(267 days)
No
The description focuses on basic infrared temperature measurement and does not mention any AI or ML components.
No.
The device is an infrared thermometer intended for temperature measurement, which is a diagnostic function, not a therapeutic one. It does not provide any treatment or therapy.
No
Explanation: The device is an infrared thermometer for measuring body temperature. While temperature can be a symptom, the device itself only measures a physiological parameter and does not provide a diagnosis of a disease or condition. Its intended use is "intermittent measurement of human body temperature," not diagnosis.
No
The device description explicitly states it is a "hand-held, non-sterile, reusable, battery operated device" and measures temperature using infrared radiation, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Valeo VT-601 Series IR Thermometer measures human body temperature by detecting infrared radiation emitted from the skin or ear. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "intermittent measurement of human body temperature," which is a direct measurement of a physiological parameter, not an analysis of a biological sample.
Therefore, based on the provided information, the Valeo VT-601 Series IR Thermometer is a medical device, but it falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for 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.
Product codes
FLL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
temporal artery over forehead, human ear, ear tympanic
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of Valeo VT-601 Series IR Thermometer (Model no .: VT-601D, VT-601E, VT-601F ) is as the followings:
-
- Performance Compliance Test is according to ASTM E1965: 1998(2009) conducted by manufacturer.
-
- Electrical Safety Compliance Test is according to IEC 60601-1 by accredited laboratory.
-
- EMC Compliance Test is according to IEC 60601-1-2 by accredited laboratory.
Clinical Test Validation Activities Performed to Determine the 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.
0
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: | +886-2-23463113 |
| Fax: | +886-2-23463115 |
| Contact: | James Jean/ President |
| e-mail: valeo@valeo.com.tw , daisy@valeo.com.tw | |
| 2. Device Name : | |
| Trade Name: | Valeo VT-601 Series IR Thermometer, |
| 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 |
| Regulatory Class: II | |
| Panel: 80 | |
| Product Code: FLL | |
| Regulation Number: 21CFR 880.2910 | |
| 4. Predicate Device: | The predicate devices are the |
| • BRAUN Thermoscan IRT 3020 Thermometer (K983295) marketed by BRAUN AG.& | |
| • 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 |
| 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】
1
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
Thermometer | Predicate Device
BRAUN Thermoscan
IRT 3020
Thermometer
(K983295) | Predicate Device
EXERGEN Temporal
- Scanner
(K011291) |
|---------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------|
| Regulation
Number: | 21CFR 80.2910 | Item | 21CFR 880.2910 |
| Displayed
Temperature
Range | Ear: 3243°C107.9°F) | 34°C
Skin: 2242.2°C109.5°F
(Ear:
89.6
Skin:
71.642.2°C108°F) | 15.5°C
(93.2°F42°C |40°C
| Ambient
Temperature
Environment | 1. Operating:
10°C
- Storage:
-20°C50°C | 1. Operating:40°C
10°C - Storage:
-20°C50°C | 1. Operating:40°C
15.5°C - Storage:
-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
2
| Accuracy | Ear: ±0.2°C,
3639°C40.0°C
±0.3°C, the rest
Skin: ±0.3°C,
22
(Ear: ±0.4°F,
96.8102.2°F104.0°F) | 1. 36.0°C(96.8 °F) to
±0.5°F, the rest
Skin: ±0.5°F,
71.6
39.0°C(102.2°F):
± 0.2°C (0.4°F)
2. Outside this
range:
± 0.3°C (0.5°F) | 36.0°C to 39.0°C:
± 0.2°C
Outside this range:
± 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
components:
- Chip IC (µP)
- IR Sensor
- LCD(Liquid
Crystal
Display) | Main components: - Chip IC (µP)
- IR Sensor
- LCD(Liquid
Crystal
Display) | Main components: - Chip IC (µP)
- IR Sensor
- LCD(Liquid
Crystal
Display) |
| Power
requirements | Two 1.5Vdc
Alkaline
Manganese
battery (AAA) | Two 3V CR 2032
batteries | One Alkaline 9V
batteries |
| (Power
Consumption) | Standby mode:
14 miliwatts
Measurement
mode:
8 miliwatts | 1. Standby mode:
16.8 miliwatts - Measurement
mode:
12 miliwatts | 1. Standby mode:
112.68
miliwatts - Measurement
mode: 112.68
miliwatts |
| Voice
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
3
-
- 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:
- Non-Clinical Discussion of Non-Clinical Tests Verification Activities Performed to Tests Verification Determine the Safety and Performance of Valeo VT-601 Series IR
-
- Performance Compliance Test is according to ASTM E1965: 1998(2009) conducted by manufacturer.
-
- Electrical Safety Compliance Test is according to IEC 60601-1 by accredited laboratory.
-
- 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
4
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.
5
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 (800) 638-2041 or (301) 796-7100 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
6
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
Page 1 of 1