VALEO VT-601 SERIES IR THERMOMETER

K111463 · Valeo Corp. · FLL · Feb 17, 2012 · General Hospital

Device Facts

• Record ID: K111463
• Device Name: VALEO VT-601 SERIES IR THERMOMETER
• Applicant: Valeo Corp.
• Product Code: FLL · General Hospital
• Decision Date: Feb 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E, VT-601F) is infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages.

Device Story

Hand-held, battery-operated, non-sterile, reusable IR thermometer; measures natural thermal infrared radiation from temporal artery (forehead) or ear tympanic membrane. Models: VT-601D (forehead/ear), VT-601E (ear), VT-601F (forehead). Device uses internal chip IC (µP) and IR sensor to process thermal radiation; displays temperature on LCD. Used in clinical or home settings by patients or clinicians. Output provides body temperature reading to assist in clinical decision-making; benefits patient through non-invasive, rapid temperature monitoring.

Clinical Evidence

Clinical investigation report compared accuracy of Valeo VT-601 series against predicate devices following ASTM E1965:1998(2009) standards. Results supported substantial equivalence.

Technological Characteristics

Hand-held IR thermometer; components include microprocessor (chip IC), IR sensor, and LCD. Powered by two 1.5V AAA alkaline batteries. Dimensions/form factor: hand-held. Connectivity: none. Sterilization: non-sterile. Standards: ASTM E1965:1998(2009) for performance, IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC.

Indications for Use

Indicated for intermittent measurement of human body temperature in 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

• BRAUN Thermoscan IRT 3020 Thermometer (K983295)
• EXERGEN Temporal - Scanner (K011291)

Submission Summary (Full Text)

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K111463

### 510(K) SUMMARY

## FEB 1 7 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

#### Date of Preparation: Dec. 6, 2011

.

| 1. Submitter's Name: | VALEO Corporation |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 4F-3, No. 161, Sung-Teh Road Taipei, Taiwan 110 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | James Jean/ President<br>e-mail: [e-mail] , [e-mail] |
| 2. Device Name : | |
| Trade Name: | Valeo VT-601 Series IR Thermometer,<br>Model no.: VT-601D, VT-601E, VT-601F |
| Common Name: | IR Thermometer |
| Classification name | thermometer, electronic, clinical |
| 3. DEVICE CLASS | The Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E, VT-601F) has been classified as<br>Regulatory Class: II<br>Panel: 80<br>Product Code: FLL<br>Regulation Number: 21CFR 880.2910 |
| 4. Predicate Device: | The predicate devices are the<br>• BRAUN Thermoscan IRT 3020 Thermometer (K983295) marketed by BRAUN AG.&<br>• EXERGEN Temporal - Scanner (K011291) marketed by EXERGEN CORP. |
| 5. Intended Use: | The Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E, VT-601F) is infrared thermometers intended for the<br>intermittent measurement of human body temperature in people of all ages. |

Product:VT-601 Series IR Thermometer (Model no.: VT-601D , VT-601E , VT-601F ) Section 4 - 510(k) Summary Page 1 of 4 REV. 【B】

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#### 6. Device Description:

Equivalence Discussion

The Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D,

VT-601E . VT-601F) is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature.

The Valeo VT-601D IR Forehead/ Ear Thermometer can measure

human body temperature in 2 ways:

- (1) The temporal artery over forehead.
- (2) Tympanic temperature via the human ear.

The Valeo VT-601E IR Ear Thermometer measures human body temperature natural thermal infrared radiation emitted from the ear tympanic.

The Valeo VT-601F IR Forehead Thermometer measure human body temperature by the temporal artery over forehead.

Operation is based on the measuring of the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear tympanic.

The Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, 7. Comparison to 510(k) Predicate VT-601E, VT-601F) have the same intended use, principles of operation, and similar technological characteristics as predicate devices. Please find Devices & Substantial Technological Characteristics as follows

| | VT-601 Series IR<br>Thermometer | Predicate Device<br>BRAUN Thermoscan<br>IRT 3020<br>Thermometer<br>(K983295) | Predicate Device<br>EXERGEN Temporal<br>- Scanner<br>(K011291) |
|---------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------|
| Regulation<br>Number: | 21CFR 80.2910 | Item | 21CFR 880.2910 |
| Displayed<br>Temperature<br>Range | Ear: 32~43°C<br>Skin: 22 ~42.2°C<br>(Ear:<br>89.6~109.5°F<br>Skin:<br>71.6~107.9°F) | 34°C~42.2°C<br>(93.2°F~108°F) | 15.5°C~42°C |
| Ambient<br>Temperature<br>Environment | 1. Operating:<br>10°C~40°C<br>2. Storage:<br>-20°C~50°C | 1. Operating:<br>10°C~40°C<br>2. Storage:<br>-20°C~50°C | 1. Operating:<br>15.5°C~40°C<br>2. Storage:<br>-20°C~50°C |

Product:VT-601 Series IR Thermometer (Model no.: VT-601D , VT-601E , VT-601F ) Section 4 - 510(k) Summary REV. (B) Page 2 of 4

