INFRARED EAR THEROMETER

K111703 · Fudakang Industrial Co., Ltd. · FLL · Mar 29, 2012 · General Hospital

Device Facts

• Record ID: K111703
• Device Name: INFRARED EAR THEROMETER
• Applicant: Fudakang Industrial Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Mar 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Infrared Thermometer (FT-F11) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population. Infrared Thermometer, (FT-F21, FT-F31, FT-F41) is intended for intermittent measurement of human body temperature in people of all ages.

Device Story

Infrared thermometers (FT-F11, FT-F21, FT-F31, FT-F41) measure human body temperature via infrared sensor. FT-F11 targets auditory canal; others for general intermittent measurement. Operation: single-key scan; automatic display of last measurement upon power-on. Used in clinical or home settings by patients or clinicians. Provides rapid, accurate temperature readings on LCD. Benefits: non-invasive, quick, easy-to-clean, memory function for tracking. Powered by AAA batteries (or CR2032 for some models).

Clinical Evidence

Clinical and bench testing performed. Bench testing validated against EN 60601-1:2006, EN 60601-1-2:2007, and EN 12470-5:2003. Clinical accuracy validated against ASTM E 1965 standard. Results support substantial equivalence to predicate devices.

Technological Characteristics

Infrared sensor-based electronic clinical thermometer. LCD display. Single-key operation. Powered by 1.5V AAA batteries (or CR2032). Measurement range 34-43°C (FT-F11/F21/F31/F41). Standards: EN 60601-1, EN 60601-1-2, EN 12470-5, ASTM E 1965.

Indications for Use

Indicated for intermittent human body temperature measurement in all ages (neonatal, pediatric, adult). FT-F11 specifically for auditory canal; FT-F21, FT-F31, FT-F41 for general use. No specific contraindications listed.

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

• Infrared Ear Thermometer (InnoTherm ICT-100, InnoTherm ICT-200) (K081788)
• THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301 (K101912)

Submission Summary (Full Text)

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## K11703

MAR 2 9 2012

## 510(K) SUMMAKY

[as required by 807.92(c)]

- 1. Identification of the Device:
-Proprietary-Trade Name: Infrared Thermometer (FT-F11, FT-F21, FT-F31, FT-F41)" / Fudakang Industrial Co., Ltd. -Classification Name thermometer, electronic, clinical, Product Code: FLL,

-Common/Usual Name: Clinical Electronic Thermometer / Infrared Ear Thermometer

- 2. Equivalent legally marketed device:
This product is similar in design and identical in function to the K081788 / INFARED EAR THERMOMETER, MODEL: InnoTherm ICT-100 / INNOCHIPS TECHNOLOGY Co., Ltd. and THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301(K101912) / HUBDIC CO., LTD

- 3. Indications for Use (intended use):
Infrared Thermometer (FT-F11) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.

Infrared Thermometer, (FT-F21, FT-F31, FT-F41) is intended for intermittent measurement of human body temperature in people of all ages.

- 4. Description of the device:
This infrared Ear Thermometer measure the temperature. It's from the ear canal which can be got more quickly and accurate the human body temperature.

This product has the following advantages:

- 1). Easy to Clean& Probe cover Free.
- 2). High speed & Accuracy scan the reading of temperature.
- 3). Conveniency, Only one key operation.

4). Automatic display last memorized measuring temperature. When do you turn on the power.

- 5. Safety and Effectiveness, comparison to predicate device:

| Infrared Ear Thermometer<br>(InnoTherm ICT-100,<br>InnoTherm ICT-200)<br>(K081788) | THE INFRARED<br>FOREHEAD<br>THERMOMETER,<br>MODEL FS- | Infrared Thermometer<br>(FT-F11, FT-F21, FT-F31,<br>FT-F41) |
|------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------|
|------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------|

