THERMOFINDER; THERMOCARE

K130361 · Hubdic Co., Ltd. · FLL · Apr 2, 2013 · General Hospital

Device Facts

• Record ID: K130361
• Device Name: THERMOFINDER; THERMOCARE
• Applicant: Hubdic Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Apr 2, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Non-Contact Infrared Thermometer is intended for measurement and monitoring of human body temperature.

Device Story

Non-contact infrared thermometer uses thermopile sensor to detect natural thermal radiation from forehead; device calculates body temperature by factoring in ambient room temperature; output displayed on LCD; intended for home or clinical use by patients or healthcare providers; provides non-invasive temperature monitoring; aids in clinical decision-making regarding fever management.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics to the predicate device and adherence to safety standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, and ISO 14971.

Technological Characteristics

Infrared thermopile sensor; measurement range 34.0°C–42.5°C (body); accuracy ±0.2°C–0.3°C; measurement time <2 seconds; LCD display; battery-powered (2x AAA); weight 120g. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, and ISO 14971.

Indications for Use

Indicated for measurement and monitoring of human body temperature in all patient populations for over-the-counter 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

• Infrared Forehead Thermometer, FS-300&301 (K101912)

Submission Summary (Full Text)

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113-0361

#### 510(k) Summary 5.

#### 2 2013 APR

A. Submission date: 01/21/2013

#### B. Applicant:

- Company name: HuBDIC Co., Ltd
- Address: B-301, Taekwang-industrial Building, 191-1, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do, Korea, 430-815.
- TEL: [phone]
- FAX: [phone]
- EMAIL : [e-mail]

#### B. Contact Person

- Name: Matt Hansen
- Address: 504 Bluegrass Drive, Canonsburg, PA15317, USA
- Tel (US): 516 279 7207
- Tel (Korea): [phone]
- E-mail: [e-mail]

#### C. Proprietary and Established Names

- · Common Name: Non-Contact Infrared Thermometer
- Classification Name: Clinical Electronic Thermometer
- Trade Names: 1. Thermofinder
- 2. Thermocare
- Establishment Registration Number: 3008729744
- Product Code and Classification Panel: FLL, 21 CFR 880.2910
- Regulatory Classification: Class II

D. Predicate device: The Infrared Forehead Thermometer, FS-300&301 (K101912)

### E. Intended use

The Non-Contact Infrared Thermometer is intended for measurement and monitoring of human body temperature.

#### F. Device Description

The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature. Its operation is based on measuring the natural thermal radiation from the forehead and the adjacent surforms a calculation that factors in room temperature, and then a calculated temperature is displayed on the LCD.

#### G. Technological Characteristics:

The Non-Contact Thermometer has the exact same technological characteristics as the predicate device. In fact, the predicate device is the same device with the same intended use, specifications, materials, etc. The only difference between the current device and its predicate is the 'Indication for Use', which will change from Rx to OTC. The specifications of the device are summarized below:

| Measurement method | Infrared measurement, Contactless measurement |
|--------------------|----------------------------------------------------|
| Measurement range | Object : 15.0°C ~ 60.0°C<br>Body : 34.0°C ~ 42.5°C |

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| | Only FS-301 Specifications<br>Humidity :20 ~ 90% RH |
|------------------|--------------------------------------------------------------------------------------------------------------------|
| Accuracy | Object : 15.0°C~60.0°C : ±2.0°C<br>Body : 34.0°C~35.9°C : ±0.3°C<br>36.0°C~39.0°C: ±0.2°C<br>39.1°C~42.5°C: ±0.3°C |
| | Only FS-301 Specifications<br>Humidity : 20% ~ 90% : ±10% |
| Display format | LCD display |
| Display unit | 0.1°C |
| Power idle mode | After 60 seconds |
| Measurement time | Less than 2 second |
| Battery | LR03(AAA) (2EA) at least 5,000 measurements |
| Weight | 120g (without holder and batteries) |

## H. Performance (Safety and Effectiveness Information)

The Non-Contact Infrared Thermometer has been manufactured and tested to meet the following safety and effectiveness requirements:

- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; -Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral -Standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004); Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004).
- IEC 60601-1-4: Medical Electrical Equipment Part 1-4: General Requirements for Safety ---Collateral Standard: Programmable Electrical Medical Systems, Edition 1.1.
- ISO 14971: Medical Devices Application of Risk Management to Medical Devices. .

### I. Conclusion:

Technically the device is exactly same as its predicate device (K101912). The 510(k) changes its indication from Prescription (Rx) use to Over-The-Counter (OTC) use.

The performance tests demonstrate that the Non-Contact Infrared Thermometer is as safe, as effective and performs in a substantially equivalent manner to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

Hubdic Company, Limited C/O Mr. David Yungvirt Responsible Third Party Official Pharmalink Technical Group, LLC 20 F Street, NW Washington, District of Columbia 20001 April 2, 2013

Re: K130361

Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 16, 2013 Received: March 19, 2013

Dear Mr. Yungvirt:

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. Yungvirt

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/CDRH0ffices/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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):_____________________________________________________________________________________________________________________________________________________

Device Name: Non-Contact Infrared Thermometer

Indications:

The Non-Contact Infrared Thermometer is intended for measurement and monitoring of human body temperature.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH. Office of Device Evaluation (ODE) Richard C. Chapman 2013.04.01 14:08:08 -04'00'

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

K130361 510(k) Number: