ECT DIGITAL THERMOMETER

K101043 · Changshan Estar Electronics Co., Ltd. · FLL · Jul 21, 2010 · General Hospital

Device Facts

• Record ID: K101043
• Device Name: ECT DIGITAL THERMOMETER
• Applicant: Changshan Estar Electronics Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jul 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

ECT digital thermometer is an electronic clinical thermometer which is intended to measure the human body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use on people of all ages.

Device Story

Digital thermometer for human body temperature measurement; utilizes thermistor sensor, reference resistor, ASIC, buzzer, and LCD. Operates via DC 1.5V battery; detects low battery condition. Used in clinical or home settings by patients or clinicians. Provides digital temperature readout; includes memory for last reading and automatic shut-off. Benefits patient by providing accurate, reusable temperature monitoring.

Clinical Evidence

Bench testing only. Device performance verified against ASTM E1112-00 (2006) for temperature range, accuracy, and repeatability. Biocompatibility confirmed via ISO 10993-5 (2009) and ISO 10993-10 (2002). Electrical safety verified per IEC 60601-1 (2005).

Technological Characteristics

Thermistor-based sensing; ASIC-based calculation; LCD display; buzzer alert. Materials: 316 stainless steel probe, ABS case. Power: 1.5V alkaline-magnesium button battery. Dimensions: 10x13x128 mm. Waterproof. Standards: ASTM E1112, IEC 60601-1, ISO 10993-5/10.

Indications for Use

Indicated for measuring human body temperature in regular mode via oral, rectal, or underarm routes. Suitable for clinical or home use on people of 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

• Omrom MC-245 (K091676)
• Basic Digital Thermometer, model DT-02 (K041694)

Submission Summary (Full Text)

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K101043

JUL 21 2010

# Changshan Estar Electronics Co., LTD

Xindu Industry Zone, Changshan County, Zhejiang Province, 324200, China Tel: [phone] Fax: [phone]

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date of summary was prepared: June 12, 2010

#### Device

Trade name: ECT digital thermometer

Common/Usual name: Digital thermometer

Classification name: Clinical electronic thermometer

Medical specialty (Panel): General Hospital

Regulation number: 880.2910

Product Code: FLL

Classification: Class II

#### Predicate devices

Omrom MC-245 (K091676), Omron Healthcare Incorporated

Basic Digital Thermometer, model DT-02 (K041694), Hangzhou Hua'an Medical & Health Instrument Co. Ltd.

### Indication for Use

ECT digital thermometer is an electronic clinical thermometer which is intended to measure the human body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use on people of all ages.

### Device description:

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

This thermometer uses a DC 1.5V battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays ' ▼' in LCD display.

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# Changshan Estar Electronics Co., LTD.

Xindu Industry Zone, Changshan County, Zhejiang Province, 324200, China Tel: [phone] Fax: [phone]

### Statement of substantial equivalence

The ECT digital thermometer is similar in design and intended use to the MC-245 and DT-02, differing only in physical dimensions, display resolution, battery replacement method. They use a thermistor to measure temperature and comprise 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.

While there are minor differences in performance specifications of the thermometers, these differences do not alter the intended use function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, ESTAR believes that the ECT digital thermometer is substantially equivalent to legally marketed devices currently in commercial distribution.

### Summary of Non-Clinical Testing

The ECT digital thermometer complied with the requirements of ASTM E1112-00 (2006) standard specifications, as well as IEC 60601-1(2005), ISO 10993-5(2009) and ISO 10993-10(2002) requirements. Bench testing confirmed the temperature range, accuracy, operating environment, storage environment, resolution, readability and repeatability. For all body contacting materials, analysis is made that the identical materials have been used in other legally marketed devices under the same use conditions.

#### Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Changshan Estar Electronics Co., Ltd. concludes that, ECT Digital thermometer is substantially equivalent to predicate devices as described herein.