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| | | 300&301(K101912) | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The device is an electronic<br>clinical thermometer using<br>an infrared sensor to detect<br>body temperature from the<br>auditory canal in the<br>neonatal, pediatric and<br>adult population. | The Infrared<br>Forehead<br>Thermometer, FS-<br>300&301 is intended<br>for intermittent<br>measurement of<br>human body<br>temperature in<br>people of all ages. | Infrared Thermometer (FT-<br>F11) is intended for an<br>electronic clinical<br>thermometer using an<br>infrared sensor to detect<br>body temperature from the<br>auditory canal in the<br>neonatal, pediatric and<br>adult population.<br><br>Infrared Thermometer,<br>(FT-F21, FT-F31, FT-F41)<br>is intended for intermittent<br>measurement of human<br>body temperature in<br>people of all ages. |
| | | | |
| Measurement<br>temp range | 32.0 ~ 43.0 °C<br>(89.6 ~ 109.4°F) | 34 ~ 42.5°C | 34°C - 43°C |
| Ambient range | 16.0 ~ 40.0°C<br>(93.2 ~ 108°F) | 15 ~ 40°C | 10.0°C-40.0°C |
| Storage range | -10 ~ 41°C<br>(14 ~ 105.8°F) | -20 ~ 50°C | -25.0°C-55.0°C |
| Display type | LCD | LCD | LCD |
| Activation | Scan button | Scan button | Scan button |
| Battery type | CR2032 * 1 pcs | Two 1.5V AAA type<br>batteries | Two 1.5V AAA type<br>batteries |
| Classification | thermometer, electronic,<br>clinical (Class II), 21 CFR<br>880.2910 | thermometer,<br>electronic, clinical<br>(Class II), 21 | thermometer, electronic,<br>clinical (Class II), 21 CFR<br>880.2910 |

- 6. Testing information and Conclusion
In all material respects, the "Infrared Thermometer (FT-F11, FT-F21, FT-F31, FT-F41)" is substantially equivalent to Infrared Ear Thermometer (InnoTherm ICT-100, InnoTherm ICT-200) (K081788) INNOCHIPS TECHNOLOGY Co., Ltd. and THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301(K101912) / HUBDIC CO., LTD. Testing was performed according to 'Harmonized Standard'. Test results support the conclusion that actual device performance satisfies the design intent.

- Contact person

NO.8 Yinhe Road ,Yuanjiangyuan Management one, Changping Town, Dongguan Guangdong, China. Tel: [phone] Fax: [phone] Contact person: Bob Yu / President

- Date Prepared: April 2011

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- Non-Clinical and Clinical Tests Performed for Determination of Substantial Equivalence:

The safe and effective performance of the device has been non-clinically and clinically established through comparative testing with market-cleared devices. Infrared Thermometer (FT-F11, FT-F21, FT-F21, FT-F41) safety has been checked and validated by CHINA CEPREI (SICHUAN) LABORATORY. The clinical and bench tests* demonstrated its accuracy and effectiveness.

- Non clinical EN 60601-1:2006 on 26th July 2010 EN 60601-1-2:2007 on 21st July 2010 EN 12470-5:2003 on 27th July 2010 - Clinical ASTM E 1965 on 19th Sep 2010

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Fudakang Industrial Company Limited C/O Mr. Daniel Nam General Manager PATS Corporation 205 South Broadway, Suite 718 Los Angeles, California 90012

MAR 2 9 2012

Re: K111703

Trade/Device Name: Infrared Thermometer (FT-F11, FT-F21, FT-F31, FT-F41) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 15, 2012 Received: March 21, 2012

Dear Mr. Nam:

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. 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. Nam

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

> 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

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## Indications for Use

510(k) Number (if known):

Device Name: Infrared Thermometer (FT-F11, FT-F21, FT-F31, FT-F41)

Indications for use: Infrared Thermometer (FT-F11) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.

> Infrared Thermometer, (FT-F21, FT-F31, FT-F41) is intended for intermittent measurement of human body temperature in people of all ages.

Federal law restricts this device to sale on or by the order of a licensed practitioner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------(21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhi C. Chay 3/29/11

(Division Sign-Off)

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Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111703