seneral Hospital.

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