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| | ECT digital thermometer | DT-02(K041694) | MC-245(K091676) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Intend use | To measure the human body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use people of all ages. | To measure the body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use on either oral, axillaries (under arm) | To measure the body temperature on either oral, axillaries (under arm) and rectal |
| Measurement method | Human temperature is detected by thermistor and calculated | | |
| Measurement area | Oral, rectum, underarm | | |
| Probe tip | Rigid | | |
| Measurement range | $90.0 ~ 109.9°F$<br>$32.0~42.9°C$ | $89.6 ~ 109.4°F$<br>$32.0 ~ 43.0°C$ | $89.6 ~ 107.6 °F$ ,<br>$32.0 ~ 42.0 C$ |
| Display resolution | $0.1°F/°C$ | $0.01°F/°C$ | 4 digits( $0.1°F/°C$ increments) |
| Accuracy | $\pm0.2 °F/\pm0.1 °C$ | $\pm0.05°C$ | $\pm0.2 °F/\pm0.1 °C$ |
| Over measurement range | Temp. $< 90 °F (32°C)$ display for low (too low)<br>Temp. > $109.9 °F (42.9°C)$ display for high (too high) | | |
| Response time | Approx. 1 min (oral)<br>Approx. 3 to 5 min (underarm)<br>Approx. 1 min (rectal) | Approx. 1 min. (oral)<br>Approx. 100 sec. (underarm)<br>Approx. 1 min (rectal) | Approx. 80 sec (oral)<br>Approx. 2 min (underarm)<br>Approx. 1 min (rectal) |

The SE comparison of the ECT digital thermometer. DT-02 (K041694) and MC-245 (K021676)

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| (Continuous) | | The SE comparison of the ECT digital thermometer, DT-02 (K041694) and MC-245 (K091676) | |
|-----------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| | ECT digital thermometer | DT-02(K041694) | MC-245(K091676) |
| Display | Reading value is displayed on LCD<br>with 3 1/2 digits (0.1 increments) | Reading value is displayed on<br>LCD with 4 digits (0.01<br>increments) | Reading value is displayed on LCD<br>with 4 digits (0.1 increments) |
| LCD Dimension | 33 x 23 mm | 15.5 x 6.5 mm | |
| Beep | When thermometer turn on and<br>after completion of measurement | Beeper sound at peak temperature | I beep when power on<br>3 beeps after measurement<br>completed |
| Power source | Alkaline-Magnesium button battery, DC 1.5V/1.55V(LR41) | | |
| Power consumption | 0.15 mW | | 0.1 mW |
| Battery life | Approx. 1 year( using time: 10<br>min/day | Approx. 200 h for continuous<br>operation | Approx. 5,000 readings (if used<br>minutes per day) |
| Weight (with battery) | Approx 1/3 oz(10.5g) | Approx 1/3 oz(10.5g) | Approx 1/3 oz(11g) |
| Dimension | 10(H) x 13(W) x 128 (L) mm | 10(H) x 18(W) x 127(L) mm | 19.4(W) x 132.5 (L) x 10.0 (D) mm |
| Operating environment | | | |
| Temperature | 41~104 °F (5 ~ 40 °C) | 41 ~ 113 °F (5 ~ 45 °C) | 50~104 °F(10~40 °C) |
| Relative humidity | 15 ~ 95% | < 80 % | 35 ~ 85% |
| Storage environment | | | |
| Temperature | - 14 ~ 128 °F (- 10 ~ 60 °C) | 77~131 °F (25~55 °C) | 4~140°F(-20~60°C) |
| Relative humidity | ≤ 85 % | < 80 % | 10 ~ 95% |

and the contraction of the comments of the comments of

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| (Continuous) | The SE comparison of the ECT digital thermometer, DT-02 (K041694) and MC-245 (K091676) | | |
|--------------------|----------------------------------------------------------------------------------------|----------------|-----------------------------------------------------------------|
| | ECT digital thermometer | DT-02(K041694) | MC-245(K091676) |
| Automatic shut-off | YES/ After about 10 min | | Approx. 30 minutes after use or 3<br>minutes when not been used |
| Memory | Recalls last temperature | | |
| Waterproof | YES | | |
| Materials | Probe: 316 S.S., Case: ABS | | |
| Clean | By 70% isopropyl alcohol or soap<br>and water | | |
| Performance tested | ASTM E1112<br>IEC 60601-1<br>ISO 10993-5 /<br>ISO 10993-10 | | |

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End of summary

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jacob Chang Changshan Estar Electronics Company, Limited #462, Sec 2, Chongde Road, Beitun District Taichung China (Taiwan) 406

JUL 21 2010

Re: K101043

Trade/Device Name: ECT Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 23, 2010 Received: June 23, 2010

Dear Mr. Chang:

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 ffor 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Chang

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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

510(k) Number (if known): K101043

Device Name: ECT digital thermometer

Indications for Use:

ECT digital thermometer is an electronic clinical thermometer which is intended to measure the human body temperature in regular mode orally, rectally or underarm. The device is reusable for clinical or home use on people of all ages.

Prescription Use Over-The-Counter Use X (Part 21 CFR 801 Subpart D) AND/OR (Part 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)

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

510(k) Number: 1( 1(

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