EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65

K042627 · Mesure Technology Co., Ltd. · FLL · Oct 18, 2004 · General Hospital

Device Facts

• Record ID: K042627
• Device Name: EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
• Applicant: Mesure Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Oct 18, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Handheld electronic ear thermometer; uses thermopile infrared sensor to detect auditory canal temperature; includes reference thermistor for comparison; signal processed by ASIC-controlled circuit; displays temperature on LCD; powered by 3.0V DC battery; includes low-battery detection; intended for home use by patients of all ages; provides digital temperature readout to assist in monitoring body temperature.

Clinical Evidence

Bench testing only. Verification performed according to ASTM E 1965-00, EN 60601-1, EN 60601-1-1, and EN 60601-1-2 standards.

Technological Characteristics

Thermopile infrared sensor; reference thermistor; ASIC-controlled circuit (hard-wired, non-programmable); 3.0V DC battery power; LCD display; buzzer; handheld form factor. Standards: ASTM E 1965-00, EN 60601-1, EN 60601-1-1, EN 60601-1-2.

Indications for Use

Indicated for measuring body temperature via the auditory canal in patients of all ages in a home-use setting.

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

• Ear Thermometer Model ST613C & ST613F (K011254)

Submission Summary (Full Text)

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

## 510(K) SUMMARY

K042427

This summary of 510(k) safety and effectiveness information is being submitted in accordance rrills Sunnifiery of OTO(1) and Should 21.CER 807.92, and the relevant 510(K) submission quidance.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ Submitter's Identifications: Company: Mesure Technology Co., Ltd. Address: 7F, No. 86, Sec. 1, KwangFu Road, Sanchung City, Taipei Hsien, Taiwan, R.O.C. Contact person: John Chen / Ph. D.

- 1. Name of the Device: Ear Thermometer / Models ST61, ST62, ST63, ST64 and ST65
- Information of the 510(k) Cleared Device (Predicate Device): 2. Ear Thermometer Model ST613C & ST613F.(K011254)

#### 3. Device Description:

The Mesure ear thermometer, models ST61, ST62, ST63, ST64, and ST64, are the handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile 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 ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared.

This system uses a 3.0 V 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 ST61, ST62, ST63,ST64 and ST65, they were designed and verified according to the US standard ASTM E 1965-00.

- 4. Intended Use:
The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.

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

Since the new models ST61, ST62, ST63, ST64 and ST65 were developed from the cleared device ST613C and ST613F through the design control procedures of Measure Technology Co., Ltd. with only the small change in dimension, device housing, and some non-performance and safety related features, the new device is substantial equivalence to that of device being modified, ST613C and ST613F

- 6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1965: 2000, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.

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

K002227

## 7 Conclusions

The Mesure ear thermometer, models ST61, ST62, ST63, ST63, ST64, and ST65 Hic wesdre our themnomerer the hechnological characteristics as the cleared device of Nave the Same intended ass and 1013F. Moreover, verification and validation tests Mcasure o mousl of this submission demonstrate that the difference in the submitted demonstrate oontainou in 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.

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

Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines that resemble a bird in flight or a flowing design. The emblem is black, and the text is also in black, set against a white background.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2004

Dr. John Chen General Manager Mesure Technology Company Limited 7f, 86, Sec.1, Kwang Fu Road San Chung City, CHINA (TAIWAN) 241

Re: K042627

K042027
Trade/Device Name: Ear Thermometer, Models ST61, ST62, ST63, ST64 and ST65 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 25, 2004 Received: September 27, 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 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 the read 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 var 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.

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

#### Page 2 - Dr. Chen

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that I Dr o leasination that your device complies with other requirements incall that I DA nas made a decessand regulations administered by other Federal agencies. of the Act of ally I oderal barates are systements, including, but not limited to: registration 1 ou must comply with an the Hooding (21 CFR Part 801); good manufacturing practice and and ilsung (21 CF RT at 807), lacelity systems (QS) regulation (21 CFR Part 820); and if requirences as set form in the quality sion 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) This reter will as w J The FDA finding of substantial equivalence of your device to a premarket notified.com - 11 veryice 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), 11 you deems 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 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,

Susan Runner

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}------------------------------------------------

K042627

# Indications For Use

510(k) Number (if known):

Device Name: Ear Thermometer, Models ST61, ST62, ST63, ST64 and ST65..

Indications For Use:

The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification, by mouning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.

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)

Aina Vmx

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental D

Page 1 of _ 1

510(k) Number:_