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| Accuracy | Ear: ±0.2°C,<br>36~39°C<br>±0.3°C, the rest<br>Skin: ±0.3°C,<br>22~40.0°C<br>(Ear: ±0.4°F,<br>96.8~102.2°F<br>±0.5°F, the rest<br>Skin: ±0.5°F,<br>71.6~104.0°F) | 1. 36.0°C(96.8 °F) to<br>39.0°C(102.2°F):<br>± 0.2°C (0.4°F)<br>2. Outside this<br>range:<br>± 0.3°C (0.5°F) | 36.0°C to 39.0°C:<br>± 0.2°C<br>Outside this range:<br>± 0.3 °C |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Resolution | 0.1°C / 0.1°F | 0.1°C / 0.1°F | 0.1°C |
| Display | 4 digits LCD | 3 and 1/2 digits LCD | 3 digits LCD |
| Components | Main<br>components:<br>1. Chip IC (µP)<br>2. IR Sensor<br>3. LCD(Liquid<br>Crystal<br>Display) | Main components:<br>1. Chip IC (µP)<br>2. IR Sensor<br>3. LCD(Liquid<br>Crystal<br>Display) | Main components:<br>1. Chip IC (µP)<br>2. IR Sensor<br>3. LCD(Liquid<br>Crystal<br>Display) |
| Power<br>requirements | Two 1.5Vdc<br>Alkaline<br>Manganese<br>battery (AAA) | Two 3V CR 2032<br>batteries | One Alkaline 9V<br>batteries |
| (Power<br>Consumption) | Standby mode:<br>14 miliwatts<br>Measurement<br>mode:<br>8 miliwatts | 1. Standby mode:<br>16.8 miliwatts<br>2. Measurement<br>mode:<br>12 miliwatts | 1. Standby mode:<br>112.68<br>miliwatts<br>2. Measurement<br>mode: 112.68<br>miliwatts |
| Voice<br>Function | With | No | No |

#### SUBSTANTIAL EQUIVALENCE DISCUSSION:

Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D , VT-601E , VT-601F) has the same general design with the predicate devices. It has the following similarities to the predicate devices in:

- · having the same intended use
- · using similar operating principle
- using similar technological characteristics

In summary, the Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D , VT-601E , VT-601F) described in this submission is substantially equivalent to the predicate devices.

Product:VT-601 Series IR Thermometer (Model no.: VT-601D , VT-601E , VT-601F ) Section 4 - 510(k) Summary Page 3 of 4

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- 8. Non-Clinical Discussion of Non-Clinical Tests Verification Activities Performed to Tests Verification Determine the Safety and Performance of Valeo VT-601 Series IR
Thermometer (Model no .: VT-601D, VT-601E, VT-601F ) is as the followings:

- 1) Performance Compliance Test is according to ASTM E1965: 1998(2009) conducted by manufacturer.
- 2) Electrical Safety Compliance Test is according to IEC 60601-1 by accredited laboratory.
- 3) EMC Compliance Test is according to IEC 60601-1-2 by accredited laboratory.
- Discussion of Clinical Test Validation Activities Performed to Determine the 9. Clinical Test for Effectiveness of Device is as the followings: Measurement Accuracy
- A Clinical Test Report conducted according to ASTM E 1965: 1998 (2009) performed by the manufacturer was included as Clinical Investigation report. This report was carried out in such a way that compared the accuracy performance between Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D , VT-601E , VT-601F ) and the predicate devices according to the method recommended in ASTM E1965 standard.

The results of the Clinical Test Report could positively support the claim of Substantial Equivalence for Valeo VT-601 Series IR Thermometer, ( Model no.: VT-601D , VT-601E , VT-601F ) against the chosen 510(k) predicate devices.

#### 10. Conclusions:

The Valeo VT-601 Series IR Thermometer (Model no.: VT-601D , VT-601E , VT-601F ) has the same intended use and similar technological characteristics as the BRAUN Thermoscan IRT 3020 Thermometer (K983295) marketed by BRAUN AG. & EXERGEN Temporal – Scanner (K011291) marketed by EXERGEN CORP. Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics DO NOT RAISE ANY NEW QUESTIONS OF SAFETY OR EFFECTIVENESS. Thus, the Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D , VT-601E , VT-601F ) is substantially equivalent to the predicate devices.

Product:VT-601 Series IR Thermometer (Model no.: VT-601D , VT-601E , VT-601F ) REV. 【B】 Page 4 of 4 Section 4 - 510(k) Summary

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three snakes intertwined around a staff. The seal is black and white.

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

VALEO Corporation C/O Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation 2904 N. Boldt Drive Flagstaff, Arizona 86001

FEB 1: 7 2012

Re: K111463

Trade/Device Name: Valeo VT-601 Series IR Thermometer, Model no.: VT-601D, VT-601E, VT-601F, VALEO Corporation Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 1, 2012 Received: February 6, 2012

Dear Ms. Reich: .

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 - Ms. Reich

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 Compilance ification" (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 I vision 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.

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): ____________________________________________________________________________________________________________________________________________________

Valeo VT-601 Series IR Thermometer, Device Name: Model no.: VT-601D , VT-601E , VT-601F VALEO Corporation

Indications for Use:

Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E, VT-601F) is infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

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

V 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)

Ald C. Chyn 2/17/12

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

510(k) Number: K111463

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